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Dräger Oxylog 3000 Instructions For Use Manual Download Page 111

Instructions for Use Oxylog 3000 SW 1.n

111

Technical Data

Technical Data

Ambient conditions

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During operation . . . . . . . . . . . . . . . . . . . . . . . 112
During storage and transportation  . . . . . . . . . 112

Settings

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Performance data

. . . . . . . . . . . . . . . . . . . . . 114

Measured value display

. . . . . . . . . . . . . . . . 115

Airway pressure measurement. . . . . . . . . . . . 115
Flow measurement . . . . . . . . . . . . . . . . . . . . . 115
Frequency measurement . . . . . . . . . . . . . . . . 115
Curve display . . . . . . . . . . . . . . . . . . . . . . . . . 115

Monitoring

. . . . . . . . . . . . . . . . . . . . . . . . . . . 116

Expiratory minute volume MV. . . . . . . . . . . . . 116
Airway pressure Paw . . . . . . . . . . . . . . . . . . . 116
Apnoea alarm time TApnoea  . . . . . . . . . . . . . 116

Operating data

 . . . . . . . . . . . . . . . . . . . . . . . 117

Power supply  . . . . . . . . . . . . . . . . . . . . . . . . . 117
Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Device specifications

. . . . . . . . . . . . . . . . . . 119

Materials used

. . . . . . . . . . . . . . . . . . . . . . . . 120

Technical Documentation for the 
Oxylog 3000 according to EMC standard 
IEC/EN 60601-1-2

 . . . . . . . . . . . . . . . . . . . . . 121

General Information . . . . . . . . . . . . . . . . . . . . 121
Electromagnetic Emissions  . . . . . . . . . . . . . . 122
Electromagnetic Immunity  . . . . . . . . . . . . . . . 122
Recommended separation distances . . . . . . . 124

Summary of Contents for Oxylog 3000

Page 1: ... for Use Oxylog 3000 Emergency and Transport Ventilator Software 1 n WARNING For a full understanding of the performance characteristics of this device the user should carefully read this manual before use of the device ...

Page 2: ...e text and the device Elements mentioned in the text are highlighted Unnecessary details are omitted Schematic renderings of screen images guide the user and allow to reconfirm actions performed The actual screen images differ in look or in configura tion A Letters denote elements referred to in the text Typing conventions Any text shown on the screen and any labeling on the device are printed in ...

Page 3: ...operating time for the Oxylog 3000 39 Checking readiness for operation 40 Perform device check 41 Preparation for use after system check 43 Operation 45 Starting operation 46 Preparing ventilation mode 47 IPPV CMV IPPVAssist CMVAssist 48 SIMV SIMV ASB SIMV PS 51 BIPAP PCV BIPAP ASB PCV PS 53 CPAP CPAP ASB CPAP PS 55 O2 concentration with O2 blending 59 Calibration 61 Screen brightness 61 Volume lo...

Page 4: ...mbient conditions 112 Settings 113 Performance data 114 Measured value display 115 Monitoring 116 Operating data 117 Device specifications 119 Materials used 120 Technical Documentation for the Oxylog 3000 according to EMC standard IEC EN 60601 1 2 121 Principles of Operation 125 Ventilation modes 126 BIPAP PCV 129 Functional description 131 List of Accessories 133 Index 135 ...

Page 5: ...and that all repairs also be carried out by them Dräger Medical recommends that only authentic Dräger Medical repair parts be used for maintenance Otherwise the proper functioning of the medical device may be compromised Refer to the chapter Maintenance on page 103 for additional information WARNING Only the accessories indicated on the list of accessories page 133 have been tested and approved to...

Page 6: ...ate safety monitoring that supplies adequate information on medical device performance and patient condition Patient safety may be achieved through a wide variety of means ranging from electronic surveil lance of medical device performance and patient condition to simple direct observation of clinical signs The responsibility for the selection of the best level of patient monitoring lies solely wi...

Page 7: ...nt is connected to the ventilator constant attention by qualified medical staff is required in order to provide immediate corrective action in case of a malfunction The operator shall not rely on the built in monitoring of the ventilator only and must always assume full responsibility for proper ventilation and patient safety in all situations WARNING Keep a manual resuscitation bag available If a...

Page 8: ...ctions for Use only available once CAUTION Installations to the basic device must be done in accordance with the Instructions for Use of the basic device Make sure that the connection is securely fitted onto the basic device system CAUTION Only one copy of the Instructions for Use is included in the clinical package and should therefore be kept in an accessible location for users ...

Page 9: ...Instructions for Use Oxylog 3000 SW 1 n 9 Application Application Intended use 10 Indications Contraindications 10 Environment of use 10 ...

Page 10: ... aircraft including helicopters In accident and emergency departments in the recovery room Mobile use for secondary transfers During transfer by road or air When moving ventilated patients around the hospital WARNING The Oxylog 3000 ventilator may only be used under the supervision of qualified medical personnel in order to be able to provide immediate corrective action in case of a malfunction WA...

Page 11: ...verview System Overview Front panel with all options 12 Side view right 13 Rear view 13 Reusable hose system 14 Disposable hose system 14 Available ventilation modes 14 Special modes 15 For O2 inhalation 15 With monitoring 15 Abbreviations 16 Symbols 17 ...

Page 12: ...nowledging alarm messages K Key O2 Inhalat for changing over to O2 inhalation or key 100 O2 for oxygenation L Key Insp hold for manual inspiration M Key O Start Standby N Display symbols for the power supply Charge status of the internal battery N Mains power supply connected O Central rotary knob for making selections settings and for confirming these P Control knob for setting the O2 concentrati...

Page 13: ...ntilation hose E Connector for medical gas hose F Connector for DC supply G Window for Infrared Data Association IrDA interface Rear view A Filter cartridge for intake of ambient air B Rating plate MT 156 2006 WARNING Do not block the emergency air intake This may result in ventilator malfunction B C D E F A G MT 158 2006 CAUTION Do not block the air intake This may result in ventilator malfunctio...

Page 14: ...ith PEEP SIMV ASB SIMV PS Synchronized Intermittent Mandatory Ventilation Mode for weaning patients off the ventilator after they have started spontaneous breathing with adjustable pressure assist during spontaneous breathing BIPAP ASB PCV PS Biphasic Positive Airway Pressure Pressure controlled ventilation combined with free spontaneous breathing during the complete breathing cycle and adjustable...

Page 15: ...ically switch to volume controlled mandatory ventilation if spontaneous breathing stops NIV For mask ventilation to support non invasive ventilation of spontaneously breathing patients with leakage compensation For O2 inhalation with inhalation mask With monitoring Airway pressure Paw Expiratory minute volume MV Apnoea Rapid shallow breathing High frequency alarm ...

Page 16: ...ncy fspn Spontaneous breathing rate I E Relation inspiratory time to expiratory time IrDA Infrared Data Association MV Minute volume MVe Total expiratory minute volume MVspn Spontaneous minute volume NIV Non invasive ventilation mask ven tilation O2 Set value for the inspiratory O2 con centration O2 Inhalat O2 Inhalation Paw Airway pressure PCV Pressure Controlled Ventilation plus PEEP Positive en...

Page 17: ...arms Values Curves Alarm Reset Charge status of the internal battery N Mains power supply connected Battery charge example three quarters full The device complies with UN Regulation no 10 revision 2 with respect to EMC for use in motor vehicles IPX4 Device protected from water sprayed from all directions limited entrance allowed Class II equipment device pro tected against electric shock with addi...

Page 18: ...System Overview 18 Instructions for Use Oxylog 3000 SW 1 n Do not open Temperature limitations Latex free Do not reuse Handle oil and grease free Non sterile Keep away from sunlight Symbol Explanation ...

Page 19: ...xylog 3000 SW 1 n 19 Operating Concept Operating Concept Switch ON or OFF 20 Switch ON 20 Switch OFF 20 Ventilation controls 21 Display operating controls 22 Changing screen pages in the windows 23 Screen window structure 23 ...

Page 20: ...ylog 3000 SW 1 n Switch ON or OFF Switch ON z To switch ON briefly press the O key A Switch OFF 1 To switch OFF hold down the O key A for approximately 3 seconds 2 Press the rotary knob B to confirm the switch OFF process 00337170 Oxylog 3000 B A ...

Page 21: ...e ventilation mode z Press the appropriate ventilation mode key A for approximately 3 seconds Or 1 Press the appropriate ventilation mode key A 2 Press the rotary knob C to confirm The selected ventilation mode will be activated The active ventilation mode is displayed in the upper left corner of the display B Refer to the section Operation on page 45 for additional information on ventilation mode...

Page 22: ...al for O2 inhalation or 100 O2 key optional for 100 O2 application Display operating controls A Central rotary knob for selecting and confirming options on the display B Values key to change screen pages in the Measured Values window to display the measured values C Curves key to select the main page to display the pressure curve or flow curve D Settings key to change screen pages in the Setting w...

Page 23: ...the Alarms key to display the alarms pages z Press Curves key to select the pressure or flow curves Screen window structure A Status and alarm messages window B Measured values window C Curves and measured values window D Settings and alarms window E Information window Values window A Parameter measured B Unit of measure C Trigger indicator D Measured values 1 5 1st page of 5 available pages Curve...

Page 24: ...IV Brightness fApnoea VTApnoea B Page number 1st page of 2 available pages z Press Settings key The pages are displayed consecutively Alarms window A Menu for alarm limits and alarm parameters For detailed operating instructions see Setting alarm limits on page 67 B 1st of 2 available pages To advance to the next page z Press the Alarms key Pressure curves main page Displays the Paw t curves 05737...

Page 25: ...ing Concept Flow curves main page Displays the Flow t curves Information window A Numeric values displayed when a control knob is turned Battery capacity indicator A Battery capacity indicator example three quarters full 05637171 11037171 A 13537171 A ...

Page 26: ...26 Instructions for Use Oxylog 3000 SW 1 n This page intentionally left blank ...

Page 27: ...entilation hose system 31 Connecting the power supply 32 Internal supply 32 Additional external power supply 32 Internal supply with rechargeable battery 32 Replacing the battery 32 Checking the charge of the battery 32 Installing the battery 33 External power supply with DC DC converter 33 External power supply from mains power AC DC Power pack 34 Connecting the gas supply 34 Supply from an O2 cy...

Page 28: ...veolar ventilation may lead to an increase of the retention of carbon dioxide by the patient Dead space is present as a component of the patient s artificial airway and hose system If the volume of the mechanical dead space equals or exceeds the volume of alveolar ventilation the patient may not be able to adequately evacuate carbon dioxide Therefore it is important to properly manage the ventilat...

Page 29: ...wise to secure into position 3 Push the flow sensor C into breathing valve Note the preferred position as indicated by the groove 4 Push the angled connector D onto the flow sensor 008 WARNING The rubber disc A in the housing may not be removed damaged or bent otherwise the valve will not work properly and will endanger the patient Risk of CO2 rebreathing A 009 WARNING Always use an angled connect...

Page 30: ...meters 3 Connect the flow measuring A hoses to the Oxylog 3000 4 Connect the ventilation hose B to the gas outlet on the Oxylog 3000 NOTE When using a bacterial filter or HME measured flows may deviate from the expiratory flows as temperature and humidity of the gas are reduced 010 WARNING HME and bacterial filters increase the exhalation resistance and dead space volume of the ventilation system ...

Page 31: ... on the device changed by trained service specialists 2 Reconfigure the device accordingly Refer to the Customer Service Mode on page 79 for additional information WARNING Do not use disposable hose systems other than those on the List of Accessories on page 133 The minute volume may be mea sured incorrectly and the device may malfunc tion 013 WARNING Ensure that the flow measuring hoses are corre...

Page 32: ...e 118 To have a fully charged battery on hand refer to the section Getting Started on page 37 for additional information Internal supply with rechargeable battery Replacing the battery 1 Loosen the screw C on the battery compartment cover B counterclockwise to release the cover 2 Remove the battery cover 3 Remove the battery A by pulling the tab Checking the charge of the battery z Press the butto...

Page 33: ...e vehicle the ventilator must always be connected via the DC DC converter refer to the List of Accesso ries on page 133 for additional information 1 Plug the large connector A of the DC DC converter into the on board supply 2 Plug the small connector B into the DC connector of the Oxylog 3000 3 When the Oxylog 3000 is connected to an external supply the indicator N C lights up WARNING The Oxylog 3...

Page 34: ...C DC power pack may not be used outdoors Risk of electric shock or equipment damage 017 Oxylog 3000 B C A WARNING Secure O2 cylinders so they cannot fall over and keep away from excessive heat Risk of explosion WARNING Do not grease or lubricate O2 fittings such as cylinder valves and pressure reducers and do not handle with greasy hands Risk of fire WARNING Operate cylinder valves by hand and rot...

Page 35: ...2 cylinder 3 Connect the O2 medical gas hose A to the Oxylog 3000 4 Connect the O2 medical gas hose to the pressure reducer B WARNING No smoking or open flames O2 enhances combustion of other substances and can intensify fires WARNING Only use compressed gas cylinders and pres sure reducers which comply with all applica ble regulations and have been approved WARNING Only use a pressure reducer wit...

Page 36: ...s of the claw Ensure that the rail is completely inserted in the claw To ensure optimal functioning of the claw a dis tance of at least 35 mm between rail and wall is required CAUTION Do not connect flow control valves or flowmeters in the gas supply to Oxylog 3000 The ventilator could malfunction WARNING Always check the O2 pressure of cylinder before use to prevent insufficient oxygen supply dur...

Page 37: ...of battery capacity battery operation 38 Determining the approximate pneumatic operating time for the Oxylog 3000 39 Checking readiness for operation 40 Perform device check 41 Connect the test lung 41 Switch ON 41 Check connections 42 System check 42 Troubleshooting 43 Preparation for use after system check 43 ...

Page 38: ...sories on page 133 for additional information Indication of battery capacity battery operation The remaining capacity of the battery is indicated by Oxylog 3000 in 25 increments in the lower right section of the information window when power is ON Example 75 charge The accuracy of the battery capacity indicator can vary depending on the age and condition of the battery Refer to Technical Data on p...

Page 39: ...nute volume 10 breaths min x 1 L 10 L min Operation time Calculated with average gas consumption of ventilator 0 5 L min Operation time approx 40 minutes The pneumatic operation time increases when Oxylog 3000 operates with O2 concentration of less than 100 O2 as ambient air is drawn into the device The amount of gas from the high pressure supply which is currently being consumed is indicated by t...

Page 40: ...ry six months The following functions are checked with the menu based test Gas supply present Hose system breathing valve connected and OK Alarm functions OK Ventilation functions OK Monitor functions OK Oxylog 3000 interrupts the test if a fault is detected The relevant fault is indicated on the screen WARNING The patient may be endangered if the above device check is not completed ...

Page 41: ...test and the operator is prompted on the display to activate the configura tion menu or device check Press rotary knob for device check and configuration 2 Press the rotary knob B to confirm before the bar is full 3 Select Device check in the main menu and confirm 021 CAUTION BTPS values of a test lung are not the same as the BTPS values of a patient The Oxylog 3000 mea sures and adapts according ...

Page 42: ...ress the Alarm Reset key to cancel the device check Select the correct hose system Refer to Select hose type on page 81 Restart the device check System check 1 Set the controls A below the display to the required values The Oxylog 3000 successively activates the audible and visual alarm signals and prompts the operator to acknowledge each signal 2 Confirm the audible and visual alarm signals The d...

Page 43: ... local DrägerService for support Preparation for use after system check 1 Assemble the Oxylog 3000 for operation Refer to Assembly on page 27 2 Connect to the power supply and gas supply Refer to Connecting the power supply on page 32 and Connecting the gas supply on page 34 3 Start the ventilator z Select Ventilation from the device check and confirm Or z Press the Alarm Reset key WARNING The ven...

Page 44: ...44 Instructions for Use Oxylog 3000 SW 1 n This page intentionally left blank ...

Page 45: ...MV IPPVAssist CMVAssist 48 Trigger IPPVAssist 49 Cardio pulmonary Resuscitation CPR 50 SIMV SIMV ASB SIMV PS 51 Pressure support 52 BIPAP PCV BIPAP ASB PCV PS 53 Pressure support 54 CPAP CPAP ASB CPAP PS 55 Apnoea ventilation 55 Pressure support 57 NIV Non invasive ventilation Mask ventilation 58 O2 concentration with O2 blending 59 Calibration 61 Screen brightness 61 Volume loudness 61 Shutdown 6...

Page 46: ...s the progress of the self test Upon completion of the self test the ventilator automatically begins ventilation with the default settings The opening display with configured settings is displayed if the central rotary knob is not pressed The manufacturer s default settings are Ventilation mode IPPV CMV Ventilation time ratio I E 1 1 5 Positive end expiratory pressure PEEP 5 mbar Plateau time Tpla...

Page 47: ...Set the required control below the display Or 2 Select set and confirm a parameter on the display with the rotary knob The former settings are retained if confirmation is not received within 15 seconds Attention is drawn to this fact by the advisory message Settings not confirmed When the PEEP setting is increased above 10 mbar a message Confirm PEEP above 10 mbar will appear to request confirmati...

Page 48: ...wing can be set on the display Positive end expiratory pressure PEEP Ventilation time ratio I E Plateau time Tplat in of the inspiration time When setting the ventilation frequency Freq tidal volume VT or ventilation time ratio I E the associated values for inspiration flow and inspiration time Tinsp are automatically displayed in the information window 025 WARNING Only use IPPV for patients who a...

Page 49: ...iggering is briefly indicated by an asterisk in the middle of the status and alarm message window Activating setting the trigger 1 Press the key Settings A until the trig ger parameter is displayed 2 Select the line Trigger on the display and then set and confirm the value with the rotary knob Small value high sensitivity The ventilation mode IPPVAssist is shown on the display Deactivate trigger 1...

Page 50: ...limit the airway pressure Paw to the set Pmax without ending the inspiration prematurely However if due to compressions the airway pressure Paw exceeds the set Pmax by 5 mbar the Oxylog 3000 cycles to the expiration phase Therefore in general if Pmax is set to a higher value a higher minute volume is possible However this increases the intra thoracic pressure and may reduce coronary perfusion ...

Page 51: ...rols below the display Tidal volume VT Frequency Freq minimum possible frequency 2 per min Maximum airway pressure Pmax O2 concentration O2 The following are set on the display Inspiration time Tinsp Plateau time Tplat in of the inspiration time Positive end expiratory pressure PEEP Sensitivity Trigger Successful patient triggering is indicated by an asterisk in the center of the status and alarm ...

Page 52: ... The following can also be set on the display for SIMV ASB Setting on page 1 Pressure support ΔASB above PEEP Setting on page 2 Pressure rise time Ramp flat ramp long pressure rise time medium ramp medium pressure rise time steep ramp short pressure rise time 10737171 1 ...

Page 53: ...et via the inspiratory pressure Pinsp PEEP and ventilation frequency Freq Refer to the description on page 129 for details Set the ventilation pattern with the controls below the display Frequency Freq Maximum airway pressure Pmax O2 concentration O2 The following are set on the display Inspiration time Tinsp Inspiratory pressure Pinsp Positive end expiratory pressure PEEP Sensitivity Trigger Succ...

Page 54: ... BIPAP ASB Setting on page 1 Pressure support ΔASB above PEEP Setting on page 2 Pressure rise time Ramp flat ramp long pressure rise time medium ramp medium pressure rise time steep ramp short pressure rise time BIPAP BIPAP ASB can be extended to include the application mode NIV Non inva sive ventilation see page 58 12437171 ...

Page 55: ...lume controlled mandatory ventilation IPPV CMV When an apnoea occurs the device simultaneously issues an alarm signal and switches to volume controlled ventilation with the parameters frequency fApnoea tidal volume VTApnoea and the maximum airway pressure Pmax when the apnoea time TApnoea has been reached The ventilation time ratio I E is set to 1 1 5 The plateau time Tplat is 0 The patient can br...

Page 56: ... 1 1 5 and the plateau time Tplat 0 are preset during apnoea ventilation To switch apnoea ventilation OFF z Set TApnoea to OFF To end apnoea ventilation z Press the Alarm Reset key The ventilator resumes ventilating with the original mode and parameter settings CPAP The manufacturer default settings are fApnoea 12 min VTApnoea 500 mL These default settings can be configured Refer to Customer Servi...

Page 57: ... patient triggering is indicated by an asterisk in the center of the status and alarm message window Positive end expiratory pressure PEEP Pressure support ΔASB above PEEP Pressure rise time Ramp effective for the BIPAP stroke and pressure support ΔASB CPAP CPAP ASB can be extended to include the application mode NIV Non invasive ventilation see page 58 12537171 ...

Page 58: ...ts of mask ventilation Leakage flows are com pensated automatically and the leakage alarm is inactive Apnoea ventilation is not permitted by the ventilator when NIV is active WARNING If NIV is not activated measured values for VT and MV will be inconsistent if there are leakages during ventilation WARNING Dead space increases when using masks Note the mask manufacturer s instructions WARNING Ensur...

Page 59: ...can be realized at a Pmean of 5 mbar O2 concentration which can be realized at a Pmean of 15 mbar O2 concentration which can be realized at a Pmean of 30 mbar O2 concentration which can be realized at a Pmean of 60 mbar The O2 concentration is a calculated value It is not measured by an internal O2 sensor If Oxylog 3000 can not achieve the set O2 concen trations the signal Check settings O2 prompt...

Page 60: ...s changed the message Check settings O2 may appear after some time if the desired concentration can not be reached WARNING In toxic surroundings The patient must be ventilated with 100 O2 so that toxic constituents do not enter into the breathing gas The patient must be immediately trans ferred to a breathable atmosphere in order to prevent inhalation of toxic air when spontaneous breathing resume...

Page 61: ...F Screen brightness The screen brightness levels can be set on the last page of the Settings menu from level 1 4 to 4 4 The setting Brightness is active in both mains and battery operation when adjusting the settings on the ventilator The setting Brightness is active during battery operation when no controls have been set for a period longer than one minute Volume loudness The volume loudness leve...

Page 62: ...imately 3 seconds 2 Press the rotary knob B to confirm the switch OFF process When O2 is supplied from a cylinder 3 Close the cylinder valve When medical gas is supplied from the pipeline system 4 Disconnect the high pressure connection from the source 00337170 WARNING The cylinder valve must be closed completely to avoid gas flow leakage by the device Oxylog 3000 B A ...

Page 63: ...Instructions for Use Oxylog 3000 SW 1 n 63 Alarms Alarms Types of alarms 64 In the event of an alarm 65 Setting alarm limits 67 ...

Page 64: ...e highlighted by three exclamation marks and displayed in inverted form C Example The Oxylog 3000 generates a sequence of five tones which sound twice and are repeated approximately every 7 seconds Caution An alarm of medium priority z The alarm LED B flashes yellow Caution messages are highlighted by two exclamation marks Example No int battery Oxylog 3000 generates a three tone sequence which is...

Page 65: ...isory message Suppress alarm tones 1 Press the key A The yellow LED lights up and all alarm tones are suppressed for approximately 2 minutes Alarm tones are resumed by the device after these 2 minutes If alarm tones are to be heard again before the 2 minutes have expired 2 Press the key A again and its LED goes out 037 WARNING Check the display regularly for alarm mes sages when the alarm tones ar...

Page 66: ...on device resuscita tion bag using PEEP and or increased inspiratory oxygen concentration where appropriate WARNING In the event of an internal power failure auto matic ventilation volume measurement and alarms do not operate An audible alarm announces the internal power failure Spontaneous breathing can continue through the emergency air intake Immediately start ventilating the patient with an in...

Page 67: ...lower alarm limit need not be set for the airway pressure Paw Oxylog 3000 automatically genera tes an alarm when it no longer detects a pressure difference of more than 5 mbar between inspiratory and expiratory pressure To set alarm limits for MV and fspn Display example Alarms Alarms screen with variable alarm limits lower alarm limit upper alarm limit 2 Press the key Alarms B Example Setting the...

Page 68: ...MV Measured value MV 2 L min MV Measured value MV 2 L min fspn Measured value fspn 5 min with a minimum of 10 min This automatic selection of alarm limits is performed only once when confirmed via the rotary knob The alarm limits refer to the current measured values for MV and fspn WARNING After using the function Auto alarm limits check if the new alarm limits are appropriate for the patient Risk...

Page 69: ... for Use Oxylog 3000 SW 1 n 69 Monitoring Monitoring Displaying curves 70 Displaying other measured values 70 Special functions 71 Manual inspiration Inspiration hold 71 100 O2 optional 71 O2 inhalation optional 72 ...

Page 70: ...d values Additional measured values are displayed in the measured values window Refer to the Operating concept section on page 19 for additional information To switch between the values z Press the Values key the next value is displayed on the screen The following pairs of values are displayed in the default setting Refer to Abbreviations on page 16 These options are MV O2 f VTe PEEP Pmean Ppeak P...

Page 71: ...IPAP ASB PCV PS The pressure controlled ventilation stroke is deter mined by the settings Pinsp and Tinsp For CPAP ASB CPAP PS The pressure controlled ventilation stroke is deter mined by the setting Δ ASB To activate Manual inspiration or Inspiration hold z Press key Insp hold A for as long as inspiration is required Oxylog 3000 will either extend the momentary automatic ventilation stroke accord...

Page 72: ...ng patient may only be connected to the device via an inhalation mask To activate O2 inhalation 1 Press and hold key O2 Inhalat A for approx 3 seconds or 2 Briefly press key O2 Inhalat A and confirm with rotary knob C 3 Connect the inhalation mask to the inspiration connector B WARNING The O2 inhalation function is not a ventilation mode It may only be used for patients with spontane ous breathing...

Page 73: ...ions for Use Oxylog 3000 SW 1 n 73 Monitoring Display example O2 inhalation O2 inhalation is performed with the previously effective setting 4 Set and confirm the required O2 flow via the rotary knob C 07137170 ...

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Page 75: ...information 76 Displaying configuration and information 77 Set language 77 Set gas supply 77 Display the battery type 78 Customer Service Mode 79 To enter customer service mode 80 Settings in customer service mode 80 To exit the parameter settings menu 80 Set startup settings 81 Exit customer service mode 85 ...

Page 76: ...ce or configuration 1 Switch the Oxylog 3000 ON Press the O key The device performs a self test and the operator is prompted to enter the configuration menu or device check Press rotary knob for device check and con figuration 2 Press the rotary knob and confirm The main menu is then displayed 3 Select and confirm Configuration and infor mation screen 15 ...

Page 77: ... be displayed via Configuration and information Identification No Device ID Total hours of operation Working hours Hours of operation since the last inspection and maintenance Hours since service time Battery type and battery capacity Set language 1 Press the key Settings to select the menu Configuration 2 Select and activate the line Language 3 Select the language and confirm The new language sel...

Page 78: ...s of the set O2 concentration However the control O2 can be set to 40 for example In this way Oxylog 3000 will use less medical air by additionally drawing in ambient air Display the battery type z Press the key Settings to select the menu Information The performance data of the inserted battery are displayed on the device 06637171 screen 17 2 2 ...

Page 79: ...me 004 Set measured values display window Configure the layout of measured values in the measured values window or restore manufacturer s default settings 005 Enter activation code Enter the activation code for options 006 Test buttons and potentiometer Check for correct functioning of keys and controls 007 Test loudspeaker buzzer LEDs and display Check for correct functioning of loudspeaker buzze...

Page 80: ...ith the central rotary knob 4 Activate test press rotary knob Settings in customer service mode 1 Select the required function with the cursor asterisk To select the parameter turn the rotary knob To activate the parameter press the rotary knob To set the value turn the rotary knob To confirm the value press the rotary knob To exit the parameter settings menu 1 Select the line EXIT 2 Press the rot...

Page 81: ...ct hose type The type of ventilation hose reusable or disposable hose system can be configured The gas outlet connectors for the flow measuring hoses must correspond to the hose type system selected Parameter Range Trigger 0 OFF 3 to 15 L min PEEP 0 to 20 mbar I E 3 1 to 1 4 Tinsp 0 2 to 10 0 s Tplat 0 to 50 ΔASB 0 to 35 mbar Ramp SLOW STANDARD FAST Pinsp 3 to 55 mbar O2 Flow 0 to 15 L min NIV ON ...

Page 82: ... be freely selected in any position and is only displayed at that position To define the five values to be displayed z Start configuration on page 1 5 and continue through to 5 5 Enter activation code The activation codes for options can be entered The activated options are then displayed Test buttons and potentiometer The operating elements on the front panel are displayed schematically on the sc...

Page 83: ...uded in the test Test loudspeaker buzzer LEDs and display To test the loudspeaker buzzer all LEDs and the display 1 Select the required test 2 Start the test Each function is tested by the device To test the screen display Test display 3 Turn the rotary knob various test cards are displayed The selected test remains active until the rotary knob is pressed again Display accu battery and supply data...

Page 84: ...le Advance to the next page z Select line Page confirm and turn the rotary knob Display settings logbook The operating phases with ventilator settings and time are listed in chronological order Advance to the next page z Select line Page confirm and turn the rotary knob Display language text Alarm messages and advisory messages are displayed by the ventilator in the selected display languages one ...

Page 85: ... Oxylog 3000 SW 1 n 85 Configuration Exit customer service mode 1 Press the key O for approximately 3 seconds the LED flashes yellow To switch ventilation ON 2 Briefly press the key O To switch OFF 3 Press the rotary knob ...

Page 86: ...86 Instructions for Use Oxylog 3000 SW 1 n This page intentionally left blank ...

Page 87: ...tructions for Use Oxylog 3000 SW 1 n 87 Problem Solving Problem Solving Alarm Cause Remedy 88 Messages in the alarm window 88 Messages in the information window 93 Error messages during the device check 94 ...

Page 88: ...gen The device has been set to medical air and may only be operated with medical air 30 Apnoea Spontaneous breathing by the patient has failed or dis connection Ventilate in IPPV CMV mode Ensure that hose connections are tight 6 Faulty flow sensor Replace flow sensor Apnoea ventila tion only for CPAP The ventilator has automati cally switched over to man datory ventilation after detecting an apnoe...

Page 89: ...king Ensure flow measurement hoses are connected correctly 22 Flow sensor defective Replace flow sensor Technical defect Disconnect the patient from the device and continue ventilation without delay using another ventilator Call DrägerService Gas delivery fail ure Technical defect Contact your local DrägerService for additional support 19 High frequency Patient breathes at a high spontaneous rate ...

Page 90: ...value Repair leaks in hose system and possibly in the tube Use new flow measuring hoses 9 Faulty flow sensor Replace flow sensor The ventilator may not func tion properly Contact your local DrägerService for additional support Loss of data Technical defect Contact your local DrägerService for additional support 20 Loudspeaker inop Technical defect To continue ventilation with this device verfiy th...

Page 91: ...arged Press the Alarm Reset key to confirm the alarm Change inter nal battery 26 Paw high The alarm limit Pmax for the airway pressure has been reached Patient fights the ventilator coughing Check patient s condition check ventilation pattern adjust alarm limits if necessary 3 Ventilation hose kinked or obstructed Check hose system breathing valve and tube Paw low No pressure difference 5 mbar bet...

Page 92: ...message can be confirmed or it will be cancelled automatically with the next message 28 Settings not con firmed Parameters have been changed on the screen but not confirmed Press the rotary knob to confirm the parameter changes 27 Supply pressure low Supply pressure 270 kPa Ensure that supply pressure exceeds 270 kPa 11 Alarm Cause Remedy Alarm Rank ...

Page 93: ...t I E 1 1 5 Texp 2 s Change in Tinsp or f in ventilation mode BIPAP PCV PEEP 10 mbar has been set but not confirmed The required setting of PEEP 10 mbar is only possible when confirmed via the rotary knob Gas consumption 10 L min Standard display in information window for the current gas consumption Battery capacity Standard display in information window for the current battery capacity Pinsp PEEP...

Page 94: ...g for leaks and replace if necessary Breathing valve inop Breathing valve has malfunc tioned Check correct condition of breath ing valve including diaphragm and rubber disc fit a new breathing valve if necessary or use a new disposable hose set Pressure measurement inop The ventilation hose system has not been connected correctly Connect ventilation system cor rectly Pressure measurement is not po...

Page 95: ...ion Disassembly 96 Disassemble the reusable hose system 96 Remove the disposable hose system 98 Reprocessing procedure 99 Cleaning and disinfecting 99 Disinfecting by wiping 100 Bath disinfection for reusable hose system 100 Sterilizing the reusable hose system 100 After care 101 Note service life of the hose system 101 ...

Page 96: ...the ventilation hose A from the gas output 2 Disconnect the flow measuring hoses B from the nozzles 3 Disconnect the medical gas hose C from the Oxylog 3000 046 B A C 048 CAUTION When disconnecting the ventilation hose always grip the sleeve A and not the corrugations B If this is not done the corrugations or hose may be torn from the sleeve A B ...

Page 97: ...or use force when disconnecting the flow measuring hoses from the flow sensor nozzles This can damage the flow sensor Risk of malfunction WARNING Do not allow any objects to enter the flow sensor to prevent risk of malfunctions Do not purge with compressed air The wind vane inside may be damaged and cause measuring errors B A C D B 045 WARNING Do not disassemble breathing valve any further Do not ...

Page 98: ...ectly dispose of the complete disposable hose system Refer to the chapter Disposal on page 107 rubberdisc WARNING The rubber disc A in the housing must not be removed damaged or bent otherwise the valve will not work properly and endangers the patient Risk of CO2 rebreathing 047 A A B C CAUTION The disposable hose system must not be sterilized it cannot withstand high temperatures and may be damag...

Page 99: ... are recommended Dismozon pur Incidur Sekusept Powder Trichlorol The DGHM list published by mhp Verlag Wiesba den also specifies the active ingredient in each dis infectant Disinfectants based on the active ingredients aldehydes alcohols or quaternary ammonia compounds are recommended for users in those countries in which the DGHM list is not available WARNING Always follow hospital EMS procedures...

Page 100: ...he flow sensor Dismantle the breathing valve WARNING Do not allow any liquid to enter the ventilator or medical gas hose Risk of malfunction WARNING Follow the manufacturer s instructions Agitate parts thoroughly in the solution Do not clean with a hard brush WARNING Do not allow any objects to enter the breathing valve or flow sensor Risk of malfunction WARNING Rinse parts thoroughly with distill...

Page 101: ...em After care Reassemble refer to Assembly on page 27 for information Connect to the power supply and gas supply refer to Assembly on page 27 for information Check readiness for operation refer to Getting Started on page 37 for information Note service life of the hose system The parts of the breathing valve the flow sensor the angled connector the flow measuring hoses and the ventilation hose are...

Page 102: ...102 Instructions for Use Oxylog 3000 SW 1 n This page intentionally left blank ...

Page 103: ...Instructions for Use Oxylog 3000 SW 1 n 103 Maintenance Maintenance Maintenance intervals 104 In case of ventilator failure 105 ...

Page 104: ...entilator inspected and serviced at regular two year intervals Keep a record on all preventive maintenance WARNING Clean and disinfect the device or device parts before each maintenance step and also when returning for repair to prevent risk of infection Task Frequency Performed by Replace dust filter 1 Every two years Trained service personnel Replace internal battery Every two years When the bat...

Page 105: ... 1 n 105 Maintenance In case of ventilator failure CAUTION Never operate a ventilator if it has suffered physical damage or does not seem to operate properly In this case always refer servicing to factory trained and authorized personnel ...

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Page 107: ...Instructions for Use Oxylog 3000 SW 1 n 107 Disposal Disposal Safety information 108 Disposal of batteries 108 Disposal of the medical device 108 Disposal of the disposable hose system 109 ...

Page 108: ...her informa tion visit us on the Internet at www draeger medi cal com and navigate to the DrägerService area where you will find a link to WEEE If you do not have access to our website contact your local Dräger Medical Organization Disposal of batteries The medical device battery contains pollutant substances The applicable local regulations for battery disposal must be observed in all countries D...

Page 109: ...ns for Use Oxylog 3000 SW 1 n 109 Disposal Disposal of the disposable hose system Always follow local regulations governing the disposal of disposable hose systems according to established hospital EMS procedures ...

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Page 111: ...ement 115 Frequency measurement 115 Curve display 115 Monitoring 116 Expiratory minute volume MV 116 Airway pressure Paw 116 Apnoea alarm time TApnoea 116 Operating data 117 Power supply 117 Gas supply 118 Device specifications 119 Materials used 120 Technical Documentation for the Oxylog 3000 according to EMC standard IEC EN 60601 1 2 121 General Information 121 Electromagnetic Emissions 122 Elec...

Page 112: ...re 20 to 50 o C Atmospheric pressure 570 to 1200 hPa Relative humidity 5 to 95 During storage and transportation Ventilator without replaceable battery with reusable hose system Temperature 40 to 75 o C Atmospheric pressure 570 to 1200 hPa Relative humidity 5 to 95 Disposable hose system Temperature 20 to 70 o C Atmospheric pressure 570 to 1200 hPa Relative humidity 5 to 95 Replaceable battery Tem...

Page 113: ...etting 15 of set value or 25 mL whichever is greater Inspiratory pressure Pinsp PEEP 3 mbar to 55 mbar2 O2 concentration 40 to 100 vol Accuracy of Setting 10 vol The setting depends on the inspiratory flow3 and mean airway pressure Positive end expiratory pressure PEEP 0 to 20 mbar 2 mbar no negative pressure Trigger sensitivity flow trigger 3 to 15 L min Pressure support ΔASB 0 to 35 mbar relativ...

Page 114: ...r at 60 L min 4 mbar at 30 L min 2 mbar at 5 L min Dead space including flow sensor approximately 35 mL reusable hose system approximately 33 mL disposable hose system Supplementary functions Demand valve Opens the breathing system upon failure of the gas supply permits spontaneous breathing with ambient air Relief valve Opens the breathing system at approximately 80 mbar Patient connection 22 mm ...

Page 115: ... pressure Pmean Plateau pressure Pplat Flow measurement Minute volume MV Range 0 to 99 L min BTPS Resolution 0 1 L min Accuracy 15 of measured value or 1 L min whichever is greater Tidal volume VTe Range 0 to 5000 mL BTPS Resolution 1 mL Accuracy 15 of measured value or 25 mL whichever is greater Frequency measurement Range 0 to 99 min Resolution 1 min Accuracy 1 min Curve display Airway pressure ...

Page 116: ... lower alarm limit Range of settings 0 5 to 40 L min Airway pressure Paw Alarm upper alarm limit When value Pmax is exceeded Range of settings 20 to 60 mbar Alarm lower alarm limit When the pressure difference between inspiratory and expiratory phases is less than 5 mbar Or If the set pressure level is not attained Apnoea alarm time TApnoea Alarm When respiratory activity is no longer detected Ran...

Page 117: ...attery capacity in 25 increments Accuracy of the capacity indication The indicated capacity is determined by the battery itself The accuracy depends on the type and manu facturer and may deteriorate with frequent partial discharge and during operation in extreme tempera tures The internal battery is only reconditioned after being discharged completely and recharged at room temperature 25 o C The c...

Page 118: ...r medical air O2 inlet connection either NIST1 to EN 739 or DISS2 to CGA V5 1989 or N F3 S90 116 WARNING Only use medical grade oxygen or medical grade air that is dry and free from dust and oil Contaminated gas can cause lung damage and device malfunction Gas cylinders and pressure reducers WARNING Only use compressed gas cylinders and pressure reducers which comply with all applicable regulation...

Page 119: ...C power pack approximately 0 8 kg DC DC converter approximately 0 4 kg Electromagnetic compatibility EMC Tested to EN 60601 1 2 2001 EN 794 3 36 101 10 V m ISO 10651 3 36 202 2 1 30 V m and UN Regulation nr 10 revision 2 with respect to EMC for use in motor vehicles equivalent to Commission Directive 95 54 EC Classification according to Directive 93 42 EEC Class IIb UMDNS Code Universal Medical De...

Page 120: ...x free Reusable hose system Ventilation hose flow measuring hoses Silicone rubber Flow sensor housing breathing valve Polysulphone PSU Vane in flow sensor Stainless steel Diaphragms in breathing valve Silicone rubber Disposable hose system Ventilation hose Polyethylene PE Non return valve Synthetic resin Breathing valve Polyethylene PE Flow sensor housing Polymethyl methacrylate PMMA Film in flow ...

Page 121: ...r Quick Power Connector Carrying System Refer to the List of Accessories on page 133 for additional information Additionally accessories may be used which do not affect EMC compliance if no other reasons contradict the use of them The non observance may result in increased emissions or decreased immunity of the Oxylog 3000 The Oxylog 3000 should not be used adjacent to or stacked with other equipm...

Page 122: ...ork that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker IEC 61000 3 3 Complies Electromagnetic Immunity Electromagnetic Immunity This Oxylog 3000 is intended for use in the electromagnetic environment specified below The user of the Oxylog 3000 should make sure that it is used in such an environment Immunity against IEC 60601 1 2...

Page 123: ...3 80 MHz 2 5 GHz 10 V m 30 V m Recommended separation dis tance from portable and mobile RF transmitters with transmis sion power PEIRP to the Oxylog 3000 including its lines 1 84 m PEIRP X1 RF coupled into lines IEC 61000 4 6 150 kHz 80 MHz 10 V within ISM bands 3 V outside ISM bands X2 10 V 10 V Recommended separation dis tance from portable and mobile RF transmitters with transmis sion power PE...

Page 124: ...e frequency is between 150 kHz to 2 5 GHz use the 3 V m distance column Otherwise use the 1 V m distance column Recommended separation distances between portable and mobile RF Telecommunication devices and the Oxylog 3000 maximum PEIRP W 3 V m distance m 1 V m distance m Examples 0 001 0 06 0 17 0 003 0 10 0 30 0 010 0 18 0 55 e g Garage door openers 0 030 0 32 0 95 e g WLAN 5250 5775 Europe 0 100...

Page 125: ...25 Principles of Operation Principles of Operation Ventilation modes 126 IPPV CMV 126 IPPVAssist CMVAssist 126 SIMV 126 ASB PS 127 BIPAP PCV 129 Functional description 131 Gas supply 131 Inspiration 131 Expiration 131 Safety 132 Monitoring 132 ...

Page 126: ...on and spontaneous breathing SIMV enables the patient to breathe spontaneously in regular prescribed cycles with the mechanical mandatory ventilation strokes providing a minimum ventilation during the remaining cycles The minimum ventilation is controlled by the two set values of the tidal volume VT and frequency Freq and is determined from the product of VT x Freq The ventilation pattern results ...

Page 127: ...ith pressure by ASB pressure support In the course of progressively weaning the patient from artificial ventilation the ventilation frequency f is further reduced while the spontaneous breathing time is increased so that the required total minute volume is increasingly supplied by spontaneous breathing ASB PS Assisted Spontaneous Breathing Pressure Support Pressure support for insufficient spontan...

Page 128: ...se of slow increase in pressure the Oxylog 3000 begins gently with regular inspiratory flow The patient has to take over more breathing effort With the patient adjusted pressure increase and the pressure ΔASB above PEEP the patient s own breathing activity defines the required inspiration flow ASB is terminated when the inspiration flow returns to zero during phase I i e when the patient exhales o...

Page 129: ...pontaneous breathing The frequency of the changeover is kept constant even when synchronization occurs via a trigger window with fixed time constant This smooth adaptation to the patient s spontaneous breathing requires less sedation This means that the patient returns to spontaneous breathing more rapidly As in all pressure controlled ventilation modes the patient is not prescribed a fixed tidal ...

Page 130: ...e time pattern only the Pinsp setting needs to be changed The steepness of the increase from the lower pressure level to the upper pressure level is controlled by the Ramp setting During the lower pressure level phase spontaneous breathing can be assisted by ASB The steepness of the pressure increase to ASB pressure ΔPASB above PEEP is also controlled by the Ramp setting The transition from contro...

Page 131: ...ed tidal volume corresponds with that set for BTPS taking into account the ambient pressure In this way Oxylog 3000 meters and measures roughly 10 less volume in operation with a test lung dry gas at room temperature Expiration During volume controlled inspiration pressure con trol V6 closes the inspiratory channel and controls the PEEP pressure during expiration or reduces the pressure in the ins...

Page 132: ...l pressure signal The measured monitoring values of the tidal volume minute volume and respiratory rate are derived from the measured expiratory flow The inspiratory flow signal is used for detection of the flow trigger System leakages can be identified from the balance of inspiratory and expiratory tidal volumes e g leakage alarm NIV Airway pressure measurement on the patient side supplies the Pa...

Page 133: ...2M 86 733 Reusable hose system comprising Reusable hose system 1 5 m 84 12 068 Reusable hose system 3 m 84 12 913 Breathing valve 84 12 001 Flow sensor 84 12 034 Angled connector 84 12 235 Ventstar Oxylog 150 Disposable breathing system kit 1 5 m set of 5 57 03 041 Ventstar Oxylog 300 Disposable breathing system 3 0 m set of 5 MP 00 335 Conversion kit Reusable nozzle kit ME 05 133 Conversion kit D...

Page 134: ...134 Instructions for Use Oxylog 3000 SW 1 n This page intentionally left blank ...

Page 135: ...PS 16 41 C Calibration 61 Cardio pulmonary Resuscitation CPR 50 Caution 2 7 8 64 Changing 23 Checking readiness for operation 40 Cleaning 95 CMVAssist 48 Configuration 75 Connecting the gas supply 34 CPAP 21 CPAP CPAP ASB CPAP PS 55 CPAP ASB CPAP PS 21 Customer Service Mode 79 D DC DC converter 33 Dead space 28 Device check 41 Device specifications 119 Disinfection 95 Display operating controls 22...

Page 136: ... 67 Pressure support 52 127 Pressure support BIPAP 54 R Rear view 13 Recommended separation distances 124 Restrictions of use 10 Resuscitation heart lung 50 Reusable hose system 14 29 S Safety 5 Screen 23 Screen brightness 61 Screen window structure 23 Separation distances 124 Settings 113 Settings window 24 Shutdown 62 Side view right 13 SIMV 21 126 SIMV ASB 51 SIMV ASB SIMV PS 21 Single use hose...

Page 137: ...Instructions for Use Oxylog 3000 SW 1 n 137 This page intentionally left blank ...

Page 138: ... document is provided for customer informa tion only and will not be updated or exchanged without customer request Directive 93 42 EEC concerning Medical Device Manufacturer Dräger Medical GmbH Moislinger Allee 53 55 D 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 20 80 http www draeger com 90 37 171 GA 5664 650 en Dräger Medical GmbH Edition 12 2010 09 Edition 1 2001 04 Dräger reserves the r...

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