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Air-Shields® Isolette® Infant Incubators

1. SHOCK HAZARD N An electric shock hazard exists within the controller when the cover is removed Only qualified personnel should service it SHOCK HAZARD N 4 SHOCK HAZARD To prevent equipment damage or accidental power disconnections do not plug an incubator power cord directly into an AC wall socket when the incubator is mounted on a variable height adjustable stand Always provide power to the incubator by using the power cord coming directly from the variable height adjustable stand Failure to do so could result in personal injury or equipment damage Make sure the building power source is compatible with the electrical specifications shown on the rear center column of the variable height adjustable stand or on the incubator Failure to do so could result in personal injury or equipment damage Explosion Precautions A WARNING Do not use in the presence of flammable anesthetics Personal injury or equipment damage could occur A WARNING Make sure that the oxygen supply to the incubator is turned off and that the incubator is disconnected from the oxygen supply when performing cleaning and maintenance procedures a fire and explosion hazard exists when performing cleaning and maintenance procedures in an oxygen enriched environment A WARNING Keep matches lighted cigarettes and all other sources of ignition out of the room in which the incubator is located Textiles oils and other combustibles
2. A WARNING For infant safety do not leave the infant unattended when the access panel is open 4h WARNING When the access panel is open a curtain of warm air flows from beneath the front edge of the mattress toward the top of the access panel opening 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 4h WARNING Attach the incubator to the stand cabinet or variable height adjustable stand using the clamps 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 4h 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 The high air temperature alarm might not be activated under these conditions 4h WARNING To avoid overheating or underheating continuously monitor and control the skin temperature either in Baby or Air Mode Never use rectal temperature to control skin temperature Personal injury could occur 4h WARNING Phototherapy units located too close to the incubator may affect hood wall temperature incubator air temperature and infant skin temperature Personal injury or equipment damage could occur 4h WARNING When an x ray is taken through the hoo
3. MAIN DECK 4 Install the deck plate Make sure the deck plate is properly aligned on its keying pins 5 Install the mattress tilt mechanisms on the main deck NOTE There is a right hand and left hand tilt mechanism 4h WARNING Be sure the two thumb screws that hold the tilt mechanisms to the deck are tightened securely Failure to do so could result in personal injury or equipment damage 6 Securely tighten the two thumbscrews that hold the tilt mechanisms to the deck 7 Install the mattress tray a Position the mattress tray a few inches above the mattress rails b Lower it straight down 8 Install a new disposable mattress cover over the mattress 9 Place the mattress onto the tray 10 Install the disposable iris entry port sleeves 11 Install the smaller diameter elastic band of a new sleeve over the inner ring of the port housing 12 Fold the sleeve back and slip the elastic band over the outer ring of the port housing a Rotate the outer ring to close b Rotate the outer ring to open it If properly installed the sleeve opens again 13 Install a tubing access grommet into the front edge of each side of the hood If a tubing access grommet is distorted or torn replace it 14 Install an access door gasket behind each access door ACCESS ACRYLIC 15 Install a new access door cuff onto each access door gasket pia E D a Stretch the larger diameter elastic band into t
4. Isolette Infant Incubator a Probe indicator light flashes and an alarm sounds within 10 s to indicate a damaged air temperature baby temperature auxiliary air sensor or an open circuited air flow sensor The Probe alarm also activates if the skin temperature probe 1s disconnected while in Baby Mode The Model C400 QT Isolette Infant Incubator discontinued January 2005 is equipped only for air control Therefore no Baby Mode Probe alarm is provided The Probe alarm activates to indicate a damaged air temperature or auxiliary sensor or an open circuited air flow sensor Set Temperature The Set Temperature alarm actuates if the baby or air temperature fluctuates from the set temperature as follows e Baby temperature 1 0 C 0 3 C 1 0 C 0 3 C e Air temperature 1 5 C 0 5 C 3 0 C 0 5 C 2 5 C 0 5 C for IEC units A temperature below the set temperature is indicated by a flashing light a tone and the set temperature setting alternating with LO in the Set Temp C display A temperature above the set temperature is indicated by a flashing light a tone and the set temperature setting alternating with HI in the Set Temp C display If a Set Temp alarm occurs simultaneously with a Probe alarm a shorted probe is probably the true cause of the alarm since a shorted probe appears as a high temperature condition The Set Temperature alarm is self resetting that is if the alarm condition is corrected the
5. Oxygen administration may increase the noise level within the infant compartment Personal injury could occur 4h 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 An oxygen analyzer must be used any time oxygen is delivered to an infant 6 8 2 9 Electromagnetic Compatibility Precautions General information on electromagnetic compatibility EMC according to the international EMC standard IEC 60601 1 2 2001 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 proce dures may include antistatic clothing and shoes the touch of a ground stud before and dur ing connecting the pins or the use of electrically isolating and antistatic gloves All staff involved in the above shall receive instruction in these procedures NOTE Portable and mobile RF communications equipment can affect medical electrical equipment NOTE Medical electrical equipment needs special precautions regarding electromagnetic compatibility EMC and needs to be installed and put into service according to the EMC information provided in the technical documentation available from Drager Service upon request A WARNING This product has been validated with the accessories and options listed in this manual and
6. Personal injury or equipment damage could occur 4 Secure the base assembly to the VHA stand using the clamp on each side of the VHA stand 4h WARNING The VHA stand is intended for use with incubators that use the Model C400 QT or C450 QT Isolette amp Infant Incubator base assembly Do not use the VHA stand with other incubators Incubator instability or tip over could result 5 Check to be certain that the incubator is firmly secured to the stand at both ends Do not place in service if not firmly secured NOTE This incubator has been shipped without a filter and filter cover assembly The filter cover assembly has been shipped in a separate carton Do not place the incubator into use until properly installed 6 Install the air filter and filter cover on the rear of the unit If the unit is to be equipped with a Dew ette 2 Incubator Humidifier Model DH90 2 refer to the Dew ette 2 Incubator Humidifier User Manual and install the air intake valve assembly special air filter and humidifier filter cover 7 Plug the VHA power cord into an appropriate power source 8 Plug the interconnecting power cord on the VHA stand into the incubator power cord receptacle Warm Weigh Infant Scale Model I20 Accessory For more information refer to the I20 W30 User Manual 1 Open the front access panel of the incubator 2 Remove the mattress from the incubator 3 Install the weighing platform in the incubator mattress tray
7. WITHOUT A FILTER AND FILTER COV ER ASSEMBLY FILTER COVER ASSE MBLY HAS BEEN SHIPPED IN A SEPA AN DECK MUST BE LATCHED FOR CORRECT OPERATION UNLATCH FOR REMOVAL RATE CARTON DO NOT PLACE INCU BATOR INTO USE UNTIL PROPERLY l NSTALLED REFER TO ACCOMPANYI NG INSTALLATION INSTRUCTIONS IMPORTANT DECK MUST REST ON CASTING AND WITHIN GRAY PLASTIC GASKET WARNING AIR CURTAIN COVER MUST BE IN PLACE FOR CORRECT TEMPERATURE CONTROL WARNING FOR INFANT SAFETY DO NOT RAISE HOOD WITH INFANT INSIDE TO PREVENT INFANT FALL WHEN ACCESS PANEL IS OPEN WARN N G DO NOT LEAVE INFANT UNATTENDED DO NOT FORCE TRAY WHEN eae OUT DO NOT RAISE HOOD WHEN MATTRESS IS ELEVATED A E 8 Section 4 Installation and Assembly Installation Unpacking Typically the cabinet stand or optional VHA stand discontinued in January 2005 the hood base assembly the filter and filter cover assembly and the guard rail are shipped in separate cartons When removing the equipment from the cartons take care not to scratch or otherwise damage unprotected surfaces Remove all packing materials from the shelf assembly Medical electrical equipment needs to be installed and put into service using special precautions regarding EMC and according to the EMC information provided in the manual Additionally portable and mobile RF communications equipment can affect medical electrical equipment Assembly Incubators Equipped with the S
8. and incubator receptacles The High Temperature and or The main deck or hood seat Check the installation of the main deck High Set Temperature alarms gasket are not properly or the hood seat gasket are activated installed The Set Temperature LO The access doors or iris entry Close all access doors and iris entry alarm is activated ports are left open ports The skin probe is not properly Check the skin probe connection secured to the skin when in skin mode operation only The Air Flow alarm is acti The fan has failed Replace the fan motor vated The variable height adjustable The power switch is not ON Turn on the main power switch VHA stand will not move up or down The power cord is unplugged Make sure that the power cord 1s fully plugged into the wall and the VHA receptacles The circuit breakers are tripped Reset the circuit breakers Low oxygen concentrations are The access doors or iris entry Close all access doors and iris entry determined ports are left open ports The iris entry port sleeves are Check the installation of the iris entry opened or improperly installed port sleeves The tubing access grommets are Check the installation of the tubing not properly installed access grommets The main deck is not properly Check the installation of the main deck installed The filter cover or the controller Check and secure the filter cover and are not properly secur
9. 7 When transporting the incubator make sure the cabinet stand doors are closed A WARNING To prevent injury or damage to the incubator mounted on a variable height adjustable stand when transporting two persons of sufficient strength are required to adequately control the incubator 8 When transporting the incubator mounted on a VHA stand use two persons of sufficient strength to adequately control the 140 kg 310 Ib incubator and stand 9 When the incubator is mounted on a VHA stand check the VHA stand Turn on the main Power switch b Use your foot to press the right portion of the VHA stand Up and Down switch to raise the stand to the maximum height c Press and hold the left portion of the VHA stand Up and Down switch to lower the stand to the minimum height d Verify that the stand operates smoothly and adjust it to the desired height A WARNING To keep the incubator from losing its balance always place one hand on it for support when adjusting the height Failure to do so could result in personal injury or equipment damage 10 Press the Power switch The switch lights NOTE Newer switches do not light A CAUTION Perform the self test on a daily basis Failure to do so could result in equipment damage 11 Perform the self test after maintenance or cleaning NOTE When initially turned on the controller performs a 5 s self test all alarm indicators light all mode indicators light all Heater Power i
10. Baby Mode the C450 QT Isolette display goes blank and the alarm sounds When the baby probe Infant Incubator only is disconnected from the unit in Air Mode the display goes blank but no alarm sounds Air Mode control Press to enable Air Mode amp Air Mode control Lights to indicate that the unit is operating in Air Mode indicator Air Temperature C Displays the incubator air temperature in Celsius degrees If the digital display air temperature probe fails the display goes blank Silence Reset switch Turns off the audible portion of the Set Temperature alarm for nominally 15 min If another alarm occurs within the period of silence alarm silence is automatically overridden Turns off the Power Fail alarm for two min Reset functions as the alarm reset for the air flow High Temperature and Probe alarms but only after the alarm condition is corrected Heater Power Provides an indication of relative heater output from 0 to indicator 100 Keypad Lock control Press to disable the Baby Mode control Air Mode control Up and Down arrows and gt 37 C keys Press it again to enable the Baby Mode control Air Mode control Up and Down arrows and gt 37 C keys The key indicator lights to indicate that the keypad 1s locked An unlocked keypad automatically locks after approximately 15 s of no keypad activity Keypad Lock indicator Lights to indicate that the keypad 1s locked An unlocked keypad automat
11. Down arrow Set Temp C digital Displays the baby or air set temperature setting in C as selected display by the Up and Down arrow keys During a Set Temperature alarm it flashes and alternates with LO or HI to indicate that the air or baby temperature is above or below the setpoint gt 37 control Press to place Baby Mode or Air Mode in Temperature Override Mode This key is inactive until the Set Temp C 37 temperature setting has been set to 37 C 99 F gt 37 C indicator Lights to indicate that Temperature Override Mode is selected Side Panel Controls Indicators and Connectors PATIENT AUXILIARY PROBE PORT AUXILIARY AIR PROBE AN USE ONLY USE ONLY 68 209 20 P N 68 209 80 68 209 70 CLASSIFICATION 1 POWER TYPE BF CORD POWER 220 240 14 O 1 50 Hz 161 A Ho FOR PROPER GROUND RELIABILITY USE A RECEPTACLE MARKED HOSPITAL GRADE OR HOSPITAL USE PUSH TO RESET CIRCUIT BREAKERS TO REMOVE CONTROLLER ALL CONNECTIONS MUST BE REMOVED FROM THIS PANEL Controller Side Panel Controls and Connectors Power switch switch Press to turn on or turn off the controller to breakers Provide overload protection To reset the unit press the circuit breakers Auxiliary port connector port connector Accepts the connector from the remote alarm module accessory Patient probe connector Accepts the skin temperature probe for monitoring and controlling the infant s skin temperature When the
12. Electromagnetic Compatibility EMC Guidance and Manufacturer s Declarations Guidance and Manufacturer s Declaration Electromagnetic Emissions The C400 QT and C450 QT Air Shields O Isolette Infant Incubator 1s intended for use in the elec tromagnetic environment specified below The customer or user of the unit should ensure that the unit 1s used in such an environment Radio frequency RF Group The C400 QT and C450 QT Air Shields emissions CISPR 11 Isolette Infant Incubator uses RF energy only for its internal function Therefore its RF emis sions are very low and are not likely to cause interference with nearby electronic equipment RF emissions CISPR Class A The C400 QT and C450 QT Air Shields Isolette Infant Incubator is suitable for use in Harmonic Emissions Pass all establishments other than domestic and those IEC 61000 3 2 directly connected to the public low Voltage fluctuations Pass voltage power supply network that supplies flicker emissions IEC buildings used for domestic purposes Guidance and Manufacturer s Declaration Electromagnetic Immunity The C400 QT and C450 QT Air Shields Y Isolette amp Infant Incubator is intended for use in the electromag netic environment specified below The customer or user of the unit should ensure that the unit is used in such an environment Immunity Test IEC pee Test Compliance Level a een Electrostatic 6 kV contact 6 kV co
13. and ensure it 1s level 4 Place the mattress tray and the mattress provided with the scale on the weighing platform NOTE Use the mattress supplied with the scale Using the C400 C450 mattress may cause inaccurate readings due to interference with the surrounding walls 5 Insert the cable into the hood access port NOTE The load cell must be unlocked before operating the scale Refer to the instructions provided with the scale to unlock the load cell General Operation and Functional Checkout Procedure Perform the operational checkout before the incubator is first placed into use and after any disassembly for cleaning or maintenance NOTE Two persons are required to perform this check one to lift and one to check the casters The lifting weight minimum is approximately 150 kg 331 Ib Use a block to support the raised end in the event a caster falls out A WARNING A loose caster may fall out during use if the incubator is lifted over cables door sills or elevator thresholds This could result in the incubator tipping over when lowered to floor Do not use the incubator until the loose casters are replaced Personal injury or equipment damage could occur 1 With a standard cabinet stand only check for loose casters a Lift each end of the incubator approximately 3 cm 2 b Pull down on each caster 2 Before plugging the incubator into an appropriate power source press the Power switch The Power Failu
14. be considered If the measured field strength in the location in which the unit is used exceeds the applicable RF compliance level observe the unit to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the unit d Over the frequency range 150 kHz to 80 MHz field strengths should be lt 3 V m Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the C400 QT and C450 QT Air Shields Isolette Infant Incubator The C400 QT and C450 QT Air Shields Y Isolette Infant Incubator is intended for use in the electromag netic environment in which radiated RF disturbances are controlled The customer or user of the unit can help prevent electromagnetic interference EMI by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the unit as recommended according to the maximum output power 14 of the communications equipment Separation Distance According to the Frequency of the Transmitter m 150 kHzto 150kHzto 80 MHz 80 MHz to 800 MHz to 80 Khz Outside in ISM Bands 800 MHz 2 5 GHz d 124P Rated Maximum Output Power of the Transmitter W d 1 2 P d 124P d 2 3 P 0 1m 038 m 12m 10 W 3 8m 3 8m 3 8m 100 W 12m 12m 12m For transmitters rated at a maximum output not listed above the recommended separation distance d in meters m
15. compartment through 4 the right tubing access grommet The Set Temperature LO alarm is silenced for up to 60 min after the incubator 1s turned on or until the selected set temperature 1s reached If you change the set temperature either high or low after the incubator is in operation the Set Temperature LO and HI alarms automatically silence for a specific amount of time after the change The time the alarm remains silent is 5 min per degree plus or minus from the current incubator temperature For example a 1 5 change from set temperature generates an alarm silence p period of 7 2 min If the incubator fails to reach the new set temperature after the specified time the alarm sounds 3 Thoroughly clean and dry the skin area where the probe is to be placed before placing the probe on the skin a When the infant is on its 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 infant s back P b c Never place the probe under the infant or use it s US rectally 4 Attach the probe to the infant using a Critter Covers Probe Cover 5 To stabilize the attached probe place a Critter Covers Probe Cover over the probe wire approximately 3 cm 1 to 4 cm 2 from the probe p 6 Use the Up and Down arrows to set the Set Temp C display to the desired temperature Once stabilized the infant probe temperature 1s
16. in personal injury or equipment damage 3 Tighten the knob A WARNING Always place the monitor in the center of the shelf Failure to do so could result in personal injury or equipment damage A WARNING Ensure that the monitor fits within the raised border of the shelf Failure to do so could result in personal injury or equipment damage 4 Place the monitor in the center of the shelf and ensure that the monitor fits within the raised border of the shelf A WARNING Never stack another monitor atop the monitor on the shelf Personal injury or equipment damage could occur 5 Never stack another monitor atop the monitor on the shelf NOTES Section 6 Cleaning Maintenance Replacement Parts and Storage and Handling Cleaning A WARNING Follow the product manufacturer s instructions Failure to do so could result in personal injury or equipment damage 4h WARNING Follow all hospital procedures for disinfection and potential biohazard exposure Failure to do so could result in personal injury SHOCK HAZARD Unplug the unit from its power source Failure to do so could result in personal injury or equipment damage SHOCK HAZARD Do not expose the unit to excessive moisture Personal injury or equipment damage could occur 44 CAUTION Do not use harsh cleansers solvents or detergents Equipment damage could occur General Cleaning We recommend that you clean the unit with detergent and warm wate
17. in the table on page 5 6 are intended as guidelines only Oxygen Concentration Guide for Optional Oxygen Input Valve at 50 Hz to 60 Hz Operation Oxygen Input Normal Range of Oxygen 255 30 6 Adjust the flow as required to achieve the prescribed concentrations See the warning label and important operating instructions 7 Allow 30 min for final concentrations after each change of the oxygen flow setting Humidity Reservoir The ambient relative humidity of the operating environment influences the level of relative humidity attained within the incubator When the temperature inside the incubator is significantly higher than the temperature in the nursery condensation may form on the inside of the hood When there is relatively little temperature difference between the incubator and the nursery condensation does not form This does not mean the incubator air 1s not adequately humidified but rather that the difference in temperature is not great enough to produce condensation 1 To minimize contamination in the humidity reservoir completely drain and refill it daily A CAUTION Use only sterile distilled water Use of tap water could result in equipment damage 2 Use only sterile distilled water A CAUTION Never refill a partially filled humidity reservoir Always drain the humidity reservoir completely before refilling Failure to do so could result in equipment damage 3 Never refill a partially filled
18. injury or equipment damage A WARNING When moving the incubator two persons of sufficient strength are required for adequate control Failure to do so could result in personal injury or equipment damage A WARNING If the auxiliary air probe contacts the infant s skin when the mattress is in the Trendelenburg Reverse Trendelenburg position erratic air temperature control can result Always ensure this probe tip does not contact the infant Personal injury could occur A WARNING When an IV pole is present use caution when raising the VHA stand Personal injury or equipment damage could occur A WARNING Follow all hospital procedures for disinfection and potential biohazard exposure avoidance Failure to do so could result in personal injury A WARNING The accessory equipment connected to the analog and digital interfaces must be certified according to the respective International Electrotechnical Commission IEC standards such as IEC 950 for data processing equipment and IEC 601 1 for medical equipment Furthermore all configurations shall comply with the systems standard IEC 601 1 1 Any person who connects additional equipment to the signal input or the signal output part configures a medical system and is therefore responsible for ensuring that the system complies with the system standard IEC 601 1 1 If in doubt consult the technical service department or your local representative Failure to do so could result in inf
19. panel Humidity fill pipe The humidity fill pipe provides the means to fill the humidity reservoir Tubing access The tubing access grommet provides the routing for grommet tubing probe leads etc into the infant compartment Caster lock Located on the diagonal corners of the cabinet stand the caster lock restricts the incubator movement Oxygen input Located on the rear of the incubator the oxygen input connection connection provides the connection point for output of the oxygen flow meter Controller Front Panel Operating Controls Indicators and Connectors Alarms J Probe EE Air Flow EE Set Temp Keypad Lock Heater Power SetTemp C Baby Temperature BR es Baby Mode Control Alarms _ Probe Cc Air Flow CO Set Temp Keypad Lock Heater Power 7 Power Fail LLL System Fail 0 CC High Temp Silence Reset Air Temperature E Air Mode Control LLL Power Fail L 1 System Fail CT High Temp Silence Reset Air Temperature Controller Front Panel Controls and Indicators Baby Mode control Press the Baby Mode control to enable Baby Mode Model C450 QT Isolette Infant Incubator only Baby Mode control Lights to indicate that the unit is operating in Baby Mode indicator Model C450 QT Isolette Infant Incubator only Baby Temperature C Displays the baby temperature in Celsius degrees When the digital display Model baby probe is disconnected from the unit during
20. patient probe is connected the Baby Temperature C display indicates the temperature sensed by the probe When the patient probe is disconnected the Baby Temperature C display is blank Auxiliary air probe Accepts the auxiliary air temperature probe and disconnects the connector internal air temperature probe to permit the air temperature control by the auxiliary probe Power cord connector Accepts the AC power cord Optional Features discontinued Jan 2005 Variable Height Adjustable VHA Stand Controls Indicators and Connectors PUSH TO RESET MAIN O CIRCUIT POWER BREAKERS FOR PROPER GROUND RELIABILITY USE A RECEPTACLE MARKED HOSPITAL GRADE OR HOSPITAL USE VHA stand Enables the incubator height from the floor level to be varied Up and Down ich WARNING When an IV pole is present use caution when raising the VHA stand Personal injury or equipment damage could occur Press to move the VHA stand up or down Use caution when an IV pole 1s present Circuit breakers Provide the VHA stand with overload protection To reset press the circuit breakers AC receptacle The AC receptacle accepts the AC power cord Main power switch Supplies the main power to the VHA stand and incubator The VHA stand discontinued Jan 2005 provides the Isolette Infant Incubator with the capability of varying the incubator height over a range of 21 59 cm 8 2 An electric motor powers the VHA sta
21. the mattress Warm up time as specified by sub clause 35 minutes 50 108 of EN 60601 2 19 Optional Features VHA discontinued Jan 2005 Fere Ci imennsion Variable height adjustable VHA stand power requirements including incubator 60 3 cm 23 7 to 81 9 cm 32 2 VHA stand depth 53 3 cm 20 9 VHA stand width 95 2 cm 37 4 VHA stand weight without incubator 95 2 kg 209 9 Ib mounted VHA stand weight with incubator mounted 140 6 kg 309 9 Ib VHA stand height range with incubator 87 6 cm 34 5 to 109 cm 43 mattress Alarms High temp Activates if the incubator temperature exceeds 39 5 C 0 5 C Activates if the incubator temperature exceeds 37 5 C 0 5 C for set temps lt 37 C or at 39 5 C 0 5 C for set temps gt 37 C for IEC units Activates when a fan fails or an Air Flow probe short circuits Set Temp Activates if Baby or Air Temperature fluctuate from set tem perature as follows Baby Temperature 1 0 C 0 3 C 1 0 C 0 3 C Air temperature 1 5 C 0 5 C 3 0 C 0 5 C 2 5 C 0 5 C for IEC units Power fail Activates when there is a loss of power or disconnection from the power source Probe Activates if the any of the air temperature probes are open or short circuited if the Baby Temperature Probe is open cir cuited or disconnected while in Baby Mode or if the Air Flow probe is open circuited when the temperature sensed below deck is grea
22. to raise the hood at any time while the infant is cared for in the incubator Gain access to the infant by means of the access panel access doors and iris entry ports 4 Do not raise the hood to gain access to the infant Open the access panel access doors or iris entry ports 5 Do not place the incubator in service unless the general operation and function checkout procedure has been performed see General Operation and Functional Checkout Procedure on page 4 5 6 Ventilate and pre warm the incubator in Air Mode to the temperature prescribed by the attending physician or according to the nursery standing orders During pre warming run the incubator with no water in the humidity reservoir NOTE The air curtain which functions when the access panel is open can be disturbed by drafts fans air conditioning etc 7 Take necessary measures to keep the incubator away from drafts fans or air conditioning A WARNING To prevent infant fall when the access door is open do not raise the hood when the mattress is elevated or force the mattress tray when pulling it out The tray can be dislodged from the support rails on the incubator hood baffles 8 Pull the mattress tray out to the stop Do not raise the hood when the mattress is elevated or force the mattress tray when pulling it out A WARNING When the access panel is opened a curtain of warm air flows from beneath the front edge of the mattress toward the top of the
23. A Drager and Siemens Company Ar ShieldsO Isolette Infant Incubators WARNING Models C400 QT and For a full understanding of the performance characteristics of this equipment the user C450 QT should carefully read this manual before cna Operating Instructions Table of Contents Section 1 Symbol Definition and Intended Use SOS MEO PET O ee TIT LT TT Technical De NIONS s cu aoctor once doleo mt c dp A eet ees OA ee Shee de Ite nete as ares veo pau a rete ales Mdb OO Section 2 Introduction Features and Specifications rtt AUC I OTI e oec EREU nS sus dem ee Ahn de Meth dem teal ner dem Rhonda dem tea beta eae A Functional Description 2 9 ox 2a xs Sod maed RUE RES Roco UY ROPA UA Ree hdc ae Bor ace ede a m lgs DH MT ICT rrr Standard EedtUtesus Aut id nin eae Aimee dee S Hs p rc ere oe edi uence Temperature Otto uto A RRO eae a e OR bo do Rapes Gee CMM REA TESTS T TL TC T ge ee A ea aed oe ee eco ee Continuously Variable Mattress Tilt Mechanism llle Quiet Latch ACCESS DOOS e ea avi od ret Puedo SUE SR US Pob e aed DART REL HA Optional Reales 4 22 a desd a edit adem thc Sent ascent ea ius bado dt deu as Be es dle Rt ACCESO 3 E Ss eae aed uuo ndr ed See Bar eed GUSTA US dU SOD nw RES eee qs Es SSC HC ALOIS tr debe pco dad Heo od ou ce Br sh Mt oir cd Dana Standard E SOEUR Sustrato dia A dd dc bentes ari Meters Peale iy eal Steg Optional Peares 26292 679 4959 tae Greeters ARA e ALAS tar qub em
24. Cabinet Stand 0 0 0 0 cee ene 6 7 Cleaning the Air Intake Microfilter Chamber 2 0 0 0 cece eee nee 6 7 Assemb Ater C Ie ODD uu oor cinch eh a Roc Sd e od RUE det ca ach ae RR Eke du 6 8 IMaIhifendlleE rss idad d ues ee 6 11 Power Failure Alarm Battery Maintenance 0 0 ccc ccc eee ees 6 11 Replacement Parts cau atat Qon mE eh rtr th tah doors fS Ulva lice tg sit diens he dr ear de ke Re te 6 12 Storage and Handgun sus 258 om nw as OY A eS RUE IUS dr Se ee o 6 13 user P O E E E E EE E E E E N A E EET 6 13 E E ee fia Ma Gt EE EEEE E LE A E EEE eae 6 13 Dipoi wats hath aaa dt casada aub e a aa aeaa paisa 6 13 Section 7 Troubleshooting TROUDICSNOO MING EHE IS ets ce ee NA O ae a ety nee Bs 7 1 lii NOTES Section 1 Symbol Definition and Intended Use Symbol Definition This manual contains different typefaces and 1cons designed to improve readability and increase understanding of its content Note the following examples e Standard text used for regular information Boldface text emphasizes a word or phrase e NOTE sets apart special information or important instruction clarification e The symbol below highlights a WARNING or CAUTION Warning and Caution A A WARNING identifies situations or actions that may affect patient or user safety Disregarding a warning could result in patient or user injury A CAUTION points out special procedures or precautions that
25. ING Failure to clean could result in sufficient lint build up to reduce air flow which will affect temperature control and cause high oxygen concentrations Personal injury or equipment damage could occur 3 a Remove any lint build up from the fan impeller heater and air temperature probe b Clean these surfaces with the detergent disinfectant c Dry with a clean cloth or paper towel When using the disinfecting tank perform the following a Fill the disinfecting tank with the detergent disinfectant b Immerse the rear surface of the controller c Allow it to soak as recommended by the manufacturer d Dry with a clean cloth or paper towel Cleaning the Mattress Tray and Deck Plate 1 Use the detergent disinfectant to clean all surfaces thoroughly 2 Dry with a clean cloth or a paper towel Cleaning the Mattress Tilt Control 1 Use the detergent disinfectant to clean all surfaces thoroughly 2 Dry with a clean cloth or a paper towel WARNING Do not lubricate the mattress tilt mechanism with oil or other potentially flammable material in an oxygen enriched environment Personal injury or equipment damage could occur 3 Do not lubricate the mattress tilt mechanism with oil or other potentially flammable material Cleaning the Hood and Cabinet Stand 1 Use the detergent disinfectant to clean all surfaces of the hood thoroughly including the inner wall and access door heat shield A CAUTION Alcohol can cause cr
26. W shaped baffle from the chamber and dry it with a clean cloth or paper towel 2 3 4 Place the air intake tube access door gaskets and tubing access grommets into the solution If necessary use a larger container than the humidity chamber If the chamber is not used clean it and the fill pipe separately Allow the parts to soak as recommended by the manufacturer 6 Remove them and dry completely with a clean cloth or paper towel If the humidity chamber was Cleaning the Controller filled with the disinfectant solution perform the following a Drain the humidity chamber b Scrub it thoroughly including all indentations c Dry the humidity chamber and fill pipe inside and out with a clean cloth or paper towel If it is necessary to remove the fill pipe for cleaning perform the following a Rotate the fill pipe assembly about turn to the left b Loosen the thumbscrew that secures the fill pipe bracket and rotate the bracket 4 turn to the left c Unscrew the fill pipe assembly by rotating counterclockwise d Clean the fill pipe assembly and the sleeve that becomes a loose part when the fill pipe assembly is unscrewed ATI mo i n H T Th 1 Wipe the front panel top bottom and two sides of the d controller chassis with a clean cloth dampened with the deessent sinfsetanr 2 For cleaning parts on the rear surface that are within the controlled environment perform the following WARN
27. a ESA aa nT a bos bl 1o dent id eee 5 4 Oxveen Therapy sexuees v arre 5 5 Hondt RESONO o 5o one de ad aia Ow dy Bet da e a Sk dion ee aad nek eek how Sees 5 7 Controls Indicators and Connectors llle 5 8 Opombi CTI S acaso Sy A Ged o dero d dob dua fene Dc AAA 5 14 INCCESSOME SL 1553 a Di A A A a du dus E 5 16 Cabinets and Drawers inci habe ois dom a AUS polls 5 17 SUME ado T rr 5 17 Section 6 Cleaning Maintenance Replacement Parts and Storage and Handling Situ AP DLE 6 1 General CIMAS erro aii AE e tas DS Er rt AA e 6 1 AA A A A 6 1 Steam Cleaning IIA A AA A AA As 6 2 Cleaning Difficult to ACCESS Aedes aede eo ake ea dO 6 2 Cleans Painted Sur aces 239 a s Onin ee een eed d ew de Bea 6 2 Cleaning Clear Plastic and Acrylic Surfaces 0 0 0 0 ccc eee eens 6 2 Distnfie CUNA UE DNUR ee do aha Bp be da br oe do Rd ee RE 6 2 Dis ssembby Tor Cleaning enrolla a 6 2 C TC OTHO ca te ce dein in fe tton GE P Rod Nw bn Bn BEB ew GB aha GE San ea uites 6 5 Cleaning the Skin Probe Model C450 QT Isolette Infant Incubator Only 6 5 Cleaning the Humidity Chamber and Fill Pipe Air Intake Tube Access Door Gaskets and DUBIN Access GISKES s io aer cea dui der dtt een hue odes aos edhe GM aeos 6 6 Cleaning the Controller uas duos S ederet du dv 6 eiiam 6 6 Cleaning the Mattress Tray and Deck Plate llle 6 7 Cleaning the Mattress Tilt Control ausus s dare hoa AA Pb UE 6 7 Cleaning the Hood and
28. abinet stand when not in use If there is anything you do not understand please contact your technical support representative for further information Section 2 Introduction Features and Specifications Introduction The forced air circulation system of the incubator permits stable temperature control uniform heat distribution humidification effective isolation of the infant from airborne contaminants and control of oxygen concentrations An access panel access doors and iris entry ports provide accessibility to the infant When the access panel is open a curtain of warm air flows from beneath the front edge of the mattress toward the top of the access panel opening this air curtain minimizes the temperature drop within the hood environment The incubator is designed for use in a nursery environment having a typical ambient operating temperature range of 20 C 68 F to 30 C 86 F A guard rail is standard On Model C450 QT Isolette Infant Incubator baby or air temperature control is selected by a front panel control The Model C400 QT Isolette Infant Incubator discontinued January 2005 is equipped only for air temperature control Instrumentation includes a digital display for temperature relative indication of heater output and a comprehensive visual and audible alarm system which includes an alarm test feature Functional Description The forced air circulation system controls temperature humidity and oxygen c
29. access panel opening The temperature of this air curtain is higher than the typical incubator air temperature Therefore keep the infant clear of this warm air path Personal injury could occur 9 Place the infant in the incubator through the opened access panel clear of the warm air path caused when the access panel is open 4h WARNING For infant safety do not leave the infant unattended while the access panel is open Personal injury could occur 10 Do not leave the infant unattended while the access panel is open A WARNING Positively secure both access panel latches to avoid accidental opening Failure to do so could result in personal injury or equipment damage 4h WARNING The use of infant seats head hoods or other equipment or supplies within the incubator which can alter the air flow pattern may affect temperature uniformity temperature variability the correlation of the incubator temperature reading to the center mattress temperature and infant skin temperature 4h WARNING The incubator temperature may fall below the Set Temp C setting if the access panel is left open Do not leave it open longer than essential When the access panel is open the Air Temperature C display does not accurately reflect the incubator temperature Personal injury could occur 11 Return the mattress tray to normal use position and close the access panel 12 Positively secure both access panel latches NOTE The attending physi
30. alarm automatically silences and the light turns off To silence the Set Temperature alarm press the Silence Reset key The other audible and visual alarms are not affected by the use of the 15 min alarm silence When silenced the alarm indicator remains on until the alarm condition 1s corrected If the alarm condition 1s not corrected within 15 min the audible alarm reactivates If you change the air or baby set temperature either high or low after the incubator is in operation the Set Temperature HI and LO alarms automatically silence for a specific amount of time after the change The time the alarm remains silent is 5 min per degree plus or minus change from the current set temperature If the incubator fails to reach the new set temperature after the specified time the alarm sounds For example if you change the set temperature 1 5 the alarm silence period is 7 5 min Continuously Variable Mattress Tilt Mechanism The Isolette Infant Incubator is equipped with a 0 to 9 continuously variable mattress tilt mechanism which permits placing the infant in the Trendelenburg or Reverse Trendelenburg position Quiet Latch Access Doors The Isolette Infant Incubator is equipped with quiet latching access doors The latch mechanism of these doors is designed so that the doors may be opened with an elbow one at a time or simultaneously Optional Features Optional features available for use with the Isolette Infant Incubator i
31. an be maintained from 20 C 68 F to 37 C 99 F as indicated by the Set Temp C display setting In Temperature Override Mode the temperature can be maintained from 37 C 99 F to 38 5 C 101 3 F A probe located below deck monitors the air temperature and compares it with the Set Temp C display setting The information from this probe is supplied to the heater control circuitry which proportions the heater output to maintain the air temperature at the Set Temp C display setting Actual air temperature is displayed by the Air Temperature C display A second sensor within the air temperature probe serves as a backup to limit the incubator temperature to between 39 C 102 F and 40 C 104 F At this temperature an alarm activates and the heater shuts off If desired an auxiliary air temperature probe can control the air temperature This probe is suspended above the mattress through the weighing scale hole and plugged into a special receptacle on the side of the incubator When plugged in the primary air temperature control probe is disconnected but the backup sensor within the primary temperature probe remains connected Thus the auxiliary probe controls the air temperature In Air Mode the infant s temperature is a function of the air temperature and the infant s ability to establish and maintain its own temperature A small infant or one with underdeveloped homeostatic control may not be able to maintain a stable temperat
32. ant injury personal injury or equipment damage 4h WARNING Do not use equipment adjacent to other devices unless verification of normal operation in the configuration in which it is to be used can be achieved Infant injury personal injury or equipment damage could occur A CAUTION Use only sterile distilled water Use of tap water could result in equipment damage A CAUTION Never refill a partially filled humidity reservoir Always drain the humidity reservoir completely before refilling Failure to do so could result in equipment damage Swivel Monitor Shelves A WARNING For optimum stability always lower the incubator to its lowest position prior to transport Make sure the swivel monitor shelves are empty Failure to do so could result in personal injury or equipment damage A WARNING Always tighten the knob for securing the position of the shelf when in use or after repositioning Failure to do so could result in personal injury or equipment damage A WARNING Always place the monitor in the center of the shelf Failure to do so could result in personal injury or equipment damage A WARNING Ensure that the monitor fits within the raised border of the shelf Failure to do so could result in personal injury or equipment damage A WARNING Never stack another monitor atop the monitor on the shelf Personal injury or equipment damage could occur Warning Labels IMPORTANT THIS INCUBATOR HAS BEEN SHIPPED
33. are easily ignited and burn with great intensity in air enriched with oxygen Personal injury or equipment damage could occur 4h 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 Oxygen Precautions 4h WARNING Improper use of supplemental oxygen may be associated with serious side effects including blindness brain damage and death The risks vary with each infant The method the concentration and the duration of oxygen administration should be prescribed by the attending physician 4h WARNING If itis necessary to administer oxygen in an emergency notify the attending physician immediately 4h WARNING The oxygen concentration inspired by an infant does not predictably determine the partial pressure of oxygen pO in the blood When deemed advisable by the attending physician measure blood pO by accepted clinical techniques 4h WARNING Do not use oxygen flow rates as an accurate indication of oxygen concentrations in an incubator Measure oxygen concentrations with a calibrated oxygen analyzer at intervals directed by the attending physician Failure to do so could result in personal injury or equipment damage 4h WARNING A dirty air intake filter may increase oxygen concentrations and cause carbon dioxide build up Personal injury or equipment damage could occur A WARNING
34. ation Temperature overshoot Temperature uniformity 1 0 C 08 ICE ity Correlation of indicated air temperature to actual incubator temperature after steady temperature condition is reached 0 8 C IEC CE units Correlation of indicated air temperature to set 0 5 C temperature Air Mode Correlation of indicated air temperature to set temperature Baby Mode Model C450 QT Isolette Infant Incubator only Oxygen concentration range 21 to 65 or greater Humidity with no supplemental oxygen set Typically between 50 and 60 with water in the temperature gt 32 C and ambient temperature humidity reservoir at 20 C to 30 C Height from floor mounted on cabinet stand 137 cm 53 75 4 om 55 ECICE unit 53 cm 21 without guard rail 56 cm 22 with guard rail 115 cm 45 with guard rail mounted on cabinet stand Mattress dimensions 63 cm 24 8 x 34 8 cm 13 7 Mattress tilt Trendelenburg Reverse 0 to 9 I continuously variable Trendelenburg Feature Dimension Noise level within the hood environment 60 dBA or less 10 cm 4 above center mattress in surroundings of 39 dBA or less 80 dBA or less with an alarm sounding Air velocity over mattress Does not exceed 25 cm s 11 s within the Control Zone Carbon dioxide CO within the hood 0 5 when a 4 mixture of CO in the air is delivered at 740 ml min at a point 10 cm 4 above the center of
35. attery before first use of the incubator and after the incubator has been out of operation for an extended period of time 1 Operate the unit for a period of 10 to 24 hours 2 Trigger a power failure alarm by disconnecting the AC power cord from the wall The power failure alarm activates and continues to alarm for at least 10 minutes 3 Plug the unit into the AC line and charge the battery Replacement Parts This section lists parts that you can replace Parts not listed here should be replaced by qualified service personnel Replacement Parts Part Number MU Number Description 68 209 81 MU06956 Probe auxiliary air temperature C4 C5 68 209 70 MU06951 Probe 1 temperature skin reusable 68 526 40 MU08323 Heat shield rear International Electrotechnical Commission IEC high C450 having QT features 68 232 22 R Heat shield top extra large Replacement slotted mattress tray French C450 Single Use Items Part Number MU Number Description 6 12 Options 68 410 70CC MU07783 Guard rail assembly C400 450 68 452 70 MU08068 IV pole assembly standard cabinet stand model only Cabinet stand assembly C400 450 Rail System Monitor shelf assembly 12 x 16 68 408 30 MU07752 IV tree assembly 68 408 40 MU07756 Stub mount assembly double Storage and Handling Storage Store the incubator under the following conditions Temperature range 30 C 22 F to 70 C 158 F ambient H
36. automatically controlled within 0 3 C of the Set Temp C display as indicated by the Baby Temperature C display The number of Heater Power lights illuminated provides an indication of the amount of heater output required to maintain the baby temperature The Baby Temperature C display indicates the skin probe temperature The Air Temperature C display indicates the actual incubator air temperature necessary to maintain the baby temperature Oxygen Therapy 4h WARNING Improper use of supplemental oxygen can cause serious side effects including blindness brain damage and death The risks vary with each infant The attending physician should prescribe the method the concentration and the duration of oxygen administration A WARNING Administration of oxygen may increase the noise level for the patient within the incubator Infant injury could occur 4h WARNING If itis necessary to administer oxygen in an emergency notify the attending physician immediately Failure to do so could result in personal injury or equipment damage 1 Properly administer oxygen from a wall source or the oxygen cylinder on the standard incubator cabinet stand If it is necessary to administer oxygen in an emergency notify the attending physician immediately A WARNING The oxygen concentration inspired by an infant does not predictably determine the partial pressure of oxygen pO in the blood When deemed advisable by the attending physi
37. azing of the clear acrylic hood Do not use alcohol for cleaning A CAUTION Do not expose the hood assembly to direct radiation from germicidal lamps Ultraviolet radiation from these sources can cause cracking of gaskets fading of paint and crazing of the clear acrylic hood 2 Do not use alcohol or germicidal lamps to clean the hood 3 Clean all holes indentations baffles etc 4 Dry with a clean cloth or paper towel Cleaning the Air Intake Microfilter Chamber 1 Do not attempt to clean or reverse the microfilter A WARNING A dirty intake filter may affect oxygen concentration and or cause carbon dioxide build up Check the filter on a routine basis commensurate with local conditions 2 If the air intake microfilter is visibly dirty or older than 3 months replace it 3 Before installing a new filter clean the microfilter chamber and its cover with the detergent disinfectant Assembly After Cleaning Specific assemblies inner walls main deck mattress tilt mechanisms oval gaskets are not interchangeable between the Models C100 C200 C500 550 and the C400 QT and C450 QT Isolette Infant Incubator 1 Verify proper identification of components prior to assembly 2 Install the air intake tube into the base assembly 3 Insert the humidity chamber baffle into the humidity chamber WARNING For proper operation install the deck plate Failure to do so could result in personal injury or equipment damage
38. can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter s manufacturer NOTE At 80 MHz and 800 MHZ the higher frequency range applies NOTE The industrial scientific and medical ISM bands between 150 kHz and 80 MHz are 6765 MHz to 6795 0 12 m 0 38 m 1 2m 0 01 W 0 1 W 1 W 0 12 m 0 38 m 1 2 m MHz 13553 MHz to 13567 MHz 26957 MHz to 27283 MHz and 4066 MHz to 4070 MHz NOTE An additional factor of 10 3 1s used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Section 3 Precautions and Safety Tips Precautions Electrical Precautions SHOCK HAZARD N To ensure grounding reliability plug the AC power cord only into a properly grounded three 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
39. cates the Temperature Override Mode gt 37 C selection key Temperature Override Mode gt 37 C Selection Key The symbol below indicates the Temperature Override Mode gt 37 C indicator Temperature Override Mode gt 37 C Indicator 37 The symbol below indicates the Silence Reset switch Silence Reset D The symbol below indicates the Power Off On switch Power Off On O The symbol below indicates that the cabinet stand doors must remain closed to minimize the risk of tipping during transport Cabinet Stand Doors Must Remain Closed The symbol below indicates a sensitivity to ELECTROSTATIC DISCHARGE ESD Electrostatic Discharge ESD La The symbol below indicates the surface could be hot Caution Hot Surface A Technical Definitions Control zone A plane 10 cm 4 above the mattress with an area defined by the center of four quadrants formed by lines that divide the width and length of the mattress surface Incubator temperature The air temperature at a point 10 cm 4 above and centered over the mattress surface Average incubator temperature The average of the maximum and minimum incubator temperature achieved during steady temperature condition Steady temperature condition The condition reached when the average incubator temperature does not vary more than 0 5 C over a period of 1 hour Temperature overshoot The amount by which the incubator temperature exceeds the average in
40. change it at least every three months 25 Check the air intake microfilter a b C d 26 Check the air oxygen system a 27 Check Air Mode a Loosen the two thumbscrews of the air intake filter cover Remove the air intake filter cover Inspect the microfilter If the microfilter is visibly dirty replace it Introduce a carefully measured 8 Ipm of oxygen into the optional oxygen input valve Monitor levels within the hood to verify that they reach the predicted level as indicated on the filter cover assembly With all access openings closed allow the incubator to warm up to the Set Temp C display setting of 33 0 C 91 4 F It should take less than 1 hour While the unit is warming up suspend the auxiliary probe through the hole in the top of the incubator hood and position the patient probe on the center of the mattress surface Do not connect the probe plugs to the receptacles When the Air Temperature C display has stabilized the number of Heater Power indicators illuminated typically reduce to no more than two Check that the Air Temperature C display remains within 0 5 C 0 9 F of the Set Temp C display for 15 min after stabilization 28 Check the auxiliary probe Insert the auxiliary probe connector into the Auxiliary Air Probe receptacle When the Air Temperature C display has stabilized the number of Heater Power indicators illuminated typically reduce to n
41. cian measure blood pO by accepted clinical techniques Failure to do so could result in personal injury or equipment damage 2 When deemed advisable by the attending physician measure the blood pO by accepted clinical techniques Refer to the current edition of Guidelines for Perinatal Care of the American Academy of Pediatrics The American College of Obstetricians and Gynecologists A WARNING The use of external humidification will alter predicted incubator oxygen concentrations Personal injury could occur 3 Do not use external humidification 4 Connect the output of the oxygen flowmeter to the nipple of the optional oxygen input valve by using 3 16 inner diameter surgical tubing i NOTE An oxygen concentration guide is provided on the air input filter cover on the back of the incubator 4h WARNING When administering oxygen therapy by means other than the rear panel oxygen i input valve the oxygen concentrations guide vales identified are not valid Independently measure the oxygen concentrations to verify delivery of the prescribed oxygen concentration Failure to do so could result in personal injury or equipment damage 5 When administering oxygen therapy by means other than the rear panel oxygen input valve the oxygen concentrations guide values identified are not valid To verify delivery of the prescribed oxygen concentration independently measure the oxygen concentrations NOTE The values shown
42. cian should prescribe the temperature control mode and temperature settings 13 Routinely monitor the infant s rectal and or auxiliary temperature according to the attending physician s orders or the nursery standing orders 14 Select the temperature control mode Air or Baby For instructions on using Air Mode go to Air Mode on page 5 3 For instructions on using Baby Mode go to Baby Mode on page 5 4 Air Mode To Select Use the Up and Down arrows to set the Set Temp C display to the prescribed temperature The Set Temperature LO alarm is silenced for up to 60 minutes after the incubator is turned on or until the selected set temperature 1s reached Once stabilized the incubator temperature is maintained within 0 5 C 0 9 F of the Set Temp C If you change the set temperature either high or low after the incubator is in operation the Set Temperature LO and HI alarms automatically silence for a specific amount of time after the change The time the alarm remains silent is 5 min per degree plus or minus from the current incubator temperature For example a 1 5 change from set temperature generates an alarm silence period of 7 5 min If the incubator fails to reach the new set temperature after the specified time the alarm sounds The number of Heater Power lights illuminated provides an indication of the amount of heater output required to maintain the incubator air temperature The Air Temperature C display i
43. cubator temperature during steady temperature condition resulting from a change in temperature Temperature rise time The time required for the incubator temperature to rise 11 C 20 F Temperature uniformity The amount by which the average temperature at each of four points 10 cm 4 above the mattress surface differs from the average incubator temperature at steady temperature condition The four points are the centers of four quadrants formed by lines that divide the width and length of the mattress surface Temperature variation The difference between the incubator temperature and the average incubator temperature during steady temperature condition Intended Use This manual provides instructions for installation use operator maintenance and troubleshooting of the Model C400 discontinued January 2005 and C450 Isolette Infant Incubator having QT features CE Mark version 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 of the manual or makes any repairs with unauthorized components Only qualified service personnel should perform calibration and repair Technical information 1s available through your local distributor All personnel who will be working with the unit should read thoroughly understand and have ready access to this manual Store the manual on the shelf in the c
44. d the hole in the top of the hood used with the optional sling weighing scale could show up on the x ray as a radiolucent shadow and could result in incorrect diagnosis Personal injury could occur 4h WARNING To prevent harm to the infant do not raise the hood while leads or tubing are connected to the infant or if the mattress is tilted There should be no need to raise the hood at any time while the infant is cared for in the incubator Gain access to the infant by the access panel and access doors 4h WARNING The use of infant seats head hoods or other accessories within the incubator that can alter the air flow 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 A WARNING Do not lubricate the mattress tilt mechanism with oil or other potentially flammable material Flammability is enhanced in an oxygen enriched environment Personal injury or equipment damage could occur A WARNING Be sure that all the thumbscrews that secure the mattress tilt mechanism to the deck are fully tightened to ensure mattress tray stability Failure to do so could result in personal injury or equipment damage A WARNING To minimize the risk of tipping during transport keep the standard cabinet stand doors closed during transport A WARNING If the incubator is equipped with a rail syst
45. d on the unit automatically goes through an alarm check sequence to verify proper alarm function After the automatic alarm check the low Set Temp alarm is disabled for 60 min or until the temperature reaches the Set Temp C setting whichever occurs first Each of these alarms is described below Air Flow A sensor located below deck in the normal air path of the fan controls this alarm If air flow stops due to a fan failure the temperature of the self heated sensor rises causing the Air Flow alarm indicator on the front panel to light and produce a pulsating tone A short circuited air flow sensor failure also actuates the alarm within 10 s of the failure This alarm 1s not self resetting and cannot be silenced or canceled by the Silence Reset key until the alarm condition is corrected High Temperature A second sensor within the air temperature probe sounds this alarm if the incubator temperature reaches 39 5 C 0 5 C 103 1 F 0 9 F A solid light and a pulsing tone indicate a High Temperature alarm This alarm is not self resetting and cannot be canceled by the Silence Reset key until the alarm condition is corrected Power Failure If primary power to the incubator is interrupted for any reason including a disconnected power cord an audible alarm is activated and the Power Fail indicator lights To silence this alarm for two min press the Silence Reset key To deactivate this alarm restore the primary power or set the inc
46. ed the controller High oxygen concentrations are The air intake microfilter is Replace the air intake filter determined dirty The air intake tube 1s not Install the air 1ntake filter installed The filter is not installed If necessary check and install the filter The fan impeller is dirty Clean the fan impeller 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 Customer Support D 23542 L beck 800 437 2437 Tel 4449 451 882 0 http www draegermedical com Fax 49 451 882 2080 Technical Support 800 437 2437 http www draeger com Fax 215 721 5782 Technical Support 49 1805 372 3437 Fax 4449 451 882 3779 Part number Revisions Date 68 994 40 MU08974 8 August 2005 0123 Care For Me is a trademark of Draeger Medical Infant Care Inc Critter Covers is a registered trademark of Draeger Medical Infant Care Inc Dew ette 2 is a registered trademark of Draeger Medical Infant Care Inc lsolette is a registered trademark of Draeger Medical Infant Care Inc Kleenaseptic is a registered trademark of Metrex Research Corporation Kleenaseptic B is a trademark of Metrex Research Corporation QT is a registered trademark of Draeger Medical Infant Care Inc Draeger Medical Infant Care Inc reserves the right to make changes without
47. em to avoid tip over or mechanical damage the maximum weight allowed for equipment placed on the rail system shelf is 22 7 kg 50 0 Ib The total permissible weight load for both rails combined is 45 kg 99 Ib 4h WARNING Phototherapy lamps placed over the top of the incubator hood may interfere with upward travel of the VHA stand To prevent this interference always remove the phototherapy lamp prior to repositioning the elevator Failure to do so could result in personal injury or equipment damage 4h WARNING Never place objects taller than the top of the wheel casters beneath the incubator stand Placement of these objects here could interfere with stability or operation of the VHA stand Personal injury or equipment damage could occur 4h WARNING To avoid possible tip over or damage to adjacent carts IV stands shelves etc keep at least a 30 cm 12 perimeter area around the variable height adjustable stand Failure to do so could result in personal injury or equipment damage A WARNING For optimum incubator stability always lock at least two of four variable height adjustable stand wheels during use Failure to do so could result in personal injury or equipment damage 4h 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 Failure to do so could result in personal
48. 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 1HAO936 4h WARNING Do not use equipment adjacent to other devices unless verification of normal operation in the configuration in which it is to be used can be achieved Infant injury personal injury or equipment damage could occur Safety Tips 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 4h WARNING Only properly trained personnel should use the incubator as directed by an appropriately qualified attending physician aware of currently known hazards and benefits Incubator misuse may result in harm to an infant 4h WARNING Do not use the incubator if it fails to function properly Refer service to qualified personnel Failure to do so could result in personal injury or equipment damage 4h WARNING If the access panel is left open the mattress temperature may rise above preset level Therefore do not leave the access panel open longer than essential When the access panel is open do not rely on the temperature indicator Personal injury or equipment damage could Occur
49. he auxiliary and patient probes 36 If the incubator 1s to be used place it in Air Mode and leave the incubator running until ready for use 37 If the incubator is not going to be used shut it off NOTES Section 5 Instructions for Use Instructions for Use 4h WARNING Phototherapy units located too close to the incubator may affect the hood wall temperature incubator temperature and infant skin temperature Personal injury could occur 1 Do not place phototherapy units too close to the incubator 4h WARNING If the incubator is on a variable height adjustable stand phototherapy lamps placed over the top of the incubator hood can interfere with the elevator positioning and monitor shelf placement To prevent this interference always remove the phototherapy lamp prior to positioning the elevator Failure to do so could result in personal injury or equipment damage 2 Remove the phototherapy lamp before positioning the elevator 4h WARNING For optimum stability always lower the incubator to its lowest position prior to transport and remove the monitors from the swivel shelves Failure to do so could result in personal injury or equipment damage 3 Before moving the incubator lower it to its lowest position and remove monitors from the swivel shelves 4h WARNING If leads or tubing are connected to the infant raising the hood or tilting the mattress tray could result in harm to the infant There should be no need
50. he groove in SINN the gasket NOTE ACCESS DOOR 9 When installed correctly the cuff has a small opening at its center GASKET GOES OH the access door latches with slight pressure and opens when the latch lever is pressed 16 Install the hood inner wall 17 Install a new air intake microfilter if necessary a Install the air intake microfilter cover b Tighten the two thumbscrews c Ifa new filter is installed write the date on the place provided on the cover 18 Check that incubator is securely clamped to the stand The locking bar should be approximately horizontal when the locking bar is released and the clamp is engaged in the retainer on the incubator 19 Perform a complete functional checkout procedure before returning the unit to service see General Operation and Functional Checkout Procedure on page 4 5 Maintenance 4h WARNING Only facility authorized personnel should perform preventive maintenance on the Isolette Infant Incubator Preventive maintenance performed by unauthorized personnel could result in personal injury or equipment damage Facility authorized personnel should perform calibration procedures at 12 month intervals Refer to Model C400 QT and C450 QT Isolette Infant Incubator Service Manual man203 MUO0925 NOTE For disposal of consumable materials see Disposal on page 6 13 Power Failure Alarm Battery Maintenance Check the condition of the power failure alarm b
51. he power frequency magnetic fields should be at levels characteristic of a magnetic field IEC typical location in a typical commercial or 61000 4 8 hospital environment NOTE Uy is the AC mains voltage prior to the application of the test level Power frequency 50 60 Hz 12 Guidance and Manufacturer s Declaration Electromagnetic Immunity The C400 QT and C450 QT Air Shields Isolette Infant Incubator is intended for use in the electromagnetic environ ment specified below The customer or user of the unit 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 RF communication equipment should be used no closer to any part of the C400 QT and C450 QT Air Shields Iso lette Infant Incubator including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Conducted 3 Vrms RF IEC 150 kHz to 80 d 124P 61000 4 6 MHz outside ISM bands 10 Vrms 10 Vrms 150 kHz to 80 MHz in ISM bands Radiated 10 V m RF IEC 124p 61000 4 3 80 MHz to 800 MHz 80 MHz to 2 5 GHz d 2 34P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separa
52. humidity reservoir Always drain it completely before refilling NOTE A single filling is enough for at least one full day of operation Relative humidity inside the incubator is typically at 50 to 60 under these conditions 4 If the attending physician prescribes additional humidification fill the humidity reservoir with 2200 cc of sterile distilled water Controls Indicators and Connectors Access Door O Release Latch Access Panel Release Latch Iris Entry Port Tubing Actess Grommet solette Humidity Pipe Hood Handle Mattress Tilt Handles Caster Lock Incubator Handles Latches and Openings Hood lift handle Use the hood lift handle to lift the hood assembly for cleaning or maintenance Hood hinge latch Located on the right rear corner of the incubator the hood hinge latch is used to latch the hood assembly in the open position Press to fasten Mattress tilt handles Use the mattress tilt handles to position the mattress in Trendelenburg or Reverse Trendelenburg position The angle of the mattress is variable from 0 9 Rotate clockwise to raise the mattress and counter clockwise to lower the mattress Iris entry port The iris entry port provides access to the infant compartment Access door release The access door release latch releases and latches the latch access door Access panel release Rotate the access panel release latch to latch or release latch the access
53. ically locks after approximately 15 s of no keypad activity Up and Down arrow In Air Mode press the Up arrow to raise the Set Temp C temperature setting from 20 C 68 F to 37 C 99 F In N Temperature Override Mode press the Down arrow to raise the Set Temp C temperature setting from 20 C 68 F to 38 5 C 101 3 F Press the Down arrow to lower the Set Temp C temperature setting from 37 C 99 F to 20 C 68 F In Temperature Override Mode press the Down arrow to lower the Set Temp C temperature setting from 38 5 C 101 3 F to 20 C 68 F In Baby Mode Model C450 QT Isolette Infant Incubator only press the Up arrow to raise the Set Temp C temperature setting from 34 C 93 F to 37 C 99 F In Temperature Override Mode press the Up arrow to raise the Set Temp C temperature setting from 34 C 93 F to 37 9 C 100 2 F Press the Down arrow to lower the Set Temp C temperature setting from 37 C 99 F to 34 C 93 F In Temperature Override Mode press the Down arrow lower the Set Temp C temperature setting from 37 9 C 100 2 F to 34 C 93 F To raise the Set Temp C temperature setting in 0 1 increments press the Up arrow once To raise the Set Temp C temperature setting rapidly press and hold the Up arrow To lower the Set Temp C temperature setting in 0 1 increments press the Down arrow once To lower the Set Temp C temperature setting rapidly press and hold the
54. lter and filter cover on the rear of the unit If the unit 1s to be equipped with a Dew ette 2 Incubator Humidifier Model DH90 2 refer to the Dew ette 2 Incubator Humidifier User Manual and install the special air filter 10 Connect the power cord to the incubator Incubators Equipped with a Variable Height Adjustable VHA Stand discontinued Jan 2005 NOTE Before proceeding with incubator assembly remove DOUBLE STICK TAPE FROM STAND LEGS remove the backing from the double stick tape on the legs of the VHA stand Place the base covers over the legs and press down firmly on all corners f 4h WARNING To prevent injury or damage to the incubator stand two persons of sufficient strength are required to adequately control the incubator when transporting it 4h WARNING For optimum stability always lower the incubator to its lowest position prior to transport Failure to do so could result in personal injury or equipment damage 1 Remove the controller from the incubator 2 Attach the guard rail to the underside of the base assembly using the six bolts and keps nuts supplied 3 Place the guard rail and base assembly on the variable height adjustable VHA stand 4h WARNING securely attach the incubator to the variable height adjustable stand using the clamps provided Failure to do so could result in the incubator separating from the stand if sufficiently tilted particularly with the hood open
55. move the tube from the base assembly 8 Remove the disposable access door cuff from each access door gasket by pulling it off from the outside _ i E 9 Discard the disposable access door cuffs 10 Remove the access door gaskets by pulling them free 11 Remove the tubing access grommets from each side of the hood by pulling them free 12 Remove the disposable iris entry port sleeves by pulling each one off the retainer rings 13 Discard the disposable iris entry port sleeves 14 Remove the air intake microfilter cover by loosening the two thumbscrews Cleaning Use an intermediate level tuberculocidal detergent disinfectant registered by the U S Environmental Protection Agency EPA such as KleenasepticO BTM Germicidal Cleanser When using any cleaning agent follow the manufacturer s directions for use After removing all solid wastes and contaminants from the disassembled parts clean them as follows Cleaning the Skin Probe Model C450 QT Isolette Infant Incubator Only 1 Use the disinfectant detergent to thoroughly clean all surfaces 2 Dry with a clean cloth or paper towel 1 Kleenaseptic is a registered trademark of Metrex Research Corporation 2 Kleenaseptic B is a trademark of Metrex Research Corporation Cleaning the Humidity Chamber and Fill Pipe Air Intake Tube Access Door Gaskets and Tubing Access Gaskets I r Fill the humidity chamber with the disinfectant detergent Remove the
56. nclude e Filter Cover with O Limiter e Filter Cover with Dew ette 2 Incubator Humidifier Accessories Accessories available for use with the Isolette Infant Incubator include Cabinet Stand standard e Guard Rail Micro Lite Phototherapy System Dew ette 2 Incubator Humidifier e Remote Alarm Module e Warm Weigh Infant Scale Model I20 Monitor Shelf Package e Utility Pole Assembly e V Tree Assembly e Oxygen Flowmeter Kit e Rail System Specifications Specifications for the Isolette Infant Incubator are provided All specifications are subject to change without notice Opening access doors or panels or using infant seats head hoods or other equipment or supplies within the incubator which can alter the air flow pattern may affect temperature uniformity temperature variability the correlation of the incubator temperature reading to center mattress temperature and infant skin temperature Standard Features Feature Dimension 2809 10 50760 He S00 W maximum itv 10 SG Hz 500 W maximum Sess than 100 uA Vo SSS S Air Mode temperature control range 20 C 68 F to 37 C 99 F 37 C 99 F to 38 5 C 101 3 F in Temperature Override Mode 34 C 93 F to 37 C 99 F 37 C 99 F to Baby Mode temperature control range Model C450 QT Isolette Infant Incubator 37 9 C 100 2 F in Temperature Override Mode only Temperature rise time Temperature vari
57. nd and a momentary up down foot switch controls the electric motor The VHA stand has its own power cord and provides power to the incubator that is mounted on it In addition if the VHA stand circuit breakers open power 1s still provided to the incubator which is protected by its own circuit breakers Accessories Accessories available for use with the incubators are illustrated For part numbers refer to Replacement Parts on page 6 12 Accessories Monitor Shelf Utility Pole Micro Lite amp Phototherapy AAA passum AA A a P m d i cn Double Stub ette 2 mount Humidifier Guard Rail 7 y Rail System VHA Stand and Cabinets discontinued JadBDO5 Cabinets and Drawers The incubators are equipped with a standard cabinet stand or a VHA stand discontinued Jan 2005 The cabinet is available with a metal door The VHA stand may be equipped with one or two cabinet or drawer modules or one of each These modules may also be equipped with fold down side shelves Swivel Shelves The cabinet stand or VHA stand may be equipped with up to four post mounted swivel shelves The swivel shelves operate the same way on both stands To Position the Swivel Shelves 1 Loosen the knob 2 Position the shelf to the desired position 4h WARNING Always tighten the knob for securing the position of the shelf when in use or after repositioning Failure to do so could result
58. ndicates the incubator temperature On the Model C450 QT Isolette Infant Incubator if the patient probe is connected to the patient probe receptacle the Baby Temperature C display indicates but does not control the baby temperature Otherwise this display is blank Auxiliary Air Probe NOTE The High Temperature alarm and the Air Temperature C display still use the probe below the deck If desired use the auxiliary air probe in Air Mode to control the incubator temperature rather than the probe below the main deck 1 Insert the probe end through the hole on the top of the hood 4h WARNING For proper temperature control the auxiliary air probe must be directly beneath the hole in the hood Do not operate the incubator with the auxiliary air probe outside the incubator or other than as recommended Overheating will occur and personal injury could result 2 Make sure the probe hangs freely inside the incubator 4h WARNING If the auxiliary air probe contacts the infant s skin when the mattress is in the Trendelenburg Reverse Trendelenburg position erratic air temperature control can result Always ensure that the probe tip does not contact the infant Doing so could result in personal injury or equipment damage 3 To use the probe insert its plug into the auxiliary air probe receptacle Baby Mode 1 Connect the plug of the skin temperature probe to the patient probe receptacle 2 Insert the probe into the hood
59. ndicators light the alarm pulses and each digital display shows 8 12 If any function does not occur or the digital display is missing a segment refer the unit to service 13 Set the Set Temperature C display to 33 0 C 91 4 F All five Heater Power indicators light indicating full heater output 14 Allow the unit to operate while continuing the operational checkout 15 Check the hood hinge and latch operation for proper positioning lt lt a Using the hood lift handle slowly tilt the hood back until the hood latch engages b Close the hood by releasing the hood latch 16 Check the access panel detent a Rotate both latch releases inwardly and open the access panel The air curtain cover rises slightly as the access panel opens and the detents create a noticeable drag during initial movement of the panel non IEC units only b Pivot the access panel to the full open position that is hanging straight down 17 Check the iris entry ports Rotate the outer ring of each iris port The iris opens and closes as rotation 1s continued through 360 18 Check the access panel latches a Close the access panel b Rotate both latches until fully engaged Both latches must fully engage to avoid accidental opening of the access panel 19 Check the access door latch a Press the door release of each access door Each access door swings open b Close the access doors c Check for pr
60. notice in design specifi cations and models The only warranty Draeger Medical Infant Care Inc makes is the express 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 O 2005 by Draeger Medical Infant Care Inc ALL RIGHTS RESERVED
61. ntact The floors should be wood concrete or discharge ESD 8 kV air 8 kV air ceramic tile If floors are covered with IEC 61000 4 2 synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital 2 kV for power supply lines 2 kV for power supply lines Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 kV for input out put lines 1kV differential mode 2kV common mode lt 596 Ur gt 95 dip in Ur for 0 5 cycles 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 596 Ur gt 9596 dip in Uy for 5 seconds N A for input out put lines 1kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycles 40 U 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 seconds environment There are no I O cables for this product Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the unit requires continued operation during power mains interruptions it is recommended that the unit be powered from an uninterruptable power supply or battery T
62. o more than two Check that the Air Temperature C display remains within 0 5 C 0 9 F of the Set Temp C display for 15 min after stabilization 29 On the Model C450 QT Isolette Infant Incubator check Baby Mode a b Connect the patient probe plug to the Patient Probe receptacle and select Baby Mode Set the Set Temp C display to 36 0 C 96 8 F Locate the sensor to control air temperature above the center of the mattress If the Set Temperature alarm actuates press the Silence Reset key 30 On the Model C450 QT Isolette Infant Incubator check the Baby Set Temperature alarm a b Allow the incubator temperature to stabilize at 36 0 C 96 8 F Remove the patient probe from the incubator In approximately 15 s the Set Temperature LO alarm activates 31 On the Model C450 QT Isolette Infant Incubator check the Patient Probe alarm a Disconnect the patient probe from the receptacle The audible and visual alarms activates the Baby Temperature C display blanks and the Heater Power indicators all go off Connect the patient probe and press the Silence Reset key The incubator returns to normal operation 32 Check the air flow alarm de 2 amp 0 T Set the Power switch to off Remove the controller from the incubator Remove the fan impeller from the fan motor shaft Install the controller in the incubator Set the Power switch to ON and wait for the end
63. of the Auto Test cycle that takes 5 s Within 5 min the air flow indicator flashes a pulsating alarm sounds and all the Heater Power indicators go out Install the fan impeller and restore the incubator to normal operating condition before proceeding 33 Check the High Temperature alarm a b C d Select Air Mode and set the Set Temp C display to 36 0 C 96 8 F Position the probe end of the auxiliary probe outside the incubator Press the Keypad Lock key With the keypad locked simultaneously hold the gt 37 C key and the Up arrow key for 3 s NOTE The Baby Temperature C display shows and the Air Temperature C display shows the current incubator temperature and begins to rise e If the Set Temperature alarm actuates press the Silence Reset key NOTE When incubator temperature reaches 37 5 C 99 5 F 0 5 C the High Temperature indicator comes on and the alarm sounds f g h Press the Keypad Lock key to exit the High Temperature test mode Return the auxiliary probe to inside the incubator When the incubator temperature falls below 37 0 C 98 6 F press the Silence Reset key to cancel the High Temperature alarm 34 Check the oxygen input valve filter a b 10 Check the oxygen input valve filter cartridge once every four months Replace it if the ends are gray or black c Refer servicing to qualified service personnel 35 Disconnect and store t
64. oller heater can be sufficiently hot to cause burns Avoid removing the controller or touching the heater until the unit has been switched off for at least 45 min Personal injury could occur 1 After the incubator has been off for 45 min remove the controller a Disconnect the power cord and probes from the side of the incubator b Release the latch on each side of the controller c Withdraw the unit from the incubator 2 Remove the mattress tilt mechanism by loosening the thumbscrews that secure it to the main deck 3 Remove the hood inner walls a Release the front of the inner wall by pushing it back slightly to release the wall from the two stand offs located on the front of the hood b Remove the upper inner wall by lowering it c Remove the rear inner wall by first sliding out the mattress tray several inches d Raise the inner wall up to clear the key hole slots e Remove the wall from the incubator 4 Remove the mattress tray a Close the access panel b Latch the hood assembly in the open position Lift out the mattress tray P p Remove and discard the disposable mattress cover e Raise and then lock the hood in place 5 Remove the main deck 6 Remove the deck plate 7 Remove the air intake tube Grasp the air intake tube b Twist and pull it toward the front of the incubator until the end of the tube clears the gasket c Re
65. oncentration The motor driven impeller on the controller draws a controlled amount of room air approximately 35 litres per minute Ipm through the air intake filter Supplemental oxygen introduced through the oxygen input valve on the air intake filter cover displaces a portion of room air to maintain the total gas intake including oxygen at 35 lpm Since the impeller filter characteristics control the amount of room air and the flowmeter setting controls the amount of oxygen predictable oxygen concentrations within the incubator can be attained When oxygen flow exceeds 8 lpm a valve within the oxygen inlet housing restricts air intake so that a higher oxygen concentration can be achieved without excessive oxygen flow At 12 lpm maximum air intake restriction is achieved In addition to drawing fresh filtered air into the incubator the impeller internally recirculates at a much greater flow than that of the fresh gas inflow The total flow of fresh plus recirculated air is directed past the air flow sensor and around the heater with a predetermined portion being directed over the humidity reservoir for humidification When the access panel of the hood is closed the air curtain cover is closed and all the air enters the infant compartment up through the slot at the right end of the main deck After circulating within the infant compartment the air is then recirculated down through the slot 1n the left end of the main deck There i
66. oper latching and quietness 20 Ensure that all the thumbscrews that secure the mattress tilt mechanism to the deck are fully tightened to ensure mattress tray stability NOTE The mattress elevators are provided to permit the infant to be positioned in the Trendelenburg or Reverse Trendelenburg position 2 Do not elevate both ends of the mattress at the same time except possibly during magnification x ray procedures 22 Never leave the infant unattended while both elevators are raised 23 Check the mattress elevators 4h WARNING Do not lift the main deck or touch the heater when checking the mattress elevators The heater can be sufficiently hot to cause burns a Rotate the right mattress tilt mechanism handle clockwise until it stops The right end of the mattress is at a 9 angle 4h WARNING Do not attempt to raise the hood when the mattress is raised Personal injury or equipment damage could occur b Rotate the handle counterclockwise until it stops The mattress is level c Repeat the procedure using the left mattress handle TEN ica 24 Check the mattress tray a Slide the mattress tray out to the fully extended position b Lean on the mattress tray c Make sure it is properly supported to provide a firm platform for the infant A WARNING A dirty air intake microfilter may affect oxygen concentrations and or cause carbon dioxide build up Check the filter on a routine basis and
67. personnel must follow to avoid equipment damage e The symbol below highlights a CAUGHT HAZARD WARNING Caught Hazard Warning sil e The symbol below highlights a CHEMICAL HAZARD WARNING Chemical Hazard Warning ee e The symbol below highlights an ELECTRICAL SHOCK HAZARD WARNING Electrical Shock Hazard Warning Ar This product contains different icons designed to increase understanding Note the following examples e The symbol below indicates Attention Consult accompanying documents Attention Consult Accompanying Documents Type B Equipment with an F Type Floating Applied Part A e The symbol below indicates AC power AC Power e The symbol below indicates Protective earth ground Protective Earth Ground LD The symbol below indicates Air Mode Control indicator Air Mode Control Indicator aw Pe The symbol below indicates Air Mode Control selection key Air Mode Control Selection Key g ww The symbol below indicates Baby Mode Control indicator Baby Mode Control Indicator O UN e The symbol below indicates Baby Mode Control selection key Baby Mode Control Selection Key E The symbol below indicates the Keypad Lock key Keypad Lock Key The symbol below indicates the Keypad Lock indicator Keypad Lock Indicator E 9 The symbol below indicates the Set Temperature keys Set Temperature Keys OJO The symbol below indi
68. r Do not use excessive liquid or harsh cleansers At a minimum thoroughly clean and disinfect the incubator upon discharge of an infant However depending on individual facility policy perform cleaning procedures as often as daily 1f desired Cleaning can most effectively be accomplished by disassembling and then grouping the parts and or assemblies in categories according to the method of cleaning required Cleaning Agents When the equipment is not in use and it is disassembled use an intermediate level tuberculocidal detergent disinfectant registered by the US Environmental Protection Agency Disinfect only when the equipment is not in use and disassembled see Disassembly for Cleaning on page 6 2 When using any cleaning agent follow the manufacturer s directions for use Cleaning agents safe for use with this equipment include Kleenaseptic b cleaner or 2 glutaraldehyde solutions Dilute the disinfectant as specified on the manufacturer s label Before cleaning remove all solid wastes and contaminants from the disassembled parts Steam Cleaning Do not use any steam cleaning device on the unit Excessive moisture can damage mechanisms in this unit Cleaning Difficult to Access Areas To remove difficult spots or stains we recommend that you use standard household cleansers and a soft bristle brush To loosen heavy dried on soil you may first need to saturate the spot Cleaning Painted Surfaces Use an EPA registe
69. re alarm sounds and the Power Fail indicator lights This tests the operation of the Power Failure alarm circuit and ensures that the rechargeable battery that powers the circuit 1s in good condition 3 Press the Power switch a second time to silence the alarm 4 When the incubator is mounted on a standard cabinet stand plug the AC power cord directly into the incubator 44 CAUTION Connect the incubator power cord to the variable height adjustable stand receptacle to prevent accidental disconnection or damage when the incubator is raised or lowered 5 When the incubator is mounted on an optional variable height adjustable VHA stand plug the AC power cord into the VHA stand s AC power outlet 4 SHOCK HAZARD Make sure that the building power source is compatible with the electrical specifications shown on the right side of the incubator and variable height adjustable stand For proper grounding reliability plug the power cord only into a properly marked three wire hospital grade or hospital use receptacle Do not use extension cords Personal injury or equipment damage could occur 6 Check the building power source against the specifications on the right side of the incubator A WARNING To minimize the risk of tipping over during transport when the incubator is mounted on a standard cabinet stand keep the cabinet stand doors closed during transport Failure to do so could result in personal injury or equipment damage
70. red disinfectant detergent such as glutaraldehyde based cold sterilants and quarternary ammonium compound disinfectants to clean all surfaces thoroughly Make sure to clean all holes and indentations and then dry with a clean cloth or paper towel Cleaning Clear Plastic and Acrylic Surfaces A CAUTION Do not use alcohol acetone or any organic solvents for cleaning Alcohol can cause crazing of plastic and acrylic A CAUTION Do not expose plastic and acrylic to direct radiation from germicidal lamps Ultraviolet radiation from these sources can cause cracking and crazing of clear plastic and acrylic 1 Use an EPA registered disinfectant detergent such as glutaraldehyde based cold sterilants and quarternary ammonium compound disinfectants to clean all surfaces thoroughly Make sure to clean all holes and indentations 2 Dry with a clean cloth or paper towel Disinfecting When there is visible soilage and also between patient use we recommend that you disinfect the unit using an EPA registered tuberculocidal disinfectant Cleaning agents safe for use with this equipment include Kleenaseptic b cleaner or 2 glutaraldehyde solutions Dilute and use the disinfectant as specified on the manufacturer s label Disassembly for Cleaning NOTE For routine cleaning there is no need to separate the hood base assembly from the cabinet stand If separation is necessary refer to Installation on page 4 1 4h WARNING The contr
71. t goes past the temperature sensing probe which encapsulates the air temperature control thermistor and a high air temperature alarm thermistor and back to the 1mpeller When the access panel of the hood is open the air curtain cover is raised permitting a portion of the air to flow upward past the opening creating a warm air curtain which minimizes the drop in air temperature in the incubator Features Isolette amp Infant Incubator with Standard Cabinet Stand Standard Features Temperature Control On the Model C450 QT Isolette Infant Incubator temperature is regulated by using either incubator air or the infant s skin temperature as the controlling parameter A front panel key enables selection of the desired mode The Model C400 QT Isolette Infant Incubator discontinued January 2005 provides only Air Mode In either mode of operation the heater output is proportional to the amount of heat required to maintain the desired temperature and the relative amount of heat being provided is indicated by the number of lit Heater Power indicators on the front panel Changes in the number of lamps illuminated indicate the amount of power required to maintain a given temperature During Baby Mode the Model C450 QT Isolette amp Infant Incubator provides an indication of the degree of the infant s dependency upon the temperature of its environment to maintain body temperature Air Mode In Air Mode the air temperature c
72. tandard Cabinet Stand 4h WARNING Two people are required to assemble the hood base assembly and the cabinet stand Failure to do so could result in personal injury or equipment damage 1 Remove the controller from the incubator 2 Attach the guard rail to the underside of the base assembly using the six 10 32 x V2 screws P N 99 042 01 and keps nuts P N 99 107 36 supplied 3 Install the grounding spring inside the controller opening using the six 6 32 x 3 8 screws and hex nuts supplied 4 Return the controller to the incubator 5 Place the guard rail and base assembly on the cabinet stand WARNING Attach the incubator to the cabinet stand using the clamps 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 6 8 Secure the hood base assembly to the cabinet stand using the clamp on each side of the cabinet stand Adjust the threaded clamp on the stand for positive latching The locking bar should be approximately horizontal when the clamp is engaged in the retainer Lock the clamp by rotating the locking bar to the vertical position NOTE This incubator has been shipped without a filter and filter cover assembly The filter cover assembly has been shipped in a separate carton Do not place the incubator into use until properly installed 9 Install the air fi
73. ter than 30 C to 31 C System fail Indicates a system failure Refer the unit to service immediately Silence Reset ED y Silence Silences the Set Temp audible alarm for 15 mins alarm silence is automatically overridden if a subsequent alarm occurs within the period of silence Reset Cancels High Temp Air Flow and Probe alarms if alarm condi tion no longer exists Model C450 QT only 2 10 Regulations Standards and Codes The Isolette Infant Incubator complies with the following safety standards and performance standards e EN 60601 1 7996 Medical Electrical Equipment Part 1 General Requirements for Safety including Amendments 1 and 2 e EN 60601 1 2 2001 Collateral Standard Electromagnetic Compatibility Requirements and Tests e EN 60601 2 19 7 990 Particular Requirements for the Safety of Baby Incubators including Amendment 1 e UL 60601 1 2003 Medical Electrical Equipment Part 1 General Requirements for Safety Directive 2002 96 EC of the European Parliament and of the Council of 2003 01 27 on Waste Electrical and Electronic Equipment WEEE Annex IV prEN 50419 Device Classification EN60601 Medical Electrical Equipment Part I General Requirements for Safety The C400 QT discontinued January 2005 or C450 QT Isolette Infant Incubator meets the requirements for the following classifications e Class I e Type BF e PX0O ordinary equipment Not AP e Continuous operation
74. tion distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the fol lowing symbol o NOTE At 80 MHz and 800 MHz the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The industrial scientific and medical ISM bands between 150 kHz and 80 MHz are 6765 MHz to 6795 MHz 13553 MHz to 13567 MHz 26957 MHz to 27283 MHz and 4066 MHz to 4070 MHz b The compliance levels in the ISM bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is advertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges c Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should
75. ubator Power switch to off System Fail If an internal malfunction is detected the System Fail indicator flashes and the alarm sounds This alarm is not resettable Refer the unit to qualified service personnel Probe Circuitry is provided to monitor the air skin and high temperature sensors for short circuits open circuits or disconnected conditions and the air flow sensor for an open condition The Probe alarm actuates within 10 s if the air flow sensor has an open circuit and the temperature sensed below the mattress deck 1s greater than approximately 30 C 86 F However if the temperature sensed below the mattress deck 1s less than that the alarm does not activate During warm up it can take anywhere from 15 to 30 min before the alarm actuates depending on the temperature setpoint and the ambient room temperature If the high set temperature is below 29 C 84 F the Probe alarm indicating an open circuited air flow sensor is not activated If a probe shorts except for the air flow probe or High Temperature alarm probe it also appears as a set temperature violation and the Set Temp alarm indicator lights This alarm is not self resetting and cannot be canceled by the Silence Reset key until the alarm condition is corrected If a Probe alarm occurs simultaneously with a Set Temp alarm a shorted probe is probably the true cause of the alarm since a shorted probe appears as a high temperature condition On the Model C450 QT
76. umidity range 0 to 99 relative humidity non condensing Operation Operate the incubator under the following conditions Temperature range 20 C 68 F to 30 C 86 F ambient e Humidity range 5 to 95 relative humidity non condensing Disposal This device 1s subject to EU Directive 2002 96 EC WEEE It is not registered for use in private households and may not be disposed of at municipal collection points for waste electrical and electronic equipment Drager Medical has authorized a firm to dispose of this device in the proper manner for more detailed information please contact your local Dr ger Medical organization Alternatively further information can be obtained from our national Drager Medical organization Notes Section 7 Troubleshooting Troubleshooting A WARNING Only facility authorized personnel should troubleshoot the Isolette amp Infant Incubator Troubleshooting by unauthorized personnel could result in personal injury or equipment damage If the fault cannot be localized remove the unit from use and refer servicing to factory trained or otherwise qualified personnel Troubleshooting No power and the Power Fail The Power switch is not on Press the Power switch alarm 1s not activated The Power Fail alarm is The circuit breakers are tripped Reset the circuit breakers activated The power cord is unplugged Make sure that the power cord is fully plugged into the wall stand
77. ure at the desired level Baby Mode Model C450 QT Isolette Infant Incubator Only In Baby Mode the infant s skin temperature can be maintained from 34 C 93 F to 37 C 99 F as indicated by the Skin Temp C display In Temperature Override Mode the temperature can be maintained from 37 C 99 F to 37 9 C 101 3 F A temperature sensing probe is attached directly to the infant s skin The information from the probe is supplied to the heater control circuitry which proportions the heater output to maintain the baby s temperature at the Set Temp C setting The actual baby temperature appears on the Baby Temperature C display The Set Temp C setting does not control air temperature while in Baby Mode but air temperature is still displayed The air temperature is still limited to 38 5 C 101 3 F If Air Mode is selected while the skin probe remains connected the Baby Temperature C display continues to display actual skin temperature but it does not control If the probe is disconnected from its receptacle during Baby Mode the Baby Temperature C display goes blank and a Probe alarm activates The high temperature alarm sensor within the air temperature probe remains in the circuit to limit the air temperature to less than 40 C 104 F Alarms Alarms are provided for power failure system failure inadequate air flow probe failure high temperature and variation from the set temperature Each time the unit is turne
78. us tute nda ee dri ee ten dui turpi pred idis dS ISA Res laton Standards and Codes o cu abc valet ob drole ale odd ERU Eats Deyico lasstHeAllOD ali Soa Oe bd ea qr He EAR ias Vota d RU e Electromagnetic Compatibility EMC Guidance and Manufacturer s Declaration Section 3 Precautions and Safety Tips Muse H0 TERR TETTE T TT T DIT T do A E EE Electrical Precautions s sid dao do and de do tas dO eR AN ES ra EOS VOR OE Me ep s Explosion PEreCauttOrs ia aea od os f ede ie up PN c e pc ea OXN Sen Preca oS za dvd ex er adr dara esa aote dal es Electromagnetic Compatibility Precautions 0 0 0 ccc eee eee Date PDS s acd cd dorsi a Be See an d duce eee d SWIVEL Monitor SNCIVES cia s boston cho xm RERO ORAS AE NR ma uc bruni PE MT Section 4 Installation and Assembly S 02 010 MENTO E EE OCT E E T NITET TU ae ew eee ETE ae A INSSCIMDIY rta a a A o aa oo d RE EE Incubators Equipped with the Standard Cabinet Stand 0 0 0 0 cee ee eee Incubators Equipped with a Variable Height Adjustable VHA Stand 4 3 Warm Weigh Infant Scale Model I20 Accessory 0 0 c eee eee 4 4 General Operation and Functional Checkout Procedure 0 0 000s ee eeee 4 5 Section 5 Instructions for Use Instructions TOP USE sean aba oe Reds AAA OS da oes Bates 5 1 AIEN Ode espese mes waa Sata AE aa os 5 3 T E E ANET RATON 5 3 Aa ary A PrOD a Sires canst A A dex oe A ee ees 5 3 Pab MOG nt

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