Home

Isolette® Infant Incubator - Frank`s Hospital Workshop

1. setting X ar Temperature S37 C2 a Press the Up Arrow key to raise the set 35 6 temperature from 34 0 C 93 2 F to skin 1 Sa L 37 0 C 98 6 F in 0 1 increments In 35 6 36 6 oe 1 173 Temperature Override mode press the AR d cie ES gt 37 C key and press the Up Arrow E o 5 key to raise the set temperature from pare EO a 37 0 C 98 6 F to 38 0 C 100 4 F ID A 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 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 key is inoperative until the skin set temperature has been set to 37 0 C 98 6 F This Instructions for Use manual is published for public use and is only meant for your information 24 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 Skin Probe Atta
2. C2000e Colder Products Company fitting 83 615 90 Humidity system assembly 100V C2000 Colder Products Company fitting Drawers and Tank Holder 83 440 00 Swivel drawer assembly large C2000 only 83 441 00 Swivel drawer assembly small C2000 only 83 443 00 Oxygen tank bracket assembly Isolette 85 441 17 Tray assembly large Model C2000e only 85 441 46 Swivel drawer assembly small C2000e Model C2000e only This Instructions for Use manual is published for public use and is only meant for your information 12 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Part Number Description 85 441 52 Drawer housing assembly shallow short Model C2000e only 85 441 53 Drawer housing assembly shallow long Model C2000e only 85 441 56 Swivel drawer assembly large C2000e Model C2000e only 85 441 60 Drawer housing assembly deep short Model C2000e only 85 441 61 Drawer housing assembly deep long Model C2000e only Rail and Accessories Model C2000e only 85 442 00 Monitor shelf assembly high C2000e 85 442 14 Monitor shelf assembly low C2000e 85 444 00 I V pole assembly C2000e 85 460 02 I V resuscitator bag holder
3. 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 disposable 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 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 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 12 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instruct
4. on page 5 22 7 Make sure the unit is charged fully charged before the unit is ready for transport Recovery from Power Failure 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 UPS systems Ay 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 T
5. 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 is blanked 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 1s 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 lt 2 5 C High Skin Temperature 15 min N A This alarm occurs when the indicated displayed temperature differs from the set temperature by gt 1 0 C or 0 5 C user selectable This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 15 Alarm Procedural Alarm Message Silence Silence Description Low Skin Temperature N A N A This alarm occurs when the indicated displayed temper
6. 5 29 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Humidity Control Set Point 1 Activate the humidity system see Humidity Mode on page 5 29 ar Temperature ON NOTE Set A If no keys are pressed within 15 s of selecting the 35 6 Pa oF Humidity display the display automatically reverts to 35 6 35 6 TH FL Display 1 Ar Temp 2 Adjust the humidity set point 0 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 and 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 p
7. A WARNING Only connect equipment to the serial port that complies with the relevant IEC standard and use data cables with plastic body connectors 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 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 This Instructions for Use manual is published for public use and is only meant for your information 3 12 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Section 4 Installation and Operational Checkout Installation Refer to the Jsolette 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 Unpackage the hood shell assembly and stand assembly see Unpackaging on page 4 2 NOTE If the packaging and or unit is dam
8. Hinged mayo tray 13 5 2 2 kg 5 Ib Wx9 75D Hinged mayo tray 17 0 2 2 kg 5 Ib Wx11 5D Cable organizer 2 2 kg 5 Ib Horizontal cord wrap 2 2 kg 5 Ib Standard cam adapter 2 2 kg 5 Ib Ball action adapter 2 2 kg 5 Ib Double cam adapter 2 2 kg 5 Ib Cam adapter threaded 2 2 kg 5 Ib mount Utility hook assembly 2 2 kg 5 Ib This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 2 9 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 10 Non Rail Accessory Weight Limitations Feature Dimension Monitor shelf assembly 11 kg 25 Ib high C2000e Monitor shelf assembly 11 kg 25 Ib low C2000e I V pole assembly C2000e 5 kg 11 Ib Tray assembly large 17 6 kg 40 Ib Swivel drawer assembly large Tray 0 91 kg 2 Ib Drawer 4 5 kg 10 Ib Swivel drawer assembly small Tray 0 91 kg 2 Ib Drawer 2 2 kg 5 Ib Swivel drawer assembly small C2000e Tray 0 91 kg 2 Ib Drawer 2 2 kg 5 Ib bly shallow long Drawer housing assem 2 2 kg 5 Ib bly shallow short Drawer housing assem 2 2 kg 5 Ib Swivel drawer assembly large C2000e Tray 0 91 kg 2 Ib Drawer
9. 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 Ata 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 6 1 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 Dr ger 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 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 Environmental Protection Agency EPA such as Klee
10. 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 NOTE For US markets only use an intermediate level tuberculocidal cleaners disinfectant registered by the Environmental Protection Agency EPA such as Kleenaseptic amp 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 1 Kleenaseptic b is a registered trademark of Metrex Research Corporation This Instructions for Use manual is published for public use and is only meant for your information 6 4 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 fro
11. 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 606 1 and or IEC 1 1 harmonized national standard Personal injury or equipment damage could occur This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 3 3 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Oxygen Precautions A 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 A WARNING If the patient s arterial oxyge
12. 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 A 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 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 3 7 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 A WARNING When the access panels are open a curtain of warm air flows along the length of the mattress toward the top of the a
13. 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 s 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 Up Down Arrow 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 Display Selection key The Display Selection key enables the user to select between displays which are not accessible via softkeys Q vs x This Instructions for Use manual is published
14. Weight are described below Always weigh the infant in the center of the mattress with the mattress in its flat position Do not allow stuffed toys or other objects on the mattress to lean against the incubator walls or access panels Inaccurate readings can occur Do not allow the mattress cover to touch the incubator hood 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 IV tubes to ensure they do not touch the mattress 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 IV tubes sensor leads Initial Weigh 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 To perform the initial weighing function 1 If necessary unlock the keypad At Display 1 press the Display Selection key and select Display 2 2 3 At Display 2 press the Weight softkey 4 Press the gt 0 T lt or Zero softkey The Lift Baby Dol Pr Temperature Store indicator is displayed 35 6 Set m 5 Lift the infant off the mattress 35 6 35 6 rJ 6 When the Lift Baby indicator is removed pla
15. ace hp apos E uace va rdg episc qus 2 9 Regulations Standards and Codes 5 sss pr RE RR 2 11 Electromagnetic Compatibility EMC Guidance and Manufacturer Declarations 2 11 bnan IS upon P 2 14 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Section 3 Precautions and Safety Tips lg i PR LDMTMTM 3 1 Electrical Preca tionS iode iex Fate xv IRURE REC sete tient eesses EDDIE 3 1 Explosion Precautions oo ires dd du EO reste SR Ea hp S Rd q PR dI Od pd d i d Rache 3 2 EMC Precautions MAE r r 3 3 Oxygen Precautions 222254522 atest e DECR EQUES EY RES UR dbase Ka DK CET x Rer eR ES 3 4 Humidity Precautions 21 5 lt ciceousetavenshdetiessse ee PEERS ERa e APDQr g dex de Red 3 6 scu gil P Read mEE 3 7 Section 4 Installation and Operational Checkout Installatl9fi 1isssbavaderARReE EXREIENR REG dot Xsara haad o LEA RC d EAR M ATA A dd 4 1 locu cC AMO CPC TXPIC Occ rr 4 2 C2000 Stand Assembly s o d acero 10 ee CR ac OR opos de Rr Oc A c e ca edo 4 2 20006 Stand Assembly 525 sarei sa EAREG AT EEEAVEGATRERRAREPAREEAG A RE REN 4 2 Rail Assembly and Access
16. activated the rotating wheel is 25 displayed in the Oxygen window 20 Air Temp Oxygen S 5096 s 5 If the message Cal Required is displayed calibrate the oxygen control system see Oxygen Sensor Calibration on page 5 33 6 To deactivate the Oxygen mode press the OFF softkey This Instructions for Use manual is published for public use and is only meant for your information 5 28 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Oxygen Control Set Point To set the oxygen control set point in accordance with the attending physician recommendations 1 Activate the Oxygen mode see Oxygen Control on page 5 28 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 m
17. assembly in the hood Sensor Module Slide Lock assembly NOTE When the slide lock and 100 calibration fixture are properly installed the slide lock will move up and down smoothly 11 Select the 100 calibration level see System Configuration on page 5 22 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 4 11 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 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 injury or equipment damage f SHOCK HAZARD To ensure grounding reliability plug the AC power cord only into a properly grounded 3 wire hospital grade
18. been switched off for at least 45 minutes A WARNING Only facility authorized personnel should perform preventive maintenance or troubleshooting on the Isolette amp 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 amp Infant Incubator Models C2000 and C2000e safely dispose of the unit per local requirements Failure to do so could result in personal injury 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 3 11 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 IHA036
19. device is officially published for the use of that specific device 8 Select the required setting s using the Up Arrow and Down Arrow keys 9 Press the Alarm Silence Reset key to exit the Set Configuration menu Variable Height Adjustment 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 that 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
20. eh ohh Rr ERE rh bein mms Access Door Gaskets Tubing Iris Entry Port Sleeves Cuffs Air Intake Microfilter 4 6 i445 o RR ERROR sas Re OAS ERR A E Clenmnag Procedures 56e 4 qe bb asee shen we bertiPq4esbQbeeSQ AP bee wees Reusable Skin Temperature Probe duspesves sionem xx REM Axe Ries ae RR dS Access Door Gaskets and Tubing Access Ports lllllllel eee eee Controller Shell and Stand csse nh Sensor Module Hood and Inner Walls sese Heater Radiator and Fan Impeller 1 2222 oodd hr Re has Humidity RESeryOle sce hes sax eer RE Ex Ead cS ex eae esate esaes ad Air Intake Microfilter 20 424 oes ek x RERO GUERRE OGUCR ROT SoG ee Rd Base Covers Rail and Accessories Drawers Tank Mounts Monitor shelf and I V Pole scere 0 cR Skew G4 ase Gabe RUD we e qe grs Mattress Mattress Tray X Ray Tray Main Deck Heater Impeller Cover Scale Optional and Mattress Tilt Bars Uninterruptible Power Supply UPS Air Filter 0 0 0 0 00 0 0 Reassembly After Cleaning 2uusssex eu hon hERR RR ECRERSE eoweeee abe sede eawos MAIMIENSNCE s s caet cacgnee gi RERSR ERAN RRE sans Sebo ee Bay ee du dass eee ds UPS Battery Pack Maintenance UPS Electronics Module Maintenance 444r RE RARE x RETRRAAXRRRE RA RES Air Intake Microfilter Maintenance 0 cece eee eee ence Replacement Pats 24 uote vente xev ys een ete Sey cepe Peg Sd eee eee eeu ERE Section 7 Troubleshooting Gene
21. for Use manual delivered together with a device is officially published for the use of that specific device 6 11 Part Number Description Oxygen 83 620 23 Oxygen assembly National Institute of Standards and Technology NIST fitting 83 620 30 Cell oxygen 83 620 50 Oxygen assembly green diameter index safety system DISS 83 620 51 Oxygen assembly green hose 83 620 52 Oxygen assembly white hose 83 620 53 Oxygen assembly blue hose 83 620 54 Oxygen assembly white DISS 85 620 23 Oxygen assembly NIST fitting C2000e 85 620 50 Oxygen assembly green hose DISS C2000e 85 620 51 Oxygen assembly green hose C2000e 85 620 52 Oxygen assembly white hose C2000e 85 620 53 Oxygen assembly blue hose C2000e 85 620 54 Oxygen assembly white hose DISS C2000e Humidity 83 615 70 Humidity system assembly 120V C2000 Colder Products Company fitting 83 615 80 Humidity system assembly 230V English Spanish French German Italian 83 615 81 Humidity system 230V Swedish Greek C2000 Colder Products Company fitting 83 615 90 Humidity system assembly 100V C2000 Colder Products Company fitting 85 615 70 Humidity system assembly 120V C2000e Colder Products Company fitting 85 615 80 Humidity assembly 240V English Spanish French German Italian C2000e 85 615 81 Humidity system assembly 230V Swedish Greek
22. guarantee the accuracy of these instructions with respect to your specific device type or status 4 5 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 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 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 Personal injury or equipment damage could occur Hood Shell and Stand Assembly NOTE The stand and incubator assemblies are keyed so that the incubator can only mount in one orientation Ring Lug Wingnut Power Cord This Instructions for Use manual is published for public use and is only meant for your information 4 6 We do not guarantee the accuracy of these
23. is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 6 3 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 20 Pull the access door gaskets from each side of the hood to remove them 22 Remove the disposable iris entry port sleeves from the B P 4 retainer rings e 5i rc l 21 Pull the tubing access grommets from each side of the hood 23 Wipe the retainer rings clean 24 Discard all disposable sleeves and cuffs Air Intake Microfilter 25 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 A CAUTION When cleaning the interior of the incubator shell prevent liquids from entering the motor shaft opening Equipment damage could occur A CAUTION
24. microfilter If visibly dirty refer to Air Intake Microfilter Maintenance on page 6 10 Install the air intake filter cover Introduce a carefully measured 9 Ipm 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 Tray 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 Amay iray opening Return the x ray tray Close the front access panel and 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 AEE l UL seni RI Push the sensor module lock up Module Lock When the sensor modul
25. min that the hygrometer and the humidity display reads 50 6 relative humidity RH Weighing System Operational Checkout ACCESSORY The weighing system operational checkout should be performed before the system is first placed into service and after any disassembly for cleaning or maintenance 9o m m UA des uU qoo ge 9 Ensure that the mattress is level and not in the Trendelenburg or Reverse Trendelenburg position Activate the Weighing system see Scale Measurements on page 5 27 Verify that the Weight display is shown Remove any objects from the mattress before pressing the Zero softkey Press the Zero softkey 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 Ib 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 Reweigh the object see Re weigh on page 5 28 10 Verify that the display again shows the value of the weight on the mattress 4 20 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Section
26. of that specific device System Displays The controller has two system displays Display 1 and Display 2 from which the following displays can be accessed Temperature Trend Weight Oxygen Humidity Temperature Displays Access to the temperature displays is made available at Display 1 The temperature displays enable the user to Select the air skin control set point temperature Activate the Temperature Override mode Trend Display Access to the trend display is made available at Display 2 The trend display enables the user to select one of the following parameters for trending Air temperature e Skin temperature 1 e Skin temperature 2 e Heater power e Oxygen optional Humidity optional Weight optional Weight Displays Access to the scale displays is made available at Display 2 The scale displays enable the user to Store weight measurements for trending Perform the zero tare function Calibrate the scale PN 83 600 50 only Select the weight measurement display units This Instructions for Use manual is published for public use and is only meant for your information 5 10 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Oxygen Display Access to the oxygen display is made a
27. of the VHA stand at the front of the unit to raise or lower the stand to the maximum and minimum height 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 FEATURE Ad 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 If the unit is switched off at the UPS electronic module press the On Off Test switch hold for 1 second or until the system beeps 3 Press the Power Switch on the incubator 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 We INV LOAD If the 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 Check On Off Test Switch and Low Battery Alarm 6 At the UPS electronic module press and hold the On Off Test switch for 1 second or until the system beeps Verify that the system toggles on off Quickly pr
28. of the short rail assembly to the long rails using 6 screws 10 32 x 7 16 and internal tooth washers Then tighten the screws with a 5 32 Allen wrench Repeat steps 7 through 9 for the remaining short rail assembly 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 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 Then tighten the screw and nut with a 5 32 Allen wrench or socket wrench Repeat steps 11 and 12 for the remaining 3 remaining secondary rail supports NOTE Two secondary rail supports are required on both sides of the incubator stand 14 Ensure all screws are fully tightened Short Rail Assembly Long Rail Secondary Rail Support His Secondary Rail Support Tube Type Rail Support This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Rail Accessories To install
29. 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 Thenre 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 This Instructions for Use manual is published for public use and is only meant for your information 4 12 We do not guarantee the accuracy of these instructions w
30. 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 Connect the output of the oxygen flow meter to the barbed fitting labeled Inlet 1 using the 3 16 inner diameter surgical tubing 4 Allow oxygen concentrations to stabilize NOTE An oxygen concentration guide is provided below This guide is also displayed on the back of the incubator This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 5 31 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Oxygen Concentration Guide Oxygen Supply Approximate Oxygen 3 Ipm 30 45 6 Ipm 46 60 9 Ipm 5096 7096 12 Ipm 55 75 15 Ipm 60 80 Calibration Scale Calibration NOTE The procedures described in this section do not apply to the EU Type NAWI weighing system Refer to the solette amp 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 le
31. published for the use of that specific device Section 7 Troubleshooting General A WARNING Only facility authorized personnel should perform preventive maintenance or troubleshooting on the Isolette amp 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 Possible Cause The incubator Main Power switch is Off Remedy At the stand turn on the Main Power switch The Power Fail alarm activates For non UPS systems only The power cord is unplugged 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 For non UPS systems only The power cord to the incubator is unplugged Re attach the power cord to the incubator receptacle For UPS systems only The batteries are not charged 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 The Low Air Skin Tempera
32. 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 skin 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Features The Features subsection provides a list of the standard and optional features and available accessories for the Isolette Infant Inc
33. 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 recirculated 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 in 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 to the heater control circuitry wh
34. to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Manufactured by EC Representative Draeger Medical Infant Care Inc Drager Medical AG amp Co KGaA 330 Jacksonville Road Germany Hatboro PA 19040 USA Moislinger Allee 53 55 USA and Canada 800 437 2437 D 23542 L beck http www draegermedical com Tel 01 451 882 0 Fax 01 451 882 2080 http www draeger com Part number Revisions Date 85 990 05 1 October 2004 0123 Air Shields is a registered trademark of Draeger Medical Infant Care Inc Care For Me is a trademark of Draeger Medical Infant Care Inc Isolette amp is a registered trademark of Draeger Medical Infant Care Inc Kleenaseptic B is a registered trademark of Metrex Research Corporation Vuelink is a registered trademark of Philips Medical Systems Draeger Medical Infant Care Inc reserves the right to make changes without notice in design specifi cations and models The only warranty Draeger Medical Infant Care Inc makes is the e
35. 000 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 4 cm 16 Mattress Trendelenburg Reverse Trendelenburg tilt Continuously variable to 12 1 Electrical Convenience outlets Model C2000 100V only 100V 50 60 Hz 300 W maximum Convenience outlets 120V 120V 50 60 Hz 300 W maximum Convenience outlets 230V 230V 50 60 Hz 300 W maximum Chassis current leakage 100V and 120V lt 300 LA Chassis current leakage 230V lt 500 LA Environmental Air mode control temperature range 20 0 C 68 0 F to 37 0 C 98 6 F Air mode control override temperature range 37 0 C 98 6 F to 39 0 C 102 2 F Skin mode control temperature range 34 0 C 93 2 F to 37 0 C 98 6 F Skin mode control override temperature range 37 0 C 98 6 F to 38 0 C 100 4 F the actual incubator temperature after the incubator temperature equilibrium is reached Temperature rise time at 22 C 72 F ambient lt 35 min Temperature variability lt 0 5 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 20 C 68 F to 30 C
36. 3 wire hospital grade or hospital use outlet ioi 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device UPS Electronic Module The UPS electronic module is mounted in the pedestal cover of units equipped with UPS systems UPS Electronic Module Controls DB9 Connector Display Panel Resettable circuit breaker The exposed panel of the UPS electronic module contains the following controls gt e t Inverter On Off Test switch located on the UPS 3 Air Filter Resettable On Off electroni
37. 4 5 kg 10 Ib bly deep long Drawer housing assem 4 5 kg 10 Ib bly deep short Drawer housing assem 4 5 kg 10 Ib This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Regulations Standards and Codes The Isolette Infant Incubator Models C2000 and C2000e complies with the following safety standards and performance standards e EN 60601 1 7 990 Medical Electrical Equipment Part 1 General Requirements for Safety including Amendments 1 2 12 and 13 e EN 60601 1 2 2002 Collateral Standard Electromagnetic Compatibility Requirements and Tests e EN 60601 2 19 1 996 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 emission
38. 5 27 to ensure accurate measurement of the infant weight 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 valve 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 The 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 8 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 Oxygen softkey the display automatically reverts to 35 6 36 0 OFF Displ l Skin 1 Skin 2 Cal splay 35 6 356 Gem 2 Hour 4 Press the ON softkey to activate the Oxygen mode NOTE n When the Oxygen mode is
39. 86 F Operating temperature RH sensor 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Feature Noise level within the hood environment Dimension lt 47 dBa with 37 dBa or less ambient Air velocity over the mattress 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 CO2 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 Dimension Physical Fixed Height Stand Top of hood to floor incubator with FH stand 142 cm 56 12 7 mm Mattress to floor incubator with
40. AG EVA RERESQEERERCE DAR eee TE ERE 5 5 Foot Pedal Controls uasa paa Las e Ra Rx pREA X RET R ES ER TA RE 5 6 Sia UNC MOS usada uad edo ek d are X x abb qc ei de d ad dL ac de qpde ai 5 6 Brand COD EOS secere bdo dos o Rey o ACE ded do EAQUE eed OD IE E ded dos 5 6 Convenience Outlet s eared 2x9 axo a Erden P Go ae SRG Sree Re owaleks 5 6 AC Input Connector iure aduer E RE EUR EG ODRESETIR E IRR RED ERR ERES 5 6 UPS Bleetromne Mod l 2 uxo sedie des intueri RE PRASQ AS I REVUES cakes 5 7 UPS Electronic Module Controls 12 4 d pu Rara dux EYE Gm EE EXE dx EX Rei E 5 7 UPS Electronic Module Indicators Does dot s oes a ac ea eee WOES CR ep e qu en 5 7 UPS Electronic Module Connectors 24 19 cd ntaede ciate chedadatacaoebars bao dike 5 8 Displays esek 25 0 eb Ee RR eRE ERrEEERE AREE OX EE EEE eee OE tee ee She ri Iq EE 5 9 Temperatur Window sss aeeoe ese ence dam epERF ADR pP SOEUR P Ree sets onus 5 9 Trend Alarii Window Las duck esie dac re CREE UHR ERR REOR E Eee HERR ERE RU HO KC s 5 9 Humidity Window 154r Rb I IRR RC Eua RERO ERRARE RR Ra E E S ded 5 9 Oxygen WIDOOW soo3sud Reti eo RERO YI PER t REEERE ERREA EEE Rep PET idus 5 9 Systeri Displays usse ao e HEAR B acabe aie dd ea o e LES Mad SERA RON db an AMOR 5 10 Temperature Display os ossa se x esten U EQ REA RUE i SER TER ERE seta eon ee ees 5 10 Trend Display i2s ikaxdka bk M RR RR RA RE RR EEREHAX RE REIR WE d P RERFA RR ERE EE RR 5 10 Weg Displays 2134 eosin tones Ge ERU ER RERO
41. 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 The symbol below indicates AC power AC Power Pw The symbol below indicates Protective earth ground Protective Earth Ground The symbol below indicates Caution Hot surface Caution Hot Surface gt The symbol below indicates Weight limit Weight Limit This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device The symbol below indicates Consult Accompanying Document on the Battery Weight Battery Weight AA A e The symbol below indicates Consult Accompanying Document on Battery Pack Orientation Battery Pack Orientation A AE BATTERIES ARE A MATCHED SET REPLACE ALL THREE The symbol below indicates Power Failure Power Failure s The symbol below indicates Lock casters when parked on an incline Lock Casters The symbol below indicates an ELECTROSTATIC DISCHARGE ESD sensitive part Electr
42. Drager medical A Drager and Siemens Company Isolette amp Infant Incubator Models C2000 and C2000e WARNING Operating Instructions For a full understanding of the performance characteristics of this equipment the user should carefully read this manual before operating Emergency Care OR Anesthesia Critical Care Perinatal Care Home Care Because you care This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Table of Contents Section 1 Definitions Intended Use and Disclaimer I mna M TTr r 1 1 Symbol Definitions 515 6 eR inde be tddaleate se didea ees bags PER ERE ssid des 1 1 Technical Definitions 3x x de thes end ER UE a EA ecb RG nO dae dra RIEA the cheers 1 5 rana USE PE OS MES ES Deere Edo ee ER ad a os ot E 1 6 Disclaimer seeen oa Bach es ods Bek oes ea oe Od E a ee ee Bao nee nae 1 7 Section 2 Introduction Features and Specifications Introductio x coe bee ee hale oe ER EOE EGR AOR RE POE ROR PCE Cee Pee eee ee 2 1 Syst m OVERVIEW J cue ene cade tees oeseretenden Ea aa E a o Ea a qq seduced de aus 2 1 Humidity System Optional ua o sace ra Rd m RR ode Reed onde be
43. FH stand 100 97 cm 3934 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 133 35 cm 524 12 7 mm 1 2 to 152 cm 60 stand 12 7 mm 2 Mattress to floor incubator with VHA stand 90 17 cm 35 2 12 7 mm 2 to 110 4312 12 7 mm 2 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 0 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 Input current breaker rating 15 A for 120 V 7A for 230 V This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Featu
44. OE D ERA x IH HP RC TIME REOR xk 5 10 Oxygen DISPl y p a uod qued qos EROR CERRAR EU e dde o EAR E Se ERR gr PA EURO ot REEL OR 5 11 Humidity Display iu sse um RE AR IRE ARE AT ARAREXCR Rem Eduqxx AE pd pes 5 11 Factory Default Settings ssec pua hen bene eee ER ECPERGRE AC HR EG QR IE RE pees que 5 12 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device lii System Alarms 2 224 ees bee UG Rx Aag ck RR RR RE E d RELAY RE S SX ERR 5 13 WPS Alans ody ssezadeeouen TA HPRRE E ERE EXSRT PAPE ue ke OUR Ee tee Ed ex ded dd 5 17 SUBIRE Prompts 2 ou scppscerd acero mm dado dod qe Rb n e UR dos OO ede oi RU aee AC Y dee 5 17 Natale Placement us scaad dd Boek peer ac e RR ad decus HE ees tes eee dad e 5 19 Operating nstruc bls sol ebee E Xue e Pe b ber ERE DR REPE ERES RR XU Ges 5 20 System Start Up and Shut DOSVI 414 eiTe RERO ES ORE RETINA GE RF A WEE EE 5 20 Systemi StartUp sus oy eS ODE PREX Ray ces Ew y SUP RN EODD Rope a edo bap ac d n 5 20 Initial Start up for systems without UPS llslslsesleeeeeeeeeeeeeeA 5 20 Initial Start up for systems with UPS 0 0 eee ee eee 5 20 Recovery from Power Failure non UPS systems 0 0 0 0 ee ee
45. 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 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 2 Verify the power cord from the stand is firmly attached to the connector under the incubator shell assembly Turn on the Main Power circuit breaker 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 Configuration on page 5 22 Initial Start up for systems with UPS To power up the system WARNING Do not plug the AC input supply power cord of the uninterruptible power supply UPS system
46. Precautions A 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 incubator 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 This Instructions for Use manual is published for public use and is only meant for your information 3 2 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device EMC Precautions A WARNING Use of accessories other than those listed and approved for
47. 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 The 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 which 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 Temperature correlation Incubator temperature versus control temperature The amount the average incubator temperature in Air mode at in
48. age 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 N A This alarm occurs when the controller detects a sensor module analog to digital failure Sensor Module Failure 5 N A N A This alarm occurs when the controller detects an oxygen multiplexer calibration failure Sensor Module Failure 6 N A N A This alarm occurs when the controller detects a temperature multiplexer calibration failure Sensor Module Failure 7 N A N A This alarm occurs when the controller detects a sensor module RAM test failure Sensor Module Failure 8 N A N A This alarm occurs when the controller detects that the sensor module watchdog reset Temperature Specific Alarms 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
49. aged contact a local service representative A 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 eon a 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 8 and then install the mattress restraint straps see Mattress Restraint Strap Installation on page 4 7 Assemble the hood shell assembly and the stand assembly see Hood Shell and Stand Assembly on page 4 6 To install the weighing system refer to Weighing System Scale Assembly on page 4 9 To install the humidity system refer to Humidity System on page 4 10 To install the oxygen control system refer to Oxygen Control System on page 4 10 Before the unit is placed in service perform the operation checkout procedures see Operational Checkout on page 4 12 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 4 1 Only the Instructions for Use manual d
50. alibration 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 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 Scale Failure 1 This message is displayed when the scale analog to digital converter fails Scale Failure 2 This message is displayed when the scale communication with the host fails Scale Failure 3 This message is displayed when the scale load cells fail 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 m
51. ardous projectiles if the 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 This Instructions for Use manual is published for public use and is only meant for your information 3 4 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 A WARNING A dirty air intake microfilter could affect performance or cause carbon dioxide CO 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 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 ar
52. assembly 85 460 03 Basket 18 0 W x 9 5 D x 4 0 H assembly 85 460 04 Basket 6 5 W x 4 0 D x 5 0 H assembly 85 460 05 Basket 11 0 W x 4 0 D x 4 0 H assembly 85 460 06 Basket pivoting assembly 85 460 07 Chart holder assembly 85 460 08 Hinged tray 13 5 W x 9 75 D assembly 85 460 09 Hinged tray 17 0 W x 11 5 D assembly 85 460 10 Cable organizer assembly 85 460 11 Horizontal cord wrap assembly 85 460 12 Standard cam adapter assembly 85 460 13 Ball action adapter assembly 85 460 14 Double cam adapter assembly 85 460 15 Cam adapter threaded assembly 85 460 19 Utility hook assembly UPS 83 410 08 Filter uninterruptible power supply UPS C2000e 85 410 50T Battery 3 pack rechargeable 12V 7A a Kleenaseptic b is a registered trademark of Metrex Research Corporation This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device NOTES This Instructions for Use manual is published for public use and is only meant for your information 6 14 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially
53. atient 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 5 Using the Display Selection key scroll down to the VueLink software option 6 Press the Up Arrow key to select Yes 7 Press the Alarm Silence Reset key to exit the set up menu 8 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 30 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device X Ray Tray Usage A WARNING For infant safety do not leave the infant unattended w
54. ature 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 15 min N A This alarm occurs when the Air mode is enabled ture 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 Skinl Probe Fail Alarm 5 min N A This alarm occurs in the Skin mode if the Skinl 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 hu
55. ayed after power is supplied from the Main Power Tests switch and the system is performing the self test Procedure Silence This message is displayed when no alarm conditions are present and the Alarm Silence Reset key is pressed This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 5 17 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Alarm Messages Check Skin1 Probe Description This message is displayed in the Air mode if the Skinl 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 Skinl probe is 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 C
56. c module display panel 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 2096 4096 4096 6096 6096 8096 80 100 Overload LED the red LED indicates an overload condition 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 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 indicates 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 be in automatic bypass mode due to a system failure A blinking Invertor Status LED means that the system is in Sleep mode Bypass Mode LED the amber LED indicates that output power is supplied via the bypass line filtering only Load Status LED the blue LED indicates that
57. ccess panel openings The temperature of this air curtain is higher than the typical incubator air temperature therefore 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 and warm air curtain or side vents simultaneously This may cause heat induced injury and burns Ay 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 Drager Medical Using other probes could result in personal injury or equipment damage A WARNING Never place the skin temperature probe under the infant or use it rectally Personal 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 temperatur
58. ce Cleanser or a 2 gluteraldehyde solution 2 Dry all surfaces with a clean cloth or paper towel 1 Kleenaseptic b is a registered trademark of Metrex Research Corporation This Instructions for Use manual is published for public use and is only meant for your information 6 6 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Uninterruptible Power Supply UPS Air Filter NOTE FE The filter can be inspected and cleaned during operation However it is recommended that this procedure be performed without a patient in the ib system 1 Grasp the handle and firmly pull the filter cartridge until it is ga removed from the UPS electronic module 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 l 2 3 Inspect all cleaned components for any breakage or cracks before reassembling into the incubator Install the heater radiator and fan impeller Install the heater impelle
59. ce Humidity the infant on the mattress Weight 50 5 1 134 Kg Oxygen Set 7 The Weight Sample bar fills and the weight of 50 the infant is displayed in the Trend Alarm window 8 To enter the infant weight in the Trend Alarm window press the Store key 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 5 27 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 9 To return to Display 2 press the Home key Re weigh 1 To re weigh the infant without removing or adding anything to the mattress press the Weight softkey on Display 2 2 If any objects are added or removed from the mattress or a power failure occurs refer to Initial Weigh on page
60. chment NOTE The sensor module is equipped to accept two skin probes Single Temperature Monitoring 1 While operating in the Skin mode insert a skin probe into the Skin Probe 1 connector 2 Before the probe is placed on the skin thoroughly clean and dry the skin area where the probe is to be placed A WARNING Never place the skin temperature probe under the infant or use it rectally Personal injury could occur Skin probe 2 connector Skin probe 1 connector 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 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 4 Attach the probe to the infant using a Care For Me cover a Remove the backing from the Care For Me 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 5 Set Skin Temperature to the prescribed temperature Once stabilized t
61. cubator temperature equilibrium differs from the control temperature Temperature correlation 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 1 5 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 This Instructions for Use manual is published for public use and is only meant for your information 1 6 We do not guarantee the accuracy of these instructions with respect to your specific device type or s
62. d Module into the support plate with the vented brackets Use the 2 fastener screws to secure the UPS electronic module in place Facing the front of the unit the battery pack will D slide in from the right side of the stand into the Rion Mew Battery Pack support plate Use the 2 fastener screws to secure the battery pack in place This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Weighing System Scale Assembly PN 83 600 50 NOTE The procedures in this section do not apply to the EU Type NAWI weighing system Refer to the Isolette amp Infant Incubator Type NAWI Weighing System Quick Reference Guide To install the weighing system 1 10 If required remove all rail accessories from the front rail of the unit Rotate the pawl latches and open the front access panel of the incubator Remove the mattress from the incubator Ensure that the scale cable is located on the right hand side of the incubator towards the sensor module assembly Place the scale in the incubator on the mattress tray Replace the mattress Connect the scale cable to the weight connector on the sensor module assembly see Sen
63. d or axillary temperature according to the attending physician s orders or Nursery Standing Orders Failure to do so could result in personal injury 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 A 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 This Instructions for Use manual is published for public use and is only meant for your information 3 6 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Safety Tips A WARNING Federal law restrict
64. 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 would allow for liquid pooling Personal injury or equipment damage could occur A 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
65. e 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 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 This Instructions for Use manual is published for public use and is only meant for your information 3 8 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 IV stands shelves etc keep at least a 12 30 cm perimeter area clear around the vertical height adjustable stand A WARNING Fo
66. e dud een da SENSA 2 1 Humidity Reservolt ziiedecskccckek b ROGER besa ERE Sade bees Sans taeda aes 2 1 Manifold Assembly s adenat csacerete esceeane sided ene EG d EAE QR RI E 2 1 Evaporator Assembly 25 54 4249 seds gooey Seda Pee dees Med eee eee EE ES 2 1 Oxygen Control System Optional 2 0 cece eee een eee 2 1 Weighing System Accessory 2 042 cceeievaeeeveiabs bbs bubeeeeeedneveeneadas 2 2 Uninterruptible Power Supply UPS Optional 0 0 ce eee eee 2 2 Functional DesctIDUOl 242253 edt aco e P9 duck oot ee eeu edo do a qoi Mcd ug eke ats 2 3 tg rer 2 3 Skin Mode P TTITMTM 2 4 Peal rfeS 22 xsecer ke x nee REA RCRGGDRRATREQAERCRARA TEE DORRES REE RSyeQeAaG ur EREE F 2 5 Standard Features nesis bus esas Ae eed E PRSE GE YER SQUE SR xn ERES ERA 2 5 Optional FeAtUreS MONTI 2 5 JAGOBSSOLIGS Lad de xed ede TAKE ISdasadAssuua ad Rid RT adR ed exaq hcxq rade 2 5 SDECITICUIDIS obs eddie RE RETRO REV ERN ER CURE X RERHAU I DREEERA RUE OSE SSE Edd UeERCE RE 2 6 Standard Features 1 59 ess rd sed V a e Rr AU ade PE dard oo Oden od eodd ded andes ae 2 6 Options and Accessories one dades Sat s WR ELA RR DOO EIC EROR CR CR RUNS OUR e eds 2 7 SANS 4 vereque ee sense ar bec dr eaque Eres Ra dae Le Ra pF drea api ed 2 7 H midity System TF dc 2 8 OXy sen SUSIGRU oss odo ERN e RESP da ye one ta dnd doped tea eda pus Sad edis 2 8 Weighing SySIEIH uero oodles tert EE xe
67. e eee 5 21 Recovery from Power Failure UPS systems 0 00 c eee eee eee eee 5 21 System Shut DOWN lt decane ER EM da tEh EERE Owk EEA VES ee ews de dE 5 21 System Configuration 4 52 24 ecce REESE ERRERSIG RR RA GER RE PT Ra Gees 5 22 Variable Height Adjustmetlt 222 29362i3eri herkmsezra e 6eRI RE eI RP i he ine EAR EIS 5 23 Temperature EIUS sn 8 Vies Rp eR EROR elc o d deca VE sek RO deny 5 23 IE MOOG MCN 5 23 Skin Mode o i334404 head deehseaee RERERLDRT ERE RERA E DATA ATA dud ERE Yd 5 24 Skin Probe Attachment ere edd Res RR RES RESO URROEEJ DE Ne Tad ee ede dE 5 25 Single Temperature Monitoring iiuiicaqansse sek RS RE RR RRREGRPA AP E Ee d 5 25 Dual Temperature Monitoring 2 2 2 9 RE LRL E Rma R xe 5 25 lncMI ID SPP 5 26 scale Measurements oce srce Pene RETRO ste ecedshees RI AK EA ORE ERIQUERE RES 5 277 lur rd PET Pr E E AE E S E a A a 5 27 Re Wel e iH ay ete E E wey ees dua ae E 5 28 Oxysen Controls crc ada k hb LR ERRARE ES ERES ses bee eb EE RCREGd P a cR 5 28 Oxygen Mode 2 c2 cease shes buRI RE RCRRE Eq ERE P ERU OE EERE OO SEES E ie ES 5 28 Oxygen Control Set Point ssa vos dde dot cC de Rd RCRUM RAUS ALPES eod Ro I ge 5 29 Humidity SettDiBgS sessar osised A hey hea dae RERGISRRSEERAEG RA q E RP aai rahinan ias 5 29 Humidity Mode keep ak ea RETIRER ER PARES ERG RS DIR ES Ra C TR Ed 5 29 Humidity Control Set Point lt lt 2221dec abe dseeaatee y RESRPR E ROTE T Ea RE xa 5 30 Auelank MOBIOEIE sio iR s
68. e 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 that 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 IHAO11 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 4 17 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 Press and hold the foot pedal control
69. ea 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 A 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 3 5 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Humidity Precautions A WARNING Higher incubator relative humidity at any given temperature decreases an infant s evaporative heat loss and may cause an increase in the infant temperature Routinely monitor the infant s rectal an
70. elivered together with a device is officially published for the use of that specific device Unpackaging NOTE When removing the equipment from the cartons take care not to scratch or otherwise damage unprotected surfaces C2000 Stand Assembly Carefully lift the stand assembly and remove if Y from the packaging uf VHA Stand C2000e Stand Assembly 1 Prior to removing the stand assembly N from the packing box remove the two 1 2 13 mounting screws and washers _ C2000e Rail System securing one leg of the stand assembly a dae 23x3 hechead 8x to the support 2 Atone side of the pallet remove the 4 lag bolts 25 x 3 from the cradle support 1 2 13 Screw and Washers 2x 3 Lift that end of the stand remove the 7 Cradle Support cradle support and lower the stand to y pout the pallet ace f i A p 4 Then repeat steps 2 and 3 for the gt e So remaining leg 7 BOE f i P N N Battery Backup r Pallet N UPS Assembly L Optional This Instructions for Use manual is published for public use and is only meant for your information 4 2 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Rail Assembly and Accessories Installation Perform the operation checkout procedure prior to using the
71. embly and always check before lowering the VHA that 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 3 9 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device A WARNING Accessories such as trays baskets and shelves should never be overloaded and are not intended to hold an infant 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 A WARNING Always close and latch drawers when not in use and particularly when the incubator is being moved 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
72. erate the equipment Personal injury or equipment damage could occur 1 Atthe display panel on the UPS electronic module verify the battery level 2 If the 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 the patient care during transport A 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 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 that there i
73. ernal 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 1 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 2 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 Jsolette Infant Incubator Models C2000 and C2000e Service Manual for replacement procedures This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 6 9 Only the Instructions for Use manual delivered together wi
74. ess the On Off Test switch lt 1 second in the line mode and then verify e Unit switches to battery operation for 10 seconds e AC LED turns off for 10 sec and then back on again This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 C2000e ONLY Proper latching is both visually and physically evident to the user Verify that all latches are properly secured to the rail when in n the locked position L NOTE x The mounting adapter locks when the toggle handle is AERE Mbac Poean switched to the left position 8 o clock and unlocks when 8 clock 4 clock the toggle handle is switched to the right position Oxygen Cont
75. ey Default Setting Selections 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 mode Yes No Yes Language ENG FRN GER SPN ITAL English JAP DUT DAN NOR POL POR SWE FIN FLE GREEK CZECK SLOVAK Weight unit Ib 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 ft VueLink Yes No No 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 otherwise continue at step 5 2 If the keypad is locked press the Keypad Lock key to unlock the keypad 3 Press the following key sequence Trend key Up Arrow key Keypad Lock key Down Arrow key Display Selection key Continue at 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 7a owe de Select the menu options using the Display Selection key This Instructions for Use manual is published for public use and is only meant for your information 5 22 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a
76. ey 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 grea
77. for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device OQ e Parameter Selection keys Parameter Selection Tool The Parameter Selection keys enable the user to select parameter and menu options at the various displays J C2 Softkeys LT 1 A 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 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 softk
78. gen control accuracy at 21 5 calibration This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Weighing System NOTE The procedures described in this section do not apply to the EU Type NAWI weighing system Refer to the solette amp Infant Incubator Type NAWI Weighing System Quick Reference Guide Feature Dimension Weighing System Weight display range 0 kg 0 Ib to 7 kg 15 Ib Weight display resolution 1 0 g or 0 04 oz Weight display accuracy 0 2 kg 2 g 1 2 digit gt 2 kg 5 g digit Maximum tare weight 4 0 kg 8 82 Ib Rail Accessory Weight Limitations Feature Dimension Rail System Assembly 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 11 kg 25 Ib high low C2000e I V pole assembly 5 kg 11 Ib C2000e Basket 18 0 Wx9 5 Dx 4 4 kg 10 Ib 4 0H Basket 65 W x 4 0 D x 2 2 kg 5 Ib 5 0 H Basket 11 0 W x 4 0D x 2 2 kg 5 Ib 4 0H Basket pivoting 2 2 kg 5 Ib Chart holder
79. generated audible alarms Alarm Message SE ee 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 s 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 Alarm 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 E 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 This message is displayed when oxygen control is attempted but the servo controlled oxygen system is not active and or installed Performing Power Up This message is displ
80. he 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 feature 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 1 and Skin 2 temperatures This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 5 25 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 If necessary 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 To clear all previous Trend displays press and hold the Clear softkey 4 Press the Hours softkey to select the tre
81. he 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 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 If the alarm persist
82. he system should be allowed to charge the battery for a maximum of 8 hours to ensure the battery pack is fully 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 5 21 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 Up Down AT row K
83. hen the access panel is open Personal injury could occur To use the x ray tray perform the following steps 1 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 Tray Place the x ray cassette in the center of the x ray tray Push the x ray tray back in under the mattress Place the infant at the center of the mattress DL qoe co qr Close the access panel and ensure the pawl latches are fully engaged 8 When the x ray is completed repeat steps 1 and 2 above X Ray Tray 9 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 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 following steps 1 Make sure all fittings and connections for the supply oxygen are clean 2 Administer oxygen from a wall source or the accessory
84. ice 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 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 humidity 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 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
85. ich 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 2 3 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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
86. ific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Oxygen Calibration Fixture PN 83 620 55 83 620 71 To install the 100 oxygen calibration fixture 1 Withdraw the sensor module from the hood 2 Pull out on the clip located on the left side of the module and remove the module from the hood 3 Rotate the pawl latches and open the front or rear optional access panel of the incubator 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 become loose during shipping O Ring Proper Positioning 7 Mount the sensor module slide lock and 100 calibration fixture 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 Brass Connector is properly displayed 9 Close the front access panel and rotate the pawl Md latches until they are fully engaged 10 Install the sensor module
87. in 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 and 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 T
88. information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 incubator 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 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 1 2 3 4 Facing the front of the unit the UPS electronic Electronic module will slide in from the left side of the stan
89. instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device To assembly the hood shell and stand assemblies 1 Mount the hood shell assembly on the stand with the provided screws Plug the stand power cord into the incubator power cord receptacle Remove the wing nut next to the power cord connector on the stand Place the ring lug between the washer and wingnut on the stud A Pe m Install the wing nut Mattress Restraint Strap Installation Hood Shell Assembly Pawl Latches 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 then 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 restraining strap pair This Instructions for Use manual is published for public use and is only meant for your
90. 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 Then press and hold in 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 This Instructions for Use manual is published for public use and is only meant for your information 5 20 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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
91. ions for Use manual delivered together with a device is officially published for the use of that specific device Maintenance A 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 amp 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 solette Infant Incubator Models C2000 and C2000e Service Manual 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 disposal of sealed gel cell batteries A WARNING Do not add ext
92. ith respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 5 Check the Skin mode of operation a b C a f Insert a skin probe into the skin probe 1 connector of the sensor module Place the skin probe 10 cm 4 above the center 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 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 C While operating in the Skin mode with a skin probe connected in the skin probe 1 connector insert a second skin probe into 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 pr
93. l is published for public use and is only meant for your information 5 4 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Se n so r M 0 d u le Skin Probe 2 Alarm Indicator Connector Skin Probe 1 Connector Below are the sensor module controls indicators and connectors Sensor Module Controls There are no controls on the sensor module Weighing Sensor Module Indicators Scale Connector The sensor module has one alarm indicator Sensor Module Connectors Air Temperature and Controller Interface Cable Humidity Sensor Housing The following connectors are found on the sensor module e Skin probe 1 connector e Skin probe 2 connector Oxygen Sensor Receptacle Oxygen sensor receptacle Scale connector 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with res
94. livered together with a device is officially published for the use of that specific device 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 A 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 A WARNING The heater can be sufficiently hot to cause burns avoid removing or touching the heater until the unit has
95. m 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 indentations 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 A 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 a
96. 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 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 2 1 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Weighing System Accessory NOTE The description in this section does not apply to the EU Type NAWI weighing system Refer to the Isolette amp Infant I
97. midity 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 This Instructions for Use manual is published for public use and is only meant for your information 5 16 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Alarm Message Sa rod 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 alarms conditions are signaled with an audible indication generated by the UPS system The Alarm Silence Reset key cannot be used to silence or reset UPS
98. more frequent replacements may be necessary Failure to do so could result in infant injury or equipment damage Ay 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 10 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 amp 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 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 Mattress Mattress tray e X ray tray Main deck e Heater impeller cover e 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 Surfa
99. n 2 Humidity 35 6 35 6 aaa TI samy 40 Air Temp 2Hours Humidity Window 35 t 30 Oxygen S Set 20 50 50 Oxygen Trend Window Window Alarm Silence Reset Key Display 1 Display 2 Menu Options Menu Options y a Temperature Ar m Trend Set 35 6 360 Skin Weight Skin 1 Skin 2 Humidity oc oF 35 6 35 6 Oxygen Temperature At Temp 2 Hours Humidity 96 e Override Model 0 Indicator 50 50 b Oxygen 87 5 0 o A Set 0 D S Power Failure Indicator When the Humidity mode is activated 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 humidity the message Not Installed is displayed for a few seconds and then the Oxygen window remains blank This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use
100. n 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 WARNING The oxygen concentration inspired by an infant does not accurately determine the partial pressure of oxygen pO gt 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 Ad 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 haz
101. n select the Skin mode b Verify that the Connect Skin 1 Probe alarm sounds Hood Shell Operational Checkout To check the hood shell operation 1 Check the access panel s a Rotate the pawl latches and open the front and rear optional access panels b At the controller check that the door open symbol turns on c Pivot the access panels to the full open position hanging straight down d Close the access panels and rotate both sets of latches until fully engaged e Atthe 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 b If equipped with a weighing scale disconnect the weighing scale cable from the sensor module c Close the access panel and rotate both latches until they are fully engaged d Slowly tilt the hood back until the hood locks in place e Torelease the hood pull on and hold the knob located on the right rear hinge while closing the hood f If equipped with a weighing scale perform steps g through i g Rotate the pawl latches and open the front or rear optional access panel h Reconnect the weighing scale cable to the sensor module i Close the access panel and rotate both latches until they are fully engaged This Instructions for Use manual is published for public use a
102. n window 7 Slide the sensor module inside the hood and then press the ON softkey 8 Use the Up and Down Arrow keys to set the oxygen ws percentage 9 If the message Cal Fail is displayed repeat the procedure 10 If the calibration procedure is unsuccessful a second time refer the unit to qualified service personnel 1T mm JJ amm mem This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 5 33 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Oxygen Sensor Calibration to 100 Oxygen 1 OO d QNS A To perform the 100 oxygen calibration procedure install the 100 oxygen calibration fixture on the hood see Oxygen Calibration Fixture on page 4 11 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 Ipm 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 p
103. naseptic amp b Germicidal Surface Cleanser or a 2 gluteraldehyde solution Dilute the disinfectant as specified on the manufacturer label Thoroughly dry the unit before putting it back into use 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 amp Infant Incubator Models C2000 and C2000e Service Manual Ad 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 This Instructions for Use manual is published for public use and is only meant for your information 6 2 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 equip
104. ncubator Type NAWI Weighing System Quick Reference Guide 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 The Weight softkey allows for repeated re weighing of the infant after the weighing routine has been initiated System prompts are displayed in the Trend Alarm window during the weighing procedure Uninterruptible Power Supply UPS Optional Bypass Mode When installed the UPS system provides an on line uninterruptible back up power ee supply to the incubator which can also be used for intra facility transport AC nnt With batteries fully charged the power ou i un available from battery backup is sufficient TT ewe to maintain a C2000e incubator in l operation for 30 min in a 20 C ambient at a l to Inverter Li NE uei Output EMI amp Suppression Internal Battery Charger 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 unplugged incubator within the facility The UPS system consists of two main components the electronics control module and battery pack module The bat
105. nd period 2 4 8 12 or 24 hours NOTE The Hours softkey is not required for trends of the infant weight Refer to Scale Measurements on page 5 27 5 To select one of the following Trend displays press the Display Selection key repeatedly until the desired setting is shown 6 To confirm the Trend display selection and return to Display 2 press the Home softkey Air temperature Skin temperature 1 Skin temperature 2 Heater power Oxygen optional Humidity optional Weight optional 7 To lock the keypad press the Keylock key 5 26 X J 37 Air 35 6 Skin 1 35 6 Temperature Hours 36 0 Clear Skin 2 Displa j 35 6 FHome Humidity 0 Set 50 Oxygen 50 S qe CIV EQ ID This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Scale Measurements NOTE The procedures described in this section do not apply to the EU Type NAWI weighing system Refer to the solette amp Infant Incubator Type NAWI Weighing System Quick Reference Guide Methods and Techniques to Obtain Accurate Infant
106. nd fan impeller Humidity Reservoir 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 1 Kleenaseptic b is a registered trademark of Metrex Research Corporation This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 6 5 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Do not immerse the heater assembly in liquid NOTE The evaporator raises the temperature of the water 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 WARNING A dirty air intake microfilter could affect performance or cause carbon dioxide CO 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
107. nd is only meant for your information 4 14 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 verify that the access door swings open b Close the doors and check for proper latching and quietness c Check that the access door gaskets are properly installed in the port opening behind the access door d 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 a 6 Check the mattress elevators 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 i
108. nectors 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 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 ACAUTION points out special procedures or precautions that personnel must follow to avoid equipment damage The symbol below highlights an ELECTRICAL SHOCK HAZARD WARNING Electrical Shock Hazard Warning AN This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 1 1 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device The symbol below indicates Attention Consult accompanying documents Attention Consult Accompanying Documents 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 BF type applied part A
109. ns To install the humidity reservoir 1 Mount the reservoir and reservoir lid on the humidity tray 2 Insert the humidity tray in the shell and lock the handle Oxygen Control System PN 83 620 50 51 52 53 54 23 AND PN 85 620 50 51 52 53 54 23 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 1 Remove the sensor module from the hood by withdrawing it until it stops Ce 2 Pull out on the clip located on the left side of the module e P and remove the module from the hood gf 3 Remove the oxygen sensor cover Retain the hardware 4 Withdraw the sensor cell connectors from inside the on sensor module housing 5 Screw the sensor cells into the oxygen cell mounting plate provided 6 Connect the sensor cells to the sensor module NOTE The wires can plug into either sensor 7 Install the oxygen cell mounting plate on the sensor module 8 Replace the sensor module in the hood 9 Activate the oxygen system see Oxygen Mode on page 5 28 10 Calibrate the oxygen system see Oxygen Sensor Calibration on page 5 33 This Instructions for Use manual is published for public use and is only meant for your information 4 10 We do not guarantee the accuracy of these instructions with respect to your spec
110. o could result in personal injury or equipment damage 10 Coil up the power cord and secure it A 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 IV 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 Ad 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 WARNING Always close and latch drawers when not in use and particularly when the incubator is being moved 11 Safely transport the patient within the facility This Instructions for Use manual is published for public use and is only meant for your information 5 36 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions f
111. obe 2 connector 7 Check the Skin Probe Disconnect alarm a C d e In the Skin mode disconnect the skin probe from the skin probe 1 connector of the sensor module Verify that the skin display blanks 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 T OB rh ono 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 4 13 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 9 Check the Connect Skin 1 Probe alarm a While operating in the Air mode disconnect the skin probe 1 and the
112. ode 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 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 To prolong the useful life of the humidity module use only distilled water Sterile water is not an acceptable substitute for distilled water 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status
113. odule The cable between the scale and the sensor module is broken Turn the incubator off and remove it from service A scale failure alarm is activated A scale malfunction occurred Turn the incubator off and remove it from service This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 7 3 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 This Instructions for Use manual is published for public use and is only meant for your information 4 We do not guarantee the accuracy of these instructions with respect
114. odule is not pulled out into the calibration position This Instructions for Use manual is published for public use and is only meant for your information 18 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 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 Pull the mattress tray out to the stop Place the infant on the mattress Return the mattress tray to normal use position Close the access panel and ensure the pawl latches are fully engaged 9o c An de p LY or Re install any rail accessories previously removed This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 5 19 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Operating Instructions The
115. on 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 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 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 2 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 oxygen calibration fixture 4 At Display 1 press the Oxygen softkey 5 Press the ON softkey and then the Cal softkey The message Slide Out Sensor is displayed 6 Within 5 s withdraw the sensor module from the incubator hood to prevent a Cal Fail message Sensor Module When calibration is complete the message Cal Pass In postion is displayed in the Oxyge
116. on We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 13 Alarm Procedural Alarm Message Silence Silence 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 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 when on start up 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 ou
117. or Use manual delivered together with a device is officially published for the use of that specific device 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 12 When the transport is completed 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 5 37 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Notes This Instructions for Use manual is published for public use and is only meant for your information 5 38 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Section 6 Cleaning Maintenance and Replacement Parts Cleaning A WARNING Follow the product manufacturer s cleaning instructions Failure to
118. ories Installation 0 0 0 0 0 cece eee eee eee 4 3 Rail Assembly 124225624604 RGIASeX mie rade bere hPquabeteceehnberiPgraQe ridi 4 3 Rall eur 0 EPCUPPE c rTm 4 5 Hood Shell and Stand Assembly 42 0504c4seeusse he Re RR E RE T RR S 4 6 Mattress Restraint Strap Installation llle 4 7 UPS System Installation 2d wo REDE EREXRNCA YD EET REA REGE ED RE E a Ed ERE 4 8 Weighing System Scale Assembly 222scsdeo lec ate ares RRREE A LR REA RE 4 9 Humidity System vues dexode ER RS Ea ARE ER RARE Ge d aditus d bad Races 4 10 Oxygen Control System 2 due e Rut eR OREEA ER REOR RETI E Resa qu Pep EE as 4 10 Oxygen Sensor Cells so cauce be t d o e YE E ER Ie HE ded RU Ud Dad hend d 4 10 Oxysen Calibration FIXTE sve e Ray c XEJTRRNSODDE Ter EAE ad e Y ted 4 11 Operalicnal Checkout FEET 4 12 Controller Operational Checkout 0 0 0 eee III 4 12 Hood Shgll Operational Checkout 4242 24 3k E EROR RR SESE PPE RE OO OER EE SEES 4 14 VHA Stand Operational Checkout i54 oss onkhpS RR RESERVA ET eR RAO RO gn 4 17 UPS System Operational Checkout iss esokR an RSARREERARR S ATPERTFESRT A ERR AXES 4 18 Check On Off Test Switch and Low Battery Alarm esee 4 18 Test Battery Back up Function i2 2222c per E RR RR REPRE E RA 4 19 Rail System Operational Checkout i22 scs RblaX ERR WS ER Rex REESE ERES 4 19 Oxygen Control Module Operational Checkout 0 0 cece eee ee 4 19 Humidity System Ope
119. ostatic Discharge ESD Sensitive Part ha This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device The symbol below indicates Consult accompanying documents on latch lock unlock and rail loading Latch Lock Unlock and Rail Loading A The symbol below indicates Electromagnetic interference Electromagnetic Interference 9 Interference can occur in the vicinity of the equipment marked with the Electromagnetic Interference symbol The symbol below indicates Consult accompanying document on the large tray loading large Tray Loading The symbol below indicates a Communication port Communication Port o This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Technical Definitions Incubator temperature Air temperature at a point 4 10 cm above and centered over the mattress surface Control temperature
120. pect to your specific device type or status 5 5 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 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 uL 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
121. ped with a weighing scale perform steps 6 through 8 otherwise continue at step 8 6 Disconnect the scale cable from the sensor Heater Impeller module uu l 7 Remove the cable from the clamps that hold ee it to the incubator 8 Lift the scale from the mattress tray 9 Remove the 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 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 continue at step 19 17 Compress the ends and lift up on the rear end to remove the 3 Plunger sea reservoir valve 8j Valve 18 Dismantle the reservoir valve assembly and then place them Assembly in the reservoir Spring Silicon Sponge Access Door Gaskets Tubing Iris Entry Port Sleeves Cuffs 19 Remove the disposable access door cuff from each access door by pulling it from the outside This Instructions for Use manual
122. placement Parts List Part Number Description Miscellaneous 67 020 72 Restraint strap kit 79 25174 Kleenaseptic b trigger spray 12 24 oz 81 502 02 Washer sealing oxygen air 83 001 00 Mattress foam 83 001 05 Ventilator tube support Isolette 83 101 30 Filter replacement pack of four Isolette 83 442 00 Monitor shelf assembly high Isolette amp Model C2000 only 83 442 14 Monitor shelf assembly low Isolette Model C2000 only 83 444 00 IV pole assembly Isolette Model C2000 only 83 930 30 Adapter DSub 9 pin male to 25 pin female 85 001 04 Straps monitor shelf set of 2 Probes 68 209 47 Cover probe Care For Me large 100 68 209 48 Cover probe Care For Me standard 100 83 102 21 Probe 4 skin temperature disposable box 10 CE Isolette 83 102 41 Probe 5 skin temperature reusable 83 104 15 Probe 5 large skin temperature box of 10 Cuffs 68 12071 Iris port cuffs disposable soft 100 83 300 11 Access door cuff disposable replacement carton 100 83 300 40 Cuff access door reusable carton 10 Isolette Scale Assembly 83 600 50 Scale assembly Isolette This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions
123. power is being delivered to the load This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status oe Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 AC input DB9 connector NOTE The DB connector is an electronic port for factory use only This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Di
124. r cover 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 9e Install the main deck 5 Install the mattress tilt bars on the main deck 6 7 Visually and physically examine the mattress for any holes or cuts that enable the entry of fluids onto Install the mattress tray x ray tray and scale optional the inner foam If the mattress is damaged replace it Install the mattress 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 6 7 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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
125. r 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 A 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 injury or equipment damage A 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 A 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 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 ass
126. rail accessories refer to the solette amp 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 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 This Instructions for Use manual is published for public use and is only meant for your information We do not
127. rail system see Rail System Operational Checkout on page 4 19 Short Rail Assembly Tube Type Rail Support Rail Assembly To install the rail assembly 1 6 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 Then tighten the screws with a 5 32 Allen wrench Repeat steps through 3 for the remaining long rail Select one of the short rail assemblies NOTE The position of the locating holes on the short rail assembly Left Short Rail Long Rail Secondary Rail Support Corner Bracket Locating Holes determine where the short rails are mounted on the rail Right Short Rail assembly This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 4 3 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 10 11 12 13 Align the 3 screw holes on each of the corner brackets with the 3 screw holes on the front and rear long rails Secure the corner brackets
128. ral 22 sre e OG alate SU Bn ww aad SC a aoa aa es UU ae eae UNS ae S OL USES Symptom Cause and Remedy ici oda een doe eed dune peered evhetaseda genes oud This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Notes This Instructions for Use manual is published for public use and is only meant for your information vi We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 Standard text used for regular information Boldface text emphasizes a word or phrase 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 Con
129. rational Checkout 0 0 0 0c eee eee eee nee 4 20 Weighing System Operational Checkout 0 0 eee eee eee 4 20 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Section 5 Instructions for Use Controls Indicators and Connectors 0 0 0 0000s 5 1 cipi MCN CTC E r P rncm 5 1 Inc bator Controls 2 525 03 334 D eoe ACE EE ACE a o n LU eol OR CD ER 5 1 Mathys P rrr 5 1 Nhu GET 5 2 Incubator MUO MOS ases RE awe P oe e b E IC HE vd eer PVP EEC PE PU EP 5 3 Incubator COlDBOIOES 292 vesc Ex Ea ed Ew quor VOR oa SAGE CRAVE M dex ERROR ao P d 5 4 Controller Interface Connector 0 ec eee ren 5 4 Senal POM 2a pie RREEXARRE Pd aa RAE AE RE Ado xd RE aches RE dde qus 5 4 Sensor Mod le sv ee PERIRUPRREREESOUCRPG OC CURE EERE OE VR eh On PS ELE ES 5 5 Sensor Module Controls vas serae eor hdc Co gepackt Rn 4 5 5 Sensor Module Indicators 2424 ox y eke sexed odd eens E ASEEVENCC BAV AEREKRAREENS 5 5 Sensor Module Connectors 02 44 034 eed D E CR Ee XR ES aC RR RUE 5 5 sn WM rdc rrr 5 5 Stand Controls a os p senha canes Ode Ke Die uc LA LR ate a RR B V ach apod rf 5 5 Main teu Breaker uos esqekeeskexubrRE
130. re Output circuit breaker rating Dimension 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 range 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 Oxygen Control System Dimension 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 Oxy
131. revent 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 Out Position 14 If the calibration procedure is unsuccessful a second time refer the unit to qualified service 34 personnel This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 accessory outlets To transport the patient f 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 op
132. rms if there are no current alarms present Silence one or more alarms if no previously latched alarms are present NOTE The Alarm Silence Reset key cannot simultaneously reset a previous latched alarm and silence a current alarm condition Alarm Message ae m 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 This Instructions for Use manual is published for public use and is only meant for your informati
133. rol Module Operational Checkout OPTIONAL FEATURE Perform the oxygen system operational checkout before the system is first 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 2 If necessary unlock the keypad 3 Activate the Oxygen system see Oxygen Mode on page 5 28 4 Set the oxygen set point to 45 see Oxygen Control Set Point on page 5 29 5 Verify the oxygen analyzer reads 45 5 within 5 min NOTE If the oxygen analyzer and the oxygen display do not read 45 5 within 5 min contact a local service representative This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 4 19 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Humidity System Operational Checkout OPTIONAL FEATURE To install the humidity reservoir Qv wo des Ge NP Make sure the reservoir is full Place the probe of a calibrated hygrometer inside the hood at the center of the mattress Pre warm the incubator to 35 0 C 95 0 F Activate the Humidity system see Humidity Mode on page 5 29 Set the humidity set point to 50 see Humidity Control Set Point on page 5 30 Verify within 30
134. s 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 2 11 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 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 X 8 kV air X 8 kV air ceramic tile If floors are covered with synthetic the relative humidity should be at least 30 EFT 2 kV Mains 2 kV Mains Mains power quality should be that of a IEC 61000 4 4 1 kV TOs No I Os t
135. s 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 33 The Oxygen Solenoid Failed alarm is activated The oxygen solenoid failed Turn the incubator off and remove it 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 alarm 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 3500g is on the mattress Remove the excess weight The Scale Disconnected alarm is activated The cable between the scale and the sensor module is disconnected Re connect the cable between the scale and sensor m
136. s level Repeat steps a and b for the left mattress tilt mechanism knob 7 Check the mattress tray operation This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 4 15 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device e f 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 mattress tray to the fully extended position Carefully lean on the mattress tray to ensure it is properly supported and provides a firm infant platform Return the mattress tray Close the front access panel 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 personal injury or equipment damage 8 Check the air intake microfilter which is located under the rear shell of the incubator a C 9 Check the air oxygen system located under the rear shell of the incubator a b C Loosen the two thumbscrews of the air intake filter cover and remove the cover Inspect the
137. s 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 IHAO11 5 If equipped with VHA adjust the stand to its lowest position prior to transporting the patient This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 5 35 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 s
138. s 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 A 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 A 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 IV 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
139. 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 A WARNING The drawers and rail system are labeled for acceptable weights IHA010 A WARNING Do not insert any object into any of the ventilation holes or any other opening on the uninterruptible power supply UPS system 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 A WARNING Do not add external batteries to the UPS system Personal injury or equipment damage could occur A WARNING Do not connect the Isolette amp Infant Incubator Models C2000 or C2000e to a surge suppressor This Instructions for Use manual is published for public use and is only meant for your information 3 10 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual de
140. sor Module Connectors on page 5 5 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 hood to rise to its fully open position and the mattress tray to be fully withdrawn from the hood e To allow for correct weight measurements make sure there is no interference or rubbing of the cable with the scale top Secure the scale cable to the incubator end wall using the cable clips provided on the inside of the incubator wall Loop the cable at the lower clip If required place previously dismounted rail accessories on the front rail of the unit To ensure proper operation perform the scale operational checkout see Weighing System Operational Checkout on page 4 20 A WARNING Utilize cable management clips to avoid infant entanglement and possible injury This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 4 9 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Humidity System PNs 83 613 70 80 81 90 AND PNs 83 615 70 80 81 AND 90 NOTE The humidity system is normally factory installed To install the humidity system in the field refer to the accompanying installation instructio
141. splays The controller displays supports the following windows Temperature 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 on page 5 7 Temperature Window The Temperature window also displays the actual air and or skin temperature and the set point temperature of the controlling parameter Pressing the available softkey enables the user to access the corresponding displays or perform 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 Additional trend displays are also available when the unit is equipped with any of the following Oxygen Servo Control System Humidity System and Weighing System The trend time is user selectable in intervals of 2 4 8 12 and 24 hours These intervals are applicable to all parameters except weight which provides a trend of seven days Humidity Window Temperature Window a Temperature Ar d Set 35 6 36 0 skin Skin 1 Ski
142. st 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 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 1 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 SHOCK HAZARD Due to the risk of electrical shock hazard only qualified personnel with appropriate service documentation should service the unit 1 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 f 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 1 SHOCK HAZARD The total power of all equipment connected to the convenience outlet strip on the pedestal stand must be
143. t guarantee the accuracy of these instructions with respect to your specific device type or status 5 3 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Incubator Connectors Coniroller Interface Connector The controller interface connector provides communication between the controller and sensor module Controller Interface Connector Serial Port A WARNING am Gap GP GD E Devices connecting to the serial port must be compliant with EN 60601 1 2 the EMC requirement for Medical rj Devices Failure to do so could result in personal injury n or equipment damage ep o cm Ga A WARNING Only connect equipment to the serial port that complies with the relevant IEC standard and use data cables with plastic body connectors Serial Port 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 VueLink M system Air and skin set point temperatures Current air and skin temperatures Alarm messages Oxygen set point Oxygen level Humidity set point Humidity level nfant weight 1 VueLink is a trademark of Philips Medical Systems This Instructions for Use manua
144. t 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 Position 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 This Instructions for Use manual is published for public use and is only meant for your information 14 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Alarm Mess
145. t specific device 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 F Temperature DT 37 0 C 98 6 F in 0 1 increments In 35 6 360 Temperature Override mode press the 35 6 Up Arrow key to raise the set E es temperature from 37 0 C 98 6 F to 50 39 0 C 102 2 F T Oxygen b Press the Down Arrow key to lower the ID 50 s 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 the air set temperature is set to 37 0 C 98 6 F lt P 6 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 Tolock 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 25 3 Setthe temperature to the prescribed
146. tatus Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Disclaimer Drager Medical cannot be responsible for the performance 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 1 7 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Notes This Instructions for Use manual is published for public use and is only meant for your information 1 8 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific dev
147. ter than 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 gt 37 C indicator The gt 37 C indicator lights when the set temperature is set to 37 C 98 6 F or higher 37 C 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 aS user to lift the infant from the mattress Lr 5 kg symbol The 5 kg symbol is displayed during the calibration routine It prompts the user to place a 5 kg weight on the mattress 5 Kg Rotating Wheel symbol The Rotating Wheel symbol indicates the active status of a mode of operation This gt lt 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 This Instructions for Use manual is published for public use and is only meant for your information We do no
148. tery pack module consists of 3 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 at a 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 through the slots at the front and rear of
149. th a device is officially published for the use of that specific device 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 addition 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 Damaged Visibly dirty Older than 3 months This Instructions for Use manual is published for public use and is only meant for your information 6 10 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 at 800 437 2437 Re
150. the incubator away from these drafts NOTE The attending physician should prescribe the temperature control mode and temperature settings Before attempting to operate the incubator become familiar with the operating precautions In addition refer to Controls Indicators and Connectors on page 5 1 If the incubator is turned off or has been out of service for cleaning or maintenance refer to the Isolette amp Infant Incubator Models C2000 and C2000e Service Manual and perform the function checks If the incubator is already in service and the function checks have not been performed become familiar with the various aspects of the hood shell operation Keep the infant clear of the slots where the warm air enters the patient compartment Routinely monitor the infant rectal and or auxiliary 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 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 5 23 Only the Instructions for Use manual delivered together with a device is officially published for the use of tha
151. tomer 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 L1674P outside ISM TEC 61000 4 20Vrms in 6 ISM bands D 124P in ISM 150 KHz to 80 MHz Radiated RF 10 V m E1 10 V m oo D 124P 30 MHz to 800 MHz 80 MHz to FIRME D 234P 200 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 power of the communications equipment Separation m Separation m 150 kHz to 150 kHz to Separation m ie lr m Maximum Output 80 MHz 80 MHz 80 to 800 MHz
152. ture 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 Low oxygen concentrations exist An access door or iris entry port is open Close all access doors and iris entry ports This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 7 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Symptom Possible Cause An iris entry port sleeve is open or improperly installed Remedy Check the installation of the iris entry port A tubing access port is not 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 with
153. ture control Air mode mode Skin set temperature 36 5 C 97 7 F Humidity set value 50 RH Oxygen control mode Off Oxygen control set 21 value Temperature units C Weight units kg Trend Air 2 hours Language English Altitude 0 ft 0 m Vuelink No Air set temperature 35 C 95 F a Vuelink is a trademark of Philips Medical Systems This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 Reset one or multiple latched ala
154. uas E RP EE MER Ge CENE see deen Nd EV ipai 5 30 X Ray Tray Usage eer 5 31 Non Servo Control Oxygen Usage 0 cece cece e eens 5 31 diocl Mec rc 5 32 Scale Calibration 2a us drach er Ed Po Ia RERO ad eegeteete een d pd decia 5 32 Oxygen Sensor Calibration s seacex au 6 Gases op aed ISO pease Khe Gene u e Fue daos 5 33 Oxygen Sensor Calibration to Room Air 2196 0 teens 5 33 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Oxygen Sensor Calibration to 100 Oxygen 0 0 eee eee eee Patient Transport 2 223 2 c2sekecebkeacedweaeacbhys basics sedesdhdrebhedeariekas Section 6 Cleaning Maintenance and Replacement Parts en MP PH General Cleaning 15 5 oon ad onc etalea daha ened ond oogaed enh e aeesuh ooask ens Steam Cleaning secesio sirr ititi trai eran DEEE KR A eee ERE RC eK ed Stain cn Mr Aen EE N AE EE E AEE bourse ee DHSIDIBSBLIDP urassa ae EV RI PODES PRI a Du don EE E O E N Led Disassembly for Cleaning 2 ees ecuu rx e durer EVER eee een uem ES rd x reda Mattress Tray X Ray Tray Main Deck Scale optional Heater and Impeller sz Ex ese ERE REP EREIARBb PEE EE INE Humidity Tray and Reservoir 2 244042
155. ubator Models C2000 and C2000e Standard Features Standard features include Oval access doors with a quiet latch Trendelenberg mattress tilt mechanism 0 to 12 Pedestal base cover C2000e only Rail system C2000e only Optional Features Options include Oxygen control system Humidity system Fixed height stand without UPS system VHA stand without UPS system C2000e only Fixed height stand with UPS system VHA stand with UPS system Accessories Accessories include Weighing system Ventilation support Temperature probes Port sleeves and cuffs e 5 kg weight Gas tank mounts and tanks E and D sizes C2000e only Rail mounted accessories C2000 only Non rail mounted accessories This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 2 5 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 standards and code information for the system Standard Features Feature Dimension Physical C2
156. use in this product as original or replacement items may result in increased emissions or decreased immunity A 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 A 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 the 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 A WARNING The use of accessory equipment not complying with the equivalent safety requirements of this
157. vailable at Display 1 The Oxygen display enables the user to Activate the oxygen system Select the oxygen control set point Calibrate the oxygen sensor Humidity Display Access to the humidity display is made available at Display 1 The humidity display enables the user to Activate the humidity system Select the humidity control set point This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 and 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 factory setting of 35 C 95 F Factory default settings are listed in the table below 5 12 Factory Default Settings System Parameters Defaults Tempera
158. vel and not in the Trendelenburg or Reverse Trendelenburg position To calibrate the scale 1 At Display 1 press the Display Selection key 2 At Display 2 press the Weight softkey 3 If necessary remove any objects from the mattress 4 Atthe Weight display press the gt 0 T lt or Zero softkey two times and then press the Display Selection key 5 At the Scale Calibration display press the Cal softkey C A The Wait message is displayed and then replaced 35 6 pue with the 5 kg symbol Skin 1 Skinz Lm f 35 6 35 6 Home l k 6 Within 12 s of the 5 kg symbol being displayed E Weight place a calibrated 5 kg weight on the center of the 5 000 Kg 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 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 This Instructions for Use manual is published for public use and is only meant for your information 5 32 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Oxygen Sensor Calibrati
159. within the electrical requirements shown on the rear of the pedestal stand Otherwise personal injury or equipment damage could occur This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 3 1 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device 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 1 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 1 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
160. xpress written warranty 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 Infant Care Inc 2004 by Draeger Medical Infant Care Inc ALL RIGHTS RESERVED Instructions for Use manual is published for public use and is only meant for your information was T not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device
161. ypical commercial or hospital environment Surge TEC 61000 4 5 1 kV Differential 2 kV Common 1 kV Differential 2 kV Common Mains power quality should be that of a 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 of a 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 environment 12 This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Guidance and Manufacturer s Declaration Immunity The C2000 is intended for use in the electromagnetic environment specified below The cus
162. z to Power Non ISM ISM 2 5 GHz Watts D 124P E D 1167 4E D 124P mE 0 01 0 1167 m 0 12m 0 12m 0 23 m 0 1 0 369 m 0 38 m 0 38 m 0 73 m 1 1 167 m 1 2m 1 2m 2 3m 10 3 69 m 3 8m 3 8m 7 3m 100 11 67 m 12m 12m 23m This Instructions for Use manual is published for public use and is only meant for your information We do not guarantee the accuracy of these instructions with respect to your specific device type or status 2 13 Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Device Classification The Isolette Infant Incubator Models C2000 and C2000e meets the requirements for the following classifications Class I Type BF IPXO Ordinary equipment Not AP Continuous operation This Instructions for Use manual is published for public use and is only meant for your information 2 14 We do not guarantee the accuracy of these instructions with respect to your specific device type or status Only the Instructions for Use manual delivered together with a device is officially published for the use of that specific device Section 3 Precautions and Safety Tips Precautions This section contains a list of electrical explosion EMC Oxygen and Humidity precautions Electrical Precautions A WARNING The total electrical current leakage of all items powered through the incubator including devices on the outlet strip mu

Isolette® Infant Incubator - Frank`s Hospital Workshop

Contents

Download Pdf Manuals

Related Search

Related Contents

Isolette&reg; Infant Incubator - Frank`s Hospital Workshop

Contents

Download Pdf Manuals

Related Search

Related Contents

Isolette® Infant Incubator - Frank`s Hospital Workshop