OpMan PATe ENG_v3 SC rev 2
Contents
1. Spare insufflation valve PVF 018 4 Description of the appliance A Front panel INSUF PRESS Page 8 2008 Kalas Medical B Rear panel T IPX1 No 12 PARAVENT PAT Working pressure 400 50 kPa C 1014 13 A Front panel B C eee O 7 8 9 10 Switch for adjustment of FREQUENCY BATTERIES 12V 100m A O 14 15 Switch for adjustment of TIME RATIO of inspiration and expiration Switch for manual pneumatic ventilation Manometer gauge of insufflation pressure Luminous LED indicator of batteries Luminous LED indicator for connection of the appliance to mains supply Luminous LED indicator for alarm Inspiration valve Slot for measuring catheter Expiration valve 11 Switch for adjustment of insufflation pressure Rear panel 12 Valve for connection of oxygen hose 13 14 15 Battery compartment Slot for external adapter Switch for switch ON OFF of the appliance Multi nozzle jet injector l 2 3 4 Inspiration nozzles n I ll a Ill Expiration nozzle Measuring nozzle Connection for ET cannula or for mask connection by mask s extension Connection for T piece Page 9 3 C Multi Nozzle Jet Injector 2008 Kalas Medical D Set of catheters 1 Inspiration catheter color red 2 Expiration catheter color green 3 Measuring catheter 4 LUER cone of2. Conversion table AE ter 2 1500 20 39 0 02 25 1855 2549 003 oso er 080 1 so 675 es 09 120 900 1224 1 20 Page 33 PN EE hae 2008 Kalas Medical
3. Users Manual E B1 Respiratory Care Companion VMVENT KALAS Medic al s r o tel 00421 42 4326907 4325104 Slovensk ch partiz nov 1130 50 P O BOX 48 A fax 00421 42 4326907 017 01 Pova sk Bystrica E mail kalas kalas sk info kalas sk SLOVAKIA Web www kalas sk Page 1 2008 Kalas Medical D N EE gt ECO NX OB1 This technical appliance will reliably serve its purpose only if used in accordance with this User s manual All guaranties related to the machine provided by the company Kalas Medical Ltd will be void if the appliance shall not be used and maintained in accordance with this User s manual The appliance can be used only by qualified and trained personnel that have carefully studied and considered this User s manual warnings on the appliance or corresponding documentation and followed all specified guidelines and instructions If this machine is not operating as specified in this Users manual we do not recommend its usage Operating personnel are responsible for all injuries or harm to health resulting from the incorrect use unauthorised repairs damage or non adequate maintenance performed by other than Kalas Medical Ltd personnel or contractual representatives of KALAS Medical Ltd Pova sk Bystrica Slovakia If you need any advice explanation or any additional information about the appliance please contact the commercial representative or the producer Page 2 2008 Kalas Medical
4. 4 Choose MNJI by the number which symbolises the diameter of its cylindrical cavity tolerance 0 5mm for pre chosen endo tracheal tube with the same diameter e g for tracheal tube 3 5 MNJI No 3 or 4 and measuring connector of the same size Using LUER cone connect inspiration insufflation catheter with lavage valve to the hole of inspiration nozzle of chosen MNJI marked by roman number n D 4 to C 1 While choosing the size of inspiration nozzle see also the Cookbook OBI Paravent PATe Expiration insufflation catheter with curved connector LUER is to be connected to the hole of expiration nozzle of MNJI n D 5 to C 2 see picture n 1 Connect measuring catheter by RECORD cone to the hole of measuring connector n D 6 to C 3 see pic 1 Page 12 2008 Kalas Medical PSE Picture n 1 Connection of set of catheters to MNJI D Connection of MN I to the mask 1 To the connection n C 4 of the MNJI connected to set of catheters as described in part 5 5 C connect the extension reduction for the ventilation with mask The size of the extension reduction must fit with the size of mask see picture n 2 2 Connect the mask to the extension reduction see picture n 2 Picture n 2 Connection of MNJI to the mask E Connection of ventilatorto the source of oxygen compressed air Connect the ventilator by quick coupler on the oxygen hose position B 12 to the source of oxygen or compre
5. Pa r ni DIN M and airways during the ventilation In this mode it is not recommended to use nozzle number because its power is not balanced with the expiration nozzle In this mode it is possible for the released phlegm to be splashed by expulsion effect from the proximal ending of MNJI which could contaminate surroundings For this reason part of accessory equipment contains a Fset that serves the purpose of elimination of possible contamination The T piece of the T set is to be connected by the cone F15 to the cone M15 on the proximal ending of MTG The expiration tubing from the T set is to be connected to the cone M22 Max length of tubing is 1 2 m Aerosol is captured on the walls of tube that can lead to dust bin or can be simply covered by a sheet of linen It is essential that the distal end of the hose is not closed You must ensure the prevention of tube choking as this is the only way by which expiration can be realized The Fsetis a disposable material for single patient use only 8 5 Long term ventilation Application in time periods of 1 2 hours will not cause any significant problems even without any humidification The issue of humidification and heating of breathing mixture can be partly solved by humidification and heating of that part of breathing mixture that is torn down from the atmosphere For this purpose you must use the T piece connector The Valve T connector serves o the purpose of isolating the p
6. 1 9 Close the distal end of MNJI and slowly increase the insufflation pressure up to the activation of alarm of peak pressure The output pressure of the ventilator is monitored on the manometer that is located on the top cover of the appliance Alarm of peak pressure of the appliance is activated when the output pressure exceeds the pressure of 5 kPa 0 5 kPa airway pressure measured Together with this alarm signalization the inspiration resp active expiration is disconnected up to the next breathing cycle Page 15 2008 Kalas Medical 7 2 Setting of the ventilator To make high frequency jet ventilation successful one has to choose adequate intubation including the choice of endo tracheal tube corresponding to age and weight of patient 1 Connect the ventilator assembled according to the part 5 5 to the source of oxygen compressed air and switch it on part 5 1 2 Check the level of the insufflation pressure on pressure gauge on front panel position A 4 and set its required value by switch n A 11 3 Set the required frequency by switch n A 1 4 Set the required time ration by switch n A 2 5 Choose an MNJI by the number which symbolises the diameter of its cylindrical cavity toleration 0 5mm for pre chosen endo tracheal tube with the same diameter e g for tracheal tube 3 5 MNJI No 3 or 4 and measuring connector of the same size 6 Connect distal cone ending of MNJI to endo tracheal tube of patient
7. 5 Setup assembling of the ventilator A Valve connection 1 2 Plug inspiration insufflation valve to the slot marked INSP in red field position A 8 and secure it by tightening safety bolts Plug expiration insufflation valve to the slot marked EXP in green field position A 10 and secure it by tightening safety bolts These valves are notexchangeable In the case of exchange of bolts these can tbe fastened which prevents the exchange and ensures the proper fit of valves and proper function of the appliance When unpacking the ventilator from original pack the inspiration and expiration valves are already installed B Connection of set of cathetersto ventilator 1 2 3 Connect inspiration insufflation catheter to inspiration insufflation valve red to red by quick coupler marked red n D 1 to position A 8 The Inspiration insufflation catheter ends by cone LUER and lavage valve Then connect expiration insufflation catheter to expiration insufflation valve green to green by quick coupler marked green n D 2 to position A 10 The Expiration insufflation catheter ends by curved connector with cone LUER Connect measuring catheter to connector marked MEAS CATH n D 3 to position A 3 by quick coupler marked grey The measuring catheter ends with a connector RECORD The exchange of connections of catheters to insufflation valves is not possible C Connection of set of cathetersto MNJ I 1 2 3
8. B 13 When fully charged the reserve enables the ventilator to operate for at least 8 hours The basic equipment of the ventilator includes AA sized NiMH battery charger to be used to keep the reserve in optimum state the battery charger manual is enclosed in its package The capacity of batteries plugged in the ventilator is maintained against self discharging by a small electric current as long as the ventilator is plugged to external power supply unit This state is indicated by green LED in field BATT position A 5 Regular dry or alkaline batteries of size AA are not to be used as reserve NiCd or NiMH batteries of size AA with the capacity at least 500mAh must be used Place charged batteries into the slot marked as BATIERIES position B 13 in the way it is indicated on the top of the slot If the ventilator is not connected to the external power supply by the adapter the green LED will come on position A 6 when the batteries are charged If the red LED position A 5 comes on the batteries are not sufficiently charged and it is necessary to charge them according to the user s manual in enclosed charger NiMH batteries need to be kept in a good condition with help of a charger from the basic equipment as written in the enclosed manual of the charger Once a month have the batteries recharged in the charger using the discharging mode The period of usage recommended by the ventilator manufacturer is 2 years New spare NiMH bat
9. Page 3 2008 Kalas Medical D N EE ECO NX Summary 1 Characteristics and technical specification of the appliance 5 ee Ey WS ASS o dede 6 3 Supplied equipMent sevice van s i o 7 DL BASIC QUI MENT in A tie an 7 3 2 Accessory equipment as per separate order us 8 A Description of TNE appliance ccccsscerssseccesssssccnccssssnnscssssoocersssssccnsesosseeccanssneees 8 5 Usage of VY SOME suda sk n nan ie 10 5 1 Switching ON OFF the ventilator ranas 10 5 2 Feeding by external adapter from external power SUPPIY cccccccccnnccnnannnnnoss 10 5 3 Reserve power supply batteries ss 11 5 4 P euvmahe Manual MOJE arias 11 5 5 Set up assembling of the ventilator ss 12 5 6 Disassembling of ventilator esssesesesesersesssseessesereessererssesreessserersserresessrreesseeeeess 14 6 Cleaning and sterilization of ventilator sss dansent 14 7 Process of starting ventilation sereinement 15 7 1 Control of PUNCHONS id AAA AA 15 7 2 Setting of the Venas ane v 16 8 Special modes of ventilation aii a A a at 18 8 1 Deepened ventilation Ventilation during spontaneous breathing 18 8 2 Cleaning of airways Tracheo bronchial Toilette ocococcccccnononananonannnoso 18 8 3 Inpulsion mode an sia ed ei ne 18 8 4 Expulsion Mode acdsee data ban le fade in ok 18 8 5 Long term venta ton nn ida 19 9 MOS FERINA ai ici cita 20 10 HFJV COOKBOOK Quick guide of OB 1 Paravent parameters se
10. it s mucous 2 If the MNJI together with a constant pressure generator connected to circuit load lungs constitute the source of exponentially digressive flow then a generated volume VTg is the integral of flow Qg in time Ti Page 23 2008 Kalas Medical NE DIN ER 3 Apart of the volume generated by MNJI is leaking through Ru leakage into the atmosphere and so is VTd delivered into lungs lower than VTg 4 Multi nozzle jet injectors MNJI are designed and constructed with a large reserve and principally constitute the pressure generators capable to compensate forlarge leakage whereas Pg generator pressure is not decreasing 5 The resulting volume flowing into lungs is thus dependent on the mechanical properties of lungs Raw and Cst Therefore HFJV is contraindicated in the cases of high resistance e g severe asthma ET tube Leakage X from VTg Cuff deflated VT delivered gt to lung Pneumatic model of lungs per ISO norm for individual size categories defined by the flow of ET cannula in Tab 1 Model C R Rt Rsum Q i e Tau nas c kPa kPa l s kPa l s kPa l s l s sek mm 50 0 50 0 20 0 4 0 6 2 00 0 300 8 9 25 0 25 0 35 0 5 0 85 1 00 0 212 6 7 10 0 10 1 00 1 0 2 0 0 50 0 200 5 3 0 03 5 00 2 0 7 0 0 075 0 210 3 4 0 01 10 00 2 7 12 7 0 05 0 127 2 5 Using this model calculation of VT generation was realized at
11. n C 4 7 Ventilation pressure can be seen on the gauge on the top cover of the ventilator either during the whole time frequency 20 40 c min or at its peak level at the end of inspiration frequency 120 180 c min position E 1 8 Check breathing movements of the breast of patient or auscultation which are the signs of working ventilator Furthermore you can check the level of ventilation by Common clinical signs such as complexion colour mucous colour etc and evaluate the sufficiency of ventilation In case of insufficient level of ventilation small breathing movements lasting cyanosis etc switch inspiration insufflation catheter by LUER cone from inspiration nozzle marked as number I to next inspiration nozzle marked as number II which increases the level of ventilation and check up the patient again In case of still not having high enough level of ventilation small breathing movements lasting cyanosis etc switch inspiration insufflation catheter by LUER cone from inspiration nozzle marked as number II to the next inspiration nozzle marked as number Ill which again increases the level of ventilation and check the patient again You can fine tune the power of ventilation e g according to control of blood gases by changing insufflation pressure meant as by switch INSUF PRESS position A 11 while checking the manometer on the top cover of the machine position A 4 Having higher level of ventilation power may lead t
12. 320 00 VT max L 0 83 0 87 1 02 1 33 VT actual w o leakage 0 33 0 35 0 41 0 53 VT actual with leakage 0 18 0 19 0 23 0 30 MV actual with leakage 22 11 23 11 27 22 35 56 Page 27 AN FE Y i 2008 Kalas Medical el 10 3 Overview for a guick orientation 1 Ventilation of patient without lung injury Shock statuses hemorrhagic shock trauma CPR for example in case of heart chamber fibrillation intoxication etc The suitable initial set Up is Pin MNJ I Nozzle insufflation Used no on MNJ I used TI Te Ti pressure 150 kPa Corresponding to ET or No 1 1 50 TT cannula 2 Ventilation in case of less serous lung injury over weight patient or for patient transportation It is suitable to apply so called basic set up Pin MN Nozzle insufflation Used no on MNJ I used TI Te 1 pressure 150 kPa ONE PO oi No l 1 1 50 TT cannula 3 Ventilation in case of serious lung injury pneumonia initial ALI Acute Lung Injury heavy obesity lung edema and similar The suitable initial set up is Pin insufflati MN Nozzle i i anon Used no on MNJ I used EL SL pressure 150 kPa BT SPE No 1 1 50 TT cannula 4 CAVE HHV is contraindic ated in cases of serious bronchospasm and in status asthmatic us 10 4 Applications of HH V through less common aids providing for transitional clear airways HFJV can al
13. 4 3 kg max 74 dB temperature 10 C to 40 C humidity max 80 1 Type of protection against electricity accident a external adapter 230V AC 12V DC SZ 12 2 100 from Enco is class Il b when mains feeding by external adapter 230V AC 12V DC SZ 12 2 100 from Enco the whole machine is class II Bas per SN EN 60601 1 c when using NiMH batteries as a reserve power supply the machine is using the intemal power supply 2 Level of protection against electricity accident machine is type Bas per SN EN 60601 1 3 Level of protection against harmful penetration of water External adapter 230V AC 12V DC SZ 12 2 100 from Enco and the machine itself are protected against leaking water IPX1 as per CSN EN 60601 1 4 Working mode machine can be used in permanent operation 5 Protection against the danger of inflammation of flammable anaesthetic mixtures The machine must not be used in environment where are flammable anaesthetic mixtures as per CSN EN 60601 1 For ventilation in the field or during transportation a source of compressed oxygen pressure cylinder with the capacity 2 5 or 10 L equipped with a cylinder pressure regulator with a quick coupler which is set up to outlet overpressure 400 kPa 100 kPa is required 2 Safety instruction e This user s Manual is an inseparable part of the appliance e Before using the appliance read carefully this manual e Respect all warnings e Fo
14. 7 44 8 67 MNJI 6 Nozzle Il Pin kPa 100 150 200 300 Pgmax kPa 2 55 3 70 4 80 7 30 Qgmax L 84 00 101 00 117 00 143 00 VT max L 0 35 0 42 0 49 0 60 VT actual w o leakage 0 14 0 17 0 20 0 24 VT actual with leakage 0 08 0 09 0 11 0 13 MV actual with leakage 9 33 11 22 13 00 15 89 Page 26 2008 Kalas Medical MNJI 7 Nozzle Il Pin kPa 100 150 200 300 Pgmax kPa 2 55 3 70 4 80 7 30 Qgmax L 119 00 147 00 173 00 211 00 VT max L 0 50 0 61 0 72 0 88 VT actual w o leakage 0 20 0 25 0 29 0 35 VT actual with leakage 0 11 0 14 0 16 0 20 MV actual with leakage 13 22 16 33 19 22 23 44 MNJI 8 Nozzle Il Pin kPa 100 150 200 300 Pgmax kPa 2 05 3 70 4 80 7 30 Qgmax L 155 00 193 00 225 00 277 00 VT max L 0 65 0 80 0 94 1 15 VT actual w o leakage 0 26 0 32 0 38 0 46 VT actual with leakage 0 14 0 18 0 21 0 26 MV actual with leakage 17 22 21 44 25 00 30 78 MNJI 2 Nozzle II Pin kPa 100 150 200 300 Pgmax kPa 2 55 3 70 4 80 7 30 Qgmax L 183 00 193 00 236 00 283 00 VT max L 0 76 0 80 0 98 1 18 VT actual w o leakage 0 31 0 32 0 39 0 47 VT actual with leakage 0 17 0 18 0 22 0 26 MV actual with leakage 20 33 21 44 26 22 31 44 MNJI 10 Nozzle Il Pin kPa 100 150 200 300 Pgmax kPa 2 55 3 70 4 80 7 30 Qgmax L 199 00 208 00 245 00
15. a frequency 120 c min and an insufflation pressure Pin 140 150 kPa with the use of corresponding MNJI to ET cannula 3 9 mm on nozzle no II with Ti Te 1 1 Orientation average values of VTg for the application of MNJI from 3 to 9 in corresponding models listed in Tab 1 are listed in Tab 2 ET Cannula Vig mm with Pg 3 3 kPa 8 9 0 334 6 7 0 276 5 0 110 Page 24 2008 Kalas Medical 3 4 0 033 PANNE Y lt _ 2 5 0 018 During the application of HFJV with uncuffed cannula there may be leakage along ET cannula with decreased VT delivered into lungs After the correction for leakage VTd and MY is roughly as follows in Tab 3 VTdelivered MV with dir m m with leakage leakage calculated 8 9 45 0 183 22 06 6 7 40 0 166 19 92 5 35 0 071 8 58 3 4 30 0 023 2 82 2 5 20 0 014 1 79 Minute ventilation MV calculated for f 120 b min is in comparison to the measured MV in normal lungs Cst and Raw within the range of cca 20 This calculation is only orientational because the parameters of patient lung mechanics can significantly influence the gas exchange whereas the correction of required energy Pin while monitoring Paw and the clinical indications of patient are always determined by the healthcare practitioner Page 25 2008 Kalas Medical g PNE DIN RE Orientational values of Minute Ventilation and Tidal Volume
16. art of air injected by the jet system in inspiration from expired gas mixtures from patient during expiration This feature allows the effective set up of the injected part of inspiration from the point of view of humidification and oxygenation and the elimination of contamination of the surrounding space of patient by infectious aerosol originated in such ventilation The shoulder A see pic below supplies atmospheric air torn down by the jet system in inspiration mode It has an outside cone 22M For the enhancement of humidification of breathing mixture it is possible to connect this shoulder with a 22 mm tube to the output of humidifier The input of humidifier is connected to the atmosphere Further it is possible to thin the oxygenation of the atmosphere torn down gas mixture by the external mixer of air and oxygen In this case it is necessary to set up the flow of this gas mixture between 15 and 25 l min or alternatively including a reserve bag of volume 0 5 to 2 0 L into this branch Such adjustments of the breathing mixture allow longer term high frequency jet ventilation and require relatively large experience with this type of ventilation Therefore for this application we recommend consultation with the producer or an expert clinical site that is knowledgeable in this topic The shoulder B serves the purpose of connecting to Multi Nozzle Jet Injector MNJI of the jet ventilation system It has a inward cone 15F This cone is
17. ce the inspiration insufflation catheter with the LUER cone to the hole of initial inspiration nozzle and possibly adjust the insufflation pressure 8 3 Impulsion mode To lavage the airways connect the syringe with lavage mixture to the hole in lavage valve with the cone LUER For the instillation of the mixture into the airways choose impulsion mode with the time ratio 1 2 on the switch TIME RATIO Push the mixture to inspiration insufflation catheter by slow constant pressure on the injection plunger From there it is by a pressure in inspiration insufflation catheter through the MNJI jet and by high kinetic energy of a stream of oxygen sprayed to the airways in a form of aerosol During this operation we recommend setting slightly higher ventilation power by increasing the insufflation pressure by about 20 8 4 Expulsion mode Expulsion mode is initiated by changing the I E ratio to 2 1 on the switch TIME RATIO In this instance with a frequency of 120 or 180 c min the expiration nozzle is automatically activated to limit dynamic positive end expiratory pressure PEEP in the airways In this mode it is useful to deflate the cuff of the endo tracheal tube to keep released phlegm from cumulating between the wall of trachea and the wall of endo tracheal tube Released phlegm then moves out into mouth from where it can be easily sucked out The sucking can also be performed inside endo tracheal tube Page 18 2008 Kalas Medical g
18. connected directly to the corresponding cone 15M at the end of MNJI Page 19 2008 Kalas Medical AA DIN ER The shoulder C serves the purpose of removing the expired mixture from patient It has an outward cone of 22mm It is possible to connect it to a 22mm tube of max length 1 2 m The ending of tube shall be placed inside the container where the potential infectious aerosol originated in the ventilation can be captured semi sealed container It is essential that the ending of this tube altematively the ending of the shoulder C will NOTBE CLOSED Valve Tconnector is for single patient use only the Supplier does not guarantee its function after the re sterilisation It is essential to connect the T connector as shown below so that the shoulders A and C are NOT INTERCHANGED For the correct connection the pointers show the direction of flow of gas through the T set Gas Mixture In A G Expired Gas Out Distal end of MNJI 9 Most common problems 1 Disconnection of LUER connector on inspiration insufflation catheter from MNJI when insufficiently fixed sudden loss of ventilation power and loud hiss and at the same time the alarm of non ventilation is activated SOLUTION adequate connection of inspiration insufflation catheter with LUER cone connection respiration in the hole of chosen nozzle 2 Choking of inspiration nozzle in MNJI related mostly to MNJIs with small diameter that is 3 and 4 It is
19. erial In the cases that patient is covered by bulk matter sand grain earth dirt in mine disasters etc i e lungs as well as abdomen compliance is decreased we apply the following set up also for intubation with normal suitable ET cannula but in this case we do inflate the sealing cuff of ET cannula This is only in the case that life saving ventilation is needed Pin 2 MNJ I Nozzle 7 amason Used no on MNJ used U i pressure 190 220 kPa MNJI no 4 5 No III 1 1 50 Once patient is brought off extracted insufflation pressure Pin shall be decreased to 150 170 kPa and sealing cuff is deflated 3 HB Vin Bronc hscopy When we apply HFJV in bronchoscopy in a way through ET TT cannula after we insert bronchoscope through MNJI we increase Pin to 180 210 kPa Pin MN Nozzle insufflation Used no on MNJI d TI Te Ti pressure 180 210 kPa late OT MANJI No Il 1 1 50 no 8 10 After extraction of the bronchoscope return the parameters to the initial set up as before the application of bronchoscopy Page 29 2008 Kalas Medical 10 7 Non invasive HH V M HBV by Mask KALAS PNE Y a gt In cases of non invasive ventilation by naso oral mask HFJV M through MNJI no 10 0 is applied for adult patient In the case of serious lung edema or decreased Cst static compliance Pin can be increased up to 230 kPa Pin MNJ I Nozz
20. for corresponding MNJ I with adjusted insufflation pressure Pin The tables below show measured values of MV and Vt with and without leakage for corresponding MNJI on the nozzle ll with frequency 120 bpm Ti Te 1 1 for adjusted Pin range 100 300 kPa measured on a laboratory measuring device with the accuracy of measurement 1 5 on normal lungs in terms of Cst and Raw intubated with appropriate endo tracheal tube with uncuffed seal with normal leakage around the cuff MNJI 3 Nozzle II Pin kPa 100 150 200 300 Pgmax kPa 2 93 3 70 4 80 7 30 Qgmax L 14 00 18 00 21 00 25 00 VI max L 0 06 0 08 0 09 0 10 VT actual w o leakage 0 02 0 03 0 04 0 04 VT actual with leakage 0 01 0 02 0 02 0 02 MV actual with leakage 1 56 2 00 2 33 2 78 MNJI 4 Nozzle II Pin kPa 100 150 200 300 Pgmax kPa 2 55 3 70 4 80 7 30 Qgmax L 38 00 45 00 53 00 62 00 VT max L 0 16 0 19 0 22 0 26 VT actual w o leakage 0 06 0 08 0 09 0 10 VT actual with leakage 0 04 0 04 0 05 0 06 MV actual with leakage 4 22 5 00 5 89 6 89 MNJI 5 Nozzle Il Pin kPa 100 150 200 300 Pgmax kPa 2 55 3 70 4 80 7 30 Qgmax L 46 00 56 00 67 00 78 00 VT max L 0 19 0 23 0 28 0 33 VT actual w o leakage 0 08 0 09 0 11 0 13 VT actual with leakage 0 04 0 05 0 06 0 07 MV actual with leakage 5 11 6 22
21. inspiration Kee catheter 5 LUER cone of expiration catheter 6 RECORD cone of measuring catheter E Top cover 1 Manometer gauge for the Paw pressure 5 Usage of ventilator 5 1 Switching ON OFF the ventilator To switch ON the ventilator put the switch for switch ON OFF n B 15 into the position To switch OFF the ventilator put the switch for switch ON OFF n B 15 into the position O 5 2 Feeding by extemal adapter from extemal power supply Electrical supply of the appliance is through the external adapter 220 V AC 12 VDC Plug the external adapter 12 V DC to the external power supply The green LED on the adapter will light up Plug the connector of external adapter to the slot position B 14 on the appliance On the front panel the green LED position A 6 will light up to indicate external power supply In this case the power supply is the electrical network even if the batteries are placed in the battery compartment It is possible to keep the external adapter plugged into external power supply for maintenance of NiMH battery capacity if they are placed in the battery compartment This state is indicated by green LED in field BATT position A 6 Using any other adapter than the one supplied by the manufacturer of the product is not recommended Page 10 2008 Kalas Medical 5 3 Reserve power supply batteries Electrical Reserve is provided by four NiMH batteries of size AA position
22. le insufflation Used no on MNJ I used Ti Te 11 pressure 180 kPa 230 kPa MNJI no 10 No Ill 1 1 50 10 8 HA V in Magnetic Resonance For application of HFJV in NMRI tubes of length up to 10 m are used to ventilate the patient In such case it is necessary to make the correction of pressure loss in tubes by compensating Pin versus normally set up parameters corrections are mentioned in table no 1 Table no 1 Corrections of Pin for individual MN Is MNJ I no Conection Pn 7 10 8 15 9 20 If we use the initial set up Pin MNJ Nozzle i eaten Used no on MNJ used ee pressure 150 kPa MNJI no 7 No Il 1 1 50 then if MNJ I no 7 used we need to increase by cca 10 to Pin z MNJ I Nozzle SE ton Used no on MNJ I used DENTS pressure 160 165 kPa MNJI no 7 No Il 1 1 50 If MNJI no 9 used we need to increase by cca 20 to cca 180 kPa If MNJ I less than 6 mm used the correction is not necessary 10 9 Special applications with the use of Expulsion effect mode 1 Lavage of lungs and application of Expulsion with the aim of cleaning the bronchial tee Page 30 2008 Kalas Medical In this case at the very beginning we apply Neutral mode Pin MNJ I Nozzle Ti Te 1 insufflation Used no on MNJ I used pressure 150 kPa Corresponding to ET or As per patien
23. llow the instructions Service and reparation of the appliance can be executed only by authorized persons Original rep lacement parts must be used while repairing If original replacement parts are not used the appliance can be damaged and its correct operation cannot be ensured Page 6 2008 Kalas Medical 3 Supplied eguipment 3 1 Basic eguipment Make sure the packing includes following equipment Orderi Mo Spare part ng of PHOTO Number i units Set of catheters PATe length cca 1 5m standard set 3pcs of PVF 046 2X cathethers set of MNJIs multi nozzle jet injector PVF 075 068 3x 8 torm MNJI 3 4 5 6 7 8 9 0 set set one way valve for ventilating with pure oxygen FiO2 0 95 PES set of extensions for ventilation with the mask size 5 8 10 reduction MNJI5 mask MNJI8 mask RESTE S MNJIO mask T set for expulsion mode PVF 035 1x external adapter 230V AC 12V DC a CB recharge cable for emergency vehicles PVK 047 1x back up power reserve 4 pcs NiMH type AA 1x NiMH battery charger for recharging back i fx i Up reserve user s manual 1x Page 7 2008 Kalas Medical soy i AA 3 2 Accessory equipment as perseparate order As per the extensions for rigid bronchoscope specifications of customer Set of adjusted catheters lenght 10m set of 2pcs of catheters from PVF 046 1 non magnetic material
24. luding the check of reserve power supply It is accompanied by 3x the sound of the acoustic alarm and flash of visual alarms After this the machine will start working This can be recognised by frequent exhaust from the cone LUER of inspiration insufflation catheter in frequency chosen on the switch FREQUENCY Time ratio of Ti Te is given by the switch TIME RATIO The expiration insufflation valve is automatically activated when the TIME RATIO is 2 1 and the Frequency is either 120 or 180 c min This can be recognised by frequent exhaust from the LUER cone of curved connector of expiration insufflation catheter At this time the operating personnel should check the amount of oxygen in the pressure bottle which cannot be less than 12 Mpa Control of the peak pressure pressure limit 1 Choose MNJI n 3 2 Connect the inspiration insufflation catheter with lavage valve through LUER cone into the hole of inspiration nozzle marked by the roman number Ill n D 4 to C 1 3 Connect the expiration insufflation catheter with the curved connector LUER to the hole of expiration nozzle of MNJI n D 5 to C 2 4 Connect the measuring catheter through RECORD cone into the hole of measuring catheter of MNJI n D 6 to C 3 5 Connect the ventilator to the source of oxygen compressed air 6 Set the insufflation pressure to cca 90 kPa position A 11 7 Set the frequency of ventilation to 40 c min position A 1 8 Switch on the ventilator part 5
25. meter position E 1 on the top cover of the machine either in the whole breathing cycle frequency of 20 40 c min or its peak pressure at the end of inspiration frequency of 120 180 c min g Supply pressure Flow of source of pressure Power supply Frequency Time ratio Ti Te Change of insufflation pressure Max ventilation power Pressure limit Pressure gauge of ventilation Dimensions W H L 400 kPa 100 kPa min 50 l min A 12V DC 100mA for mains feed external adapter 230V AC 12V DC SZ 12 2 100 B Reserve 4x NiMH battery size AA ensures not less than 8 working hours when fully charged C pneumatic optional 20 40 120 180 c min 5 optional 1 2 1 1 2 1 5 if 2 1 and 120 or 180 c min active the expiration jet is turned on 0 300 kPa min monitored by pressure gauge on front panel according to insufflation pressure For insufflation pressure 160 kPa d za l max 2 5 kPa nozzle n l max 2 5 kPa nozzle n Il max 4 5 kPa nozzle n Ill max 7 0 kPa expiration nozzle max 4 0 kPa fixed 5kPa 5 static max reaction time 120 ms A Whole process of breathing cycle Paw for frequencies 20 and 40 c min B The highest pressure at the end of inspiration PIP for frequency of 120 and 180 c min 235 x 100 x 250 mm Page 5 2008 Kalas Medical g Weight Noise Level Working conditions Classification soy E gt RE
26. nchanged Pin MNJ Nozzle Ti Te 1 insufflation Used no on MNJ I used pressure 150 kPa Corresponding to ET or As per patient s 1 1 50 TT cannula condition Impulsion mode must not be used so that aspiration doesn t get in bronchial tee distally Page 31 2008 Kalas Medical KALAS AA DIN RE Then we switch the ventilator into Expulsion mode Ti Te 2 1 and ventilate for 5 minutes Other parameters unchanged Pin MNJ I Nozzle Ti Te 1 insufflation Used no on MNJ I used pressure 150 kPa Corresponding to ET or As per patient S 2 1 66 TT cannula condition We interchange Neutral and Expulsion modes and repetitively apply lavage At the end of last Expulsion it is possible to inject cca 1 3 ml 0 25 0 5 Marcain into the lavage LUER valve with the purpose of mucous analgesia to improve tolerance of the ET cannula 10 10 Special applications in tacheo bronchial surgery The catheter HFJV ventilation can be performed however it requires the special training by an expert surgeon as well as anaesthesiologist at a specialized clinical site 10 11 Special applications in otolaryngologic surgery For the application of HFJV in otolaryngologic surgery the catheters from Acutronic normal and laser can be used The specification needs to be individualized and should follow consultations with a reference clinical site Page 32 2008 Kalas Medical
27. ned ventilation even in cases when the relaxation or other lowering of spontaneous breathing activity of patient is not recommended This is so called superposition of HH V on spontaneous breathing when spontaneous inspiration is discontinuely deepened by the ventilator and the work of ventilator in spontaneous expiration is discontinuely interrupted and slowed down For this type of ventilation it is recommended to choose the inspiration nozzle numbered or Il For this type of ventilation it is absolutely unacceptable to use a one way valve 8 2 Cleaning of airways Trac heo bronc hial Toilette The construction of the MNJI insufflation system including lavage valve and the principle of high frequency jet ventilation enables drawing out from tracheo bronchial areas without stopping the ventilation of the patient In this case the sucking catheter is plugged through the proximal end of MNJI into endo tracheal tube and further according to the needs at either permanent or interrupted drawing out It is recommended to set higher ventilation power or overplacing inspiration insufflation catheter with the LUER cone in MNJI to the hole of one number higher nozzle from to Il or from Il to Ill or to set higher insufflation pressure because the sucking catheter limits the ventilation power when having set higher ventilation frequencies especially 120 and 180 c min for longer period of time At the end of sucking drawing out you have to repla
28. o higher inspiration pressures over the limit of 5 kPa which starts acoustic and visual alarm red LED of front panel in the field ALARM position A 7 and temporary limitation of inspiration Using inspiration nozzle or Il the concentration of oxygen in the mixture of inspiration gases varies from 0 5 to 0 7 depending on topical resistance of patient s airways and amount of torn down surrounding air The higher the resistance of lungs the higher the concentration of oxygen in the inspiration mixture is To ventilate with pure oxygen put the one way valve on the proximal end of MNJI position D 5 and connect the inspiration insufflation catheter to the hole of inspiration nozzle marked one number higher The connection of one way valve will disable to tear down the air from the surrounding atmospheric space For this reason during the use of the one way valve it is highly important to keep checking the pressure gauge on the reducing valve of the pressure oxygen bottle cannot fall below 12 Mpa and to keep checking the functioning of ventilator Page 16 2008 Kalas Medical KALAS AA DIN RE For other setting of the ventilator see the Cookbook for OBI Paravent PATe Page 17 2008 Kalas Medical PANNE Y 8 Special modes of ventilation 8 1 Deepened ventilation Ventilation during spontaneous breathing The construction of the MNJI and the principle of high frequency jet ventilation enables an easy and effective way of deepe
29. rding to the medical norm pressure higher than 10 kPa is considered destructive to lung parenchyma and shall not be used Because the MNJI is constructed in such a way that it can generate the maximal static pressure Pgmax 10 kPa it follows from the physical principle that in open system of uncuffed ET cannula the pressure limit Pt of 10 kPa cannot be exceeded Pt tracheal pressure measured in dynamic mode on experimental animals was for Pin 300 kPa in the range 7 8 5 kPa that can be considered as safe from the point of view of barotrauma Furthermore Pin over 250 280 kPa is strongly discouraged The second degree of protection is total stop i e pressure guarding and limiting by the ventilator 10 2 Determination of MV minute ventilation and Vt tidal volume For the determination of MV minute ventilation and Vt tidal volume based on frequency and other parameters please use the attached Brychta s Ventilation Equation Ventilation equation xls Model of tidal volume Vt minute ventilation MV in HH V 1 In HFJV applications the un cuffed ET cannula normally used has a different i e smaller diameter from the diameter of the trachea this constitutes aspace for gas leakage during inspiration mainly as well as during expiration This space also creates a certain small resistance Ru for leaking gas In smaller patients children newborns the leakage is smaller considering the anatomy of trachea and
30. recognized by low ventilation power mainly in the connection of insufflation catheter to the nozzle SOLUTION wash out the particular inspiration nozzle of MNJI by physiological solution or by water from syringe or having changed the whole MNJI Insertion of any metal object metal rod syringe needle etc is NOT recomended 3 Choking of the measuring catheter or the measuring connector recognized through the unjustifiable disconnection or cancellation of ventilation and triggering of the alarm even when not connected to patient Page 20 2008 Kalas Medical SOLUTION clean the measuring catheter and or the measuring connector 4 With discharge of static electric current e g after the physical contact by operating personnel it is possible for the appliance after the discharge to signal some of the alarm states After the electrical interference has ended the alarms will stop and the appliance will function as normal Page 21 2008 Kalas Medical g PANNE Y hae 10 HA V COOKBOOK Quick guide of OBI Paravent parameters set up 10 1 Set up of basic parameters In principle the set up of basic flow and pressure parameters is defined by the construction of the MNJI Multi Nozzle J et Injec tor In the case where ET endo tracheal or TT tracheostomic cannula with adapted MNJI corresponding to patient s weight is used the contemplated pressure flow parameters are pre set by the technical construction sol
31. so be applied through laryngeal mask or through combi tubus or other aid providing for transitional clear airways In the case of well sealing hermetic aid this set up can be used Pin a MN Nozzle a insufflation Used no on MNJ I used Ti Te 11 pressure 150 170 kPa MNJI no 7 9 No l or Il 1 1 50 10 5 Less standard situations In cases of heavy obesity or serious lung injury it is suitable to start HFJV with this initial set up Page 28 2008 Kalas Medical KAAS AA Y a gt Pin E p MNJ Nozzle en Used no on MNJ I used EMO pressure 170 180 kPa SLON S SSE No l or lil 1 1 50 cannula Higher MV Minute Volume and Paw airway pressure will be achieved Only rarely in the cases of very collapsed hepatized lungs is it necessary to apply pressure levels around 200 kPa 10 6 Non standard situations 1 Life saving coniopunction In the case of life saving coniopunction e g Minitrach II Portex it is also possible to connect MNJI no 4 5 to the cannula in case of ventilation of adult patient To increase the ventilatory performance this set up can be used Pin i MNJ I Nozzle ULE Used no on MNJ I used Te re pressure 190 220 kPa MNJI no 4 5 No III 1 1 50 This kind of ventilation shall be use only for life saving cases then quickly apply trecheostomy 2 Patient covered by bulk matter mat
32. ssed air central distribution or oxygen bottle with reduction and quick coupler Page 13 O 2008 Kalas Medical KALAS Pla r ni Y kr M 5 6 Disassembling of ventilator After finishing ventilation and the ventilator is disconnected from the compressed oxygen 1 Disconnect inspiration insufflation catheter by quick coupler n D 1 from position A 8 2 Disconnect expiration insufflation catheter by quick coupler n D 2 from position A 10 3 Disconnect measuring catheter by quick coupler n D 1 from position A 9 4 Unscrew nuts to release and pull out insufflation valves position A 8 and A 10 for their sterilization 5 It is possible to leave external adapter permanently connected to the machine to conserve charged NiMH batteries that are kept in the ventilator this mode is indicated by a green LED lit on in the BATT field position A 6 See the part 5 3 6 Cleaning and stenlization of ventilator MNJI s one way valves and T pieces are packaged in an ISO certified sterile environment and remain sterile until opened These pieces cannot be re sterilised once open and are designed for single patient usage only as re sterilisation may alter the physical properties and thus have an effect on airflow through the device Possible modes of cleaning and sterilization of individual parts of ventilator insufflation valves steam sterilisation at the temperature of 120 C number of sterilization cycles is set by the durabili
33. t S 1 1 50 TI cannula condition For the instillation of lavage liquid through lavage LUER valve we use the Impulsion mode Ti Te 1 2 Ti 33 with other parameters unchanged Impulsion must not exceed 120 seconds Pin MNJ I Nozzle Ti Te 1 insufflation Used no on MNJ I used pressure 150 kPa Corresponding to ET or As per patient S 1 2 33 TI cannula condition Then we switch the ventilator into the Expulsion mode Ti Te 2 1 and we ventilate for 5 20 minutes Pin MNJ I Nozzle Ti Te 1 insufflation Used no on MNJ I used pressure 150 kPa Corresponding to ET or As per patient S 2 1 66 TT cannula condition At the end of Expulsion it is possible to inject cca 1 3 ml 0 25 0 5 Marcaine in the lavage LUER valve with the purpose of mucous analgesia to improve tolerance of the ET cannula 2 Lavage of lungs in the case of acid aspiration prevention of Mendelson s syndrome inhalation of chlorine hot and toxic gases In this case atthe beginning we apply Expulsion mode at least for 2 5 minutes Pin MNJ Nozzle Ti Te 1 insufflation Used no on MNJ I used pressure 150 kPa Corresponding to ET or As per patient S 2 1 66 TT cannula condition For the instillation of lavage liquid bicarbonate 2 4 corticoids through the lavage LUER valve we use Neutral mode Ti Te 1 1 Ti 50 with other parameters u
34. t up 22 10 1 Set up of basic ele o 0 i i 22 10 2 Determination of MV minute ventilation and Vt tidal volume 23 10 3 Overview for a quick orientation ss 28 10 4 Applications of HFJV providing for transitional clear airways 28 10 5 Less standard situafions ida 28 10 6 Non standard situations ns en unes denses 29 10 7 Non invasive HFJV M HFJV by MOSK sosa 30 10 8 HFJV in ao a a le GS io 30 10 9 Special applications with the use of Expulsion effect mode 30 10 10 Special applications in tracheo bronchial surgery ccoccccccccnccananananononononnns a2 10 11 Special applications in otolaryngologic surgery ss 92 Page 4 2008 Kalas Medical PANNE Y i 1 Charactenstics and technical specification of the appliance The OB1 Paravent PAT is an electronically controlled high frequency jet ventilator with changeable frequency of 20 40 120 180 c min switch FREQUENCY position A 1 optional time ratio inspiration time expiration time 1 2 1 1 and 2 1 switch TIME RATIO position A 2 and adjustable insufflation pressure 0 300 kPa switch INSUF PRESS position A 11 which is monitored postion A 4 The insufflation pressure varies with the change of insufflation nozzles of the multi nozzle jet injector MNJ I to ventilating pressure levels according to the chosen nozzle independently of the size of MNJI used Ventilated pressure is monitored on the mano
35. teries can be bought from the manufacturer or their authorised agent If the reserve is unplugged from the machine this is indicated with the ventilator plugged into the mains feed and turned on by red LED position A 5 in the field BATT Lower voltage of back up power reserve is indicated by red flashing LED position A 5 in the field BATT once in two seconds when the machine is plugged to mains feed and in case of running the ventilator from the reserve it is also indicated by the acoustic alarm 0 5 second long beep 1x in 10 seconds Insufficient voltage of back up power reserve is indicated by red flashing LED position A 5 in the field BATT twice in a second when the machine is plugged to mains feed and in case of running the ventilator from the reserve it is also indicated by an acoustic alarm 2x in a second together with visual alarm and by stopping the machine In this case the manual controls of inspiration and expiration time by the switch MANUAL can be used position A 3 5 4 Pneumatic manual mode If necessary it is possible to Use manual operation of inspiration and expiration time by switch MANUAL position A 3 By pushing this switch you define the time of the inspiration and while it s released the expiration is proceeding Repeat the manual ventilation as needed In pneumatic manual mode it is imperative the ventilator is connected to the oxygen or compressed air source Page 11 2008 Kalas Medical 5
36. ty of material the set of catheters ethylenoxid sterilisation number of sterilization cycles is set by the durability of material min 50 times after the usage of lavage valve it is necessary to disassemble and disinfect the lavage valve clean it with an antivirus active cleaner wash it in distilled water and dry it before proceeding the sterilisation set of extensions for ventilation with the face mask made for one time use only the set of extensions for rigid bronchoscope ethylenoxid sterilisation number of sterilization cycles is set by the durability of material min 50 times MNJI one way valve T set single patient use only attempts to sterilise may compromise the physical shape and therefore resulting flow of air through the MNAJI and is not safe cover of ventilator can be cleaned using any possible cleaner with the exception of abrasive ones In case of staining the cover with biological material e g blood etc disinfect it by use of an antivirus active cleaner Page 14 2008 Kalas Medical 7 Process of starting ventilation 7 1 Control of functions 1 Set up the ventilator as described in section 5 5 2 Set the required insufflation pressure by turning the insufflation pressure switch postion A 11 The actual value is monitored and shown on the manometer position A 4 3 Switch on the ventilator part 5 1 This activates the ventilator and checks its ability to work inc
37. ution of nozzle receiving channel MNJI ET or TT cannula so that the requested anticipated level of gas exchange in lungs can be achieved Basic Insufflation pressure is Pin 150 5 kPa Ventilation is performed with unsealed ET or TT cannula seal cuff on ET cannula is not inflated Basic Frequency of ventilation 120 c min Mean Pgmax maximal generator pressure for Pin 150 kPa connected to Nozzle I 2 0 kPa 20 Nozzle Il 3 5 kPa 20 Nozzle III 5 5 kPa 20 This overview is applicable to all sizes of MNJ I which provide comparable Ventilatory performance it is a static pressure when the outflow end of MNJI is closed Pgmax maximal generator pressure for maximal allowable Pin 300 kPa for all sizes of MNJI connected to Nozzle 4 0 kPa 20 Nozzle Il 7 1 kPa 20 Nozzle Ill 10 2 kPa 20 Typical course of pressure curve of MNJI no 8 connected in nozzle Il with Pin 150 kPa blue curve for comparison linear regression black line Page 22 2008 Kalas Medical Q in l min MGT 8 2 150kPa 250 00 200 00 150 00 Pin Qmax 100 00 Line rn Qmax 50 00 0 00 0 00 0 50 1 00 1 50 2 00 2 50 3 00 3 50 4 00 Pg max kPa Acco
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