Viessmann VitoAid Operating Instructions Manual

VIESMANN Ventilator for continuous respiratory support VITOAID 6152712 GB 6/2020 Please keep safe.

tions closely to prevent accidents and material losses. Safety instructions explained Danger This symbol warns against the risk of injury. ! Please note This symbol warns against the risk of material losses and environmen- tal pollution. Note Details identified by the word "Note" contain additional information. Target group These operating instructions are inten- ded for system users. Before using the device, the operator must have fully read and understood these operating instructions. The ventilator may only be used under the direction of a physician by trained specialist medical personnel with knowl- edge of mechanical ventilation. The ventilator is not intended for use by patients, children, individuals with reduced physical, sensory or mental fac- ulties, or persons lacking the appropriate experience and knowledge. Safety instructions for working with the device Connecting the device ■The device may only be put into opera- tion by trained specialist medical per- sonnel with knowledge of mechanical ventilation. ■The device may only be connected to the power supply at permanently instal- led 230 V standard sockets using the factory-installed power cable with standard plug. ■Connection via extension cables or sockets switched by means of wall or dimmer switches is not permissible. ■Modifications to the existing installation may only be carried out by authorised specialists. Danger Incorrectly performed connections can lead to life threatening condi- tions for the ventilated patient. The breathing tube of the VentStar Oxylog VE300 single-tube system and the oxygen supply tube may only be connected by trained spe- cialist medical personnel with knowledge of mechanical ventila- tion. Safety instructions For your safety 6152712

■All settings and work on the device must be performed as specified in these operating instructions. No other work on or modifications to the device are permissible. ■Do not open the device. ■Do not remove casings. ■Do not modify or remove attachments. Safety instructions for operating the device Danger Incorrect settings and use of the wrong components can put the ven- tilated patient at risk. ■Ventilation must only be provided via the VentStar Oxylog VE300 single-tube system, 1.5 metres (standard delivery) and HME filter. ■The device may only be operated with an externally controllable oxy- gen supply. ■Regularly check tube connections during operation. Do not discon- nect tube connections. Danger Contamination and dirt on the device and on the tubes can harm the ventilated patient. ■Check connections and tubes daily for contamination and dirt. ■Immediately remove any fluids and biological matter. ■Keep the air inlet grille on the device clear at all times. Before every use, check the air inlet grille for contamination and dirt. Permissible ambient conditions ! Please note Incorrect ambient conditions can result in damage to the device and put safe operation at risk. ■Only use the device in dry, enclosed spaces and at ambient temperatures between 5 °C and 35 °C. ■Do not use the device in MRT environments. ■The device must not be used in hyperbaric chambers. General information on the safe use and handling of oxygen Source: Bundesanstalt für Materialfor- schung und -prüfung [German Federal Institute for Materials Testing and Research], Berlin Safety instructions For your safety (cont.) 6152712

■Do not allow oxygen to flow into enclosed rooms/spaces as this can lead to an oxygen-enriched atmos- phere and consequently may present a fire hazard. ■Keep away from open flames and sources of ignition. Safety instructions for medical per- sonnel and users ■Oxygen must only be handled by trained or instructed personnel ■Secure oxygen bottles to prevent them from tipping over or falling down. ■Always open oxygen valves slowly. ■Keep oxygen fittings and system com- ponents free of oil and grease at all times. ■On completion of work, close all oxy- gen fittings and valves. ■Improper use of oxygen is prohibited, e.g. using it instead of compressed air or for cooling or cleaning clothing ■Under no circumstances should leak- ing or faulty oxygen bottles, fittings or system components be used. Safety instructions For your safety (cont.) 6152712

6 Intended use .......................................................................................... 6 Your device is preset at the factory ........................................................ 7 2. Device overview Overview of connections and controls ................................................... 8 3. Connecting VitoAid Connecting the oxygen supply and breathing tube ............................... 9 Adjusting the oxygen supply .................................................................. 10 4. Switching on and off Switching on VitoAid .............................................................................. 11 Switching off VitoAid .............................................................................. 11 5. Where to find the controls Operating VitoAid ................................................................................... 12 ■Screen displays .................................................................................. 12 6. Switching ventilation on and off Switching on ventilation ......................................................................... 14 Switching off ventilation ......................................................................... 14 7. Setting the ventilation parameters Selecting the ventilation mode ............................................................... 15 ■Pressure-controlled ventilation (PCV) ................................................ 15 ■High-flow CPAP (continuous positive airway pressure) ...................... 15 Setting the positive end-expiratory pressure (PEEP) ............................ 15 Setting the inspiratory pressure ............................................................. 15 Setting the respiratory rate .................................................................... 16 Setting the ratio of inspiratory time to expiratory time ............................ 16 8. Setting alarm limits Setting the lower limit for respiratory volume ......................................... 18 Setting the upper limit for respiratory volume ........................................ 18 9. Further settings Restoring factory settings ...................................................................... 19 10. Checks Checking values .................................................................................... 20 11. Alarms and fault mes- sages Acknowledging alarms and fault messages ........................................... 21 12. What to do if... is shown on the display. .................................................................... 22 is shown on the display. .................................................................... 22 is shown on the display. .................................................................... 22 is shown on the display. .................................................................... 22 is shown on the display. .................................................................... 22 is shown on the display. .................................................................... 22 is shown on the display. .................................................................... 22 and a numeric code > are shown on the display. ........................... 23 13. Maintenance Cleaning the device surface .................................................................. 24 Cleaning the air inlet grille ..................................................................... 24 14. Service VitoAid Hotline ....................................................................................... 25 Index Index 6152712

further information 1. Step in a diagram: The numbers correspond to the order in which the steps are carried out. Warning of material losses and environ- mental pollution Live electrical area Pay particular attention. ■Component must audibly click into place. or ■Acoustic signal ■Fit new component. or ■In conjunction with a tool: Clean the sur- face. Dispose of component correctly. Dispose of component at a suitable collec- tion point. Do not dispose of component in domestic waste. Standard delivery ■VitoAid ventilator ■VentStar Oxylog VE300 single-tube system, length: 1.5 metres Intended use The VitoAid ventilator is designed to provide continu- ous respiratory support to adult patients who require mechanical ventilation. The VitoAid ventilator may only be used in emergency situations where the capacities of the existing supplies of approved ventilators are not sufficient. The ventilator is intended solely for use in care facili- ties and hospitals for invasive and non-invasive posi- tive pressure ventilation. Intended use requires the following: ■Ventilation with external oxygen supply: The ventilator is connected via a silicone tube to a supply of medical oxygen with pressure control. ■Ventilation without external oxygen supply: The tube connection for the oxygen supply to the ventilator is closed (delivered condition). Introductory information Symbols 6152712

VE300 single-tube system, 1.5 metres (standard delivery) and HME filter. The HME filter must be positioned close to the patient. ■The supply tubes comply with the specification for ventilators. Usage for a purpose other than invasive and non-inva- sive positive pressure ventilation shall be deemed inappropriate. Incorrect usage or operation of the device (e.g. open- ing of the device) is prohibited and will result in an exclusion of liability. Incorrect usage also occurs if the components of the ventilator or the tubes connected to it are modified from their intended function. Your device is preset at the factory The ventilator is preset at the factory for pressure-con- trolled ventilation (PCV) with the following parameters: You can change these settings individually at any time: See page 15 onwards. Ventilation parameters ■The positive end-expiratory pressure (PEEP) is set to 10 millibars. ■The inspiratory pressure is set to 25 millibars. ■The respiratory rate is set to 15 breaths per minute. ■The ratio of inspiratory time to expiratory time is set to 1 : 2. Alarm limits ■The alarm limit for expiratory pressure equates to the setting for positive end-expiratory pressure (PEEP). ■The alarm limit for inspiratory pressure is 45 milli- bars. ■The alarm limit for the lower respiratory volume is set to 0. This means that monitoring for this value is deactivated. ■The alarm limit for the upper respiratory volume is set to 999. This means that monitoring for this value is deactivated. Note The alarm limits are only active if PCV (pressure-con- trolled ventilation) is set: See page 15. Power failure All settings are retained if there is a power failure. Introductory information Intended use (cont.) 6152712

log VE300 single-tube system (standard delivery) ■Internal 7 of breathing tube: 22 mm ■Tube length: 1.5 metres B Tube connection for oxygen supply ■Internal 7: 6 mm C Transport handle D ON/OFF switch E Buzzer for acoustic signals F Connection for factory use only: Do not connect anything here! G Status LED H Operating unit with 2-part display and operating buttons K Air inlet grille: It is essential to keep this grille clear. Danger If it is not possible to draw in a sufficient amount of air through the air inlet grille, the ventilation parameters may deviate from the set values. This could potentially harm the patient. ■Keep the air inlet grille clear at all times. ■Before using the device, always check the air inlet grille for contamination and dirt. ■If required, clean the air inlet grille with a vac- uum cleaner. Device overview Overview of connections and controls 6152712

B Tube connection for oxygen supply C Oxygen supply tube ■Internal 7: 6 millimetres D VentStar Oxylog VE300 single-tube system with HME filter ■Internal 7: 22 millimetres ■Tube length: 1.5 metres 1. Pull the protective caps off tube connections A and B. 2. Push oxygen supply tube C onto tube connection B. 3. Push the breathing tube of the VentStar Oxylog VE300 single-tube system with expiration valve and HME filter D onto tube connection A. 4. Secure both tubes, e.g. with tube clips, to prevent accidental disconnection. 5. Secure the ventilator to prevent it from accidentally tipping over. Connecting VitoAid Connecting the oxygen supply and breathing tube 6152712

the flow rate of the oxygen supply according to the curve shown below. Note To measure the oxygen flow rate, a flow meter needs to be integrated into the oxygen supply. 80 60 20 0 100 Oxygen flow rate in l/min oxygen concentration in % 5 10 15 20 25 40 Inspiratory Fig. 3 Curve for adjusting the oxygen supply Connecting VitoAid Adjusting the oxygen supply 6152712

single-tube system is correctly connected to the ven- tilator. For ventilation with external oxygen supply: ■The oxygen supply tube (if present) is correctly con- nected to the ventilator. ■The flow rate for the oxygen supply is set to the required respiratory air oxygen concentration: See previous section. 1. Insert the power plug into a standard socket. 2. Switch on the ON/OFF switch (position "I"). After approx. 4 seconds, a value is shown on the operating unit display. This indicates that the ventilator is ready for opera- tion. Switching off VitoAid Ventilation of the patient has ended. 1. Switch off the ON/OFF switch (position "0"). The display on the operating unit goes blank. 2. Pull the power plug out of the standard socket. Switching on and off Switching on VitoAid 6152712

operating unit. Fig. 4 "Status" Display area for selecting information, e.g. for the positive end-expiratory pressure (PEEP) "Service" Display area for showing the currently set value To scroll up through the display or increase a set value. To scroll down through the display or reduce a set value. Only if an alarm or device fault is present: Briefly press the button: ■This switches off the acoustic alarm and fault signal. The alarm or device fault remains active. Press the button for at least 2 seconds: ■This acknowledges an alarm or fault mes- sage: The device's internal fault memory is deleted. ■In the event of device faults, this will also reset the operating unit's control electron- ics. All settings are retained. For further information: See page 21. Briefly press the button: ■To switch ventilation on or off. To select a menu or confirm a changed set- ting. Press the button for at least 2 seconds: ■The numeric code is shown in the "Serv- ice" display area. You are now in the settings menu. Note To reset the ventilator to the factory settings, press and simultaneously for more than 2 seconds. Screen displays The display screen is split into two areas, the "Status" area (left) and the "Service" area (right). Different letters can be shown in the "Status" display area. These letters indicate which values are currently being shown or changed in the "Service" display area. The level of information shown depends on the set ventilation method. To set the ventilation method: See page 15. "Status" Information displayed in "Service" Ventilation method: See page 15. PCV CPAP ■Ventilation is switched on: Current expiratory pressure ■When making settings: Positive end-expiratory pressure (PEEP) in millibars: See page 15. X X ■Ventilation is switched on: Current inspiratory pressure ■When making settings: Set value for inspiratory pressure in millibars: See page 15. X — Set respiratory rate: Number of set respiratory cycles per minute, see page 16. X — Where to find the controls Operating VitoAid 6152712

Ventilation method: See page 15. PCV CPAP Ratio of inspiratory time to expiratory time Note The values are shown without a decimal point and are relative to the inspiratory time. Example: Displayed value: "17" The ratio of inspiratory time to expiratory time is 1 : 1.7. Example: Displayed value: "05" The ratio of inspiratory time to expiratory time is 1 : 0.5 = 2 : 1 For an overview of possible settings: See page 17. X — Numeric code for faults or alarms: See page 22. X X Ventilation is switched on: Current respiratory volume in millilitres X — When making settings: Lower alarm limit for the respiratory volume in millilitres X — When making settings: Upper alarm limit for the respiratory volume in millilitres X — Note "- - -" in the "Service" display area indicates that inter- nal data is being processed. This display disappears automatically as soon as the process is complete. Where to find the controls Operating VitoAid (cont.) 6152712

■The patient can receive the appropriate supply via the breathing tube. For ventilation with external oxygen supply: ■Oxygen is supplied at the required flow rate. Press . The patient is ventilated using the set ventilation method and the set values. Note ■If ventilation does not start, reset the control elec- tronics. To do so, press for more than 2 seconds. All set values are retained. ■You must wait at least 2 seconds before you can switch ventilation off again. Switching off ventilation Ventilation is switched on. 1. Press . The patient is no longer ventilated. The status LED illuminates for 30 seconds. 2. Shut off the oxygen supply, for example by closing the relevant external valve. Note You must wait at least 2 seconds before you can switch ventilation on again. Switching ventilation on and off Switching on ventilation 6152712

and high-flow CPAP (continuous positive airway pres- sure). Pressure-controlled ventilation (PCV) The patient is ventilated in controlled mode in accord- ance with the set values for inspiratory pressure, posi- tive end-expiratory pressure (PEEP), respiratory rate and the ratio of inspiratory time to expiratory time. Spontaneous ventilation is neither detected nor assis- ted here. To activate pressure-controlled ventilation, set the inspiratory pressure higher than the positive end- expiratory pressure (PEEP). High-flow CPAP (continuous positive airway pressure) With this method, a continuous supply of air/oxygen is administered via a suitable mask to generate a positive end-expiratory pressure (PEEP), which provides respi- ratory support to a spontaneously breathing patient. To activate high-flow CPAP, set identical values for the inspiratory pressure and the positive end-expira- tory pressure (PEEP). If ventilation is switched on, only the expiratory pres- sure ( ) is shown on the display. The other information is not relevant for this ventilation method and is therefore not displayed: See page 12. Note With this ventilation method, monitoring of the alarm limits is switched off. Setting the positive end-expiratory pressure (PEEP) The settings for the positive end-expiratory pressure (PEEP) and the inspiratory pressure are interdepend- ent. The difference between the two pressures must not exceed 25 millibars. Example: You have set the positive end-expiratory pressure (PEEP) to 15 millibars. You cannot set the inspiratory pressure higher than 40 millibars. If the inspiratory pressure was previously set to a higher value, this setting will be automatically reset to 40 millibars. 1. Press for longer than 2 seconds. is shown in the "Service" display area. 2. Use or to select the letter in the "Status" dis- play area. 3. Press . The value shown in the "Service" display area flashes. 4. Use or to set the required pressure in milli- bars in the "Service" display area. The setting is made in millibars. 5. To accept the set value, press again. Note The ventilator regulates the respiratory pressure to the set value. If this value cannot be achieved for pres- sure-controlled ventilation, an alarm is triggered. Setting the inspiratory pressure The settings for the positive end-expiratory pressure (PEEP) and the inspiratory pressure are interdepend- ent. The difference between the two pressures must not exceed 25 millibars. Example: You have set the positive end-expiratory pressure (PEEP) to 15 millibars. Setting the ventilation parameters Selecting the ventilation mode 6152712

40 millibars. If the inspiratory pressure was previously set to a higher value, this setting will be automatically reset to 40 millibars. 1. Press for longer than 2 seconds. is shown in the "Service" display area. 2. Use or to select the letter in the "Status" dis- play area. 3. Press . The value shown in the "Service" display area flashes. 4. Use or to set the required pressure in milli- bars in the "Service" display area. The setting is made in millibars. Note The maximum setting is 45 millibars. 5. To accept the set value, press again. Note The ventilator regulates the respiratory pressure to the set value. If this value cannot be achieved for pres- sure-controlled ventilation, an alarm is triggered. Setting the respiratory rate The respiratory rate is set by specifying the number of respiratory cycles per minute. 1 respiratory cycle comprises 1 inspiration process and 1 expiration process. 1. Press for longer than 2 seconds. is shown in the "Service" display area. 2. Use or to select the letter in the "Status" dis- play area. 3. Press . The value shown in the "Service" display area flashes. 4. Use or to set the required respiratory rate (respiratory cycles per minute) in the "Service" dis- play area. 5. To accept the set value, press again. Setting the ratio of inspiratory time to expiratory time This setting enables you to specify the ratio of inspira- tory time to expiratory time. 1. Press for longer than 2 seconds. is shown in the "Service" display area. 2. Use or to select the letter in the "Status" dis- play area. 3. Press . The value shown in the "Service" display area flashes. Setting the ventilation parameters Setting the inspiratory pressure (cont.) 6152712

time to expiratory time in the "Service" display area, in accordance with the following table. Note The values are shown without a decimal point and are relative to the inspiratory time. Setting val- ue Ratio of inspiratory time to expira- tory time 05 1 : 0.5 = 2 : 1 06 1 : 0.6 = 1.67 : 1 07 1 : 0.7 = 1.43 : 1 08 1 : 0.8 = 1.25 : 1 09 1 : 0.9 = 1.11 : 1 10 1 : 1 11 1 : 1.1 12 1 : 1.2 13 1 : 1.3 14 1 : 1.4 15 1 : 1.5 16 1 : 1.6 17 1 : 1.7 ... ... 30 1 : 3 5. To accept the set value, press again. Setting the ventilation parameters Setting the ratio of inspiratory time to… (cont.) 6152712

lower limit, an alarm is triggered: See page 21. Note ■This alarm limit is only active if PCV (pressure-con- trolled ventilation) is set: See page 15. ■To deactivate monitoring of the lower limit for respira- tory volume, set the value to "0". 1. Press for longer than 2 seconds. is shown in the "Service" display area. 2. Use or to select the symbol in the "Status" display area. 3. Press . The value shown in the "Service" display area flashes. 4. Use or to set the required lower alarm limit for respiratory volume in millilitres in the "Service" dis- play area. 5. To accept the set value, press again. Setting the upper limit for respiratory volume If the measured respiratory volume exceeds the set upper limit, an alarm is triggered: See page 21. Note ■This alarm limit is only active if PCV (pressure-con- trolled ventilation) is set: See page 15. ■To deactivate monitoring of the upper limit for respi- ratory volume, set the value to "999". 1. Press for longer than 2 seconds. is shown in the "Service" display area. 2. Use or to select the symbol in the "Status" display area. 3. Press . The value shown in the "Service" display area flashes. 4. Use or to set the required upper alarm limit for respiratory volume in millilitres in the "Service" display area. 5. To accept the set value, press again. Setting alarm limits Setting the lower limit for respiratory volume 6152712

and simultaneously for more than 2 seconds. The two display areas together show the following combination of letters: (= Parameter dELeted) For factory settings: See page 7. Further settings Restoring factory settings 6152712

set respiratory parameters on the display. Use or to select the required letter, e.g. , in the "Status" display area. A list of the information and letters which can be dis- played is given in the table on page 12. Checks Checking values 6152712

trolled ventilation) is set: See page 15. You can recognise alarms and faults on the ventilator as follows: ■ and a numeric code are shown on the display. ■The Status LED illuminates. ■An acoustic signal sounds. Danger Where possible, ventilation of the patient contin- ues during alarms and device faults. However, the patient may not be ventilated with the opti- mum parameters. The patient being ventilated may be harmed as a result. ■Rectify the cause of the alarm or device fault immediately. ■Acknowledge the alarm or fault message. Switching off the acoustic signal Briefly press . ■The acoustic signal stops, but the alarm or fault mes- sage remains active. ■ and the numeric code are shown on the display. ■The Status LED illuminates. Acknowledging the alarm or fault message 1. Rectify the cause of the fault or the alarm: See page 22. 2. To acknowledge the alarm or fault on the ventilator, press for at least 2 seconds. ■ and the numeric code are no longer displayed. ■The Status LED goes off. ■If not switched off beforehand, the acoustic sig- nal stops. Note If you acknowledge the alarm or fault on the device without rectifying the cause, the alarm or fault will most likely occur again within a short time. Alarms and fault messages Acknowledging alarms and fault messages 6152712

the set value for positive end-expiratory pressure (PEEP). ■Check the tube connections and tubes for leaks. ■Check the air inlet grille for contamination and dirt. If necessary, clean this grille with a vacuum cleaner. is shown on the display. Cause Remedy During ventilation, the expiratory pressure does not reach the set value for positive end-expiratory pressure (PEEP). ■Check the tube connections and tubes for leaks. ■Check the air inlet grille for contamination and dirt. If necessary, clean this grille with a vacuum cleaner. is shown on the display. Cause Remedy During ventilation, the set inspiratory pressure is not reached. ■Check the tube connections and tubes for leaks. ■Check the air inlet grille for contamination and dirt. If necessary, clean this grille with a vacuum cleaner. is shown on the display. Cause Remedy During ventilation, the set inspiratory pressure is ex- ceeded. ■Check the patient. ■Check whether the tubes are bent or constricted. is shown on the display. Cause Remedy During ventilation, the inspiratory pressure exceeds 45 millibars. ■Check the patient. ■Check whether the tubes are bent or constricted. ■Check the setting for the inspiratory pressure. If nec- essary, adjust this pressure. is shown on the display. Cause Remedy The measured respiratory volume has fallen below the set lower limit. Check the ventilation parameter settings. If necessary, adjust these parameters: See page 15. is shown on the display. Cause Remedy The measured respiratory volume has exceeded the set upper limit. Check the ventilation parameter settings. If necessary, adjust these parameters: See page 15. What to do if... is shown on the display. 6152712

Press for more than 2 seconds. The control electronics are reset. All set values are retained. If the fault persists after resetting the control electron- ics: ■Turn off the ON/OFF switch. ■Wait for approx. 5 seconds. ■Turn on the ON/OFF switch again. If the fault persists after switching the ventilator off and back on again: ■Pull the power plug out of the standard socket. ■Wait for approx. 5 seconds. ■Re-insert the power plug. If the fault persists continuously: Stop using the ventilator. Contact the seller from whom you purchased the de- vice. What to do if... and a numeric code > are shown on the display. 6152712

mercially available domestic cleaning agent. Do not use scouring agents. Clean the surface of the operating unit with a microfi- bre cloth. Cleaning the air inlet grille Danger If it is not possible to draw in a sufficient amount of air through the air inlet grille, the ventilation parameters may deviate from the set values. This could potentially harm the patient. ■Keep the air inlet grille clear at all times. ■Before using the device, always check the air inlet grille for contamination and dirt. ■If required, clean the air inlet grille with a vac- uum cleaner. Maintenance Cleaning the device surface 6152712

have any questions or require maintenance or repair work on your ventilator: +49 6452 70 1661 Service VitoAid Hotline 6152712

repair work. You can find local contractors on the internet at www.viessmann.de. Viessmann Limited Hortonwood 30, Telford Shropshire, TF1 7YP, GB Telephone: +44 1952 675000 Fax: +44 1952 675040 E-mail: [email protected] Viessmann Werke GmbH & Co. KG D-35107 Allendorf Telephone: +49 6452 70-0 Fax: +49 6452 70-2780 www.viessmann.com 6152712 Subject to technical modifications.