Carina Guidelines. The Carina Guidelines are not a replacement or substitute for the Instructions for Use.

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1 Carina Guidelines The Carina Guidelines are not a replacement or substitute for the Instructions for Use. Any use of the device requires full understanding and strict observation of the Instructions for Use. The user must be familiar with the device according to the national and local laws and recommendations.

2 Table of contents Page Table of contents Intended Use Carina What is what 4. Control panel, top 4. Carina underside 4. Front connection block 5.4 Rear connection block 5.5 Trolley -78 cm 6.6 Screen Layout 6.7 Status line for displaying current device settings 6 4 Preparation 7 4. Connecting electrical power 7 4. Connecting the oxygen supply 7 4. Setting up the ventilator breathing circuit Powering up the ventilator Ventilator setting Setting alarm limit 4.7 Displaying set value and measured value 4.8 Configuration 4.9 Locking bottons 5 Alarm handling 5. In the event of alarm 5. Suppressing the alarm tone 6 Standby and switch OFF 4 6. Switching Carina to Standby 4 6. Switching OFF the device 4 7 Cleaning and maintenance 5 7. Cleaning intervals 5 7. Maintenance intervals 5 8 Alarm message Cause & Remedy 6 9 Accessories 8 9. Accessories for Carina 8 9. Mask cleaning 9 0 Preparation procedure 0

3 Intended Use Intended Use Carina long-term ventilator for ventilatordependent patients or ventilator-assisted patients. For treatment of sub-acute care patients in hospital or medical rooms. For invasive ventilation or non-invasive ventilation. For patients with a tidal volume of at least 00 ml. For use by qualified medical personnel. WARNING! Not intended for acute inpatient care of nonstabilized patients who require ventilation with comprehensive continuous monitoring according to IEC or EN Sub-acute care definition Sub-acute care is comprehensive, inpatient care for patients who: Have had an acute event resulting from injury, illness or exacerbation of a decease process; Have a determined course of treatment; Though stable, require diagnostics or invasive procedures, but not intensive procedures requiring an acute level of care. The severity of the patient s condition requires: Active physician direction with frequent on-site visits; Professional nurse care; Complex medical and/or rehabilitative care. Typically sub-acute care is designed to return patients to the community or transition them to a lower level of care.

4 What is what Control panel, top Carrying handle Screen Buttons for functions and parameters 4 Rotary knob 5 Audio paused min. button 6 LED for indicating power supply: LED lit = External power supply (mains/external battery), internal battery is charged LED flashes = External power supply (mains/external battery), internal battery is being charged LED off = battery operation 7»Start/Standby«button 8»Select Menu«button. Carina underside Switch for hose system with leak valve or hose system with expiration valve masked by sliding cover (not illustrated) Future functions Holes for positioning on the trolley (4 off). Front connection block Ventilation hose connection Emergency air inlet and oxygen overflow Connection for control hose (for hose system with expiration valve) 4

5 What is what.4 Rear connection block Not assigned Connection for nurse call system RS serial port (MEDIBUS) 4 Not assigned 5 Inlet filter (HEPA filter) 6 Connection for HPO oxygen supply 7 Connection for LPO oxygen supply 8 Mains switch 9 Connection for external battery 0 Power cable connection Trolly Carina bracket Standard rail grip Universal bracket with standard rail, optional 4 Trolley column 5 Pedestal 6 Red locking lever of the column mount closed (under pedestal) 7 Dual rollers with locking brakes, 4 each

6 What is what Screen layout Alarm line for alarm message Status line for current device settings Display for real-time waveforms of flow and pressure 4 Display for measured values, configurable 5 Information line 6 Display of ventilation parameters Status line for displaying current device settings LPO oxygen supply Power supply int Internal battery ext External battery Mains Charge of internal battery Hose system expiration valve or leak valve Ventilation method tube or mask Set ventilation mode Patient effort detection 6

7 4 Preparation 4. Connecting electrical power Plug the ventilator power cable into device AC power A Secure with the wire clip. Insert the mains plug into a power socket. The LED flashes or lights up according to the charge of the internal battery. If you are using an External battery or heated humidifier, plug their power cord to AC power as well. A 4. Connecting the oxygen supply Screw the O compressed gas hose onto the HPO nozzle B or tube from O gas cylinder onto the LPO nozzle of Carina. Supply with oxygen from the central supply or from the O gas cylinder/concentrator C. B C 7

8 4 Preparation 4. Setting up the ventilator breathing circuit Select hose system Leak valve system or expiration valve system Open the sliding cover on the underside of Carina. Using a coin, turn the switch to your hose system Close the sliding cover. 4 5 Leak valve hose system: 4 Connect the filter to socket. 5 Connect the ventilation hose: VentStar Carina LV (MP00) to filter. The hose system is displayed on the status line of the screen as follows:»leakv«. or: Expiration valve hose system: 4 Connect the filter to socket. 5 Connect the ventilation hose: VentStar Carina EV (MP00) to filter 6 Connect the pilot line of the expiration valve to pilot hose socket. The hose system is displayed on the status line of the screen as follows:»expv«. 8

9 4 Preparation 4.4 Powering up the ventilator Carina switching on Set the mains switch to Carina conducts a self-test. During the self-test the screen indicates the progress of the self-test. That is followed by the screen showing the ventilation mode and parameters last set. The device is in standby mode. Starting ventilation Press the»start/standby«key. Carina ventilates at the ventilation parameters set. The screen shows the current ventilation waveforms and values. For configuration of the screen display, see page 86 Instruction for Use. 9

10 4 Preparation 4.5 Ventilator settings Push Menu key Vent. Settings Alarms Values Config. Un locked VC-SIMV AF PC-BIPAP * PC-AC SPN-PS Volume guarantee SPN-CPAP Apnoea ventilation Volume Control Synchronized Intermittent Mandatory Ventilation AF - AutoFlow Trigger can be switched OFF VC-CMV Pressure Control Biphasic Positive Airway Pressure Trigger can be switched OFF PC-CMV Pressure-controlled, assisted ventilation Spontaneous - Pressure Support For patients with sufficient spontaneous breathing. VG can be switched on in ventilation mode SPN-PS. Tidal volume guarantee Spontaneous - Continuous Positive Airway Pressure For automatically switching to volume-controlled, mandatory ventilation (VC-SIMV AF) in the event of apnoea. Only on SPN-PS and SPN-CPAP * Trademark used under license 0

11 4 Preparation 4.6 Setting alarm limits The current measured value is displayed between the upper and lower alarm limits. Vent. Settings Alarms Values Config. Un locked Alarm Paw high MVi high MVi low f high Tapnea Tdisconn Setting range 0 to 55 mbar to 40 L/min 0. to 9 L/min 0 to 50 bpm 5 to 60 seconds Mask: 0, 5, 0, 60, 90, 0 sec. Tube: 0, 5, 0, 60 sec. 4.7 Displaying set values and measured values Measured values, set values and pressure curve are displayed. The screen displays: Settings Measured values graphic representation of Paw Vent. Settings Alarms Values Config. Un locked NOTE: Measured Frequency on VC-SIMV and PC-BIPAP displays only mandatory breaths per minute. (Spontaneous breaths are not counted)

12 4 Preparation 4.8 Configuration The configuration menu shows the configurable functions and parameters: Vent. Settings Alarms Values Config. Un locked st page Service: for system and contact information and log book (Password:45) Volume: adjustable from to 5 Tone: default tone or Dräger tone can be selected Screen: adjustable for displaying curves or values nd page Set value: for selecting measured values to display value and value Method: for setting mask or tube ventilation LPO: for setting LPO oxygen supply Ti / I : E: for selecting the setting used for Ti or I : E ratio rd Page Night: for switching on the screen in night screen mode after min. display 4.9 Locking buttons All the buttons (apart from the»audio paused min.«button) can be locked in order to prevent them from being pressed accidentally. Locking: Press the»un-locked«button and keep it pressed until the colour of the button switches to red and the button indicates»locked«. Vent. Settings Alarms Values Config. Un locked Unlocking: Press the»locked«button, thus unlocking the buttons. Vent. Settings Alarms Values Config. Locked

13 5 Alarm handling 5. In the event of an alarm If the alarm message, e.g.»mv high!!«, appears in the alarm line on the screen. MV high!! Carina assigns the message an appropriate level of priority. Red!!! = Alarm Message with the highest priority Yellow!! = Important Message with medium priority Yellow! = Note Message with low priority 5. Suppressing the alarm tone for up to minutes: Press»Audio paused min.«key. The alarm tone is suppressed for approx. minutes. The symbol of silent alarm is displayed on the screen. If an alarm with a higher or equal priority occurs during the period when the alarm tone is suppressed, the alarm tone sounds again.

14 6 Standy-by and Switch OFF 6. Switching Carina to Standby Press»Start/Standby«key for approx. seconds Carina is in standby mode. LED in the key flashes. The alarm line shows»standby activated«. 6. Switching off the device Switch Carina to standby. Set the mains switch to Carina is switched off. Carina cannot be switched off during ventilation. Carina signals»switch off via standby!!«the internal battery is also charged when the device is switched off. 4

15 7 Cleaning and maintenance 7. Cleaning intervals Part Time schedule Activity Carina basic unit Per patient Wipe outside Trolley, hinged arm Per patient Wipe outside HPO hose Silicon hose Per patient/ weekly Immerse if possible Reusable water trap Sterilise hot steam 4 C / 0 min Cleaning and disinfection machine 9 C / 0 min VentStar Carina LV Per patient / weekly Replace (MP00) VentStar Carina EV Per patient / weekly Replace (MP00) Leakage valve Per patient Replace Disposable component: Please follow the instructions from the factory. Please change disposable component weekly or in accordance with the rules specified or applicable for your hospital. 7. Maintenance intervals Clean and disinfect equipment and/or components before any maintenance procedures and before returning for repair. Part Time schedule Activity Nurse call (if applied) Per month Test HEPA filter 6 monthly Replace Internal Battery monthly Recharge battery (if not used temporarily) To be replaced by NiMH batteries should be disposed technicians after years. of as special waste Technical and safety Annually Device check inspections by service Use surface disinfectant: Aldehydes Quaternary ammonium compounds To avoid the possibility of damage to material do not use any disinfectants based on: Alkylamine-based compounds Phenol-based compounds Halogen-releasing compounds Strong organic acids Oxygen-releasing compounds 5

16 8 Alarm message Cause & Remedy These tips are not a replacement for the Instructions for use. 8. Trouble shooting tips: Clinical related alarms Error message Cause Remedy Airway pressure high!!! The excess pressure alarm can be Check condition of patient, caused by continuous coughing. check ventilation pattern, correct alarm limit if necessary. Airway pressure low!!! A connection has become detached. Make sure the hoses, filters and other components are secure again. Check the setting of Tdisconn. High frequency!!! Patient is breathing at a high Check condition of patient, spontaneous frequency, therefore check ventilation pattern, correct the monitored overall frequency alarm limit if necessary. is too high. MV high!! The minute volume has exceeded Check condition of patient and the upper alarm limit. ventilation pattern, correct alarm Leak in breathing system. limit if necessary. MV low!!! The minute volume has exceeded Check condition of patient and the lower alarm limit. ventilation pattern, correct alarm Leak in breathing system. limit if necessary. Apnoea ventilation!!! The device has detected respiratory Apply controlled ventilation or arrest in SPN-PS or SPN-CPAP mode extend apnoea alarm time Tapnea. and will ventilate under control in VC-SIMV mode until Spontaneous breathing resumes. 8. Trouble shooting tips: Functional related alarms Error message Cause Remedy Disconnection/high After the leakage alarm, Carina Check hoses, filters and other leakage! delivers a low constant flow at components to make sure the PEEP level. When the leak has connections are not leaking been eliminated, Carina and are secure. Automatically resumes operation at the previous ventilation settings. Large leakage!!! Note: This is only displayed Check hoses, filters and other after the rd ventilation stroke. components to make sure the The hose system is leaking. connections are not leaking and are secure. Insufficient O /LPO O supply is too low. Check the HPO and LPO settings set?! Carina is working in LPO or HPO in the Configuration menu mode if the O -compressed In HPO mode: Check central gas connection is not correct. gas supply. Inlet filter missing!! The inlet filter has been removed Insert inlet filter. or is not inserted correctly. Check that the inlet filter is secure. 6

17 8 Alarm message Cause & Remedy These tips are not a replacement for the Instructions for use. 8. Trouble shooting tips: Battery related alarms Error message Cause Remedy External power failure!! The device has no external Check the mains supply or DC power supply. power supply. The mains or DC plug is loose. Insert the mains plug or DC plug properly at both ends. The mains or DC cable has a break. Connect a replacement battery. Mains power failure. Connect to the mains. Charge The external battery is flat. external battery. Int. battery activated! Lack of an external power supply. Reconnect external power supply. Int. battery low! Battery charge: less than 50 % Charge the battery: Connect external power supply. Int. battery low!!! Battery charge: less than 5 % Charge the battery: Connect external power supply. Int. battery empty!!! Battery charge: less than 5 % Connect ventilator immediately to The operating time with supply mains power supply or to a fully from the internal battery has expired. charged external battery. 8.4 Trouble shooting tips: Technical failure alarms Error message Cause Remedy Auto Reset!!! Internal system fault. The device performs a restart. Ventilation continues. After attempts the device stops ventilation. Disconnect the patient from Carina and continue ventilation immediately using a different, separate ventilator. Call DrägerService. Technical alarm!! The device has a technical problem. Use a replacement device. This Technical Failure does not affect Call DrägerService. to the breathing function. e.g. Hard key defect Technical alarm!!! The device has a technical problem. Use a replacement device. This Technical Failure might affect to Call DrägerService. the breathing function. e.g. Temperature sensor defect Device failure!!! The device has a fatal technical Immediately disconnect the patient problem. Device will immediately from Carina and continue ventilation stop ventilation. e.g. Blower defect using a different ventilator. If the device cannot be turned off, remove the O hose from the central supply and then turn off the device. Call DrägerService. 7

18 9 Accessoires 9. Accessories for Carina VentStarLV VentStarEV NovaStar CareStar HEPA filter Pump ball Nr. Product Number Description Ventstar Carina LeakV MP00 Dispo. hose with leakage valve Length: 50 cm, 5 pieces Ventstar Carina ExpV MP00 Dispo. hose with expiration valve Length: 50 cm, 5 pieces Filter CareStar 0 MP0770 For device protection 4 HEPA filter Consumable parts for Carina Exchange: Every 6month 5 NovaStar size L MP058 Gel mask: Reusable 6 NovaStar size M MP0580 Gel mask: Reusable 7 NovaStar size S MP0579 Gel mask: Reusable 8 ClassicStar size L MP0575 Air cushion Mask 9 ClassicStar size M MP0574 Air cushion Mask 0 ClassicStar size S MP057 Air cushion Mask Two-side pump ball MP0590 To inflate ClassicStar Air cushion Leak valve "silent flow" MP004 Dispo. leakage valve, 5 pieces Expiration valve MP000 Dispo. expiration valve, piece 4 Spiral hose E 50 cm 6564 Reusable silicone hose: 50 cm 8 ClassicStar

19 9 Accessoires 9. Mask cleaning Headband: Separate the headband from the mask. Hand wash the headband in warm water using pure soap. Rinse thoroughly in cold water and allow to dry in the air, protected from direct sunlight. Mask: Separate the headband from the mask. Soak the mask in enzymatic cleaning agent, then rinse thoroughly in cold water and allow to dry in the air, protected from direct sunlight. NovaStar Disinfection Chemical disinfection: Immerse the mask in one of the solutions listed below for 5 minutes and then allow to dry, protected from direct sunlight. Gigasept FF Korsolex extra Korsolex plus Cidex OPA NOTE Cleaning agents containing care or moisture additives must not be used as these leave residues. NOTE If adhesive substances are not removed, the mask must be replaced. NOTE The headband cannot be disinfected or sterilized. NOTE The manufacturers specification must be observed when using cleaning agents or disinfectants. 9

20 9 Preparation procedure Checklist After a successful check, Carina is ready for use on the patient. Aspect Measure Requirement Checked System Prepare the device, HPO Hoses configuration see chapter "Preparation", Electrical cables as of page Instructions for Use. HEPA Inlet filter and components must be connected properly. Additional components for example: LPO hose External battery Set hose system: Leak valve, The hose system used must page 40 Instructions for Use. be set correctly on the device. Expiration valve, page 4 Filters Instructions for Use. VentStar LV (MP00) or Filters VentStar EV 4 (MP00) 4 Pressure tube Hygiene Take all hygiene precautions. Device, hoses, cables and See "Cleaning" on page 0 components must be perfect Instructions for Use. in terms of hygiene. LEDs, check Switch on the device, LEDs light up alarm tone see page 54 Instructions for Use. Main switch LED LED Safety Connect the test lung to the hose system. 0

21 9 Preparation procedure Checklist Aspect Measure Requirement Checked Alarm Set ventilation mode to»pc-bipap«start ventilation:»airway PEEP = 5 mbar Press»Start/Standby«button. pressure high«pinsp = 5 mbar Squeeze the test lung firmly RR = 0 bpm and frequently. Each time it is Set Tinsp = s compressed, expiration should Ramp = 0. s. be initiated instantly. Paw high = 0 mbar After the second compression: The screen shows»airway pressure high!!!«. Alarm Set ventilation mode to»spn-ps«when the apnoea alarm time»apnoea and Tapnea to 5 seconds. has elapsed: The screen shows alarmapnoea ventilation!!!«. Steadily inflate and deflate the Then apnoea ventilation starts. test lung to simulate spontaneous Switch back to PC-BIPAP breathing, then stop simulation. mode again. Alarm Set MVlow value higher than The screen shows»mv low!!!mv low«the current measured value: Set MVlow value again, below (higher than MV) the current measured value. Alarm Set Tdisconnect to 5 seconds. Paw low alarm will occur after»airway Disconnect the test lung from the 5 sec. red alarm lamp pressure low«hose system. flashes and the screen shows»airway pressure low!!!«re-connect the test lung Alarm Disconnect device from all The screen shows»external external power supplies.»external power failure!!«this power failure«alarm will be held for min. Silence bottom lights in yellow. Reconnect the power supplies Test battery To test the charge indicator: LED for power supply flashes. indication After a few minutes of battery operation, reconnect the external power supply.

22 Europe, Middle East, Africa, Latin America, Asia, Pacific: Dräger Medical AG & Co. KG Moislinger Allee Lübeck GERMANY Tel: Fax: info@draeger.com Manufacturer: Dräger Medical AG & Co. KG 54 Lübeck, Germany The quality management system at Dräger Medical AG & Co. KG is certified according to ISO 485, ISO 900 and Annex II. of Directive 9/4/EEC (Medical devices) / / ls-dw / Printed in Germany / chlorfrei - umweltverträglich / Änderungen vorbehalten / 008 Dräger Medical AG & Co. KG

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