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Instructions for use Babylog 8000 plus SW 5.n

7

For your safety and that of your patients

For your safety and that of your patients

General safety information

...........................

8

Strictly follow these instructions for use...........

8

Maintenance....................................................

8

Safety checks ..................................................

8

Accessories .....................................................

8

Not for use in areas of explosion hazard.........

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Connected devices ..........................................

9

Device combinations .......................................

9

Patient safety................................................... 10
Patient monitoring............................................ 10
Information on electromagnetic compatibility .. 10
Disposable product.......................................... 11
Sterile accessories .......................................... 11
Installing accessories ...................................... 11
Storing the instructions for use ........................ 11
Training............................................................ 11

Product-specific safety information

............ 12

Ensuring ventilation using an independent 
manual ventilator ............................................. 14

Содержание Babylog 8000 plus

Страница 1: ...Instructions for use Babylog 8000 plus WARNING To properly use this medical device read and comply with these instructions for use Intensive care ventilator for neonates Software 5 n...

Страница 2: ...the sense of IEC 60601 1 but also for consumables removable parts and attached parts Product name used In these instructions for use the designation Babylog 8000 is used for Babylog 8000 plus Screen r...

Страница 3: ...are persons who are responsible for the maintenance of the product Service personnel must be trained in the maintenance of medical devices and install reprocess and maintain the product Experts Exper...

Страница 4: ...4 Instructions for use Babylog 8000 plus SW 5 n Abbreviations and symbols Explanations can be found in the sections Abbreviations and Symbols in chapter Overview...

Страница 5: ...eadiness for operation 58 Operation 62 Setting ventilation 63 Endotracheal suction 68 Manual inspiration 69 Medication nebulization 70 Analog and digital interface 76 Terminating operation 80 Alarms 8...

Страница 6: ...racteristics 133 Displayed measured values 134 Displayed calculated measured values 137 Monitoring functions 138 Operating characteristics 139 Device outputs 141 Essential performance characteristics...

Страница 7: ...fety checks 8 Accessories 8 Not for use in areas of explosion hazard 9 Connected devices 9 Device combinations 9 Patient safety 10 Patient monitoring 10 Information on electromagnetic compatibility 10...

Страница 8: ...0 Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels Failure to observe these safety information statements constitut...

Страница 9: ...llowing standards IEC 60601 1 3rd edition general requirements for safety device combinations software controlled functions IEC 60601 1 2 electromagnetic compatibility IEC 60601 1 8 alarm systems Or I...

Страница 10: ...vation of clinical signs The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device Information on electromagnetic compatibility General info...

Страница 11: ...manufactured for disposable use only Reuse reprocessing or sterilization can lead to a failure of the accessories and cause injuries to the patient Do not reuse reprocess or sterilize disposable prod...

Страница 12: ...be impaired Do not use the medical device in hyperbaric chambers WARNING Risk of patient injury with PEEP 2 5 mbar 2 5 cmH2O If the PEEP is set to 2 5 mbar 2 5 cmH2O and the following settings are al...

Страница 13: ...cylinder only use pressure reducers compliant with ISO 10524 Slowly open the pressure reducer manually Do not use tools WARNING Risk of fire The medical device may catch fire as a result of oxygen en...

Страница 14: ...ts Keep the medical device away from sources of heat Only operate the medical device in rooms with sufficient ventilation Do not cover the medical device or slide the rear of the device against a wall...

Страница 15: ...Instructions for use Babylog 8000 plus SW 5 n 15 Application Application Intended use 16 Environment of use 16...

Страница 16: ...sonnel Each user must be trained and familiar with the instructions for use Environment of use Babylog 8000 is intended for use in intensive care units Do not use Babylog 8000 in the following environ...

Страница 17: ...18 Control and display unit 19 Patient connection panel 20 Rear 21 Trolley 22 Range of functions 23 Ventilation functions 23 Monitoring functions 23 Power supply 23 Gas supply 23 Data transfer optiona...

Страница 18: ...for use Babylog 8000 plus SW 5 n Babylog 8000 Ventilator on trolley A Control and display unit display panel B Control and display unit control panel C Control panel cover D Trolley E Patient connecti...

Страница 19: ...f medium or high priority Flashes yellow if set value TI is incorrect E Key to suppress alarm tone for 2 minutes F OK key G Key to select dialog windows H Vent Mode key for ventilation modes I Vent Op...

Страница 20: ...iew 20 Instructions for use Babylog 8000 plus SW 5 n Patient connection panel A Exhaust muffler B Rocker lever for expiratory valve C Expiratory port GAS RETURN D Inspiratory port GAS OUTPUT 21100 A B...

Страница 21: ...r cable D Cover for mains connection and 2 mains fuses E Potential equalization pin F O2 connection INFLATING GAS INPUT G Air connection INFLATING GAS INPUT H Connection for pneumatic medication nebul...

Страница 22: ...ylog 8000 plus SW 5 n Trolley A Babylog 8000 B Device holder C Trolley column D Hose holder E Castor with locking brake 2 pieces F Castor with locking brake 2 pieces G Base plate H Holder I Lateral st...

Страница 23: ...nd tidal volume VT Leakage rate Leak Respiratory rate for panting breathing Panting Apnea alarm time Apnoea time Babylog 8000 calculates additional lung parameters using the measured values for pressu...

Страница 24: ...ime IMV Intermittent Mandatory Ventila tion Setting knob for inspiratory flow IPPV Intermittent Positive Pressure Ventilation IRV Inverse Ratio Ventilation kg Kilogram L Liter Insp Flow lbs Pound unit...

Страница 25: ...VThf Tidal volume generated by high frequency pulses averaged over multiple high frequency pulses VTim Tidal volume applied with man datory breaths during high fre quency ventilation measured on the i...

Страница 26: ...number Serial number Batch designation Use by Keep away from sunlight Protect from moisture Storage temperature Relative humidity XXXX REF LOT Atmospheric pressure Do not use if package damaged Lower...

Страница 27: ...us SW 5 n 27 Overview Product labels Product label Explanation Maximum loads and conditions for maintaining the stability of the device on the trolley Nominal weight and maximum weight for further inf...

Страница 28: ...erating concept Control and display unit 29 Layout of the control and display unit 29 Setting knobs 29 Keys with fixed and variable functions 30 Displays 32 Dialog windows 33 Dialog window layout 33 O...

Страница 29: ...ntilation Setting knobs The setting knobs are used to set the following ventilation parameters A O2 Vol B TI C TE D E Pinsp F PEEP CPAP The setting knobs which can be set for the current ventilation m...

Страница 30: ...d Set the value for PEEP Keys with fixed and variable functions Setting the ventilation mode 1 Press the Vent Mode key C 2 Press the key E for the desired ventilation mode e g SIMV 3 Press the On key...

Страница 31: ...ed to the keys are displayed in the bottom line of the respective dialog window See chapter Overview of dialog windows The following table shows the keys with symbols and their associated functions Pr...

Страница 32: ...ssages Trigger display If the device detects an inspiratory effort the yellow Trigger LED A lights up Display of airway pressure Airway pressure Paw is indicated as a bar display Display of alarms Ala...

Страница 33: ...Keys with fixed functions Vent Mode Vent Option Cal Config 6 keys with variable functions Press a key to open the associated dialog window Main screen The main screen is displayed after the device is...

Страница 34: ...Operating concept 34 Instructions for use Babylog 8000 plus SW 5 n Overview of dialog windows Dialog windows for ventilation 21029...

Страница 35: ...Instructions for use Babylog 8000 plus SW 5 n 35 Operating concept Dialog windows for displays alarms and logbook 21031...

Страница 36: ...Operating concept 36 Instructions for use Babylog 8000 plus SW 5 n Dialog windows for calibration and configuration 21032...

Страница 37: ...ional components 43 Preparing the breathing gas humidifier 43 Attaching the bacterial filter 44 Attaching the breathing hoses 44 Attaching the Y piece and the flow sensor 46 Replacing the flow sensor...

Страница 38: ...of personal injury from damaged trolley If e g the castors are defective the device may move unintentionally Do not use the trolley if damage is visible Contact experts WARNING Risk of tipping over If...

Страница 39: ...e 4 Lower the device insert the rear tabs in the grooves in the mounting plate and secure the device with knurled screws at the rear 22547 Range Maximum load Example A Device holder 40 kg 88 lbs of wh...

Страница 40: ...raphic Screen to another PC using another data cable e g in order to archive data For additional information see the Graphic Screen option instructions for use CAUTION Risk of patient injury If the br...

Страница 41: ...ons for use Babylog 8000 plus SW 5 n 41 Assembly and preparation Mounting the Graphic Screen on Babylog 8000 For information on mounting and connection see the Graphic Screen option instructions for u...

Страница 42: ...new O2 sensor The circular conductors must face the cover 5 Snap the cover into place and tighten both screws 6 After a warm up time of 15 minutes carry out the calibration of the O2 sensor see page 9...

Страница 43: ...ly high this is indicated by an alarm This indicates that the measured PEEP is more than 4 mbar 4 cmH2O above the set PEEP Check the bacterial filter and replace it if this is the cause of the PEEP al...

Страница 44: ...Conditions The breathing circuit in use must be suitable for the individual patient When no incubator is being used a hinged arm with clamp must be used CAUTION Risk of contaminating the device In th...

Страница 45: ...d arm can be fitted to the left or right side 2 Rotate the inspiratory and expiratory ports down or in the direction of the patient 3 Connect the breathing hoses to the inspiratory and expiratory port...

Страница 46: ...11130 Y piece flow sensor 8410185 Attaching the ISO 15 flow sensor 1 Insert the Y piece A into the breathing hoses 2 Insert the ISO 15 flow sensor C into the Y piece 3 Position the Y piece such that t...

Страница 47: ...sides while pulling the insert out of the flow sensor housing 3 Push the new insert C in until it engages Ensure that the two markings are aligned 4 Connect the plug A of the flow sensor cable to the...

Страница 48: ...ne Connect the sample line to the adapter with safety valve In order to prevent condensate from accumulating the Luer Lock connector must face upwards CAUTION Risk of patient injury When gas analyzers...

Страница 49: ...e central gas supply system WARNING Risk of patient injury If compressed gases that are not approved for medical use are being used device function may be impaired Only use compressed gases approved f...

Страница 50: ...n the voltage range indicated on the rating plate Either 100 V to 127 V Or 220 V to 240 V Insert the mains plug into the mains power socket WARNING Risk of electric shock and of device failure If the...

Страница 51: ...sed Only devices with safety extra low voltage SELV must be connected to the COM connection serial RS232 interface Connect the external device to the COM port A Configuring the interface For a descrip...

Страница 52: ...ctive earth connection During operation the potential equalization connectors must be readily accessible and the connection must be able to be disconnected without the use of tools Connecting the pote...

Страница 53: ...does not solely serve to position the medical device Increasing stability 1 Set the hinged arm to minimum extension 2 Empty the water container of the breathing gas humidifier 3 Do not attach any add...

Страница 54: ...mation 55 Switching on the ventilator 55 Starting ventilation 56 Charging the battery for the power supply failure alarm 57 Checking readiness for operation 58 Device check after reprocessing 58 Devic...

Страница 55: ...ve the protective flap over the mains switch CAUTION Malfunctions from condensation Condensate may form when the device is moved from a cold storage location to a warm environment Only switch on the d...

Страница 56: ...displayed The device is ready for operation after approx 15 seconds If the automatic calibration of the O2 sensor is activated O2 measurement is only available after 5 minutes Starting ventilation 1 P...

Страница 57: ...ilator in order to prevent alarms while the battery is charging 2 Switch the ventilator on 3 Allow the charging time to expire WARNING Absence of alarm during mains power supply failure If the battery...

Страница 58: ...ratory valve breathing circuit and flow sensor must be correctly connected The test lung must be connected Checking the power supply failure alarm 1 Unplug the mains cable 2 Switch the device on see p...

Страница 59: ...m message is no longer displayed Checking the IPPV ventilation mode 1 Set the following ventilation parameters 2 On the main screen press the Meas key 3 Press the Paw key The displayed values must be...

Страница 60: ...diately before using the device on a patient in order to check the operability of the device Conditions Gas supply must be ensured The expiration valve breathing circuit and flow sensor must be correc...

Страница 61: ...irway pressure of 5 mbar After approx 5 seconds ventilation is continued and immediately interrupted again The procedure repeats 2 Release the expiratory breathing hose 3 Disconnect the connector on t...

Страница 62: ...n 67 Endotracheal suction 68 Closed suction 68 Manual inspiration 69 Starting manual inspiration 69 Medication nebulization 70 Safety information on medication nebulization 70 Preparing and removing t...

Страница 63: ...found in chapters Description of ventilation modes on page 156 and Additional settings for ventilation on page 161 SIMV SIPPV and PSV ventilation modes If the patients becomes apneic ventilation begi...

Страница 64: ...he patient can be ventilated with or without a pressure plateau in the IPPV IMV SIPPV and SIMV ventilation modes In the PSV ventilation mode and when using the additional setting VG the pressure plate...

Страница 65: ...d PEEP are not displayed 1 Set the CPAP ventilation mode 2 Adjust the view so that the flow waveform and the measured pressure values are displayed see page 87 3 Set the airway pressure to CPAP level...

Страница 66: ...is switched on and Volume Guarantee is already activated check the setting for Vtset and adjust if necessary Deactivating Volume Guarantee Volume Guarantee must be deactivated when the device is switc...

Страница 67: ...least 3 mbar 3 cmH2O 10 On the main screen press the Values key 11 Press the Meas2 key 12 Monitor the tidal volume VThf and the diffusion coefficient DCO2 and adjust the amplitude and frequency if nec...

Страница 68: ...tion modes An appropriate flow must be set for suction Set the appropriate flow with the setting knob WARNING Development of atelectasis If the suction catheter used is too large air feed is blocked T...

Страница 69: ...nually started breath corresponds to the ventilation pattern of the ventilation mode currently set Starting manual inspiration 1 Limit the inspiratory pressure with the Pinsp setting knob B 2 Press th...

Страница 70: ...delivered tidal volume and O2 concentration may deviate from the displayed values Only use medication nebulizers listed in the current list of accessories CAUTION Ventilation impaired If a bacterial f...

Страница 71: ...he sealing plug is a component of the pneumatic medication nebulizer Installing the flow sensor When using the ISO 15 flow sensor Install the flow sensor C between the Y piece and the tube D When usin...

Страница 72: ...constant set the O2 concentration using the nomogram Example With an inspiratory flow of 10 L min and a desired O2 concentration of 80 Vol the O2 Vol setting knob must be set to 90 Vol during medicat...

Страница 73: ...screw on the housing with a coin 2 Screw the coupling A into place with the mounting screw 3 Insert the plug B into the socket on the rear of the device until it locks in place Installing the pneumat...

Страница 74: ...is generated Increasing the O2 concentration during nebulization 1 The required O2 concentration can be found on the nomogram see page 72 2 Increase the O2 concentration with the O2 Vol setting knob T...

Страница 75: ...bulization see page 70 4 Do not switch on the nebulization function on Babylog 8000 as the Aeroneb Pro nebulizer does not require a nebulizer flow from Babylog 8000 5 Remove the flow sensor from the b...

Страница 76: ...end memory Measurement waveforms Or Data is transmitted to a patient monitor or personal computer Impulse output port The impulse output port displays the following events Triggered mandatory breath M...

Страница 77: ...h otherwise L Alarm L during an alarm condition otherwise H 1 Connect the printer input resistance 1 M using the cable 8306487 2 Select the signal see page 103 Connecting a printer Any of the followin...

Страница 78: ...ort is finished Canceling the print process Press the Stop key Automatically printing a report every 30 minutes 1 Press the Select key repeatedly until 30 min report is highlighted 2 Start the print p...

Страница 79: ...3 Start the print process by pressing the Start key The key function changes to Stop Canceling the print process Press the Stop key Transferring data to the patient monitor Devices e g monitor PC tha...

Страница 80: ...from the wall terminal units of the central gas supply system 21196 A B CAUTION Contamination of the central gas supply system Supply gases may flow back into the central gas supply system due to smal...

Страница 81: ...coustic alarm signals 82 Alarm priorities 82 Suppressing the acoustic alarm signal 83 Early reactivation of the alarm signal 83 Acknowledging alarm messages 83 Alarm limits 84 Automatic alarm limits 8...

Страница 82: ...larm signal can be regulated see page 100 Failure of the acoustic alarm signal If the speaker for the alarm signal main alarm fails due to a fault a continuous tone will be generated as an auxiliary a...

Страница 83: ...ayed on the screen If the fault triggering the alarm is not resolved after 2 minutes the alarm signal sounds again Press the key The yellow LED on the key lights up Early reactivation of the alarm sig...

Страница 84: ...larm limit Setting range MV 0 to upper alarm limit MV Lower alarm limit to 15 L min The alarm delay time Alarm delay delays the fol lowing alarms 0 to 30 seconds MV low VT low Check settings Apnea ala...

Страница 85: ...pnea monitoring can be deactivated in order to avoid false alarms Use a separate monitoring device for apnea Respiratory rate for panting breathing Deactivating the alarm limit Apnoea time 1 Select th...

Страница 86: ...se Babylog 8000 plus SW 5 n Trends Displaying waveforms and measured values 87 Displaying waveforms 87 Displaying measured values 87 Displaying all set values and measured values 89 Displaying trends...

Страница 87: ...waveform Press the Stop key Displaying measured values Displaying the measured pressure values 1 On the main screen press the Meas key 2 Press the Paw key The following measured pressure values from t...

Страница 88: ...ess the Meas key 2 Press the MV O2 P key The following measured values are displayed example 21075 C Dynamic compliance of the respiratory system R Airway resistance including the tube C20 C Index ind...

Страница 89: ...ess the Values key The Set1 dialog window is displayed Displaying additional set values Press the Set2 key Displaying all measured values 1 On the main screen press the Values key 2 Press the Meas1 ke...

Страница 90: ...to select the length of the segment max 24 hours min 2 hours The times displayed indicate the beginning and end of the segment 4 Use the and keys to shift the segment FiO2 Inspiratory O2 concentration...

Страница 91: ...After 100 logbook entries the oldest entry is overwritten as each new entry is recorded The entries in the logbook are not retained in memory after the device has been switched off or following a pow...

Страница 92: ...og 8000 plus SW 5 n Monitoring Information on monitoring 93 Sensors and calibration intervals 93 O2 monitoring 94 Calibrating the O2 sensor 94 Flow monitoring 95 Calibrating the flow sensor 95 Deactiv...

Страница 93: ...he flow sensor has been unplugged only briefly Sensor Calibration Pressure sen sor Automatic calibration O2 sensor Automatic calibration every 24 hours Manual calibration after replace ment Flow senso...

Страница 94: ...key The device calibrates the O2 sensor and displays a message A O2 Cal B is displayed in the status field The calibration is completed after approx 5 minutes O2 Cal B is no longer displayed in the st...

Страница 95: ...B WARNING Risk of fire Residual vapors of easily flammable disinfectants e g alcohols and deposits that were not removed during reprocessing can ignite when the flow sensor is in use Ensure particle...

Страница 96: ...sful Replace the flow sensor insert see page 42 Replace the flow sensor cable Deactivating and activating flow monitoring 20918 20996 21028 WARNING Risk of patient injury The device cannot adequately...

Страница 97: ...he flow sensor cable from the flow sensor B The device displays an alarm message C An information D is displayed in the status field 2 Acknowledge the alarm message by pressing the OK key Activating f...

Страница 98: ...time 99 Setting the volume of the alarm signal 100 Setting the screen contrast 100 Selecting the language 101 Configuring the data interfaces 101 Selecting the measuring signals and scale range for t...

Страница 99: ...e version Optional enhancements Operating hours Reference conditions for flow measurement and the sensor type being used Setting date and time This setting is saved after the device is switched off 1...

Страница 100: ...volume sounds as the volume is increased stepwise Setting the screen contrast This setting can only be made on devices with LC screens This setting is saved after the device is switched off 1 Open the...

Страница 101: ...ing the data interfaces The following data interfaces can be configured Analog output ports Impulse output RS232 This setting is saved after the device is switched off Selecting the measuring signals...

Страница 102: ...0 V FiO2 0 100 Vol 0 10 V Flow 40 40 L min 0 10 V 20 20 L min 0 10 V 10 10 L min 0 10 V 5 5 L min 0 10 V Volume 0 500 mL 0 10 V 0 100 mL 0 10 V 0 50 mL 0 10 V 0 25 mL 0 10 V Tidal volume 0 500 mL 0 10...

Страница 103: ...h Mandatory breath Alarm Default value Mandatory breath 1 Open the dialog window by pressing the Cal Config Config Com keys 2 Press the Param key repeatedly until is highlighted 3 Use the or key to se...

Страница 104: ...drate is highlighted 3 Use the or key to select one of the following values 9600 2400 1200 4 Press the Param key repeatedly until Parity is highlighted 5 Use the or key to select one of the following...

Страница 105: ...Instructions for use Babylog 8000 plus SW 5 n 105 Troubleshooting Troubleshooting Failure of the power supply 106 Alarm Cause Remedy 106...

Страница 106: ...orked through in the order listed until the alarm has been resolved Alarm message Cause Remedy Airway pressure high Exp valve opened Increased pressure in the breath ing circuit The expiratory and eme...

Страница 107: ...ee page 94 Mixer function impaired Contact Dr gerService O2 supply pressure too low Ensure pressure greater than 2 7 bar 39 2 psi Flow measurement disturbed Measurement switched off Flow sensor discon...

Страница 108: ...psi Medical air supply pressure measurement disturbed Pressure sensor or pressure reducer faulty Contact Dr gerService MV high Lung compliance has increased Resistance has decreased Hyperventilation...

Страница 109: ...5 mbar 5 cmH2O above PEEP PEEP is limited by Pinsp Increase Pinsp reduce PEEP Pressure measurement disturbed Liquid in expiratory valve Replace expiratory valve Condensate in the breathing hoses Remov...

Страница 110: ...cting the breathing hoses 113 Removing the expiratory valve 113 Dismantling the accessories 113 Reprocessing methods 114 Classification of medical devices 114 Testing of methods and agents 114 Non cri...

Страница 111: ...device failure Dismantling the ventilator This chapter describes how to disconnect the contaminated ventilation accessories and dismantle them for reprocessing Before dismantling 1 Switch off the devi...

Страница 112: ...processing list see page 117 Reprocess the Y piece flow sensor in accordance with the respective reprocessing instructions and the reprocessing list see page 117 Dismantling the pneumatic medication n...

Страница 113: ...ance with the reprocessing list see page 117 Removing the expiratory valve 1 Tilt the rocker lever A up 2 Pull the expiratory valve forward to remove it 3 Remove the muffler from the expiratory valve...

Страница 114: ...classic by ECOLAB Y piece flow sensor Manual disinfection Korsolex extra by Bode Chemie Concentration 3 contact time 15 min Machine cleaning Neodisher MediClean by Dr Weigert Machine disinfection The...

Страница 115: ...2 After the contact time has elapsed rinse the components thoroughly under running water until disinfectant residues are no longer discernible 3 Inspect components for visible soiling and damage Repe...

Страница 116: ...nce with DIN EN 285 preferably with fractional vacuum CAUTION Risk due to faulty accessories Even reusable accessories have a limited service life e g disinfectant residues can corrode the material du...

Страница 117: ...le Per patient Yes Yes Compressed gas hoses Per patient Yes Yes Items which can be reprocessed Recom mended repro cessing intervals Preclean ing Machine cleaning and disin fection Manual Steriliza tio...

Страница 118: ...solution three times Perform manual disinfection in the same manner Flow sensor insert Daily According to the corresponding Instructions for use Breathing gas humidifier Per patient weekly According...

Страница 119: ...e flow sensor housing B until it locks in place Ensure that the two markings are aligned 2 Connect the plug C of the flow sensor cable to the flow sensor Preparation for next use 1 Assemble and prepar...

Страница 120: ...uctions for use Babylog 8000 plus SW 5 n Maintenance Overview 121 Inspection 122 Safety checks 122 Preventive maintenance 124 Table of preventive maintenance intervals 124 Repairs 125 Replacing the co...

Страница 121: ...r Do not remove the housing cover Maintenance measures must be performed by the personnel responsible Dr ger recommends Dr gerService for repairs and complex maintenance tasks CAUTION Malfunction Soil...

Страница 122: ...from the outside are in compliance with the specified values Country specific labeling of gas types 3 Using the instructions for use check that all components and accessories needed to use the produc...

Страница 123: ...or power socket strip e g on the trolley are used they must be subjected to the same check The check must be performed on individual devices and in the integrated system Protective ground contact res...

Страница 124: ...Avoid contact with the body Immediately clean affected skin areas with soap Component Interval Measure Personnel responsible O2 sensor When the O2 sensor can no longer be calibrated Replace see page 4...

Страница 125: ...essure reducer Every 6 years Replace Experts O rings for inspiratory block Every 6 years Replace Experts Micro switch for pneu matic valve Every 6 years Replace Experts Washer for safety valve Every 6...

Страница 126: ...n Replacing the cooling air filter 1 Pull the cooling air filter A out of the holder in the rear panel 2 Replace the cooling air filter or clean it in warm soapy water and dry thoroughly 3 Insert the...

Страница 127: ...ctions for use Babylog 8000 plus SW 5 n 127 Disposal Disposal Disposal of the medical device 128 For countries subject to the EU Directive 2002 96 EC 128 Disposal of batteries 128 Disposal of O2 senso...

Страница 128: ...search function with the keyword WEEE to find the relevant information If access to the Dr ger website is not possible contact the local Dr ger organization Disposal of batteries The medical device ba...

Страница 129: ...posal Disposal of O2 sensors O2 sensors can be sent back to Dr ger WARNING Risk of explosion and of chemical burns Improper handling of O2 sensors can result in explosions and chemical burns Do not th...

Страница 130: ...141 Essential performance characteristics 142 Alarm criteria 143 Safety principle 145 EMC Declaration 146 General information 146 Electromagnetic emissions 146 Electromagnetic environment 147 Electro...

Страница 131: ...Relative humidity 10 to 95 without condensation Depending on the accessories used more stringent ambient conditions can apply Strictly observe the corresponding instructions for use Unless explicitly...

Страница 132: ...cy 2 to 5 mL 0 5 mL 5 mL 10 Inspiratory flow Range 1 to 30 L min Resolution 1 to 10 L min 0 1 L min 10 to 30 L min 1 L min Accuracy 10 Expiratory flow Range 1 to 30 L min Resolution 1 to 10 L min 0 1...

Страница 133: ...re limited O2 is delivered by the integrated air O2 mixer Trigger delay time 40 to 60 ms Device compliance with breathing circuit without breathing gas humidifier Prerequisite Inspiratory fraction app...

Страница 134: ...essure in HFV ventilation mode Airway pressure may be subatmospheric during expiration however it will not fall below 4 mbar 4 cmH2O in the event of a fault Airway pressure measurement Sensor 2 piezo...

Страница 135: ...mbar 12 cmH2O at 30 L min Neonatal flow sensor ISO 15 8411130 Dead space 0 9 mL Resistance 11 mbar 11 cmH2O at 30 L min Flow Range 0 2 to 30 L min Tidal volume VT Range 0 to 999 mL Resolution 0 1 mL A...

Страница 136: ...1 bpm 10 to 999 bpm 1 bpm Accuracy 1 bpm Inspiratory O2 measurement Sensor Fuel cell integrated in device Measurement is taken in the inspiratory flow The sensor is not barometrically pressure compen...

Страница 137: ...0 01 cmH2O Accuracy 20 Resistance R Range 10 to 999 mbar L s 10 to 999 cmH2O L s Resolution 1 mbar L s 1 cmH2O L s Accuracy 20 Time constant Tc Range 10 to 999 ms Resolution 1 ms Accuracy 30 Overinfla...

Страница 138: ...has been exceeded Range 0 10 to 0 99 L min in steps of 0 01 L min 1 0 to 9 9 L min in steps of 0 1 L min 10 to 15 L min in steps of 1 L min Lower alarm limit alarm If the lower alarm limit has been ex...

Страница 139: ...50 60 Hz 220 to 240 V 50 60 Hz Current consumption At 230 V 0 8 A At 110 V 1 3 A Power consumption Approx 140 W Device fuses Range 100 to 127 V T4AH250V IEC 60127 2 V 5x20 2x Range 230 to 240 V T4AH2...

Страница 140: ...dth x height x depth Basic device 212 mm x 280 mm x 390 mm 8 4 in x 11 0 in x 15 4 in Device with trolley 550 mm x 1273 mm x 559 mm 21 7 in x 50 1 in x 22 0 in Weight Basic device Approx 14 5 kg 32 lb...

Страница 141: ...compared to sensor signals When a separate mea suring device is used and its signal is compared to the analog output of the device this delay must be taken into consideration Output resistance Approx...

Страница 142: ...tions minimum breathing gas flow maximum airway pressure minimum and maximum O2 concentration in the breathing gas or if a set limit is exceeded an appropriate alarm Integrated monitoring also generat...

Страница 143: ...limitation during mandatory inspiration The limitation may be exceeded by max 5 mbar 5 cmH2O so that coughing for instance will not trigger an alarm Above the alarm threshold of Pinsp 5 mbar 5 cmH2O...

Страница 144: ...e may be Pinsp is set too low The ventilation pressure is insufficient for the desired VT No plateau during inspiration because the inspiratory flow is too low or the inspiration time TI is set too sh...

Страница 145: ...Safety principle Babylog 8000 is a software driven device The safety concept is based on 2 microprocessor systems that function independently of one another and monitor each other s functions The meas...

Страница 146: ...nt with CISPR emission requirements can interfere with reception of wireless data When selecting wireless systems wireless communication media pager systems etc for use in installations where wireless...

Страница 147: ...edical device uses radio frequency energy only for its internal function Therefore its radio frequency emissions are very low and are not likely to cause any interference in nearby electronic equipmen...

Страница 148: ...or hospital environment Longer input lines out put lines 1 kV 1 kV Surges IEC 61000 4 5 Common mode 2 kV 2 kV Mains voltage quality should be that of a typical commer cial or hospital environment Dif...

Страница 149: ...es 1 150 kHz to 80 MHz 3 V outside ISM bands2 3 V 1 For PEIRP insert the highest possible equivalent isotropic radiated power of the adjacent radio frequency transmitter In the vicinity of equipment m...

Страница 150: ...frequen cies Examples 0 03 0 32 m 1 1 ft 0 96 m 3 2 ft WLAN 5250 5775 Europe 0 10 0 58 m 1 9 ft 1 8 m 5 9 ft WLAN 2440 Europe 0 17 0 76 m 2 5 ft 2 3 m 7 6 ft Bluetooth RFID 2 5 GHz 0 20 0 82 m 2 7 ft...

Страница 151: ...device Description of the network interface Description of network based alarm systems Dr ger recommends observing IEC 80001 1 risk management for IT networks with medical devices Serial interfaces T...

Страница 152: ...irway Pressure CPAP 156 Intermittent Positive Pressure Ventilation Intermittent Mandatory Ventilation IPPV IMV 156 Synchronized Intermittent Positive Pressure Ventilation SIPPV 158 Synchronized Interm...

Страница 153: ...etering of mixing and metering unit G Magnetic switch over valve H Magnetic valve I Magnetic valve J Non return valve K Filter L Pneumatic control valve M Metering N O2 sensor O Pneumatic control valv...

Страница 154: ...he environment Controlled ventilation The continuous flow flows via the inspiratory line to the Y piece The inspiratory oxygen concentration is measured at the O2 sensor N by the open pneumatic contro...

Страница 155: ...air via the metering system M for approx 2 5 minutes The sensor is then flushed with O2 in a similar manner After the calibration the magnetic valve G switches back to air the magnetic valve I closes...

Страница 156: ...rmittent Mandatory Ventilation IPPV IMV Mandatory ventilation with continuous flow without taking spontaneous breathing into account Mechanical breaths are applied at a rate between TI and TE No disti...

Страница 157: ...ase 2 no plateau Without an inspiratory plateau Pinsp has no influence Part of the flow fills the breathing circuit with each mechanical breath and does not reach the lungs Part of the ventilation sol...

Страница 158: ...of the spontaneous inspiration must correspond to a volume of at least the selected trigger sensitivity The inhaled volume Vtrig A must be inhaled until the end of TE In addition a mechanical breath...

Страница 159: ...eous breathing but averaged over time correspond to the set respiratory rate Breaths are triggered in the same way as in the SIPPV ventilation mode The shape of the mechanical breath is set in the sam...

Страница 160: ...he speed with which the lung pressure adapts to the airway pressure depends on the time constant Trs of the respiratory system The shorter Trs the faster the lungs fill Thus in the PSV ventilation mod...

Страница 161: ...s with Volume Guarantee the device always ventilates with the right pressure required for the tidal volume desired The pressure load on the lungs is limited to the extent absolutely necessary Without...

Страница 162: ...f manually triggered mechanical breaths can be set separately A reduced expiratory flow can be used to save oxygen High frequency ventilation HFV Ventilation with high frequency pressure oscillations...

Страница 163: ...ratory time TE They end 100 milliseconds before an IMV breath and resume 250 milliseconds after the breath The pause following the breath is intended to allow sufficient time to exhale and prevent air...

Страница 164: ...measured specifically for high frequency ventilation DCO2 VThf 2 x f Transport coefficient for CO2 which analogous to the minute volume in conventional ventilation is a measure of high frequency vent...

Страница 165: ...cuits The device uses this estimated value to calculate the following PY PI 0 7 x PI PE PI PE Represents the pressure drop throughout the entire breathing circuit averaged over time If a breathing cir...

Страница 166: ...rement during expiration it is lost before measurement The tidal volume measured on the inspiratory side is therefore greater and that on the expiratory side less than the actual tidal volume Averaged...

Страница 167: ...120 measured values are taken per second The data are evaluated and the results are displayed Then another ventilation cycle is saved and so forth The displayed results thus are not for the current me...

Страница 168: ...2 x Ppeak The results are displayed until the next evaluation is completed If however no new measured values are available within one minute the display is cleared Rate Volume Ratio RVR The quotient...

Страница 169: ...g 57 Disposal 128 Breathing circuit Checking for leaks 60 Safety information 43 Breathing gas humidifier 43 Breathing hoses Attaching 44 Disconnecting 113 C Calibration intervals 93 Compressed gas hos...

Страница 170: ...pply 49 Graphic Screen 40 H High frequency ventilation Description 162 Setting 67 I Impulse output Configuring 103 Inspiration Manual 69 Intended use 16 Interface Analog and digital 76 Configuring 104...

Страница 171: ...e Ratio Description 168 Readiness for operation Checking 58 Rear Overview 21 Repairs 125 Report Printing 78 Reprocessing list 117 Reprocessing methods 114 S Safety checks 8 122 Safety principle 145 Sa...

Страница 172: ...Description 156 Setting 30 Ventilation parameters Setting 29 Ventilator Dismantling 111 Preparation 42 Switching off 80 Switching on 55 Visual inspection 116 Volume 100 Volume Guarantee Description 16...

Страница 173: ...Instructions for use Babylog 8000 plus SW 5 n 173 This page intentionally left blank...

Страница 174: ...r use are provided for customer information only and will only be updated or exchanged upon customer request Directive 93 42 EEC concerning medical devices Manufacturer Dr ger Medical GmbH Moislinger...

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