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Weinmann VENTIlogic LS, Инструкция по эксплуатации

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Weinmann VENTIlogic LS Скачать руководство пользователя страница 37

Safety instructions

37

EN

3.3  Side effects

When using the therapy device, the following undesired side effects may occur in short-
term or long-term use:

• pressure points on the face from the breathing mask and the forehead cushion

• reddening of facial skin

• blocked nose

• dry nose

• dry mouth in the morning

• feeling of pressure in the sinuses

• irritated mucous membrane in the eyes

• gastrointestinal insufflation of air (“bloating”)

• nosebleeds

• muscular atrophy in the case of long-term ventilation

Содержание VENTIlogic LS

Страница 1: ...Ventilation device Description of device and instructions for use for devices from serial number 20 000 VENTIlogic LS VENTIlogic plus ...

Страница 2: ... program 61 5 12 After use 62 5 13 Travel with the therapy device 64 6 Hygiene treatment 67 6 1 Intervals 67 6 2 Clean leakage ventilation 68 6 3 Clean the housing 70 6 4 Clean coarse dust filter change fine filter 70 6 5 Clean the fan filter 71 6 6 Clean the accessories 71 6 7 Clean the SpO2module 71 6 8 Disinfect sterilize 71 6 9 Change in patients 73 7 Function check 74 7 1 Intervals 74 7 2 Met...

Страница 3: ...life supporting medical electrical devices and medical electrical systems 123 11 12Electromagnetic interference immunity for NON LIFE SUPPORTING medical electrical devices or medical electrical systems 124 12 Warranty 125 13 Declaration of conformity 125 ...

Страница 4: ...lable as an option 3 Control panel and displays 4 Handle 1 Device outlet port 16 Housing fan 8 Card reader 9 Serial ports 13 Power connection 15 Oxygen connection 11 Remote alarm connection 14 Device ID plate 10 Filter compartment lid air inlet 12 Cable securing clip 2 O2 coupling 7 Replaceable battery optional ...

Страница 5: ...er supply to the therapy device 8 Card reader Slot for a Weinmann memory card Therapy data are stored on the memory card which the doctor can call up 9 Serial ports For connecting devices for displaying and evaluating therapy data 10 Filter compartment lid air inlet For covering and securely positioning the coarse dust and fine filters 11 Remote alarm connection For connecting the hospital s inter...

Страница 6: ...ent 21 Sealing plug 2x For sealing off the pressure measuring tube during cleaning only with leakage ventilation 22 Drying adapter Required to dry the patient circuit with the aid of the therapy device and for the function check 23 Exhalation system Carbon dioxide enriched exhaled air escapes here during therapy 24 Connection for O2 sensor For connecting an oxygen sensor which can be used to measu...

Страница 7: ...ube to the device 27 Test adapter Required for the function check of the therapy device 28 Connection for valve control tube For connecting the valve control tube to the device 29 Single patient circuit Delivers respiratory air to the patient 26 Connection for pressure measuring tube marked blue 29 Single patient circuit 30 Pressure measurement tube marked blue 31 Valve control tube 32 Patient val...

Страница 8: ...g and closing the patient valve 32 Patient valve For routing the patient s exhaled air out of the patient circuit 33 Connection for patient This is where the patient ventilator interface is connected 34 Connection for device outlet port This is where the patient circuit is connected to the device outlet port of the therapy device ...

Страница 9: ...rapy device 38 Connection for valve control tube For connecting the valve control tube to the device 39 Device connection for patient valve For connecting the patient valve to the device inlet port of the therapy device 39 Device connection for patient valve 36 Connection for pressure measurement tube marked blue 41 Double patient circuit 43 Y adapter 44 Patient valve 46 Valve control tube 48 Pres...

Страница 10: ...d serves as an adapter for connection to the patient ventilator interface 44 Patient valve For routing the patient s exhaled air out of the patient circuit 45 Connection for device inlet port This is where the patient circuit is connected to the device outlet port of the therapy device 46 Valve control tube For controlling opening and closing the patient valve 47 Connection for device outlet port ...

Страница 11: ...tion For protecting the device from contamination in particular when the device is used by several patients patient change 53 Set O2 sensor WM 15732 For measuring oxygen concentration at the device outlet port 54 Protective bag WM 27106 For protecting the therapy device during transport 50 Carrying bag WM 27976 54 Protective bag WM 27106 53 Set O2 sensor WM 15732 52 Bacteria filter WM 27591 only v...

Страница 12: ...aximum supply rate 15 l min at 1000 hPa 2 VENTIlogic LS Opening for exhaled air when operated with double patient circuit with patient valve do not seal opening or block in any other way VENTIlogic plus Opening is not used with VENTIlogic plus 7 6 5 4 3 2 1 12 11 10 9 15 18 14 16 17 8 13 ...

Страница 13: ...haled air at 0 45 hPa with patient circuits with patient valve 0 40 hPa with leakage ventilation 8 Device outlet port only patient circuits with a diameter of Ø 15 mm 22 mm are permitted Right hand side 9 Connection for optional attachments e g Analog box D A max current delivery at 5 V 50 mA 10 Connection for specialist staff to set therapy parameters using VENTIviews max current delivery at 12 V...

Страница 14: ...ces is required 18 Device inlet port inlet port for ambient air at room temperature Device ID plate rear Type BF application part Protection class II protective insulation Year of manufacture Do not dispose of device in domestic waste SN Serial number 100 V 230 V 50 60 Hz Electrical rating CE 0197 symbol Confirms that the product conforms to the applicable European directives Protect device from w...

Страница 15: ... menu 5 O2 key Starts calibration of the O2 sensor Has other functions in the Clinical menu 6 Menu key For switching from the default display to the menu and vice versa 7 LED for power supply The green LED comes on when there is a power supply 8 LIAM insufflation For triggering a coughing episode or ventilating a sigh 9 Program key For switching to one of the three pre configured programs manually...

Страница 16: ...f the battery is being charged the segments are shown in succession 7 Memory card symbol Appears if a memory card is present and there is data saved on the memory card 8 Respiratory phase change display Indicates whether the current respiratory phase change is spontaneous or mandatory spontaneous S mandatory T the display changes from left inspiration to right exhalation depending on respiratory p...

Страница 17: ...ressure display For the graphical display of therapy pressure 11 Oxygen concentration optional Gives oxygen concentration in respiratory air in percent 12 Ventilation parameters The relevant current ventilation parameters are displayed depending on the active mode 13 Patient circuit The relevant text to suit the set patient circuit appears in the status line ...

Страница 18: ...ivated Blower off standby mode Battery display green 2 5 segments battery capacity over 25 Battery display orange battery capacity below 25 Battery display red battery capacity below 10 Segments are displayed in succession device operated by power supply battery charging Battery not present Battery not ready for use battery defective or battery too cold or battery too hot Battery not recognized as...

Страница 19: ...otected or defective No data can be recorded Alarm window Low priority alarm triggered Medium priority alarm triggered High priority alarm triggered Main window Plateau signal switched on Plateau signal switched off Symbol Significance ...

Страница 20: ...ive V Volume compensation activated after mode e g PCV V A AirTrapControl activated after mode e g ST A LIAM LIAM enabled displayed under the current mode e g PCV LIAM LIAM LIAM Lung Insufflation Assist Maneuver active Prog Active ventilation program Main window Monitor IPAP Inspiration pressure EPAP PEEP Exhalation pressure PSIMV Specifies the inspiration pressure level of the back up ventilation...

Страница 21: ...e Te Exhalation time O2 21 Mean oxygen concentration Shown in brackets measuring cell not calibrated perform oxygen calibration SpO2 Oxygen saturation bpm Pulse beats per minute Tapnoe Time since patient s last spontaneous breath only in MPVv and MPVp modes Symbol Significance Therapy device SN Serial number of device Permitted temperature for storage 40 C to 70 C Permitted humidity for storage ma...

Страница 22: ...nstructions for use Safety information in these instructions for use is marked as follows Warning Warns of risk of injury and potential material damage Caution Warns of material damage and potentially false therapy results Note Contains useful tips ...

Страница 23: ... tidal volume of at least 50 ml and a body weight of at least 5 kg 2 1 2 VENTIlogic plus VENTIlogic plus is used for invasive and non invasive non life support ventilation in accordance with ISO 10651 6 The device can be used in both static or mobile operation both at home and in appropriate hospital departments Note VENTIlogic plus is not a ventilator for intensive care purposes in accordance wit...

Страница 24: ...etect the pressure at the patient ventilator interface and in the patient circuit as well as the respiratory phase change The blower accordingly provides the respiratory volume and the IPAP and EPAP PEEP pressures prescribed by the doctor 2 3 2 Display and operation The display shows the therapy mode and as a function of the mode the currently applied values for CPAP IPAP and EPAP PEEP respiratory...

Страница 25: ...atient valve by means of the valve control tube When the double patient circuit with patient valve is used VENTIlogic LS only an exhalation tube also routes exhaled air into the ambient air through the device 2 3 6 Therapy modes The therapy device can be operated in the following therapy modes leakage ventilation S T ST CPAP MPVp MPVv valve ventilation PCV aPCV PSV VCV VENTIlogic LS only aVCV VENT...

Страница 26: ...d only tidal volume on inspiration can be measured whilst with the double patient circuit VENTIlogic LS only total tidal volume can be measured Spontaneous or mechanical respiratory phase switches and the pressure change are also shown in graphical form 2 3 7 SIMV mode SIMV mode synchronized intermittent mandatory ventilation is a mixture of mandatory and assisted ventilation If there is no sponta...

Страница 27: ...ery running time will depend on the load and operating temperature in question Detailed information on the different loads with the corresponding battery operating times are provided in section 11 on page 108 The internal battery is automatically charged or maintained in a charged state as long as the device is supplied with power 2 3 11 Mobile power supply There is the additional option of a mobi...

Страница 28: ...py data Therapy data are stored in the device on a removable SD card The VENTIviews PC software can be used to enable a doctor to evaluate the therapy data 2 3 15 Analog output of therapy data The device has an interface for connecting to analog box WM 27560 It is used for a time synchronized display of therapy data such as pressure flow leakage and volumes e g on a PSG Mode specific data such as ...

Страница 29: ...the patient circuit Depending on the settings this could prevent life saving alarms from being triggered For example if the Disconnection alarm fails then the patient may be put at risk Make absolutely certain that the VT low and VT high alarms are active Ensure that appropriate values are used for the VT low and VT high alarms Check that the alarms are working Carry out an alarm check every time ...

Страница 30: ...Ensure that appropriate values are used for the Pressure high and Pressure low alarms Warning An alternative ventilation option e g a replacement device or a manual ventilating bag needs to be kept to hand for patients who are dependent on a ventilation device in case the device fails It is critical that patients who are dependent on the ventilation device are monitored by the person caring for th...

Страница 31: ...vice Risk of fire explosion Ensure that ventilation tubes and cables are routed so that they cannot lead to the patient being strangled Ensure that there are no small parts close to the patient otherwise they might get into the patient s respiratory flow and put him her at risk Masks of third party manufacture may only be used following authorization by the manufacturer Weinmann The success of the...

Страница 32: ...se voltages Ensure that the power cord is connected correctly Always secure the power plug with the cable securing clip to prevent the plug being removed by mistake The device must be connected to an easily accessible socket so that the plug can be taken out quickly in the event of a fault Do not use sockets with an On Off switch or dimmable sockets Do not set up the device close to a radiator and...

Страница 33: ...he replaceable battery has been handled incorrectly have it checked by Weinmann or an authorized specialist dealer When operated on a wheelchair this system requires a certificate of conformity To obtain this consult a specialist dealer authorized by the manufacturer Weinmann this dealer will also perform the attachment Caution The internal battery is not intended for mobile operation Always use o...

Страница 34: ...e end of therapy Then leave the therapy device to run for a short time before turning it off otherwise some residual oxygen will remain in the device In the event of a fault this could lead to a risk of fire To supply oxygen use only the therapy device connection provided for this purpose Never supply oxygen via the patient ventilator interface or the T adapter otherwise the oxygen supply cannot b...

Страница 35: ...nd maintenance work carried out only by the manufacturer Weinmann or by specialist staff expressly authorized by the manufacturer Have modifications to the device carried out only by the manufacturer Weinmann or by specialist staff expressly authorized by the manufacturer Note If the therapy device is stored or not used for a prolonged period the battery will discharge This is a property of rechar...

Страница 36: ...cularly in combination with intravascular volume depletion Severe epistaxis High risk of barotrauma Pneumothorax or pneumomediastinum Pneumoencephalus Skull trauma Status following brain surgery and following surgical intervention at the pituitary gland or the middle inner ear Acute sinusitis otitis media or perforated eardrum Dehydration Mask ventilation must particularly not be used in the case ...

Страница 37: ... term use pressure points on the face from the breathing mask and the forehead cushion reddening of facial skin blocked nose dry nose dry mouth in the morning feeling of pressure in the sinuses irritated mucous membrane in the eyes gastrointestinal insufflation of air bloating nosebleeds muscular atrophy in the case of long term ventilation ...

Страница 38: ... this deviation in the display The therapy device can be operated with both leakage and valve ventilation The doctor supervising treatment or the authorized specialist dealer converts the device to the variant appropriate for the patient s form of treatment The necessary settings on the device are likewise made by the doctor supervising treatment You need only follow the relevant section depending...

Страница 39: ... the device connected to the power supply for at least 6 hours to charge the internal battery The device is now operational 4 2 Patient ventilator interfaces The therapy device is intended for operation with nasal masks oronasal masks and full face masks as well as with mouthpieces endotracheal cannulas and endotracheal tubes It is essential to follow the instructions for use of the patient ventil...

Страница 40: ...tilator interface and of the patient circuit 4 3 2 Double patient circuit VENTIlogic LS only In addition to the ventilation tube which delivers air to the patient the pressure measurement tube and the valve control tube the double patient circuit also has an exhalation tube which routes exhaled air back to the device and into the ambient air On the double patient circuit the patient valve is locat...

Страница 41: ...nd of the patient circuit 4 4 Connect leakage ventilation Connect leakage ventilation using click adapter Proceed as follows to connect up the leakage circuit 1 Plug the click adapter of the patient circuit onto the ventilation outlet on the device 2 Connect the patient ventilator interface e g a mask It is essential to follow the instructions for use of the patient ventilator interface and of the...

Страница 42: ...ilation tube would rise to critical values and thus obstruct breathing An exhalation system can either be integrated in the patient ventilator interface e g a mask or must be plugged in between the patient ventilator interface and the patient circuit in the form of an accessory If the patient ventilator interface e g the mask does not have an exhalation system a separate exhalation system e g Sile...

Страница 43: ... adapter is available as an accessory for the use of Fisher Paykel humi difiers Be aware that technical data change when third party humidifiers are used 4 5 1 Leakage ventilation We recommend humidifier HC 150 from Fisher Paykel with the corresponding patient circuit Follow the associated instructions for use 4 5 2 Valve ventilation We recommend humidifiers HC 850 or HC 550 from Fisher Paykel wit...

Страница 44: ...4 6 2 Valve ventilation In combination with valve ventilation use bacteria filter WM 27591 If the bacteria filter is used alone it is connected directly to the device outlet port and the ventilation tube is plugged onto the bacteria filter If a humidifier and or an oxygen sensor is to be connected as well a different sequence applies Combination with a humidifier 1 Connect the bacteria filter dire...

Страница 45: ...ever supply oxygen via masks or the T adapter Note Supplying oxygen via a connection not intended for this purpose leads to an erroneous volume display as the oxygen flow cannot be included in the measurement A supply rate of max 15 l min at 1000 hPa pressure at the inlet for the oxygen supply is permitted Use an oxygen sensor to monitor oxygen supply The oxygen source must have an independent flo...

Страница 46: ...ce The safety valve for the oxygen supply automatically shuts off the oxygen supply after 1 minute Oxygen can be supplied via an oxygen concentrator e g Weinmann Oxymat 3 via the central gas supply system only with corresponding pressure reducer of a hospital in the form of liquid oxygen with a continuous flow or of an oxygen cylinder with a corresponding pressure reducer 4 7 2 Measure oxygen conc...

Страница 47: ...ration and pulse Using the optional non invasive SpO2module oxygen saturation levels SpO2 heart rate and alarms can be measured showed on the display of the device and saved to the SD card The SpO2 and heart rate parameters can each be monitored using upper and lower alarm limits synchronized using VENTIviews software and represented on a computer screen with other ventilation data 1 Connect the S...

Страница 48: ...rating times are provided in section 11 on page 108 As soon as the power supply is restored the device is automatically supplied from the power supply again and the internal battery is charged The green power supply LED comes on and the consecutive segments in the battery symbol indicate the charging process in the display If you are using a replaceable battery then in the event of a power outage ...

Страница 49: ...ing the dial see Navigating with the dial on page 50 The other functions 1 can only be operated by the doctor Menu key Use the menu key to switch from Monitor to Menu Current values during therapy are displayed in Monitor You can make settings to the device in Menu The menu key has other functions e g back depending on context The current function is always displayed on the left of the display nex...

Страница 50: ...the dial anticlockwise to move the selection bar in the display upwards Press the dial to confirm selection of a menu item and to open the corresponding submenu or to select a value you want to change Set values Move the dial clockwise to increase a value Move the dial anticlockwise to decrease a value Press the dial to save a value Exit menu item Move the dial clockwise until the selection bar in...

Страница 51: ...n standby mode If the device is switched off completely the blower and the display are likewise switched off and no settings can be made on the device Note On standby the display switches off if it is not used for 5 minutes applies only in patient mode 5 2 2 Starting up 1 Connect the device to the power supply with the aid of the power cord The standby screen appears in the display after about 5 s...

Страница 52: ...witches to the default display 5 2 3 Displays on screen Ventilation parameters such as set therapy mode therapy pressures CPAP pressure only in CPAP mode in hPa the selected patient circuit and current respiratory frequency in 1 min are shown in the display Note 1 01973 hPa correspond to 1 cm H2O The bar chart shows the pressure curve for inspiration and exhalation The respiratory phase change dis...

Страница 53: ... 600 charge discharge cycles The batteries must be replaced in accordance with the intervals listed in Section 9 on page 95 If the life of the batteries is exhausted before that the message Service life ended Have internal battery replaced Have replaceable battery replaced appears in the display Note the instructions on battery care see 9 2 1 Care of batteries on page 96 1 Connect device to the po...

Страница 54: ... breathing current operating temperature The display is continuously updated 5 3 4 Operation with replaceable battery You can change the battery both with the device switched off and during operation Note Only remove the replaceable battery The internal battery may only be replaced by the manufacturer Weinmann or an authorized specialist dealer Use only genuine Weinmann replaceable batteries 1 Pre...

Страница 55: ...atient takes off the patient ventilator interface You can only switch off the therapy device using the On Off key Note Auto switch on can only be activated or deactivated in standby mode 1 Start up the therapy device see 5 2 Start up the device on page 51 2 Press the menu key to do so The patient menu appears in the display 3 Use the dial to select the menu item Auto switch on and confirm the sele...

Страница 56: ... retained even if the entire power supply power supply and internal battery fails In this case the data can be called up for up to two years The alarm list is overwritten after two years or when servicing is carried out Alarms are always retained in the event of a power failure 5 6 Adjust brightness You can change the brightness of the display 1 In the patient menu select the Brightness menu item ...

Страница 57: ...e following values and their residual running times under LIAM info Duration Interval Cycles Plateau signal activated or deactivated 5 7 1 Activate deactivate plateau signal In patient mode you can switch the plateau signal on or off under LIAM info 1 In the LIAM info menu use the dial to select the plateau signal 2 Confirm your selection by pressing the dial 3 Use the dial to select the status pl...

Страница 58: ... with the corresponding patient circuit or humidifier PMH5000 from Wilamed Follow the associated instructions for use 5 10 LIAM insufflation 5 10 1 Information about the function LIAM stands for Lung Insufflation Assist Maneuver LIAM is a pressure controlled hyperinsufflation maneuver with the aim of administering an increased tidal volume which can be used in all ventilation modes except CPAP and...

Страница 59: ...rval either one LIAM stroke Cycles 1 or up to 10 consecutive LIAM strokes are executed LIAM to support a coughing maneuver LIAM can be used to support a coughing maneuver by initially expanding lung and thorax adequately during hyperinsufflation This makes more air available for the subsequent cough At the same time optimized initial tensioning of the lung and thorax increases the effectiveness of...

Страница 60: ...s plateau signal can be switched on and off in the menu under LIAM info see 5 7 1 Activate deactivate plateau signal on page 57 You can also have the following values displayed under LIAM info Duration Interval and Cycles LIAM ends automatically once the set duration has elapsed or can be cancelled manually see 5 10 3 Canceling LIAM on page 61 5 10 2 Method You can trigger LIAM manually during ven...

Страница 61: ...ble for the respective patient are enabled If a variety of settings are intended for one patient mode parameters alarms i e ventilated with settings during the day which are different to those during the night you can select one of the programs configured for the patient in each case 1 Press the program button 2 Select the desired program and confirm your selection Under the menu item Displays Sum...

Страница 62: ...he power supply For optimal battery charging however we recommend not to disconnect the device from the power supply To switch off the device completely in battery operated mode first switch to standby by pressing the On Off key for about 2 seconds until the blower switches off Then press the On Off key again for at least 2 seconds until the device switches off completely and the display goes out ...

Страница 63: ...o the card otherwise therapy data may be lost End the therapy before removing the memory card Check whether the symbol is displayed in the status line When the symbol no longer appears in the status line you can remove the memory card safely Note The SD card can only be detected by the device when ventilation mode is running After inserting the memory card run the device briefly until the SD card ...

Страница 64: ...e VENTIlogic LS plus The terms of commercial transport do not currently apply to individuals who would like to travel with the therapy device see 3 1 5 Transport accessories spare parts maintenance on page 34 The therapy device is currently permitted as checked baggage or hand baggage for travel by plane under the applicable provisions for the carriage of dangerous goods You may take two spare bat...

Страница 65: ...ort the therapy device any distance in the protective bag WM 27106 intended for it If you want to use the therapy device on a mobile basis you must use it in carrying bag WM 27706 Proceed as follows to operate the device on a mobile basis 1 Fit the patient circuit and the patient ventilator interface 2 Now put the therapy device in the bag The ventilation tubes must be fed through the tube of fabr...

Страница 66: ...aving to remove the therapy device from the bag Simply open the hook and loop closure on the side of the bag The small accessories bag is provided for a second replaceable battery You can attach the accessories bag to the front of the carrying bag or to the shoulder strap If you charge the batteries in the bag the device may become so hot under high load that the charging process for the batteries...

Страница 67: ...tions for use on the hygiene treatment for the patient ventilator interface Interval Activity Daily Clean the patient ventilator interface in accordance with the relevant instructions for use Clean the patient circuit Clean bacteria filter WM 24148 in accordance with the instructions for use Clean the exhalation system in accordance with the instructions for use every time it is used Every 24 oper...

Страница 68: ... small opening of the adapter using the second sealing plug so that no water can penetrate 3 Clean the creased tube with a little detergent in hot water and make sure no residues are left behind Flush the inside of the tube through thoroughly in the process 4 Rinse the creased tube thoroughly inside and out using clean hot water 5 Thoroughly shake out the patient circuit 6 Hang up the patient circ...

Страница 69: ...rying adapter 3 Press the menu key to do so The patient menu appears in the display 4 Use the dial to select the menu item Drying process and confirm this selection by pressing the dial The message Drying process active 30 min appears This display remains active throughout the entire drying process and indicates remaining drying time After the drying process is complete the device switches off 5 I...

Страница 70: ...id under running water until there are no residues Then dry it carefully 5 Insert the coarse dust filter and the filter compartment lid as described in 9 3 Change filter on page 97 6 Remove the fan filter on the front of the device and clean it as described in 9 3 Change filter 7 Put the fan filter back in 6 4 Clean coarse dust filter change fine filter 1 Take off the filter compartment lid as des...

Страница 71: ...eatment in the corresponding instructions for use 6 7 Clean the SpO2module The housing of the SpO2module should be cleaned at regular intervals depending on contamination Wipe the SpO2module and the connecting cable with a soft damp cloth 6 8 Disinfect sterilize If required e g following infectious diseases or unusual contamination you can also disinfect the housing the power cord the patient circ...

Страница 72: ...rcuit valve ventilation Patient circuits with patient valve are not suitable for reuse Follow the enclosed instructions for use in this regard 6 8 4 Oxygen sensor The housing of the oxygen sensor is cleaned by wiping with disinfectant No further cleaning or hygiene treatment is possible If the oxygen sensor has been used without a bacteria filter before a change of patient it must be replaced 6 8 ...

Страница 73: ...the particulate filter inside it If the device is to be used for another patient without a bacteria filter being used it must be subjected to a hygiene treatment beforehand This must be performed by the manufacturer Weinmann or by an authorized specialist dealer The procedure for hygiene treatment is described in the service sheet and in the servicing and repair instructions for the therapy device...

Страница 74: ...hygiene reasons suitable disposable gloves should be worn if you seal the opening of the patient circuit with your thumb or hand 3 Switch on the device by pressing the On Off key If the device works perfectly two different acoustic signals should sound after switching on and both LEDs next to the alarm acknowledgement key should come on Depending on the operating mode set now test the following fu...

Страница 75: ... actually in use 3 Press the menu key to access patient mode 4 Use the dial to move the black selection bar to Function check and press ENTER 5 Confirm the function check in the following window The message window Function check running opens The remaining duration of the function check is displayed 6 If the function check is completed successfully the message Function check ok appears If the func...

Страница 76: ...r supplied onto the patient connection 3 The subsequent steps are described in 7 2 1 Check flow measurement and flow sensors pressure sensors leakage ventilation starting from step 2 Function check using a double patient circuit with patient valve VENTIlogic LS only 1 Connect the patient circuit to the device 2 Plug the test adapter supplied onto the patient connection 3 The subsequent steps are d...

Страница 77: ...nly be performed on the oxygen supply if the oxygen supply has been activated by the doctor beforehand flow meter or oxygen concentrator In order to carry out a function check on the oxygen supply proceed as follows 1 Start up the therapy device 2 Connect the oxygen source to the therapy device and start it up 3 At the oxygen source set the oxygen flow to the value prescribed by the doctor 4 Selec...

Страница 78: ...oxygen sensor once a day to avoid the weather affecting measuring results The device will issue the relevant message each day to remind you to perform calibration This message also appears if the device has previously been disconnected from the power supply 24 hours have passed since the last calibration the oxygen sensor has been disconnected electrically from the device and then reconnected Note...

Страница 79: ...or depends on the concentration of the oxygen supplied on ambient temperature on duration of use and on the device settings Under normal conditions ambient temperature 21 C 40 oxygen concentration the sensor lasts 6 months Note The sensor becomes exhausted even if it is not connected 7 3 5 Change oxygen sensor Once the oxygen sensor is exhausted remove it from the device Connect a new oxygen senso...

Страница 80: ...aler or by Weinmann 3 Check battery capacity shown in the status line of the display If fewer than three segments are displayed in the battery symbol the battery is not fully charged In this case charge the battery by connecting the device to the power supply 7 4 3 Replaceable battery if present 1 Push the replaceable battery into the device until you hear the latch engage The symbol for the repla...

Страница 81: ...ter change Filter dirty Press alarm acknowledgement key clean change filter as soon as possible 6 4 Page 70 Filter change indicator appears Clean change filter as soon as possible 6 4 Page 70 Battery discharged Internal battery of device exhausted Press alarm acknowledgement key have battery replaced by a specialist dealer so that course of therapy is recorded correctly Clock not set Internal cloc...

Страница 82: ...y with a firmware version 2 9 0 Update the firmware to version 2 9 0 or above Replaceable battery is hard to push in or jams Particles of dust in guide rails Clean guide rails on replaceable battery and lower part of housing Service life ended Have replaceable battery replaced The replaceable battery has reached the end of its service life Replace the replaceable battery Service life ended Have in...

Страница 83: ...gh priority alarms indicated by the symbol in the alarm window a flashing red LED and an acoustic alarm issued buzzer 8 2 1 Deactivate alarms The doctor supervising treatment can decide which physiological alarms to activate or deactivate If the symbol appears in the status line all the physiological alarms have been deactivated by the supervising doctor see Physiological alarms on page 84 8 2 2 A...

Страница 84: ...hown below 1 High priority alarms 2 Medium priority alarms 3 Low priority alarms If a new alarm with a higher priority occurs after one alarm is displayed the alarm display switches to the higher priority The low priority alarm is retained and is displayed again once the high priority alarm has been eliminated if it still applies 8 2 4 Physiological alarms Display Alarm Cause of fault Remedy IPAP ...

Страница 85: ...sing treatment VT high Maximum tidal volume exceeded High priority Leak in the single patient circuit only with patient circuit with patient valve Find and eliminate leak replace patient circuit if required Patient breathing as well Have settings checked by the doctor supervising treatment O2 high Maximum oxygen concentration exceeded at device outlet port Medium priority Oxygen supply too high as...

Страница 86: ...r interface faulty or defective Check ventilator interface and replace if necessary Oxygen supply faulty or inadequate Check oxygen supply and correct if necessary Ventilation parameter settings pressure volume frequency I E not suitable Check ventilation parameter settings and adjust if need be Alarm settings implausible Check alarm settings and correct if necessary SpO2 high Maximum alarm settin...

Страница 87: ...gh Volume is not reached VENTIlogic LS only Maximum pressure exceeded Low priority after 10 breaths rises to medium priority Various possible causes e g reduction in lung impedance Have settings checked by the doctor supervising treatment Pressure low VENTIlogic LS only Minimum therapy pressure undershot Medium priority Filter dirty Clean change filter Patient ventilator interface leaking Adjust h...

Страница 88: ...e Have the settings checked by the doctor supervising treatment Leakage Only available in dual leakage ventilation system Medium priority Leakage Find and eliminate leak replace patient circuit if necessary Display Alarm Cause of fault Remedy Display Alarm Cause of fault Remedy Battery capacity critical Medium priority Battery discharged under 25 capacity remaining Restore power supply and charge ...

Страница 89: ...y value of internal battery implausible Maintain internal battery 9 2 1 Page 96 or have internal battery replaced Battery temp critical High priority Battery too hot Allow device to cool down find a more suitable location to set it up Use alternative ventilation option Internal batt off due to temperature High priority Battery too hot Allow device to cool down find a more suitable location to set ...

Страница 90: ...y possible Have device repaired Excessive pressure High priority Pressure sensor defective Have device repaired Disconnection High priority Patient circuit is incorrectly connected to the device or not connected at all Check tube system Device being operated with patient ventilator interface open not put on Put on patient ventilator interface or switch off device Excessive temperature High priorit...

Страница 91: ...physician supervising treatment Device defective Have device repaired Control pressure high High priority The patient circuit selected in the menu does not correspond to the patient circuit connected Change patient circuit or have settings corrected by doctor supervising treatment Valve control tube and pressure measuring tube the wrong way round Check tube system Control pressure low High priorit...

Страница 92: ...defective Have device repaired EPAP high High priority The pressure drop on exhalation is inadequate possible cause pressure drop at patient valve too slow Ensure that the exhaled air can escape freely at the patient valve Check tube system Continuous pressure High priority Device defective Disconnect device from power supply and switch off Check connections for tubes Restore power connection and ...

Страница 93: ...er cord is firmly connected If necessary check the function of the socket by connecting a different device e g a lamp Blower failure Change device High priority Device switches off Device defective Have device repaired CPU failure Change device High priority Device switches off Internal processing faulty device defective Have device repaired I2C failure Medium priority Device defective Have device...

Страница 94: ...ntenance is carried out In any event alarms are retained in the event of a power failure 8 2 7 Passing on of alarms via the remote alarm connection All high and medium priority alarms are switched to a remote alarm connection in parallel The only low priority alarm which is passed on to the connection is the No power supply alarm If the device is operated in a hospital the therapy device can be co...

Страница 95: ...reasons we recommend replacing the following parts at the intervals specified 9 1 1 Leakage ventilation Pressure measuring tube every 6 months earlier if dirty Clean the patient ventilator interface in accordance with the relevant instructions for use Clean the exhalation system in accordance with the relevant instructions for use If necessary other accessories in accordance with the associated op...

Страница 96: ... battery for patients dependent on a ventilation device The internal battery may not be maintained with patient ventilation in progress To prolong the life of your batteries we recommend the measures below Run down the battery completely every 6 to 12 months by running the device without a power cable using the red test adapter until the device switches to the internal battery switches off and the...

Страница 97: ...ry on page 54 Wait until just one segment is showing in the status line before charging the battery Replaceable batteries which have been stored for over a month must be charged up before they are used to guarantee an accurate display 9 3 Change filter 9 3 1 Change coarse dust filter Use original filters from Weinmann only Using third party filters invalidates any claim under warranty and may resu...

Страница 98: ...and take it off 2 Replace the fine filter with a new fine filter WM 15026 Dispose of the old filter in normal domestic waste 3 Put the filter compartment lid into the cutout in the housing bottom edge first Then push the filter compartment lid into the housing until the latch engages Reset filter change indicator After you have changed the fine filter you must reset the filter change indicator Thi...

Страница 99: ...ce over so that the underneath points upwards 2 Grasp the fan filter with your fingertips and pull it out of the opening 3 Take a new clean filter and put it in Ensure that the fan filter is straight and that the corners are not tilted by the opening 4 Turn the device back over so that the top points upwards 5 Dispose of the used filter with domestic waste 9 3 4 Bacteria filter When using bacteria...

Страница 100: ...ment tube 9 5 Safety check The legally specified interval for performance of the safety check Sicherheitstechnische Kontrolle STK in accordance with 6 of the German law governing medical devices Medizinprodukte Betreiberverordnung Germany only is 2 years In addition servicing must be carried out as a preventive measure by the manufacturer Weinmann or by a specialist dealer expressly authorized by ...

Страница 101: ...spose of the device properly contact a licensed certified electronic scrap disposal merchant This address is available from your Environment Officer or from your local authority 9 6 2 Batteries Do not dispose of batteries with domestic waste To dispose of batteries properly contact a licensed certified electronic scrap disposal merchant This address is available from your Environment Officer or fr...

Страница 102: ...domestic waste To dispose of the SpO2module properly contact a licensed certified electronic scrap disposal merchant This address is available from your Environment Officer or from your local authority The device packaging cardboard and inserts can be disposed of in paper recycling facilities ...

Страница 103: ...sting of adapter leakage ventilation drying adapter patient circuit WM 15545 WM 27199 WM 24203 WM 24130 Information and spare parts set consisting of coarse dust filter fine filter packed coarse dust filter fan O2 coupling Hex socket wrench size 3 WM 15494 WM 24880 WM 15026 WM 27759 WM 27166 WM 24708 Tube adapter hospital adapter WM 15880 Instructions for use EN WM 67781 Parts Order number VENTIlo...

Страница 104: ...ith panel WM 27951 Power cord WM 24177 Protective bag for VENTIlogic LS WM 27106 Set conversion to double patient circuit with patient valve packed consisting of exhalation module packed double patient circuit with patient valve WM 15546 WM 27185 WM 27182 Test adapter packed WM 27140 Information and spare parts set consisting of coarse dust filter fine filter packed coarse dust filter fan O2 coupl...

Страница 105: ...e ventilation packed WM 27199 Drying adapter WM 24203 Information and spare parts set consisting of coarse dust filter fine filter packed coarse dust filter fan O2 coupling patient passport Hex socket wrench size 3 WM 15494 WM 24880 WM 15026 WM 27759 WM 27166 WM 66810 WM 24708 Set O2 measurement consisting of connecting cable for O2 sensor O2 sensor T piece O2 sensor WM 15732 WM 27792 WM 27128 WM ...

Страница 106: ...ing of coarse dust filter fine filter packed coarse dust filter fan O2 coupling patient passport Hex socket wrench size 3 WM 15494 WM 24880 WM 15026 WM 27759 WM 27166 WM 66810 WM 24708 Instructions for use EN WM 67781 Parts Order number VENTIlogic plus basic device with panel WM 27991 Power cord WM 24177 Protective bag for VENTIlogic plus WM 27106 Single patient circuit valve ventilation WM 27181 ...

Страница 107: ...re parts You can order accessories and spare parts separately if required A current list of accessories and spare parts can be ordered on the Internet at http www weinmann medical com en medical_professionals products ventilation or via your dealer ...

Страница 108: ...ectrical rating 100 230 V AC 50 60 Hz Tolerance 20 10 Current consumption during operation standby 230 V 100 V 0 35 A 0 8 A 0 05 A 0 13 A Maximum power consumption 120 W Breaking capacity of remote alarm connection 60 V DC 2 A 42 V AC 2 A Internal battery Model Nominal capacity Nominal voltage Nominal output Li Ion 3100 mAh 39 6 V 121 Wh Life span of internal battery internal and removable battery...

Страница 109: ... 8 EN 61000 4 11 Mean sound pressure level operation to EN ISO 17510 at a distance of 1 m from the device in the patient position approx 28 dB A at 10 hPa Sound pressure level of alarm message approx 69 dB A to EN 60601 1 8 IPAP pressure range EPAP PEEP pressure range CPAP pressure range Pressure accuracy Increment 6 to 40 hPa leakage ventilation 4 to 45 hPa valve ventilation 4 to 20 hPa leakage v...

Страница 110: ...3000 ml Accuracy of volume measurement Measuring range 50 ml to 3000 ml at 23 C 20 at least 25 ml Max permitted flow rate for oxygen supply 15 l min at 1000 hPa Max heating of respiratory air at 35 C ambient temperature 41 C Pressure consistency measured to EN ISO 17510 in CPAP mode 10 hPa Ąp 0 5 hPa 10 hPa Ąp 1 0 hPa Fine filter degree of separation up to 2 m ø 99 7 Fine filter service life 1000 ...

Страница 111: ...ice checks after 5 breaths whether the target volume has been reached and changes the pressure by 1 0 hPa If the pressure reaches a corridor around the target volume the device switches to precise control In the fast stage the device checks after each breath whether the target volume has been reached and changes the pressure by 1 5 hPa If the pressure reaches a corridor around the target volume th...

Страница 112: ...NTIlogic LS with double patient circuit with patient valve Standard configuration 0 24 0 38 0 4 O2 sensor WM 27128 0 47 0 49 Bacteria filter WM 27591 0 48 0 5 O2 sensor WM 27128 and bacteria filter WM 27591 0 57 0 59 Bacteria filter WM 24148 for leakage ventilation Product class to Directive 93 42 EEC IIa Dimensions Ø x L in cm 7 4 x 9 8 Weight approx 51 g Temperature range operation storage 5 C t...

Страница 113: ...e time for particulate filter 24 h Material of housing PC Housing can be autoclaved in devices to EN 285 134 C Oxygen sensor Measuring range 0 100 oxygen Linear fault 3 of measuring range limit value Response time T90 12 s Drift at constant temperature and constant pressure over 6 h 21 oxygen 60 oxygen 3 of final measured range value 4 of final measured range value Temperature range operation stor...

Страница 114: ...x D 67 x 66 x 28 mm Weight approx 150 g Cable length up to finger clip sensor 2 5 m Display SpO2 Pulse 0 to 100 0 to 300 beats per minute Temperature range operation storage 5 C to 40 C 25 C to 70 C Permitted humidity in operation and storage 10 to 95 no condensation ...

Страница 115: ...age flow 0 l min 320 l min Channel 4 Tidal volumes 0 ml 3000 ml Channel 5 All spontaneous respiration modes on inspiration trigger All mandatory modes not in use All spontaneous respiration modes on inspiration trigger All mandatory modes not in use All spontaneous respiration modes on inspiration trigger All mandatory modes not in use Channel 6 not in use not in use not in use Channel 7 not in us...

Страница 116: ...r Flow measuring section insp O2 valve Non return valve Bacteria filter Silentflow Patient Pressure sensor for patient Pressure sensor for device outlet port Flow sensor Pressure sensor for atmosphere O2 supply 0 15 l min at 1000 hPa Exhaled air flushed out via leakage system Humidifier ...

Страница 117: ...2 valve Non return valve O2 sensor Patient valve Patient Pressure sensor for patient Pressure sensor for device outlet port Flow sensor Pressure sensor for atmosphere Pressure sensor for valve control Switching valves for exhalation valve Non return valve with reverse leakage Exhaled air Bacteria filter Humidifier ...

Страница 118: ...2 sensor Patient valve Patient Pressure sensor for patient Pressure sensor for device outlet port Flow sensor Pressure sensor for atmosphere O2 supply 0 15 l min at 1000 hPa Pressure sensor for valve control Switching valves for exhalation valve Non return valve with reverse leakage Exhaled air Flow sensor Flow measuring section exp Humidifier Bacteria filter ...

Страница 119: ...ns is reserved Recommended safety distances between portable HF telecommunication devices e g cellphone and the therapy device Nominal output of HF device in W Safety distance depending on transmission frequency in m 150 kHz 80 MHz outside ISM bands 150 kHz 80 MHz within ISM bands 80 MHz 800 MHz 800 MHz 2 5 GHz 0 01 0 04 0 12 0 12 0 23 0 1 0 11 0 38 0 38 0 73 1 0 35 1 20 1 20 2 30 10 1 10 3 80 3 8...

Страница 120: ...re with adjacent electronic devices HF emissions to CISPR 11 Class B The VENTIlogic LS VENTIlogic plus is suitable for use in facilities other than the domestic sphere and in those which are connected directly to the PUBLIC POWER SUPPLY NETWORK which also supplies buildings used for habitation purposes as long as the warning below is observed Warning this device system is intended only for use by ...

Страница 121: ... kV for power supply cables 1 kV for input and output cables The quality of the supply voltage should correspond to that of a typical business or hospital environment Surge immunity to IEC 61000 4 5 1 kV voltage line line 2 kV voltage line ground 1 kV voltage line line 2 kV voltage line ground The quality of the supply voltage should correspond to that of a typical business or hospital environment...

Страница 122: ...pital environments NOTE UT is the alternating line voltage prior to application of the test levels Guidelines and manufacturer declaration electromagnetic INTERFERENCE IMMUNITY The VENTIlogic LS VENTIlogic plus is intended for operation in the ELECTROMAGNETIC ENVIRONMENT as outlined below The customer or the user of the VENTIlogic LS VENTIlogic plus should ensure that it is used in an environment ...

Страница 123: ... ENVI RONMENT guideline Portable and mobile radio devices should not be used at a distance from the VENTIlogic LS including its cables of less than the recommended safety distance calculated in accordance with the equation applicable to the transmission frequency Recommended safety distance Conducted HF interference to IEC 61000 4 6 10 Veffective value 150 kHz to 80 MHz within ISM bands 10 V 1 7 m...

Страница 124: ...sed in an environment of this type INTERFERENCE IMMUNITY tests IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVI RONMENT guideline Portable and mobile radio devices should not be used at a distance from the VENTIlogic LS including its cables of less than the recommended safety distance calculated in accordance with the equation applicable to the transmission frequency Recommended safety d...

Страница 125: ...onformity Weinmann Geräte für Medizin GmbH Co KG Kronsaalsweg 40 22525 Hamburg Germany the manufacturer of the therapy devices described in these instructions for use declares herewith that the product complies with the respective regulations of the Medical Device Directive 93 42 EEC The unabridged text of the Declaration of Conformity can be obtained from the manufacturer Weinmann www weinman med...

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Страница 128: ...Weinmann Geräte für Medizin GmbH Co KG Kronsaalsweg 40 D 22525 Hamburg Germany T 49 0 40 5 47 02 0 F 49 0 40 5 47 02 461 E info weinmann medical com www weinmann medical com WM 67781d 12 2015 EN ...

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