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International Biomedical AirBorne NxtGen Transport Incubator Service Manual

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  • Page 2 Servi ice M Manua hone: (51 12) 873-00 ax: (512) 873-9090 Mail: les@int-b bio.com ebsite: h http://www w.int-bio. .com ailing add dress: ternation al Biome edical 206 Cross s Park Dr. ustin, TX 78754 uthorized d represen ntative in n Europe for Regu ulatory Af ffairs: mergo Eu...
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  • Page 4: Table Of Contents

    TABLE OF CONTENTS GENERAL INFORMATION ....................... 15 1.1. Introduction ........................15 1.2. Intended Use ......................... 15 1.3. Classification ........................ 15 1.4. Safety Summary ......................15 1.5. Safety Notice ......................... 16 1.6. Important Safety Considerations ................. 16 1.7. Symbols ......................... 28 INITIAL SETUP .........................
  • Page 5 TABLE OF CONTENTS 6.4. Setup ..........................53 6.4.1. Skin Temperature Probes .................. 53 6.5. Admitting a Patient ....................... 60 6.5.1. Patient Positioning Straps Installation and Application ......... 61 MESSAGE CENTER ......................... 62 7.1. Indicators ........................62 7.2. Power off the Device ..................... 64 GENERAL ALARM INFORMATION ..................
  • Page 6 TABLE OF CONTENTS OBSERVATION LIGHT......................82 12.1. Introduction ........................82 12.2. Setup ..........................82 12.3. General Operation ......................83 12.3.1. Turning the Observation Light ON ..............84 12.3.2. Turning the Observation Light OFF ............... 85 12.3.3. Adjusting the Observation Light Intensity ............ 85 12.3.4.
  • Page 7 TABLE OF CONTENTS 19.1. Introduction ......................... 103 19.2. Pre-Use Checkout ....................... 103 19.2.1. Operational Check ..................103 19.2.2. Infant Chamber Check .................. 104 19.2.3. Mattress Tray Check ..................104 19.2.4. Light Bar ......................104 19.2.5. Accessories ....................104 19.2.6. Sensors and Cables ..................105 19.3.
  • Page 8 TABLE OF CONTENTS Operational Specifications ....................126 Pulse Oximeter Specifications (Optional Feature) ............. 126 Range ..........................126 Resolution ........................127 Sensor Peak Wavelengths ................... 127 Sensor Maximum Power Output ................. 127 Masimo Sensor Accuracy .................... 128 Nellcor Sensor Accuracy ..................... 131 Interfering Substances ....................
  • Page 9 TABLE OF CONTENTS This page intentionally left blank. Part No. 715-0132, Rev. C - 6 -...
  • Page 10 LA A NGUAG G E DIS SCLAIM M ER Par rt No. 715-013 3 2, Rev. C - 7 -...
  • Page 11 LA A NGUAG G E DIS SCLAIM M ER Par rt No. 715-013 3 2, Rev. C - 8 -...
  • Page 12 LA A NGUAG G E DIS SCLAIM M ER Par rt No. 715-013 3 2, Rev. C - 9 -...
  • Page 13 LA A NGUAG G E DIS SCLAIM M ER Par rt No. 715-013 3 2, Rev. C - 10 -...
  • Page 14 LA A NGUAG G E DIS SCLAIM M ER Par rt No. 715-013 3 2, Rev. C - 11 -...
  • Page 15 LA A NGUAG G E DIS SCLAIM M ER Par rt No. 715-013 3 2, Rev. C - 12 -...
  • Page 16 LA A NGUAG G E DIS SCLAIM M ER Par rt No. 715-013 3 2, Rev. C - 13 -...
  • Page 17 LANGUAGE DISCLAIMER This page intentionally left blank. Part No. 715-0132, Rev. C - 14 -...

  • Page 18: General Information

    NxtGen Transport Incubator. Read the NxtGen manual thoroughly to understand all instructions, warnings, cautions, and notes before operating the device. International Biomedical is not responsible for any malfunction due to improper use or service by unauthorized International Biomedical personnel.

  • Page 19: Safety Notice

    Any seriou us incident t that occurs s in relation to this dev vice should be reported d to Internation nal Biomedi ical and the e competen nt authority of the appr ropriate me ember state 1.5. Safety Not tice The Trans port Incuba ator has bee...
  • Page 20 As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Do not modify this equipment without proper authorization from International Biomedical. The NxtGen Transport Incubator should be used by appropriately trained personnel and under the direction of qualified medical staff familiar with currently known risks and benefits of the NxtGen Transport Incubator use.
  • Page 21 Stop using the device if it is defective, indicate on the device that it is out of order, and contact your provider or International Biomedical representative. Different alarm presets on the same or similar equipment in the same area could lead to operator confusion and patient danger.
  • Page 22 Do not place the pulse oximeter or accessories in any position that might cause it to fall on the patient. Misapplication of a PULSE OXIMETER PROBE with excessive pressure for prolonged periods can induce pressure injury. INTERFERING SUBSTANCES: Dyes or any substance containing dyes that change usual blood pigmentation may cause erroneous SpO readings.
  • Page 23 Incorrect use of the light or the use of parts and accessories that are not manufactured or supplied by International Biomedical can damage the light and may cause injury to the patient and/or operator. Do not look directly into the LEDs. During observation/phototherapy light use, always protect the patient’s eyes with eye shields or equivalent.
  • Page 24 Bilirubin Photoisomers may cause toxic effects. Intensive phototherapy may not be appropriate for all infants (i.e. preterm infants 1000 g). Refer to the jaundice management guidelines or regulations in your country to determine the best treatment path for neonatal hyperbilirubinemia; such as the AAP Guidelines (American Academy of Pediatrics Clinical Practice Guideline - Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation);...
  • Page 25 his Transpo ort Incubato or was calib rated with t the infant c hamber ori ginally sup plied. If thi s chamber xchanged fo or an infant chamber o of a differen nt configura ation or size e, the tempe erature cali bration will fected.
  • Page 26 Pulse Oximeter Pulse oximeter probes and cables are designed for use with specific monitors. Only use Masimo sensors and patient cables for Masimo pulse oximetry model. Only use Nellcor sensors and patient cables for Nellcor pulse oximetry model. Verify the compatibility of the monitor, sensor, and cable before use, otherwise patient injury can result.
  • Page 27 Route the observation light power cord carefully to keep out of patient’s reach. Oxygen Monitor Only use the approved International Biomedical cable and sensor for ambient oxygen monitoring. Use the ambient oxygen monitor when oxygen is delivered to the infant.

  • Page 28: Physical Description

    Do not allow sharp instruments to penetrate the mattress. Inspect surface before and after each use. Mattress should not be used if there is any sign of penetration or damage. Replace battery only with an International Biomedical part. Do not replace the battery unless properly trained.
  • Page 29 There are safety considerations that should be read and understood before use. The phototherapy unit uses a specific type of LED. Consult International Biomedical for repair and replacement of LEDs. Use of incorrect LEDs can adversely affect performance and/or damage the light.
  • Page 30 Ambient Oxygen Monitor If the submenu exit is touched during the O calibration process, the system will discard the current calibration information. The oxygen sensor utilizes an electrochemical reaction and once exposed to the environment, the oxygen sensor will begin its degradation process. Ambient oxygen monitor alarms will not be active during operator disabled state.

  • Page 31: Symbols

    1.7. Symbols The follow wing symbol s are used on the dev vice and its packaging Symbol Description Symbol Descrip ption Observatio on Light Type e BF Equipm ment (Indicates In ntensity) Patie ent Tempera ature Power b utton Recycle or D Dispose of Cham ber Temper...
  • Page 32 creen locked Screen Se ettings Timer Play Screen un nlocked Configure Timer R Reset Cancel Icon Timer Pa ause low alarm li Confirm Icon Date e/Time set ic Pre-Heat Menu rm Limits Ico Set high ala arm limit vent Log Ico Battery Icon nfiguration Ic...

  • Page 33: Initial Setup

    Warning Air Out tput xygen Outpu Blended Ga s Output ntilator Switc Valve O Open Pressu Valve Closed Measure ement nctional Ear Class II D Device ownload Ico INITIA AL SETUP 2.1. Unpacking g Instruction Open and remove the e outer pac ckaging mat terial.

  • Page 34: Mounting Provisions

    2.2. Mounting P Provisions Four moun nting points s on the bas se of the Nx xtGen Tran nsport Incub bator are pr rovided to mount the Transport Incubator to o an interfa ace that will l securely fi ix the Trans sport Incubator s system in a...

  • Page 35: System Overview

    SYSTE EM OVERV VIEW The Nx xtGen Tran nsport Incub bator is an electromec chanical sys stem design ned to ther mally suppo a neon natal patien nt during int tra-facility o or inter-facil ity transfer . The syste em may be used withi the ho spital, in tra...

  • Page 36: Rear Electronics Panel

    3.1.2. Rea ar Electron nics Panel Figure 3-3 Figure 3- umber escription Battery AC Powe er Input Co nnector External DC Power Output Co onnector External DC Power Input Conn nector AC Fuse es (2 ) Data Key y Receptac DC Circu uit Breaker (Output Po...

  • Page 37: Patient Connector Panel (Located On Left Or Right End Panel)

    3.1.3. Pat tient Conne ector Pane el (Located d on left or r right end panel) Figure 3-5 Figure 3- umber escription Observati ion Light Co onnector (O Optional: O bservation/ /Photothera Light Bar) Pulse Oxi imeter Con nector (Op tional: Mas simo, Nellco or, or None...

  • Page 38: Battery Power

    3.2.3. Bat ttery Powe tery power will automa atically be s selected wh hen neither r AC power nor DC wer are ava ilable. Whe en operatin ng on intern nal battery, the Battery y Power indi cator will b e displayed d.

  • Page 39: Dc Power

    3.3.2. Ext ternal DC P Power power is su upplied thro ough the DC C cable with the listed p polarity. 3.3.3. Mu ltiple Sock ket Outlets gure 3-7 Figure 3- e multiple so ocket outle t supplies p power only when Exte rnal AC po wer is...

  • Page 40: Dc Power Outlet

    3.3.4. DC Power Ou utlet e DC power r outlet supp plies power r only en External DC power is connecte ed. The power outle et supplies up to 3 A o of current at th he same DC C voltage a as the exter rnal DC wer for conn...

  • Page 41: Infant Chamber Check

    If external DC power is to be used, check the DC power cord and ensure that it has no cuts or severe bends and that the connectors have not been damaged. Turn on suction device (if applicable) and ensure it operates. Turn off suction device.

  • Page 42: Pre-Heat Mode

    5.3. Pre-Heat M Mode Once the b boot up seq quence is c omplete, th he device w will enter Pre e-Heat mod de. Pre-He mode allow ws the devi ce to be wa armed to a predeterm ined set po oint and ma intain that s point indef...
  • Page 43 Administ trator Menu u Screens Administ trator Menu Access: To acces ss the admin nistrator menu, to ouch or use t the wheel to highlig ght and sele ct the 4 digit pas sword. Administ trator Menu Password: 1258 Once the e correct pas ssword is entered,...
  • Page 44 Alarm Lim mits: To chang ge the devic ce’s alarm limit pres sets, select t submenu u icons by to ouch or with the control whee Use the control whee el to adjust the icon’ s value. Confirm the value ch hange by pressing the control...
  • Page 45 Configur ration: To chang ge the config gured accessor ries or the P Pre-Heat Tempera ature set poi nt, select the subm menu icons b by touch or with the control whee Use the control whee el to adjust Pre-Heat t Temperatu ure set point’s va...
  • Page 46 PulseOx x - Masimo (O Optional): To chang ge the devic ce’s pulse oximetry y settings, se elect the submenu u icons by to ouch or with the control whee Use the control whee el to adjust the icon’ s value. Confirm the value ch hange by...

  • Page 47: Service Menu

    Administ trator Menu Exit: Touch th he return ico n to return to the Pr re-Heat scre If change es have bee en made, a dialog wi ill open befo transition ning to the P Pre-Heat screen. Touching g the confirm m icon will save all c changes ma...
  • Page 48 Service M Menu Featu res: 1. Subm menu Selecti ions 2. Retur rn Icon Clock: To chang ge the devic ce’s time and date e, select the submenu icons by touch or wit th the control w wheel. Use the control whee el to adjust the icon’...
  • Page 49 Heater C Calibration: The devi ice will heat chamber r to 36.0 C. This will take app proximately 4 minutes. Manual H Heater Calib bration: Use whe eel to change e the value on the sc creen to the temperat ture measur red by the calibratio...
  • Page 50 Fuel Gau uge Calibrat tion: Battery T Type Review t the “BATTER RY TYPE” widget a nd confirm t the type is correct. SLA (Se aled Lead A Acid) LiFePO ( (Lithium Iron Phospha ate) Battery Capacity To chang ge the devic ce’s battery capacity , select the s...
  • Page 51 Event Lo System e events will b displayed d in sequent tial order. The up a and down ar rows can be used to cycle thro ough older events. About: The devi ice’s total ac ctive time will be di isplayed.

  • Page 52: Normal Operation

    NORM MAL OPERA ATION To beg gin normal operation o of the devic e, touch an nywhere in the center circle to ex xit Pre-Heat mode and enter t the main sc creen. Figure 6-1 Main Scree Figure 6-2 rt No. 715-013 32, Rev.

  • Page 53: Main Screen Navigation

    6.1. Main Scre en Navigat Navigation n about the main scree en can be d done either by touch o or by highlig ghting and selecting a an icon with h the wheel . As a gen eral rule, if the icon is circular, it can be...
  • Page 54 Icon State Opera tor Disabled d State: The op perator has t the ability to o disable cert tain feature es of the dev vice, but not all features have t he ability to be disabled . The featur which can be disa bled are liste ed below.

  • Page 55: Thermal Operation

    6.2. Thermal O Operation User r Interface - Thermal Control D etails 1) T1 Temperatur re (Primary) 2) Air Controlled M Mode Icon 3) Ser rvo Controlle ed Mode Ico 4) Hea ater Power ( (0-100%) 5) T2 Temperatur re (Referenc 6) Set t Temperatu 7) Act...

  • Page 56: Thermal Control System Description

    6.3. Thermal C Control Syst tem Descrip ption The Trans port Incuba ator has two o methods to control a and maintai in temperat ture to an operator s elected set t point: air (manual) co ontrolled an nd servo (b baby) contro olled mode T1 is the p...
  • Page 57 The blue “X” will appe ear at the to p of the circle and an oran nge ring will appear ar round the cir rcle. Once i n the thermal s ubmenu, the e cursor will default to the set tem perature val lue.
  • Page 58 If Air Mod de is used fo or a prolonge period, a skin temper rature probe should be e used to clo osely monito r the patient’s t temperature e. Air Mode does not autom matically adju ust the heate output ba ased on the i nfant...
  • Page 59 hermal Con ntrol Opera ation - Serv v o (Baby) C C ontrol Mo o de Touch or use the whe eel to select center cir rcle and ente er the therma submenu The blue “X” will appe ear at the to p of the circle and an oran...
  • Page 60 Once the desired set point is reac ched, the opera ator can sele ect with the w wheel to confirm m and accep t the value. Ensure th he skin temp perature prob be is properly a attached. A secondary temperatu ure probe ca an be used t...
  • Page 61 Transitionin ng from Ai ir Control t t o Servo C C ontrol Mod d e Touch or use the whe eel to select center cir rcle and ente er the subme enu. Touch the e circular se rvo mode ico on or use the w wheel to high...
  • Page 62 Tran nsitioning f from Servo o Controlle e d to Air C C ontrolled M M ode Touch or use the whe eel to select center cir rcle and ente er the subme enu. Touch the e circular air r mode icon or use the whee l to highlight...

  • Page 63: Admitting A Patient

    6.5. Admitting a a Patient Once you are ready t to admit the e patient, to ouch or sele ect the “Tou uch to Start t” icon in th center of t he Pre-Hea at screen an nd the syst em will ente er normal o operation m...

  • Page 64: Patient Positioning Straps Installation And Application

    Push the patient tray back into th chamber until the tray y locks into position. Ensure the tray is locke ed by gently pu lling it towar rds you to ve erify the lock h has been eng gaged. Plug the t temperature e probe conn nector...

  • Page 65: Message Center

    Steps s to Apply Patient Po ositioning S Straps Remove two (2) pa irs of straps s from the p plastic pack kaging. Pull on a all tabs to e nsure their integrity. D Do not use if integrity i is comprom mised.
  • Page 66 The batte ery charge pe ercentage w will be shown ov ver the powe er off button for 3 seconds. ta storage Icon If the dev vice is storing g data to the e Data Key, the d data storage e icon will be displayed Time...

  • Page 67: Power Off The Device

    7.2. Power off the Device ysical Butt tons olding down the encoder r wheel for 1 0 seconds ll shut down the device. ccessible fro m the rear c center conso ole, holding e reset butto on for 5 seco onds will shu ut down the evice.

  • Page 68: General Alarm Information

    ouching the c cancel icon ( (X) will retur rn the perator to the e previous sc creen. ouching the a accept icon w will shut dow wn the evice. ouching the p pre-heat icon n will transiti ion the evice into pre e-heat mode GENE...
  • Page 69 High Alar If a high a alarm condit ion occurs, t alarm me essage will b be displayed the mess age center. The Alarm will flash red. The pa arameter tha at is in an alar rm state will be red, and if the high alarm m is associa...

  • Page 70: Alarm Dropdown

    8.2. Alarm Dro pdown 1. Alarm Dropdown Icon: If mult tiple alarms or alerts are signal ing simultan neously, the alarm dropd own icon (+) ) will appear r in the right h hand corner of the scree Touch the e alarm drop pdown icon ( (+) to...

  • Page 71: Alarm Audio Pause

    8.3. Alarm Aud dio Pause 1. Alarm Audio Icon: To pa use an activ ve alarm, tou uch the Alarm Bar. The audio o pause icon n will be disp played to the righ ht of the alar rm message e to indicate t he alarm au...

  • Page 72: Alarm Verification

    8.5. Alarm Verification The function of the alarm system should be verified at least annually using the methods below. The Alarm Audio (speaker) will be tested automatically each time the Transport Incubator is powered on. 8.5.1. Test of Temperature Alarms Alarm Priority Mode...

  • Page 73: Test Of O Alarms

    Disconnect the sensor from the Transport Incubator. An alert message should be displayed in the message center on the screen. 8.5.3. Test of O Alarms To ensure the ambient oxygen monitor is generating the proper alarm indications, perform the following: After the oxygen sensor is placed in the area to be monitored, verify the out-of-range alarms are functional by setting the oxygen high and low alarm limits beyond the oxygen readings of the area.

  • Page 74: Setup

    9.2. Setup 1. Data K Key Recepta acle: Insert the Data Ke ey (removab ble digital media a) into the da ata key recep ptacle locate ed on the rea ar center con nsole. 9.3. General O Operation If the dev vice is storing g data to the e Data...

  • Page 75: Pulse Oximetry Theory Of Operation

    This section contains information regarding the optional pulse oximetry feature. The pulse oximeter is to be operated by, or under the supervision of, qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. For a complete description of alarms and alerts associated with the PulseOx system, see Appendix D.

  • Page 76: Setup

    10.3. Setup stalling the e Pulse Ox ximeter Ca able Locate th e SpO cabl le and the S cable s ensor. Remove t the SpO able sensor f from its pack kaging and c connect it to the end of t the cable lab beled “Sensor”.
  • Page 77 Subm enus (7) Su bmenu Exit (%SpO (8) Su bmenu Curs (9) Su bmenu Exit (PR) (10) S ubmenu Cur rsor Opera ator Disable This ic con represen nts the opera ator disabled state o of the SpO system. The e SpO syste can be...

  • Page 78: Setting Alarm Limits - %Spo

    Inadeq quate Signa If the S sensor r is unable to o detect an adequ ate signal fr om the patie ent – the dis plays will sh ow “---“ 10.5. Setting Ala arm Limits - - %SpO Touch or highlight and select t the %SpO icon.

  • Page 79: Setting Alarm Limits - Pulse Rate

    Touch or highlight and select t the submenu u exit to retu rn to the hom me screen. 10.6. Setting Ala arm Limits - - Pulse Rat Touch or highlight and select t the Pulse Ra icon. Select t the Pulse R Rate Low Ala arm Limit.

  • Page 80: Signal Strength

    10.7. Signal Stre ength he signal stre ength of the senso or is splayed as a a dynamic eq quator on th e SpO 10.8. Perfusion Index (Mas simo Only) If e enabled in th he administr rator menu, t erfusion Inde ex value rep resents a ra...

  • Page 81: Sensors

    10.10. Sensors Refer to Section 21, ACCESSORIES, for vendor contact information to request sensor technical data. Multiple sensor geometries are compatible with the integrated pulse oximetry system. Before selecting a sensor, carefully read the sensor’s instructions for use. When selecting a sensor, consider the patient’s weight, the adequacy of perfusion, the available sensor sites, and duration of monitoring.

  • Page 82: Setup

    11.2. Setup If equipped d, the photo otherapy sy ystem is int egrated into o the obser rvation light t. See Section 12 2, OBSERV VATION LIG GHT, for set tup. 11.2.1. C heck Inten nsity urn on the P Photothera py Light an nd, using a...
  • Page 83 To initiate e photothera apy, enter the heater su ubmenu and select the photother rapy icon wit th touch or t wheel. An alert w will be displa ayed in the message center to re emind the op perator to cover t the infant’s e eyes with eye protection...

  • Page 84: Effective Surface Area

    11.3.1. Ef ffective Su urface Area he following g graph sho ows the nor rmalized sp pectra of the e Royal Blu ue LEDs ompared to standard w wavelength frequencie he maximu m intensity of the light t is 35 W/c cm2/nm an d 22 W/cm m2/nm for t...

  • Page 85: Phototherapy Light Lifetime Indicator

    11.3.2. Ph hototherap py Light Li fetime Ind icator When the red d photother rapy lifetime e indicator on the light t bar is illum minated, the ue LEDs ha ave exceed ded their 39 9,000 hour limit and it is time to re eplace the ght bar.
  • Page 86 sure the cor rd passes t hrough the cord reces ss on the ou uter chamb ber. Figu ure 12-3 gure 12-4 ce the light bar and its s cord are in n the prope er location a and routed c correctly, cure the out ter chambe...
  • Page 87 The observ vation light has four st tates illustra ated and de escribed be elow: Norm mal Operatio - ON, Norm mal operatio on - OFF, s submenu, a and disconn nected. servation Light Oper rational St ates Norma al Operation n (OFF Stat (1) Ob bservation Li...
  • Page 88 12.3.2. Turning the Observation Light OFF Once the observation light is in the ON state, it can be turned off by press and hold of the icon. The icon will highlight orange and the observation lights will turn OFF. The observation light icon reverts to the normal operation - OFF state.
  • Page 89 This results in a sensor with a superior technical advantage over KOH-type sensors in applications where these gases are present. Use only Maxtec Max-250E oxygen sensors and International Biomedical supplied cables with the Transport Incubator. Max-250E oxygen sensors offer quick response, stability, and life greater than 9000 hours.
  • Page 90 13.2.1. Ca alibration or oxygen r readings to be accurat te, the amb bient oxygen n monitor m must be ermally sta able when c calibrated a and when m measuremen nts are take alibration s hould also be done at t the same pressure as s when in u...
  • Page 91 13.3. General O Operation The ambie ent oxygen monitor is o operated th hrough the user interfa ace and is p physically connected d at the con nector pane el. The am mbient oxyg en monitor r icon is loca ated in the lower left h hand corne...
  • Page 92 Cable/ /Sensor Dis sconnected If the a ambient oxyg gen monitor cable or sen nsor is unplu ugged, the am mbient oxyge en monitor w will automatic cally enter th cable/s sensor disco onnected sta ate and an a lert “Connec ct O Cable”...
  • Page 93 nnect the he eated mattr ress cable t to the botto om center c connector a as depicted belo Figure 14- 14.3. General O Operation The heate d mattress is operated d through th he user inte erface and is physicall y connecte at the conn nector bay.
  • Page 94 To turn on n the heated d mattress, e enter the heate er submenu a and select th heated m mattress icon with touch o or the wheel. To turn of ff the heated d mattress, e enter the heate er submenu a and select th heated m...
  • Page 95 Connect t the short co nnection tub be from the Suction m module to the e Suction Ca anister. Prior to u se, connect an ISO 883 6 compliant suction ca atheter (not supplied) to the Suction Canister. Occlude tu bing and ch eck the maximum...
  • Page 96 Enter the heater subm menu and se elect the suctio on icon with touch or the wheel. Use the w wheel to adju ust the suctio pressure (occlude the e tubing to d isplay suction pr ressure). The displ ayed pressu ure value wil change c olors depen...
  • Page 97 To turn of ff the suction n device, en the heate er submenu a and press an hold the s suction icon. While the e suction is O ON, to reente er the icon and adjust the su uction press sure, tap the ic TIMER...
  • Page 98 Timers Operationa al States Normal O Operation - Timer Active (1) Time v value is disp played (count tdown or sto opwatch) Submenu (3) Subm enu Exit (4) Stop W Watch Icon (5) Count tdown Timer r Icon Submenu u - Stop Wa atch (6) Subm enu Exit...
  • Page 99 Set & Pla ay Countdo own Timer r Select t the Countd own Timer I Select t the countdo own timer va alue and turn n the wheel clockwise to o the desired d time. Sele the va lue again to confirm.
  • Page 100 DEVIC CE SETTIN 17.1. Introductio The device e settings m menu is a st tandard fea ature of the Transport Incubator. The menu allows the operator to o adjust the e screen bri ghtness, ad djust the al arm volume e, or lock th he screen.
  • Page 101 The scree en will no lon nger accept command ds from the t touch screen n. The message center can still be touch hed. To unlock k the screen , press the w wheel or touch t the lock icon Adjust S Screen Bri i ghtness Select the...
  • Page 102 Adjust sc reen brightn ness with the wheel. Select the e screen set ttings icon w with touch or w with the whe eel. Adjus st Alarm V V olume Select the e alarm volu me icon. Adjust ala arm volume with the whe eel.
  • Page 103 CLEA NING 18.1. Introductio Use a soft clean cloth h and a disi nfectant so olution for c cleaning and d disinfectio on. After each infan nt use, follow w the hosp ital’s infecti ion control procedures s for equipm ment disinfection n.
  • Page 104 Carefully remove the e infant cha amber and 4. R Remove inf fant mattre ss and cha amber gask separate e each piece (inner & ou uter) on a stable sur rface. Slide out t the patient tray and de epress red 6.
  • Page 105 Remove a airflow cove er plate. 8. R Remove ai rflow impel ler. Once disa assembled, thoroughly y clean all 10. O Once all of f the compo onents are c clean and d dry, surfaces w with approv ved cleaning g solutions reverse the e steps to re...

  • Page 106: Introduction

    Visually inspect the inside of the mattress for contamination and discontinue use if internal contamination is found. If the cover is torn or damaged, discontinue use and contact your International Biomedical representative. Use a soft clean cloth and a disinfectant solution for cleaning and disinfection. After each infant use, follow the hospital’s infection control procedures for equipment...

  • Page 107: Infant Chamber Check

    If external DC power is to be used, check the DC power cord and ensure that it has no cuts or severe bends and that the connectors have not been damaged. Turn on suction device (if applicable) and ensure it operates. Turn off suction device.

  • Page 108: Sensors And Cables

    19.2.6. Sensors and Cables Inspect the oxygen sensor and the pulse oximeter sensor for damage. Replace, if necessary. Inspect the temperature probe cables, heated mattress cable, oxygen sensor cable, and pulse oximeter cable for wear or damage. Replace, if necessary. 19.3.

  • Page 109: Airflow Tray Filter Replacement

    19.4.2. A irflow Tray y Filter Rep placement Repla ace the airflo ow tray filte er annually or when vis sibly dirty. The fi lter is locat ed behind t the right, re ear door. No too ols are nec essary to re eplace filter r, turn filter...

  • Page 110: Battery Maintenance

    19.5. Battery Maintenance If the Transport Incubator is not to be used for an extended period of time, or during storage or transport, disconnect and remove the battery. After use or complete discharge, immediately recharge the battery. If not regularly used or maintained on charge, the battery should be recharged on a monthly basis to prevent battery degradation.

  • Page 111: Phototherapy Light Lifetime Indicator

    TROUBLESHOOTING The following list describes the most common issues that arise through use of the Transport Incubator and the suggested corrective actions. If further assistance is needed, refer to this manual or contact International Biomedical. 20.1. General Trouble Action to Take The battery could be completely depleted.

  • Page 112: Power On Self-Test

    20.2. Power On Self-Test Erro or Reported Action to Take Ensu ure the heat ted mattress s is connecte ed or Mattress disa able the heat ted mattress s in the admi inistrator Ensu ure the suct ion module is connected d or Suction disa...
  • Page 113 Secondary y Patient Te emp Probe (T2) 700-34 CS Patient C Cable, 10 ft (Masimo) 711-0 C-10 Patien t Cable (Ne ellcor) 711-1 Observatio on + Photot therapy Lig 387-0 Observatio on Lights 387-0 Photothera apy Light M Meter 736-0 Photothera apy Eye Sh hield, Small...
  • Page 114 Suction Di sposables: Filter (as re 738-1 equired) Canister 738-1 18” Vacuu m Tube (no ot shown) 738-1 72” Vacuu 738-2 m Tube (no ot shown) DC Input C Connector ( (Customer m must wire) 738-24 DC Output t cable, 1 m 738-24 Data Toke 738-24...
  • Page 115 Service able and R Replaceme ent Parts attress Tray y Knob (4 p per device) 738-2 2497 hamber Ga sket 738-2 2055 hamber Filt 738-2 2291 rflow Tray C Cover Pane el Assembly 738-2 2529 an, Impeller r-CCW, Bla 738-2 2155 ear Doors ( 3 per devic...
  • Page 116 Service able and R Replaceme ent Parts FePO Batt tery, 12.8 V V, 20.0 Ah 888-0 0016 may replace device with h LiFePO only) ouch Screen n Assembly 738-2 2151 ontact cust omer servic ce to coord inate SD ard transfer omplete Air rflow Tray A Assembly...

  • Page 117: Internal Component Access

    SERVICE ONLY BY QUALIFIED PERSONNEL: The incubator should be serviced only by qualified personnel in the Electronics Maintenance or Biomedical Engineering Department within the hospital or by International Biomedical Personnel. WARNING: HIGH VOLTAGES: Dangerous voltages may be contained on circuitry internal to the unit.

  • Page 118: Electronics Location And Description

    commende ed Tools fo or Servicin ng or Replacing g Most Co mponents 2.5 mm m Hex Driv 3 mm Hex Driver 4 mm Hex Driver 8 mm Socket 10 mm m Socket Torx T 22.1. Electronics s Location a and Descri ption umber...
  • Page 119 ntly lift the a airflow tray off of the in ncubator ch hassis to ex xpose the tw wo cables neath, and u unplug the two cables before com mpletely rem moving the airflow tray y. e airflow tra ay assembly y can now b be complete ely remove...

  • Page 120: Power Module Removal

    22.3. Power Mo dule Remo This sectio on details th he procedu re to remov ve the powe er module a assembly. procedure to gain acc cess to the electronics s compartm ment must b be followed before beginning this proced dure.

  • Page 121: Touch Screen Assembly Removal

    22.4. Touch Scr reen Assem mbly Remov This sectio on details th he procedu re to remov ve the cont rol module assembly. procedure s to gain ac ccess to the e electronic cs compartm ment and to o remove th he power module mu ust be follow...

  • Page 122: Knob Assembly Removal

    22.5. Knob Asse embly Rem oval This sectio on details th he procedu re to remov ve the knob b asembly. The proce edure to gai access to the electron nics compa artment mus st be follow wed before b beginning t this procedure...

  • Page 123: Suction Removal

    22.6. Suction Removal This section details the procedure to remove the suction module assembly. The procedure to gain access to the electronics compartment must be followed before beginning this procedure. Disconnect any patient tubing from the suction module. Disconnect the suction power cable from the top of the suction module. Twist locking nut counterclockwise to release.

  • Page 124: Auxiliary Medical Devices

    Disconnect the nuts or screws as necessary and then carefully remove the medical device from the chassis. REPAIR POLICY Warranty repair and service should be performed by a qualified International Biomedical Representative. Contact a qualified representative by calling technical support at 1-512-873- 0033.

  • Page 125: Warranty

    Company’s products. This warranty is rendered void and International Biomedical cannot be held liable for conditions resultant therefrom if: 1. Damage to the unit is incurred as a result of mishandling.

  • Page 128: Appendix A Specifications

    Appendix A Specifications Operating, Storage, and Transport Environment Storage: Temperature -25 C to 60 C (Remove battery prior to transport or storage. Allow incubator to stabilize at room temperature for at least 4 hours after storage.) Humidity 5% to 95% non-condensing Pressure 50 kPa to 110 kPa Transient Operating:...

  • Page 129: Electrical Specifications

    Electrical Specifications AC Power (Max) 100-240 VAC, 50 - 60 Hz, 2000 VA Max AC Power (Incubator) 100-240 VAC, 50 - 60 Hz, 3 A Max Accessory outlets (AC) 7 A Max Total, at input voltage External DC Power Input 12-28 V, 15 A External DC Power Output 3 A, at input voltage...

  • Page 130: Resolution

    Resolution Oxygen Saturation Pulse Rate 1 bpm Sensor Peak Wavelengths Masimo 660 nm (red light), 905 nm (infrared light) Nellcor 660 nm (red light), 900 nm (infrared light) Sensor Maximum Power Output Masimo less than 15 mW (at 50 mA pulsed) Nellcor less than 15 mW Part No.

  • Page 131: Masimo Sensor Accuracy

    3,4,5,6 Masimo Sensor Accuracy During No Motion Conditions 70 - 100% Oxygen Saturation - Neonates 0 - 69% unspecified 70 - 100% Oxygen Saturation - Pediatrics 0 - 69% unspecified Pulse Rate - Neonates / Pediatrics 25 - 239 bpm 3 bpm 9,10 During Motion Conditions...
  • Page 132 Measure ed Oxygen n Saturatio n Accurac y per Deca (M-LN NCS/LNCS/ /LNOP YI S Series) 70 - 80% 80 - 90% 90 - 100% Measure ed Oxygen n Saturatio n Accurac y per Deca (M-LN NCS/LNCS Series) 70 - 80% 80 - 90% 90 - 100% he Bland-Al...
  • Page 133 Co o rrelation P P lot for SpO (LNOP S S ensor): S S aO vs. S S pO Par rt No. 715-013 3 2, Rev. C - 130 -...

  • Page 134: Nellcor Sensor Accuracy

    6,12 Nellcor Sensor Accuracy During No Motion Conditions 13,14 Oxygen Saturation - 70-100% Range 2% (OxiMax Series) 13,15 Oxygen Saturation - 60-80% Range 3% (OxiMax Series) Error! Bookmark not defined.,15 Pulse Rate 20 - 250 bpm 3 bpm During Motion Conditions 15,16 Oxygen Saturation - 70-100% Range 3% (OxiMax Series)
  • Page 135 Bla a nd-Altman n for SpO (All Data): : SaO (SpO - Sa Correlatio on Plot for (All D Data): SaO vs. SpO Par rt No. 715-013 3 2, Rev. C - 132 -...

  • Page 136: Interfering Substances

    Interfering Substances Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings. Ambient Oxygen Monitor Specifications (Optional Feature) Measurement Range 10.0% to 100% Resolution...

  • Page 137: Phototherapy Specifications

    Phototherapy Specifications Light Spectrum Range 450 - 465 nm Low Chamber: 35 µW/cm2/nm (Light Bar @ 7.8” above mattress) Maximum Irradiance at mattress XL Chamber: 22 µW/cm2/nm (Light Bar@ 9.8” above mattress) Low Chamber: 12.3 in 9.2 in ellipse Effective Irradiated Area XL Chamber: 15.1 in 10.8 in ellipse...

  • Page 138: Appendix Bemc Specifications

    The customer or the operator of the Transport Incubator can help prevent electromagnetic interference by operating the device in the environments and with the minimum separation distances specified below. Additionally, periodic maintenance as specified by International Biomedical will allow the device to continue to provide basic safety and essential performance.
  • Page 139 GUIDANCE AND MANUFACTURER’S DECLARATION - IMMUNITY The Transport Incubator is intended for use in the electromagnetic environment specified below. The customer or operator of the Transport Incubator should ensure that it is used in such an environment. IEC 60601 COMPLIANCE ELECTROMAGNETIC IMMUNITY TEST TEST LEVEL...
  • Page 140 GUIDANCE AND MANUFACTURER’S DECLARATION - IMMUNITY The Transport Incubator is intended for use in the electromagnetic environment specified below. The customer or operator of the Transport Incubator should ensure that it is used in such an environment. ELECTROMAGNETIC IEC 60601 COMPLIANCE IMMUNITY TEST ENVIRONMENT -...
  • Page 141 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE TRANSPORT INCUBATOR The Transport Incubator is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or operator of the Transport Incubator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the Transport Incubator as recommended below, according to the maximum output power of the communications equipment.

  • Page 142: Appendix C Essential Performance

    Appendix C Essential Performance The accuracy of the set temperature to the Transport Incubator temperature will be maintained within 2 C at ambient temperatures between 10 and 20 C and within 1.5 C at an ambient temperature of 25 C 1 C for normal operation.

  • Page 143: Appendix D Alarms And Alerts

    Appendix D Alarms and Alerts Audio Alarm Alarm Description Alarm Condition Priority Pause Type Duration Baby temperature is 1.2 C Baby Hot - Check Baby High Clinical greater than set point. Baby temperature is 0.7 C Baby Hot - Check Baby Medium Clinical greater than set point.
  • Page 144 Audio Alarm Alarm Description Alarm Condition Priority Pause Type Duration The battery charge is at Critically Low Battery High System 7% or less. The battery charge is at Low Battery Medium System 10% or less. External AC power has AC Power Removed Clinical Acknowledge been removed.
  • Page 145 Audio Alarm Alarm Description Alarm Condition Priority Pause Type Duration An error has occurred with Internal SpO Error System the SpO hardware. An error has occurred with Suction Error System the suction hardware. An error has occurred with Touch Screen Failure the touch screen Medium System...
  • Page 146 Alert Description Alert Condition Priority USB Open Error Error opening removable digital media Alert USB Read Error Error reading removable digital media Alert USB Write Error Error writing to removable digital media Alert USB Full The removable digital media is full. Alert AC Connected External AC power has been connected.
  • Page 147 Alert Description Alert Condition Priority Perfusion Index is Low The SpO perfusion index is low. Alert The SpO hardware has detected too much Interference Detected Alert interference with the SpO sensor. The SpO sensor is not attached to the Sensor Off Patient Alert patient.

  • Page 148: Appendix E Product Disposal/Recycle

    Appendix E Product Disposal/Recycle The incubator should be returned to International Biomedical for recycling when it reaches the end of its life (8 years). The incubator’s battery can be taken to any battery recycling facility when it reaches the end of its life.

  • Page 149: Appendix F Error Codes

    Appendix F Error Codes Error Error Error Definition Error Definition Code Code 0x0000 SUCCESS 0x8169 SPO2_RESV_0800_0000 0x8001 PAT_TEMP_TOO_HIGH 0x816a SPO2_RESV_4000_0000 0x8002 PAT_TEMP_TOO_LOW 0x816b SPO2_RESV_8000_0000 0x8003 PAT_TEMP_HIGH 0x816c SPO2_CABLE_NEAR_LIFE 0x8004 PAT_TEMP_LOW 0x816d SPO2_SENSOR_NEAR_LIFE 0x8005 PRIMARY_PAT_PROBE_ERROR 0x816e SPO2_ADHESIVE_NEAR_LIFE 0x8006 PRIMARY_PAT_PROBE_ERROR_EXIT 0x816f SD_BAD_MEDIA 0x8007 CHAMBER_TEMP_TOO_HIGH 0x8170...
  • Page 150 Error Error Error Definition Error Definition Code Code 0x804c INVALID 0x8203 SYSTEM_SHUTDOWN 0x804d INT_RAM 0x8204 TIMEOUT 0x804e EXT_RAM 0x8205 SELFTEST_DISABLED_SYSTEM 0x804f INT_FLASH 0x8206 SELFTEST_FAILED_TOUCH 0x8050 EXT_FLASH 0x8207 POST_FAILED_MATTRESS 0x8051 SYS_FAILURE 0x8208 POST_FAILED_SUCTION 0x8052 NO_MEM 0x8209 POST_FAILED_PATIENT_PROBE 0x8053 WATCHDOG_TRIP 0x820a POST_FAILED_SPO2 0x8054 CHAMBER_ERROR 0x820b POST_FAILED_ACCEL...

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