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CARAT I-eng-291111-15.indd

1. 42 Ventilation 42 Ventilation Parameters the Standard Display 42 Settings in the PCV Mode nra a ee 42 Settings in the PSV MOJE Ser ras irri 43 Settings in the SIMV Mode n n a n 44 settings in the VOV IMOdG ankamen 45 Description of Ventilation Parameters 46 PAP 46 a ri 46 Volume aie 46 46 Frequency SIMV 46 Apnea Tite ces ttt teet e ae 47 Inspiration EE xoc ce eme gs 47 RAMO site eee Se SG Shab 48 InsBiratisnTriggen Pm 49 mager 50 Expiration 20 DU 50 Minimum volume NR 50 Additional Pressure iv ma fear 51 Alarm Parameters sse SU etn i eG ORs 52 Alarm Parameters on the Standard Display 52 Settings in the PCV PSV and SIMV 52 settings im the VOV Modes 52 4 Contents Alarm Parameters on the Display of Extended Parameters 53 Gommissi ning 54 Setting up the Ventilator HH 54 Using the Functional Bag Optional 54 Power Supply iin
2. 1 Here user is meant in the sense of Responsible Organization Compliance level x 6 kV contact 8 kV air 2 kV for power supply lines x 1 kV for input output 1 kV voltage outer conductor outer conductor 2 kV voltage outer conductor ground Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Manufacturer s Declaration on Electromagnetic Compatibility 91 Guidance manufacturer s declaration electromagnetic immunity Immunity test Voltage dips short interruptions and voltage variations on power supply input lines acc to IEC 61000 4 11 Power frequency 50 60 Hz magnetic field acc to IEC 61000 4 8 Conducted RF acc to IEC 61000 4 6 IEC 60601 Test level lt 596 gt 95 96 dip in U for 1 2 cycle 40 96 Ur 60 96 dip in for 5 cycles 70 30 96 dip in for 25 cycles lt 596 95 96 dip in for 5 sec 3 A m 10 Vettective value 150 kHz 80 MHz within the ISM bands 8 92 Manufacturer s Declaration on Electromagnetic Compatibility Compliance level gt 95 96 dip inder for 1 2 cycle 60 96 dip in U for 5 cycles 30 96 dip in
3. On device start the patient circuit may already be connected to the ven tilator but not to the patient yet Turn the CARAT ventilator on via the main switch on the rear of the sys tem It will then emit an acoustic signal tone The display of the ventilator indicates the serial number the software version the therapy counter and the operation hours The device performs an internal hardware test and checks the parameters for plausibility If the hardware test is completed successfully the device automatically displays the Standard screen If an error is deteted the appropriate error message is displayed The device will not return to the Standard screen until this error message is confirmed by pressing the MFK If an O2 measuring cell was connected before the ventilator is turned on this cell is calibrated automatically during system start If the ventilator is not connected to external power supply while being turned on an acoustic signal tone is emitted accompanied by the message Battery Operation in the text indication field This message has to be confirmed by press ing the Alarm key 56 Commissioning OXYGEN SUPPLY AWARNING Oxygen only supplied if prescribed physician exces sive oxygen supply may result in serious complications for the patient If you supply the patient with oxygen via the ventila tor a FiO2 measurement should be carried out Please be absolutely sure to observe the in
4. a 8 General SYMBOLS USED IN THIS USER S MANUAL Important information is denoted by symbols in this user s manual Be sure to follow these instructions in order to avoid accidents personal injury and material damage In addition the local accident prevention regulations and general safety regulations in force in the area of use must be observed This symbol denotes general safety instructions Follow these instruc tions to avoid accidents personal injury or material damage AWARNING This symbol denotes hazardous situations that may lead to serious injuries or death CAUTION This symbol denotes hazardous situations that may lead to moder ately severe injuries NOTICE This symbol denotes situations that may lead to material damage or damage to the device IMPORTANT This symbol denotes information tips and instructions for the effi cient error free use of the device General 9 SAFETY INFORMATION GENERAL SAFETY INSTRUCTIONS Settings on the ventilator may only and exclusively made by qualified trained medical personnel under the supervision of a physician The ventilator may only be operated by persons who have com pletely read and fully understood these User s Manual and have familiarized themselves with the system before putting it into operation Any non observance of these instructions may result in dangerous situa tions for the patient The ventilator may only be used unde
5. SIMV Mode Tidal volume lower than the min vol ume VCV Mode Volume smaller than the set volume since Max pressure has been reached Difference between expira tion and inspiration volumes greater than the set leakage Measured FiO higher than the set max oxygen Measured FiO2 ower than the set min oxygen 68 Alarms and Error Messages 15 sec or successive breaths 15 sec or successive breaths 3 successive breaths none 3 successive breaths 3 successive breaths Alarm Priority Cause DEEN Message Min Volume LOW Tidal volume lower than the set 3 successive breaths not reached min volume DEFINED ALARMS AND ERROR MESSAGES ERROR MESSAGES OF THE HARDWARE TEST ON DEVICE START Parameter Error Invalid parameters Invalid parameters and settings have checksum error been detected and are reset to the fac tory settings all ventilation and alarm parameters must be checked Error RTC General clock fail Date and time must be reset if the clock ure invalid time or is defective device service is required invalid date Sensor Error Sensor signal outside Ventilation not possible or possible of the valid range only to a limited degree device ser vice required Incorrect Invalid calibration Ventilation possible measured pres Calibration Data data checksum error sure and volume inaccurate device service required Error Int Battery Battery defective Ventilation possible only with external pow
6. that are adjustable in relation to the particular ventilation mode All of the adjustable alarms are preserved when CARAT is turned off and will again be active on device restart All of the alarms and error messages are indi cated visually acoustically and by means of text messages The acoustic and visual indications vary depending on the priority of the alarm e HIGH priority 10 fast pulses repeated every 5 sec red flashing at a rate of 2 Hz e MEDIUM priority 3 slow pulses repeated every 5 sec yellow flashing at a rate of 0 5 Hz e LOW priority 1 pulse yellow steady light If more than one alarms are initiated shortly one after the other or at the same time it is always the alarm with the highest priority that will be displayed The acoustic signal is turned down after the alarm conditions have been removed although the alarm remains displayed by an orange light and a text message until the confirmation by pressing the Alarm key The alarm tone can be silenced for 2 minutes by pressing the Alarm key During this period also possible subsequent alarms are silenced with respect to the alarm tone The alarm Empty battery is an exception and its alarm can in no situation be silenced The alarm LED keeps on displaying the alarm optically during the silenced alarm tone If the alarm cause has not been removed the acoustic alarm rings out again after two minutes The vol ume of the acoustic signal can be set in 10 steps on the
7. 0 5 hPa 1 0 hPa or Pressure lt 50 hPa PS 5 96 of value IMPORTANT If the apnea time is set to a value gt 15sec a corresponding mes sage has be confirmed If frequency is set to OFF the device works in PSV S mode and only reacts on spontaneous breathing of the patient 1 at frequency setting OFF apnea time becomes an alarm parameter 2 dependency does not apply for PSV S mode Parameters 43 SETTINGS IN THE SIMV MODE Adjustment range Settings steps IPAP 4 to 50hPa 0 5 hPa 1 0 hPa or 5 of value PS 4 to 50 hPa 0 5 hPa 1 0 hPa or 5 of value BEER O to 20hPa 0 5 hPa 1 0 hPa or PEEP IPAP PS 3 hPa 5 96 of value SIMV Frequency 4to 50bpm 1bpm 1bpm Inspiration Time 0 3 to 8 0 sec 0 1 sec 0 1 sec Ramp stage 1 to stage 5 1 stage 1 stage Inspiration Trigger stage 1 to stage 5 AUTO 1 stage 1 stage Trigger Lock OFF 0 5 to 4 0 s lt 80 96 of 0 15 0 15 max expiration time Expiration Trigger AUTO 10 to 90 10 1 44 Parameters SETTINGS IN THE VCV MODE Adjustment range Settings steps Volumen 0 05 to 21 0 011 0 03 or V lt 1 5 V sec x Insp time 20 of value PEEP O to 20 hPa 0 5 hPa 1 0 hPa or 5 of value Frequency 4 to 50 bpm 1 bom 1 bom Inspiration Time 0 3 to 8 0 sec 0 1 sec 0 1 sec E 1 0 3 to 1 4 0 0 1 0 1 Ramp stage 1 stage 4 1 stage 1 stage Inspiration Trigger OFF stage 1 to stage 5 1 stage 1 stage AUTO Trigger Lock OFF 0 5 to 4 0 s lt 80 96 0 15 0 15 of expi
8. 1 0 hPa or 5 96 of value Max Oxygen OFF 30 to 100 96 1 96 5 96 adjustable only with connected sen sor Min Oxygen OFF 18 to 90 96 1 5 adjustable only with Min Oxygen lt Max connected O2 sen Oxygen 10 96 sor Parameters 53 COMMISSIONING IMPORTANT Prior to operating the device for the first time and whenever the patient is exchanged functional check must be performed see section Functional Check Before commissioning the ventilation system ventilator tube humidi fier etc check all connections for leaks as well as the stability of the connected accessories SETTING UP THE VENTILATOR Place the ventilator on a plane and stable surface The ventilator can also be operated in any other position in which case the air inlet must be reliably prevented from getting blocked USING THE FUNCTIONAL BAG OPTIONAL ACCESSORY IMPORTANT When using the device in the functional bag the following advice should be noted for safe and error free operation Set the alarm sound to 100 volume Make sure that all necessary alarm messages can be read through the viewing window and that the bag s ventilation openings are not blocked The air supply for the device must be guaranteed at all times Use the bag in such a way that the device is protected from overheating dust and water All accessories connected such as tube filter supply lines etc must be arranged such that they cannot
9. 3 0 hPa Max Inspiration time 4 sec Leakage OFF Max Oxygen OFF Min Oxygen OFF Language ENG Specifications Performance Dimensions W x D x H Weight 305 x 250 x 165 mm 4 6kg Technical Data 87 Specifications and Performance Max stable pressure limit Min stable pressure limit Max working pressure Min working pressure Maximum flow Parameter Pressure Pressure bargraph Volume Flow Oxygen Frequency MV Display range 0 0 to 99 9hPa 0 0 to 60 0hPa 0 0 to 2 5hPa O to 100 O to 99 bpm 1 0 1 1 25 0 0 251 88 Technical Data 60 hPa OhPa 50hPa OhPa 250 l min Increments of the display 0 1 hPa 5hPa 0 01 1 1 bom 0 1 0 11 Measurement 0 0 to 100 hPa 0 0 to 100 hPa Calculated from flow measure ment to 200 l min O to 100 Calculated from period duration of inspiration expiration in 0 002 s Calculated from period duration of inspiration expiration in 0 002 s Calculated from flow measure ment Accuracy 1 0 hPa or 5 of value 1 0 hPa or 5 of value 0 03 or 20 of value 0 2 l min or 4 96 of value 5 96 1 bpm 0 2 0 03 or 20 of value Maximum Minute Volume PCV mode IPAP 50 PEEP R5 C50 45 l min R5 C20 33 l min R20 C20 26 l min R20 C50 30 l min VCV mode limited to 90 l min Lowest value at 1 m distance 64 dBA setting 10 96 Highest value at 1 m distance 79 dBA setting 100 9
10. Note 1 Uzis the a c mains voltage prior to application of the test level Note 2 At 80MHz and 800 MHz the higher frequency range is essential Note3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM frequency bands for industrial scientific and medical applications between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range from 80 MHz and 2 5 GHz are intended to reduce the probability that mobile portable communication facilities can cause interference when they are accidentally brought into the range of the patient For this reason the additional factor of 10 3 is applied in the calculation of the recommended safety clearances in these frequency ranges Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic side survey should be considered If the measured field strength outside the location in which the CARAT I ventilator is used exceeds the compliance level the CARAT I ventilator should
11. and the text message Battery Operation is displayed Confirm the message by pressing the MFK Charging of the internal battery is indicated by the LED Internal power supply and the see saw battery symbol OPERATION BY THE INTERNAL BATTERY IMPORTANT In order to prevent the internal battery from discharging the ventila tor should remain connected to external power supply in the standby Recharging of a completely discharged battery takes approx 4 hours If CARAT is turned on without any connection to external power supply or the device is disconnected from external power supply during running operation an acoustic signal is emitted and the text indication field dis plays the message Battery Operation Briefly press the Alarm key to turn Operation by External Power Supply and Battery 81 off the acoustical signal and to confirm the message Depending on the battery residual capacity the Internal power supply LED is lit as follows LED color Battery capacity green 80 to 100 yellow 30 to 79 red O to 29 AWARNING When the Int Battery discharged alarm is triggered the ventila tor must be connected to an alternative power supply without delay Battery test IMPORTANT In order to ensure the operating safety of the CARAT ventilator a battery test must be carried out at the prescribed intervals To check the functionality of the internal battery a battery test must be carri
12. be observed to verify normal operation If abnormal performance is observed additional measures my be necessary Such as relocating or using another location of the CARAT I ventilator d Over the frequency range of 150 kHz to 80 MHz the field intensity should be less than U V m Manufacturer s Declaration on Electromagnetic Compatibility 93 Recommended separation distances between portable mobile communication equipment the CARAT The CARAT ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the CARAT ventilator can help prevent electromagnetic interference by maintaining a minimum distance between por table and mobile RF communications equipment transmitters and the CARAT ventilator as recommended below according to the maximum output power of the communications equipment Rated maximum output power Separation distance according to frequency of transmitter W of transmitter m 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz 142 WP le 12 d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 27 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the
13. display of the advanced parameters The alarm tone can already be silenced before an alarm situation arises 66 Alarms and Error Messages by pressing the Alarm key e g before the tube system is shortly discon nected to carry out the suction of the patient After the alarm cause has been removed the alarm tone can also be reactivated within the two min utes by pressing the Alarm key once more The previous 15 alarms including the date of the alarm the alarm time the alarm cause and the measured values at the time of the alarm can be Seen on the service screen of the device Additionally the alarms can be read out via the PC software The alarm cause the settings of the device and the alarm time are stored Furthermore the pressure and flow curves are stored from one minute before to one minute after the occurrence of the alarm cause Optionally the alarms of middle and high priority can be transmitted to the remote alarm box Serial Number corLoooo0 Software Version 2 300LP1 Theraps Counter 12 4 Alarm Memora 3 1 5 09 05 2011 20 14 04 i g SAVING ALARMS Frequency too high i bess You can view the last 15 alarms directly in the service screen on the device This provides the following information Pressure Sensor Calibr Flow Sensor Calibr Cause of the alarm Test Tight i ma s e Time of the alarm The alarms can also be read out using CaratControl In addition the val ues measured at the time
14. electromagnetic environment specified below The user 1 of the CARAT I ventila tor should assure that it is used in such an environment Emissions test RF emissions acc to CISPR 16 1 2 RF emissions acc to CISPR 16 1 2 Harmonic emissons acc to IEC 61000 3 2 Voltage fluctuations flicker emissions acc to IEC 61000 3 3 Compliance Group 1 Class B Class A Complies Electromagnetic environment guidance The CARAT ventilator uses RF energy only for its internal func tion Therefore RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The CARAT ventilator is suitable in all establishments includ ing domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes Guidance and manufacturer s declaration electromagnetic immunity The CARAT I ventilator is intended for use in the electromagnetic environment specified below The user of the CARAT I ventila tor should assure that it is used in such an environment Immunity test Electrostatic discharge ESD acc to IEC 61000 4 2 Electrical fast transient Burst acc to IEC 61000 4 4 Surges acc to IEC 61000 4 5 IEC 60601 Test level x 6 kV contact x 8 kV air 2 kV for power supply lines x 1 kV for input output x 1 kV voltage outer conductor outer conductor 2 kV voltage outer conductor ground
15. for 25 cycles gt 95 96 dip in for 5 sec 3 A m 10V Electromagnetic environment guidance Mains power quality should be that of a typi cal commercial or hospital environment If the user of the CARAT I ventilator requires contin ued operation during power mains interruption itis recommended that the CARAT I ventilator is powered from an UPS or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Portable and mobile communications equip ment should be used no closer to any part of the CARAT I ventilator including cables than the recommended separation distance calcu lated from the equation applicable to the fre quency of the transmitter Recommended safety clearance dE Guidance and manufacturer s declaration electromagnetic immunity Radiated RF acc to IEC 61000 4 3 10 V m 10 V m d 2 1 2 J P for 80 MHz to 800 MHz 80 MHz 2 5 GHz d 2 3 JP for 800 MHz to 2 5 GHz with P as the rated maximum output power of the transmitter in watts W according to the transmitter s manufacturer and d as the rec ommended safety clearance in meters m b Field strengths from fixed RF transmitters as determined by an electromagnetic site sur vey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equip ment marked with the following symbol t9
16. lead to any impedance or malfunction of the device 54 Commissioning POWER SUPPLY To operate the CARAT with external power supply connect the supplied power supply unit to the DC socket on the rear of the ventilator and to the power cord Then connect the ventilator to a 100 250 V AC 20 96 10 96 50 60 Hz voltage source via the mains cable CONNECTING A SINGLE LINE PATIENT CIRCUIT IMPORTANT When a nasal or full face mask is used for noninvasive ventilation this mask must not contain any expiration opening 1 Connect the measuring tube to the connector measuring tube 3 on the device 2 Connect the control tube for the expiration valve to the connector con trol tube X on the device SMM 02 3 Connect the therapy tube of the single line patient circuit to the tube connector for inspiration 05 on the device FM 22 Figure 16 Connecting a Single Line Patient Circuit Commissioning 55 TURNING THE VENTILATOR ON IMPORTANT An acoustic signal must be generated when the device is switched on If this is not the case the device must not be used and should be checked by an authorized service technician If there is a big difference between the temperature at the place of use of the ventilator and the temperature at the place where the ventilator was positioned before then half an hour must elapse before the ventilator is put into operation in order to allow the temperature to compensate
17. set a minimum tidal volume intended to ensure the necessary volume during pressure controlled ven tilation 50 Parameters Peak flow 100 Expiration trigger threshold 25 Time sec Figure 14 Respiratory curve with peak flow and trigger threshold Peak flow 100 96 3 Time sec Figure 15 Respiratory curve with peak flow and automatic trigger ADDITIONAL PRESSURE To ensure the minimum volume it is possible to specify an additional pres sure which can be added to the IPAP or PS pressure if the minimum volume fails to be reached The value of the set additional pressure is a maximum value In order to calculate the actually required additional pressure the minimum volume is set in relation to the actual volume and the necessary inspiratory pressure is calculated from the current inspiratory pressure On the one hand the increase in pressure is limited by the set additional pressure as a maximum value on the other hand it is limited by a maxi mum additional pressure of 2 hPa as compared with the inspiratory pres sure of the previous breath Parameters 51 ALARM PARAMETERS ALARM PARAMETERS ON THE STANDARD DISPLAY The alarm parameters listed below are displayed on the left hand side of the Standard display and can be changed within the appropriate adjust ment ranges The particular display ofthe changeable parameters depends on the ventilation mode selected SETTING
18. used as well as a Siemens test lung are required for the functional check Connect the patient circuit and the test lung to the ventilator Connect the supplied power supply unit to the DC socket on the rear of the device and to the mains cable Then connect the device to a voltage source via the mains cable Turn on the ventilator by means of the main switch on its rear and start ventilation by pressing the control key Power failure alarm Disconnect the ventilator from external power supply An acoustical signal will be emitted and the text field will display the message Battery Operation Leakage alarm Disconnect the test lung from the system After 15 seconds an acoustic signal will be emitted and the text indication field will display the message Leakage Alarm Frequency too high Operate the ventilator in the PSV mode Set the max frequency alarm parameter higher than the frequency currently measured Simulate spon taneous breathing using the test lung until the acoustic alarm is initiated and the text indication field displays the message Frequency too high Alarm Pressure too low Operate the ventilator in the VCV mode Set the value of the min pres sure alarm parameter higher than the maximum pressure reached After 15 seconds an acoustic signal will be emitted and the text indication field will display the message Pressure too low 78 Functional Check Alarm Volume too low Operate the ventilat
19. 6 Resistances Inspiratory resistance of the device at 3 6hPa with 60 l min the patient connection port Total system resistance lt 6hPa with 60 l min Operating Conditions Operating temperature 5 C to 50 C Relative air humidity 10 95 Operating conditions 600 hPa 1000 hPa Storage temperature 10 C to 50 Storage conditions store in a dry vibration free and vertical position store device and accessories in their original packing Technical Requirements for Accessories CE mark required Oxygen Inlet Type of connection port Quick coupling Pressure lt 1000 hPa Technical Data 89 Technical Requirements for Accessories CE mark required Flow lt 15 Bacterial Filter Connections 22 15mm cone acc to EN1281 1 Resistance lt 2 8 hPa with 60 l min Compressible volume 66 ml Internal volume 200 ml The system complies with the following standards and guidelines Directive 93 42 ECC DIN EN 60601 1 DIN EN 60601 1 2 DIN EN 60601 1 4 DIN EN 60601 1 8 DIN EN ISO 14971 DIN EN ISO 10651 6 DIN EN 1041 DIN EN 980 DIN EN 13328 2 ISO DIS 15001 ANSI F1246 91 CE marking as per EC directive 93 42 EEC The manufacturer reserves the right to make technical changes without notice 90 Technical Data MANUFACTURER S DECLARATION ON ELECTROMAGNETIC COMPATIBILITY Guidance and manufacturer s declaration electromagnetic emissions The CARAT I ventilator is intended for use in the
20. AUTION The CARAT ventilator must not be used as a life support device 16 Safety Information CONTRAINDICATIONS The following conditions may be a contraindication for non invasive ven tilation Severe cardiac arrhythmia Severe hypotension Severe epistaxis Pneumothorax or pneumomediastinum Pneumoencephalus Cranial trauma Status after cranial or brain surgery Acute inflammation of the paranasal sinuses middle ear infection or a perforated ear drum e Aspiration hazard In individual cases the attending physician must decide on the therapy SIDE EFFECTS The following undesired side effects may occur in connection with artifi cial respiration Invasive ventilation e Complications due to tube tracheal cannula Mask ventilation Pressure points and skin defects in the face Eye irritation due to leaks Gastric inflation Aspiration Sinusitis Nose bleeds General complications of mechanical ventilation e Pulmonary barotrauma volutrauma caused by ventilation e Ventilator associated pneumonia e Effects on the cardio vascular system Safety Information 17 DESCRIPTION OF THE DEVICE FRONT VIEW Handle A LED Alarm LED External power supply b Tube connector for inspiration LED Internal i power supply b ON OFF key Connector 2 control tube 4 Connector Multi Functional Key measuring tube MFK esc mode key Modus LED s Connector external Alarm
21. Gee tee Qe o Qe s 84 Batteries ito edad a e a s a a s a d i 84 Oxygen SENSOr ra suse uu aa ae 84 ACCESSOS Ku T 85 Scop oft AEV n SU NEN eR FETU TU NEN VeRO NUTUS 85 Optional AI 86 Technical ide 87 Manufacturer s Declaration on Electromagnetic Compatibility 91 IET TIT E 95 6 Contents SCOPE OF DELIVERY Adapter for oxygen connection straight e Adapter for P A power supply ud 9 33 GEO mW cassette User s Manual and Short Manual Ventilator Mains cable Expiration valve Connector x Patient Power supply EN 5 2 Exhalation Single line patient circuit Connector CARAT am fine filter Scope of Delivery 7 GENERAL INFORMATIONEN ON USER S MANUAL Read this user s manual through carefully before using the ventilator for the first time Follow the safety and cleaning instructions in particular Keep the manual in a safe place close to the device so that you can refer to it immediately if necessary SYMBOLS ON THE RATING PLATE Observe the warning and safety instructions in the user s manual BF application part Protection class II protective insulation gt 23 CE conformity declaration Manufacturer contact the relevant customer services department to find out X Do not dispose of the device in the household waste Please how to dispose of the device properly
22. PARAMETERS To select the appropriate parameter turn the MFK irrespective of whether itis a ventilation or an alarm parameter The parameter currently selected is highlighted by a black bar for 3 seconds Confirm your selection of this parameter by pressing the MFK Thereafter both the parameter and its value are highlighted by a black bar To change the parameter value turn the MFK If the changed parameter value is associated with one or more dependent parameters which are also changing then the values of these parameters are highlighted with a black bar as well To confirm the changed value or the several changed parameter values once again press the MFK After having been confirmed changed values are applied at once IMPORTANT If a changed parameter value is not confirmed by turning the MFK the parameter selected will be exited automatically after 30 seconds the changed value will not be applied Operation 63 CHANGING DISPLAYS The display can only be changed if none of the parameters is selected If necessary press the esc mode key It can be moved among the displays by pressing and holding the MFK gt 1 5 sec in the following order e Standard display e Display of Extended Parameters e Service display e Display Real Time Monitoring e Standard display IMPORTANT If there is not actuated any control element in the display of Extended Parameters or Service display for 30 seconds the system automati ca
23. Quality makes the Difference m m m m User s Manual Ventilator as of device software 2 300 SERIAL NUMBER Every HOFFRICHTER GmbH device is supplied with a serial number for traceability purposes Please enter your device s serial number here You will find the serial num ber on the rating plate on the back of the device Seralnumber aaee e Please always quote the serial number for all queries and complaints CONFORMITY C The ventilator complies with the requirements of Directive 93 42 2 Info CONTENTS Scope of Delivery mea eses 7 LENET l E 8 Informationen on User s 1 e 8 Symbols on the Rating plate sssssses e 8 Symbols used in this User s 9 Safety Information eeeeeeeeeeeeeee esses eene nennen 10 General Safety Instructions sssssssee 10 Installation Requirements and 13 Instructions Before 14 SAIS De 15 IndendediUsen 23 2 Ra esse NG NE BADEN BASEN ta BADEN these 16 COMTAINGICATIONS an ne 17 Side Efects asien tt t et ig eae ts 17 Description of the Device 18 Front VIGW s ioi e te etur 18 Bacle
24. S IN THE PCV PSV AND SIMV MODES Alarm parameter Adjustment range Settings steps Max Volume OFF 0 20 to 2 501 0 01 I 0 03 I or 20 of value Min Volume OFF 0 01 to 2 001 0 011 0 03 I or Min Volume lt Max 20 of value Volume 0 11 Max Frequency OFF 10 to 120 bpm 1bpm 1 bom PCV SIMV Max Frequency gt Frequency 5 bpm SETTINGS IN THE VCV MODE Alarm parameter Adjustment range Settings steps Max Pressure 11 to 50 hPa Max Pres 0 5hPa 1 0 hPa or sure gt PEEP 3 hPa 5 of value Min Pressure 2 to 40hPa 0 5hPa 1 0 hPa or Min Pressure gt PEEP 5 of value 2hPa Min Pressure lt Max Pressure Max Frequency OFF 10 to 120 bpm 1bpm 1bpm Max Frequency gt Frequency 5 bpm IMPORTANT The Max Pressure setting limits the upward pressure and influences the Volume setting see page 45 52 Parameters ALARM PARAMETERS ON THE DISPLAY OF EXTENDED PARAMETERS The alarm parameters listed below are displayed in the left lower area of the display of Extended Parameters and can be changed within the appro priate adjustment ranges These parameters are displayed independently of the ventilation mode selected gt see section Display of Extended Parameters Alarm parameter Adjustment range Settings steps Max Insp Time 1 to 10 sec 1 sec 1 sec only applies in the PSV mode and dur ing spontaneous respiration in the SIMV mode Pressure Difference 1 to 10hPa 0 5 hPa
25. VI8W ei 19 Display S unse He Bea 20 Display AVOUT ea ee Rees en 20 21 Actual Valu amp sx ssi cette deeds 21 SymboltEleld s siut tte o E ote 22 Remaining Battery Capacity 23 Te xt Indicatior Elelds iiit edt ea 23 Standard Display tus 24 Display of Extended 25 TII iii E AR ROM ORR b dieti 25 Date dae Eid Mia 25 Brightness Display s tte etd etd etu bs 25 Display SGreetianc iati il 26 Alarm Volume hi eh tete 27 Bie m 27 27 Extended Alarm 28 Standard Values in Display Extended Alarms 28 Contents 3 Service DIsplay Rs na mre t RT o RR eos 29 Display Real Time e 29 Technology of the Device 32 Eaedem 32 Furictional Description neigen vente ttt vota tor d e Re 36 Ventilation 38 PONV Moderne ie eee ee ee i ie i 38 Mode cete ee n ee 39 SIMV MOd6 ttc MEM ss Hl 40 41
26. ace of the oxygen sensor may be wiped off with a damp cloth Before being reconnected the oxygen sensor must be completely dry HUMIDIFIER Clean and disinfect any reusable humidifiers according to the manufac turer s instructions BACTERIAL FILTER Exchange the bacterial filter at the intervals specified by the manufacturer To exclude any biological contamination bacterial filters should always be installed between the ventilator and the patient circuit especially in case of clinical use 74 Cleaning and Disinfection PREPARING THE DEVICE WHEN CHANGING PATIENT Before using the ventilator on a different patient clean and disinfect it to such an extent that it is free from any human pathogens Please ensure that all tools used such as measuring instruments and test lung are free from human pathogens If MRSA contamination is suspected the device must packaged with the appropriate labeling and disinfected accordingly IMPORTANT If the accessories e g tube system mask filter humidifier etc are intended for repeated use the manufacturer s provisions must be followed The preparation of the device must be recorded PREPARATION PROCEDURE 1 MANUAL PREPARATION IMPORTANT The manual procedure must not be used for the preparation of MRSA contaminated devices The hygienic preparation during a patient change may only be carried out by companies with a QM system and appropriately qualif
27. all into water Do not try to open the device Maintenance and repairs may only be performed by personnel autho rized by HOFFRICHTER GmbH Safety Information 15 INDENDED USE AWARNING The use of the device contrary to its intended use can lead to a haz ard to the health of the patient CARAT is intended for ventilation of patients which are not completely dependent on mechanical ventilation The device is suitable for ventila tion of adults as well as of children with a tidal volume of 50 ml and higher CARAT has been designed specifically for use in home care but is also applicable for use in hospitals Ventilation is either pressure controlled or volume controlled and is ensured by setting one of the ventilation modes listed below e PCV Pressure Controlled Ventilation Pressure controlled or pressure controlled assisted ventilation e PSV Pressure Supported Ventilation e SIMV Synchronous Intermittent Mandatory Ventilation e VCV Volume Controlled Ventilation Volume controlled or volume controlled assisted ventilation Both invasive ventilation e g via tracheostoma and non invasive ventila tion via a ventilation mask are possible CARAT provides the technical features required for operation with a single line patient circuit The sys tem can be connected to a low pressure gas source for ventilation with an increased oxygen concentration In addition it is also possible to com bine CARAT with a humidifier AC
28. d by the device Spontaneous breathing on the patient s part is not possible To ensure exclusively controlled ventilation the inspiration trigger must be set to OFF The ventilatory period is based on the set frequency and requires a defined l E ratio The inspiratory pressure IPAP as well as the end expiratory pres sure PEEP defines the range of pressure for ventilating the patient The rise in pressure can be selected by setting a ramp defining the course of the flow curve The inspiration volume is automatically adjusted to the lung s condition compliance and resistance To ensure a minimum volume it is possible to specify a value and to optionally increase the pressure IPAP pressure addition to reach this minimum volume Pressure controlled assisted ventilation In its ventilation parameters the pressure controlled assisted ventilation is equal to the exclusively controlled ventilation By setting an inspiration trigger however the patient can stop expiration by inspiration efforts once he reaches the trigger threshold and initiate the next inspiration phase As in the case with exclusively controlled ventilation these additional respiratory strokes are only controlled by the device The inspiration time is defined The patient can only shorten the expiration time by his own breathing efforts thus increasing the set frequency rate In the PCV mode the alarm parameters that can be set are the maxi mum and minimum vol
29. d delivers a maximum pressure of 50 hPa with a flow of 250 I min On its air inlet side the blower is provided with an air filter cassette with a coarse filter and a fine filter micro filter ultra filter Power management The power management permits selection of the operating voltage DC or battery as well as on and off monitoring The value of the motor current depends on the set pressure and flow The charging current for the internal battery is limited to a battery charging current of 1 0A The power man agement is also intended for displaying the current operating state i e operation by battery or external power supply In addition it determines the capacity and the charging state of the internal battery The data of the battery are transferred to the processor for display purposes Power supply Power is supplied either via an AC DC switched mode power supply unit PCM120 PS24 or SNPA129 M or by the internal battery The switched mode power supply unit has a wide range input of 100 250 VAC 20 10 96 at 50 60 Hz The output voltage is 24V 5A The internal battery is a lithium ion battery with a nominal voltage of 28 8 V and a capacity of 2 25 Ah Also the external AAKUPACK uni BASE can be used as power supply please ask your local after sales service 1 expected to be available from February 2012 Technology of the Device 33 Pneumatic block The pneumatic block is the connection assembly for the single li
30. d for disinfecting the external surfaces of the ventilator Disinfectants which are recognized according to the RKI Guideline can also be used Before being put into operation the ventilator should be completely dry AIR FILTER IMPORTANT Never operate the ventilator without air filter Only and exclusively use original HOFFRICHTER filters Clean the coarse filter once a week To do this remove the filter cassette and take the coarse filter out of the cassette To continue operation of the ventilator insert a spare coarse filter or use a complete spare filter cassette Wash out the coarse filter using mild soap water Then thoroughly rinse with clear water Before being re inserted the coarse filter must be completely dry The white fine filter cannot be cleaned It should be visually checked once a week and must be exchanged once a month or if it is very dirty even more often To exchange the fine filter remove the filter cassette and first take out the coarse filter Then you can remove and exchange the fine filter Cleaning and Disinfection 73 PATIENT CIRCUIT AND MASK Clean and disinfect reusable patient circuits and masks according to the manufacturer s instructions If worn or damaged strongly the patient circuit or the mask must be replaced Dispose of any patient circuits that are not suitable for re use OXYGEN SENSOR Do not place the optional oxygen sensor in cleaning solution nor sterilize it If necessary the surf
31. displaying and changing the most important ventilation and alarm parameters which are always based on the ventilation mode currently selected gt see section Ventilation Modes and section Alarm Parameters 20 r 0 hPa IPAP and PEEP Pressure bargraph FEEF 5 r 0 hPa Frequency Actual values Insriration Time 1 0 3 Ramer r1 Insriration Trigger 3 Ventilation parameters Trig8Jer Lock Fes Min Volume 0 50 Additional Pressure E F Ones 2 00 Volume Symbol field Remaining battery capacity Min Volume Text indication field OFF ees mm Freduenca Figure 3 Standard display in the PCV Alarm parameters made 24 Description of the Device Figure 4 Display of Extended Parameters for all respiration modes ifthe Oo sensor is connected DISPLAY OF EXTENDED PARAMETERS On the display of Extended Parameters additional presetting can be made for the ventilator This display also displays the alarm limits which are inde pendent of the ventilation mode and can be changed Time 20 15 pte 09 08 2011 Brightness Disrlau bisrlas Screen Alarm Volume Language bisrlas hE Hax Inzr Time Pressure Difference 3 0 hFa Ox49en x Min Cxuden 18 x 03 05 2011 20 15 TIME Use this menu item to update the time DATE Use this menu item to set the date BRIGHTNESS DISPLAY The display brig
32. e a new inspiration both spontaneously and under ventilator control PEEP can be set in all ventilation modes FREQUENCY SIMV FREQUENCY When a frequency is set in the controlled ventilation modes PCV VCV then a defined frequency is specified by a machine In the PSV mode and in the assisted PCV or VCV mode the set frequency is defined as the mini mum frequency which can be increased by spontaneous breaths of the patient In the SIMV mode the SIMV frequency is defined as the frequency used to supply the ventilator strokes to the patient at the IPAP specified and during the inspiration time specified Thus the SIMV frequency ensures the patient s minimum frequency 46 Parameters In between the ventilator strokes the patient can increase his her frequency by means of spontaneous inspiration APNEA TIME In the PSV mode an apnea time can be set if it is intended to permit respi ratory pauses between the patient s spontaneous breathing efforts The apnea time serves to set the delay time which after having elapsed will ini tiate ventilator strokes in the event of respiratory pauses If the apnea time is set to AUTO the ventilator strokes are initiated without delay accord ing to the set frequency When the frequency is set to OFF apnea time becomes an alarm parameter INSPIRATION TIME The inspiration time or I E ratio can be set in the PCV and VCV modes The Display of Extended Parameters provides the op
33. e pressure unit can be converted from hPa to cm H20 or mbar by using the PC software SETTINGS IN THE PCV MODE Adjustment range Settings steps IPAP 4 to 50hPa 0 5 hPa 1 0 hPa or 5 96 of value BEER O to 20hPa 0 5 hPa 1 0 hPa or PEEP lt IPAP 3 hPa 5 96 of value Frequency 4 to 50 bpm 1bpm 1 bom Inspiration Time 0 3 to 8 0 sec 0 1 sec 0 1 sec IHE 1 0 3 to 1 4 0 0 1 0 1 Ramp stage 1 to stage 5 1 stage 1 stage Inspiration Trigger OFF stage 1 to stage 5 1 stage 1 stage AUTO Trigger Lock OFF 0 5 to 4 0 s lt 80 96 0 15 0 18 of expiration time Minimum Volume OFF 0 05 to 21 0 011 0 03 or if IPAP gt 47 hPa then 20 96 of always OFF value Additional Pressure to 10 hPa Additional 0 5 hPa 1 0 hPa or Pressure lt 50 hPa IPAP 5 96 of value 1 only available for pressure controlled assisted ventilation 42 Parameters SETTINGS IN THE PSV MODE Adjustment range Settings steps 4 to 50hPa 0 5 hPa 1 0 hPa or 5 96 of value BEER O to 20hPa 0 5 hPa 1 0 hPa or PEEP lt PS 3 hPa 5 96 of value Frequency 4 to 50bpm OFF 1 bpm 1 bpm Apnea Time 3 to 60 sec OFF 1 sec 1 sec Ramp stage 1 to stage 5 1 stage 1 stage Inspiration Trigger stage 1 to stage 5 AUTO 1 stage 1 stage Trigger Lock OFF 0 5 to 4 05 lt 80 96 0 15 0 15 of expiration time Minimum Volume OFF 0 05 to 2 0 01 0 08 or if PS gt 47 hPa then 20 of always OFF value Additional Pressure to 10 hPa Additional
34. ected whether the ventilation parame ter to be set and displayed in the PCV and VCV modes is the inspiration time in seconds or the I E ratio LANGUAGE The device has one of three available language packets Language packet 1 contains the languages German DEU English ENG French FRA and Italian ITA Language packet 2 contains the languages German DEU English ENG Polish PLK and Turkish TUR Language packet 3 contains the languages German DEU English ENG and Spanish SPA Description ofthe Device 27 EXTENDED ALARM PARAMETERS The following alarm parameters can be set in the display of Extended Parameters Alarm parameter Adjustment range Settings steps Max Insp Time 1 10sec 1 05 1 05 Pressure Difference 1 10hPa 0 5 hPa 1 0 hPa or 5 96 of value Max Oxygen OFF 30 100 96 1 096 5 96 Min Oxygen OFF 18 90 96 1 0 96 5 96 1 not applicable to PCV and VCV modes adjustable only with connected O gt sensor STANDARD VALUES IN DISPLAY EXTENDED ALARMS Brightness Display 100 96 Display Screen STD Alarm Volume 50 96 Display Leakage OFF Max Insp Time 4 sec Pressure Difference 3 0 hPa Min Oxygen OFF Max Oxygen OFF 28 Description of the Device Figure 8 Service screen SERVICE DISPLAY The service display contains information on the serial number and the soft ware version of the device In addition the number of therapy hours operat ing hours and respiration hours are
35. ed out monthly To this end operate the device with continuous ven tilation for one hour without a mains power supply The capacity of the battery must then still be at least 10 96 i e the Int Battery low alarm must not yet have been triggered If the battery fails the test it must be changed by an authorized service technician 82 Operation by External Power Supply and Battery Figure 20 AKKUPACK uni BASE right AKKUPACK uni PLUS left OPERATION BY THE EXTERNAL BATTERY NOTICE Only the HOFFRICHTER AKKUPACK uni BASE may be used for the external power supply Before initial commissioning you must read the User s Manual ofthe AKKUPACK uni BASE The AKKUPACK uni BASE enables the device to be operated indepen dently of the mains power supply The battery pack is optionally available as an accessory To supply the battery pack with power use the power cable and the power supply unit of the ventilator At full capacity and factory settings the AKKUPACK uni BASE enables CARAT I to operate for up to 8 hours Using AKKUPACK uni BASE together with AKKUPACK uni PLUS doubles operation time to up to 16 hours For further information on connecting and handling the device please refer to the AKKUPACK uni BASE User s Manual 1 expected to be available from February 2012 Operation by External Power Supply and Battery 83 DISPOSAL DEVICE The ventilator must not be disposed of with the household waste Please co
36. ement values of the system are read in and evalu ated Target values are calculated on the basis of the set parameters and or ventilation modes Then the target values are transferred to the motor control via a digital to analogue converter DAC The proximal pressure and the valve control pressure as well as the inspi ration flow are measured This data is taken to calculate the inspiration volume and the frequency In addition the actual patient flow is determined by calculating the leakage flow If an oxygen sensor is installed the oxygen content of the inspira tion air FiO2 is measured Pressure or flow sensors detect the patient s spontaneous breathing and initiate the triggers mask leakages are compensated The trigger sensitivities can be adjusted A pressure trigger is used for inspiration The expiration trigger is a flow trigger and is set in percent of the maximum inspiration flow 36 Technology of the Device Alarms Alarm conditions are continuously checked If occurring an alarm is indi cated by an acoustic and a visual signal As soon as the alarm condition is eliminated the acoustical signal is turned off the visual alarm is still shown on the display until it is acknowledged In doing so the cause of the alarm the settings of the device the time of the alarm and the current measured values at the time of the alarm are stored The display of the device allows reading up to 15 alarms The alarms are saved in the sy
37. ent set oxygen sensor T adapter housing 0000 4944 gas duct oxygen sensor connection cable Oxygen sensor 2300 0018 T Adapter 2300 0019 Housing gas duct 2300 0020 Oxygen sensor connection cable 0001 4116 Oxygen connection adapter angled 4100 0087 Control tube connection adapter 4100 0088 Functional bag 0000 4879 AKKUPACK uni BASE incl accessories 0001 1100 AKKUPACK uni PLUS incl accessories 0001 1099 Remote Alarm Box 0000 4035 Silicone NIPPV full face mask size S 0000 3461 Silicone NIPPV full face mask size M 0000 3442 Silicone NIPPV full face mask size L 0000 3438 Silicone NIPPV full face mask size XL 0000 3462 Silicone NIPPV PSU full face mask size L autoclavable 0000 3439 For ordering of accessories please contact a HOFFRICHTER service partner 1 expected to be available from February 2012 86 Accessories TECHNICAL DATA Voltage Mains power 100 250 VAC 20 96 10 96 50 60 Hz DC power 24VDC 5A Internal battery power Lithium ion battery 28 8 V nominal voltage 2 25 Ah 3 W External battery power AKKUPACK uni BASE AKKUPACK uni BASE plus AKKUPACK uni PLUS Maximum power consumption 60 W 24 V nominal voltage 8 8 Ah 24 V nominal voltage 17 6 Ah Electric safety class Factory settings Class 11 type BF Mode POV Display E Display Pressure Unit hPa Display Screen STD Safety lock software manually Safety lock OFF Alarm Volume 50 96 Pressure Difference
38. er supply device service required Processor Error Safety function ofthe Ventilation possible device service controller not active required Alarms and Error Messages 69 DEFINED POWER SUPPLY ALARMS Alarm Priority Cause Remedy Message Int Battery HIGH Battery The battery needs recharging discharged discharged 1 minute until the power supply fails completely ventilation pos sible only with external power supply Error Int Battery MEDIUM Battery defective Device service required Int Battery low MEDIUM Battery capacity The battery needs recharging lt 10 MISCELLANEOUS DEFINED ALARMS Alarm Priority Cause Remedy Message Leakage HIGH Inspiration flow too Check the system for leaks in high for an extended the tubing or the mask period gt 15 sec Check Mea HIGH Pressure difference Check the connection of the suring Tube from 2nd pressure measuring tube to the connec sensor greater than tion port 3 hPa gt 15 sec Error Pres HIGH Offset outside of Device service required sure Sensor range calibration error pressure con Stant over extended period 15 sec Stenosis HIGH Measured tidal vol Check the patient curcuit and ume less than 30 ml the tube for occlusion Constant flow over a period of 15 sec High HIGH Pressure higher than Device service required Pressure 60 hPa device error Emergency venti lation 70 Alarms and Error Messages Alarm Priority Cause Remedy Message conti
39. etting AUTO has been selected the device calculates the proper time of triggering from a combination of volume and flow trigger on its own and starts the inspiration Parameters 49 TRIGGER LOCK The trigger lock is especially applicable in the ventilation of patients with obstructive pulmonary diseases e g COPD In these patients fluctua tions often occur during the expiration phase This leads to the device registering spontaneous respiration and the inspiration trigger is released too soon To prevent false triggering it is possible to define a period of time trigger lock for the expiration phase in which the inspiration trigger is suppressed EXPIRATION TRIGGER The expiration trigger is a flow trigger The peak flow of the inspiration is measured with each breath The setting of the expiration trigger defines the percentage of the peak flow at which the ventilator switches over to expiration When AUTO is set the retrigger threshold is determined dynamically depending from the duration of the inspiration For this purpose the maximum flow during the inspiration is also analysed The threshold increases pro portionately to the inspiration duration and corresponds after 3 sec to 100 96 of the maximum inspiration flow i e 33 after 1 sec 66 96 after 2 sec etc Should the current flow fall below this threshold a switching to expiration takes place MINIMUM VOLUME In the PCV and PSV modes it is possible to
40. g of the safety lock has been activated and must still be confirmed by pressing the MFK If the safety look is active all set tings on the Standard display and the display of Extended Parameters are disabled The Service display and the display Real Time Monitoring can not be chosen Spontaneous inspiration g Initiation of the trigger This symbol appears if a spontaneous inspiration was detected The sym bol is displayed for the entire inspiration time and disappears as soon as expiration starts Trigger Lock Trigger suppression The symbol shows that the trigger lock is activated 22 Description of the Device 09 08 2011 20 00 REMAINING BATTERY The battery symbol represents and indicates in percent the remaining capacity of the internal battery This value is only for reference purposes To obtain as accurate a value as possible ventilation should be activated for approx 1 minute to permit calculation of the battery capacity If a DC voltage source is connected to the ventilator the battery is charged automatically indicated by a see saw battery symbol TEXT INDICATION FIELD The text indication field is provided for displaying alarms messages and device errors in plain text This display always shows the event having the highest priority If there are no events the display shows date and time Description of the Device 23 STANDARD DISPLAY The Standard display is intended for
41. hanged To change the scaling select the symbol by turning the MFK and confirm the selection by pressing the MFK The maximum value and the unit will be marked The scaling can be changed by turning the MFK and the picture will be built on newly If the scaling was chosen to small the curves will be displayed just to the boundary value Se Resolution Pressure Flow Volume Time 0 60hPa 0 30hPa 200 200 l min 100 100 l min 50 50 l min 0 2 5 0 1 25 0 0 625 0 12 5 sec 0 25 sec 0 50 sec 1 0 hPa 0 5hPa 5 0 l min 2 5 l min 1 25 l min 0 051 0 0251 0 01251 0 05 sec 0 1 sec 0 2 sec Description of the Device 31 TECHNOLOGY OF THE DEVICE MAIN ASSEMBLIES The CARAT ventilator consists of the following assemblies e Blower e Pneumatic block e Power supply internal battery switched mode power supply unit e Power management e Controller control and operating unit e External interfaces Switched mode Oxygen power supply input 100 250 VAC 20 96 10 96 Ventilator Y Internal gt Power management battery k Controller Control and operating unit Display Sensors RS232 Valves Blower Remote alarm Single line patient circuit bise PO with exhalation valve input Nurse call Figure 11 Block diagram of the overall system 32 Technology of the Device Blower The blower is installed in a sound absorbing box an
42. he PC or vice versa Stop Ventilation The main switch has been activated during the ongo YES NO ing respiration acoustic signal is active in order to ter minate the respiration the query must be confirmed with YES via the MFK Attention The query if the respiration should be cancelled was Main Switch OFF confirmed with NO The message stays until the main switch is turned on again Press and hold key for The ON OFF key has only been briefly pressed dur 3 sec to turn ventilation ing the ongoing respiration in order to terminate the off respiration this key must be pressed longer 3 sec Apnea Time set to A value of gt 15 sec has been selected for the apnea 15sec time in the PSVmode This indication must be confirmed by pressing the MFK 72 Alarms and Error Messages CLEANING AND DISINFECTION Disconnect the power plug before cleaning the ventilator We do not recommend standard sterilization methods for the CARAT ventilator Do not use aggressive abrasive or other cleaners e g acetone for cleaning the ventilator Do not immerse the ventilator in water or solvent DEVICE SURFACE Use a cloth moistened with soap water to clean the external surfaces of the ventilator Then wipe the ventilator with clear water to remove residual cleaning agent When the ventilator is in clinical use its surfaces should be disinfected at regular intervals and in case of suspected contamination We recommend Mikrozid Liqui
43. he operating unit The set ventila tion parameters and the associated alarms are saved and the alarms are shown on the display as well as indicated by LED The operating assem bly is provided with a real time clock It communicates with the external RS232 interface and the remote alarm as well as with the controller via the serial interface The monochrome display is a 1 4 VGA screen which is 320x 240 mm in size Interfaces The system is provided with a serial interface for the PC software Carat Control and for software updates It is also provided with a port for the nurse call or a remote alarm box Technology of the Device 35 FUNCTIONAL DESCRIPTION The operating principle ofthe CARAT ventilator is based on a control mech anism which in a closed control loop adjusts the capacity of the blower to the air output required for therapy The blower output is controlled by the signal of the airway pressure and by the signal of the inspiration flow System start initialization When the system is started the parameters are read from the memory EEPROM and checked for validity In addition the pressure and flow sensors as well as the acoustic signal generator are tested In the event of an error the error detection is saved and output The calibration data is downloaded from the EEPROM and checked for validity If connected the oxygen sensor is calibrated against ambient air Measurement of parameters The analogue measur
44. htness relates to the backlighting in the dark state and can be set to values ranging from O to 100 The backlighting will always be automatically darkened to this value whenever none of the control elements has been actuated and or an event has not been detected during ventilation for 30 seconds As soon as a ventilation alarm occurs or a control element is actuated the brightness will be automatically set to 100 Description of the Device 25 DISPLAY SCREEN Using this menu item it can be selected one of the following screens which are displayed while ventilation is in progress and backlighting is darkened Standard screen STD Insriration Time Ramr Insriration Trigger Trigger Lack r Min Volume 0 50 Additional Pressure Bn hFa Max Volume 2 00 OFF Min Vol 30 09 08 201 20 00 Figure 5 Standard screen STD Frequency brem XXL screen XXL Screen displaying the actual values in enlarged size but not displaying the setting parameters appropriately used in hospitals Figure 6 XXL screen 26 Description of the Device Figure 7 Patient screen PAT Patient screen PAT Screen displaying minimum information without actual values nor dis playing the setting parameters appropriately used in home care ALARM VOLUME The alarm volume can be set to values ranging from 10 to 100 In incre ments of 10 DISPLAY I E Using this menu item it can be sel
45. i teten een Debbie 55 Connecting a Single Line Patient 55 Tumming ihe Ventilator Qr snsnsbsbebebebbbeobbbb6bbbLiundes 56 Oxygen SUPPI V arnasean oeenn neeaaeia 57 De e e A m E AAAA AAA 58 p 60 Turning the Device On and Off 60 Start and End of Ventilation nennen nenne ernennen ern 60 Starbsot Ventllalons rer rer 60 Endiof Ventilation mda est dada Da ds dada dia 61 Enabling and Disabling the Safety 61 F nctionrof thie ese mode Key eate ak 62 ethdhery 62 Selecting the Ventilation 62 Changing the Ventilation Mode with Ventilation not Running 62 Changing the Ventilation Mode with Ventilation Running 63 Changing the Ventilation and Alarm 63 Ghanging DIsplaySi tertie te beet ete 64 Functional Assignment of the Control Elements 65 Alarms and Error Messages eese 66 General Informa on ese mL 66 Saving ALAM A INE AEA NER AL ALAN 67 Transmitting iei tee boot tee oe te oe te oe tee oes tee babe bee 67 Adjustable Alarms zi n o mt t ui m a et 68 Defined Alarms and Error 69 Err
46. ied authorized and experienced specialist personnel To reprocess the device carry out the following steps e Properly dispose of the carrying case and if necessary the functional bag as well as all accessory components that carry respiratory gas e Dismantle the device s sensor block The sensor block s plastic parts are autoclaved The sensors must not come into contact with cleaning fluids A spray disinfection e g using Mikrozid Liquid is possible The sensors must be completely dry before replacing them in the sensor block Cleaning and Disinfection 75 e Disinfect all the parts of the housing and the connections with a suitable agent e g Mikrozid Liquid e Dispose of the filter cassette and replace it with a new one e Reassemble the device e After reprocessing carry out a safety related check according to this User s Manual see page 80 e Until the device is used again store it safe from contamination with human pathogens VALIDATED PREPARATION PROCEDURE 2 KR1000 KEREDUSY IMPORTANT The KR1000 Keredusy preparation procedure is suitable for the preparation of MRSA contaminated devices Other procedures must not be used The hygienic preparation during a patient change acc to the validated pro cedure KR1000 Keredusy may only be carried out by companies with a QM system and appropriately qualified authorized and experienced spe cialist personnel The type and scale of the preparati
47. ient air which is assumed to con tain 21 96 oxygen Depending on the ambient conditions the sensor can require up to 30 min utes after installation to reach signal stability The supply of oxygen is possible anytime The valve for oxygen supply is opened during the running ventilation IMPORTANT Oxygen sensors have a limited durability A durability of 15 months after the date of manufacture applies for oxygen sensors supplied by HOFFRICHTER The period of use of the sensors is 6 months After that the oxygen sensor must be replaced by a new The date of manufacture can be found on the oxygen sensor For the longest possible sensor service life we recommend storage at 15 C to 5 Oxygen Supply 59 OPERATION TURNING THE DEVICE ON AND OFF Turn the ventilator on and off by actuating the main switch on the rear of the device After the ventilator has been turned on the device performs an automatic hardware test gt see section System start initialization The ventilator can only be switched off if the respiration has been termi nated before Should the main switch on the backside of the device be set to during an ongoing respiration a warning pops up reading Stop Ventilation Yes No Additionally an acoustic alarm rings out If you con firm with Yes the respiration is terminated If you select No you receive the warning Attention Main Switch OFF The device
48. if the Standard display is shown and none of the parameters is selected If necessary press the esc mode key The ventilation mode currently selected is indicated by the appropriate mode LED emitting steady light By pressing the esc mode key the mode menu will open By turning the MFK the desired ventilation mode can be selected Confirm the selection by pressing the MFK and the device will switch to the Selected mode 62 Operation CHANGING THE VENTILATION MODE WITH VENTILATION RUNNING The mode can only be changed ifthe Standard display is shown and none of the parameters is selected If necessary press the esc mode key The ventilation mode currently selected is indicated by the appropriate mode LED emitting steady light By pressing the esc mode key the mode menu will open By turning the MFK the desired ventilation mode can be selected Pressing the MFK will confirm preselection of the new mode the mode LED will continue flashing Thereafter the ventilation and alarm parame ters can set and or change of the new mode on the left hand side of the Screen The old still activated mode is indicated by the mode LED still emitting steady light Once the parameters for the new mode are set turn the MFK to select the Accept settings options in the text indication field Confirm the selection by pressing the MFK Once the next inspiration is started ventilation will be continued in the new mode CHANGING THE VENTILATION AND ALARM
49. indicated The respiration hours can be deleted menu driven by pressing the MFK The last 15 alarms can be read out of the alarm storage The respective values measured at the time of the alarm are indicated in the actual value screen This function can only be used in standby operation In addition to this the service screen offers the authorized service personnel the possibility of executing various tests and calibrations on the CARAT Serial Number Cur Lago Software Version Therary Counter Alarm Memory 09 05 2011 20 14 04 Frequency too high O02 Menu Pressure Sensor Calibr Flow Sensor Calibr Test Tidhtness 09 08 2011 20 20 Battery Check DISPLAY REAL TIME MONITORING The display Real Time Monitoring shows during running ventilation pressure flow and volume curves in real time The current position of the curves is shown by arrows A W in the upper and lower border of the display Spontaneous inspiration is symbolized by an arrow W in the upper posi tion which will stay until the next cycle of curves Figure 9 Description of the Device 29 Figure 9 Display Real Time Monitoring PSV Mode Figure 10 Display Real Time Monitoring PCV Mode 30 Description of the Device The current display can be frozen by pressing the multi functional key Pressing again the multi functional key the real time monitoring will con tinue with the next inspiration The scaling ofthe curves and the time axis can be c
50. ing oxygen Ensure that the oxygen fittings as well as all ports and surfaces near the oxygen lines are free of grease Do not smoke and do not handle naked flames When using oxygen an increased oxygen concentration in the ambient air can occur Oxygen can be supplied in all ventilation modes The oxygen inlet for external oxygen supply is provided on the rear of the ventilator The only O2 adapter type that may be used is the one that is delivered with the ventilator Oth erwise the return stop in the connection port may be damaged Please note that changing the ventilation parameters such as respiratory pressure I E frequency will also change the FiO2 content O2 MEASUREMENT O2 measurement is performed with the optionally available O2 sensor Fit the sensor in the T adapter which matches the ventilator and the patient circuit The T adapter is provided with a connector 22 mm which must be fitted onto the tube connector for inspiration Insert the O2 sensor cable into the Connector O2 sensor on the front of the ventilator and screw on the plug by a clockwise rotation The O2 sensor is calibrated automati cally on device start If the sensor is connected at a later point the text indication field will display the message Calibrate O2 sensor Calibrate 58 Oxygen Supply Figure 17 Connecting O2 sensor then the sensor in stand by mode by selecting O2 MENU on the Ser vice display Calibration is against amb
51. lly returns to the Standard display The display Real Time Monitor ing will be left automatically only if an alarm occurs If the safety lock is enabled the Service display is disabled In this case only the Standard display or the display of Extended Param eters can be selected 64 Operation FUNCTIONAL ASSIGNMENT OF THE CONTROL ELEMENTS Control element ON OFF key Alarm key Multi functional key MFK esc mode key Ventilation on Ventilation off Mutes the alarm tone in case of a ventilation alarm Acknowledges the venti lation alarm Selects the parameters Activates the parameters Sets the parameters Confirms the parameter Selection Confirms the changed parameter values Changes the screen display Freezing and continu ing the curve display in the display Real Time Monitoring Activates the ventilation mode menu Enables and disables the safety interlock Escape from choosen parameters screens Press briefly Press and hold 3 sec Press briefly Press briefly Turn Press briefly Turn Press briefly Press briefly Press and hold gt 1 5 sec Press briefly Press briefly Press and hold gt 1 5 sec Press briefly Operation 65 ALARMS AND ERROR MESSAGES GENERAL INFORMATION ACAUTION Alarm limits may only be set by qualified and skilled personnel under the supervision of a physician The alarms of the CARAT ventilator are either defined alarms or alarms
52. m volume it is possible to specify a value and to optionally increase the pres sure PS Additional Pressure to reach this minimum volume In the PSV mode the alarm parameters that can be set are the maximum and minimum volumes as well as the maximum frequency In PSV mode the frequency and the apnea time because of the depen dence both synchronously can be OFF At this setting the message PSV S appears in the Text Indication Field and the apnea time becomes an alarm parameter IMPORTANT With this setting the device only reacts on existing spontaneous breathing of the patient Ventilation Modes 39 SIMV MODE SIMV Synchronous Intermittent Mandatory Ventilation The SIMV mode provides a combination of pressure controlled machine ventilation and pressure assisted spontaneous breathing Machine ventilation is based on a defined respiratory rate SIMV frequency and a defined inspiration time The inspiratory pressure IPAP as wellas the end expiratory pressure PEEP defines the range of pressure for venti lating the patient The rise in pressure can be selected by setting a ramp defining the course of the flow curve The inspiration volume is automati cally adjusted to the lung s condition compliance and resistance The patient cannot manipulate these ventilator strokes by his own ventilatory drive Only their beginning is adjusted to spontaneous breathing if necessary Spontaneous breathing on the patient s part is po
53. n the following areas e Pressure bargraph e Actual values e Symbol field e Remaining battery capacity e Text indication field 20 Description of the Device PRESSURE BARGRAPH The pressure bargraph indicates the pressure course during ventilation The arrows indicate the set IPAP or PS upper arrow and the set PEEP lower arrow The currently achieved maximum pressure of the last spon taneous breath is indicated by the peak mark horizontal bar ACTUAL VALUES The actual values indicate the currently measured values listed below e Peak pressure e Vi Inspiration volume of the previous breath MV Minute volume e bpm Frequency e IE EE ratio If the device is in stanby mode the display will show lines If the sensor is connected the current oxygen content appears instead of the ratio Description of the Device 21 SYMBOL FIELD Acoustic alarm off This symbol indicates that the acoustic alarm has been muted for 2 min Any new alarm will also be suppressed acoustically until the 2 min interval has elapsed By pressing the Alarm key the acoustic alarm can be disactivated before the alarm appears Pressing the Alarm key again will activate the alarm again IMPORTANT The alarm for Int battery discharged cannot be muted during bat tery operation Safety lock mO The key signals that the safety lock is activated A flashing key symbol indi cates that disabling enablin
54. ne patient circuit and consists of the following units Inspiration unit with flow sensor check valve and standardized tube connector M 22 Pressure connection port o 3 5 mm Connection valve control with quick coupling SMM 02 Oxygen supply with oxygen block including valve and automatically controlled connection Valve control with proportional valve and pneumatic inspiration valve Qxygen outlet Oxygen connection port Mechan valve O val in the port ZVANS Air inlet Blower Valve membran 1 v Air outlet A Proportional valve Figure 12 Block diagram of the pneumatic block 34 Technology of the Device Flow sensor 1 Pressure sensor 1 Pressure sensor 2 Mechan valve in the port Tube connector Inspiration Connector Measuring tube Connector Control tube Controller control and operating unit The control unit controls the blower and the valves in order to implement the ventilation modes set The control unit is also provided for the detection of alarm situations In addition the control unit exchanges data with the oper ating controller and the power management Using the operating unit you can select and display the ventilation modes the operating unit also allows entering the ventilation parameters by means of the multi functional key and showing the ventilation parameters on the LC display Ventilation is started via t
55. nitoring can not be chosen any longer The enabled safety lock is indicated by the key symbol being shown in the symbol field The safety lock can only be enabled and disabled if the Standard display is shown To enable and disable the safety lock press and hold the esc mode key gt 1 5 sec and then confirm by pressing the MFK while the key symbol is flashing An automatic safety lock can be activated via the PC software CaratControl This safety lock activates automatically if no button is pushed for 5 minutes Operation 61 FUNCTION OF THE esc mode KEY The esc mode key has two functions On one hand the function esc escape to cancel unwanted entries and on the other hand the function mode to change ventilation modes ESCAPE By pressing the esc mode key not yet confirmed entries can be cancelled If a parameter is selected and changed but has not yet been confirmed by pressing the MFK the entry can be cancelled by pressing the esc mode key Irrespective of on which display you are the esc mode key will always take you back to the standard display Pressing the esc mode key while you are in the standard screen will take you to the selection menu of the ventila tion modes If this has happened by mistake the entry can also here be cancelled by pressing the esc mode key SELECTING THE VENTILATION MODE CHANGING THE VENTILATION MODE WITH VENTILATION NOT RUNNING The mode can only be changed
56. ntact the relevant customer services department to find out how to dis pose of the device properly Proper disposal saves natural resources and prevents harmful substances being released into the environment PACKAGING The packaging is taken back by the distributor but it can alternatively be disposed of separately in the normal household waste BATTERIES Exchanged batteries must be recycled in accordance with battery regula tions Please contact the relevant customer services department to find out how to dispose of the device etc properly OXYGEN SENSOR The oxygen sensor must not be disposed of with the household waste Please contact the relevant customer services department to find out how to dispose of the device etc properly 84 Disposal It bt 5 be ACCESSORIES SCOPE OF DELIVERY Scope of delivery Article number Carrying case 0000 4875 Power supply cable approx 1 83 m 0000 4206 Mains cable approx 1 80 m 31100013 Single line patient circuit for adults 22 mm 1 80 m 0000 7967 Filter cassette 0000 4880 2 pack coarse filter 0000 4950 5 pack fine filter 0000 4951 Adapter for bacterial filter 0000 4933 Adapter for oxygen connection straight 41000104 User s manual 5000 0102 Short manual 0000 4851 For ordering of accessories please contact a HOFFRICHTER service partner Accessories 85 OPTIONAL Optional Article number Single line patient circuit for children 15 mm 1 50 m 0000 4923 FiOo measurem
57. ntilator e a functional check and e acheck of the ventilation accessories for possible damage Moreover the components required must be exchanged in the course of the safety related check These are contained in the maintenance kit Every twelve months the ventilator must be subjected to maintenance measures These measures include replacement of the components con tained in the maintenance kit 1 80 Maintenance and Safety related Check OPERATION BY EXTERNAL POWER SUPPLY AND BATTERY The CARAT ventilator automatically detects the voltage sources avail able If the device is connected to an external voltage source via the power supply unit PMC120 PS24 or SNP A129 M this is always used with the highest priority and then the internal battery The current voltage source is always indicated by the appropriate LED being lit OPERATION BY EXTERNAL POWER SUPPLY IMPORTANT Only the supplied power supply unit PCM120 PS24 or SNP A129 M may be used for operating the ventilator by external power supply If the CARAT ventilator is connected to a 100 250 V AC 20 96 10 96 50 60 Hz voltage source via the power supply unit the LED external power supply emits green light This is also applicable if the main switch is turned off because the internal battery is recharged if necessary If the ventilator is disconnected from external power supply an acoustic alarm is emitted with the ventilator on the LED emits yellow light
58. nuous Device Error HIGH tone Disconnec HIGH tion Error Oxygen MEDIUM Sensor Calibrate O2 sensor LOW Error in the commu nication between the controllers Inspiration and or expiration part of the tube system is not connected to the device Mask Tracheal tube is not connected to the tube system Pressure measuring tube is not connected to the device Sensor defective cal ibration error The O2 sensor was fitted after the device has been turned on Device service required Connect inspiration and or expiration part to the device Connect the mask tracheal tube to the tube system Connect the pressure mea suring tube to the device Replace or recalibrate the oxy gen sensor Subsequent calibration via Ser vice display required Alarms and Error Messages 71 ADDITIONAL MESSAGES Battery Operation The device was disconnected from external power supply and is now operated by the internal battery confirm message by pressing alarm key Safety Mode No spontaneous breathing on the patient s part mini mum frequency ensured by device in PSV modes only Saving Data Data are saved after actuation of the main switch Device is switching off Accept settings The mode was changed during running ventilation to activate anew mode select this message by turn ing the MFK and then confirm the message by press ing the MFK Communication active Data are currently transferred from the system to t
59. of the alarm can be viewed here The memory depth is approximately 1 year TRANSMITTING ALARMS Alarms can be transmitted by means of a nurse call or the optionally avail able remote alarm box This allows even better monitoring of the device to be achieved in the home or clinic The use of the remote alarm box or a nurse call is especially recommendable when several ventilators are used in one room as this allows the device generating the alarm to be easily identified Figure 19 Remote Alarm Box Alarms and Error Messages 67 ADJUSTABLE ALARMS IMPORTANT Before changing alarm parameter settings check the patient s con dition If an adjustable alarm parameter on the Standard display results in an alarm then it is simultaneously highlighted by a black bar Alarm Priority Cause Delay Message Pressure too high Pressure too low Frequency too high Apnea Volume too high Volume too low Leakage Oxygen too high Oxygen too low HIGH HIGH HIGH HIGH HIGH HIGH HIGH MEDIUM MEDIUM Pressure higher than the set maximum pressure or positive pressure difference greater than the set difference Pressure lower than the set min imum pressure or negative pres sure difference greater than the set difference The measured frequency exceeds the max frequency Set apnea time exceeded only with frequency OFF Tidal volume higher than the max volume PCV PSV
60. on of the system Please notify the service agency in such a case Place the device in such a way that the mains plug is easily accessible so that it can be unplugged quickly in the event of a hazard Do not use the device if the housing or the cable of the device or the power supply are damaged 14 Safety Information ELECTRICAL SAFETY Only the supplied power supply unit PCM120 PS24 bzw SNP A129 M may be used for operating the ventilator Do not use any electrically conducting or electro stati cally chargeable patient tubes The device must never be put near other devices or equipment such as defibrillators diathermy units mobile phones microwaves remote controlled toys etc Electromagnetic fields that exceed 10 V m may adversely affect the operation of the ventilator Please pull off the power plug to disconnect CARAT from external power supply Disconnect the power plug before cleaning the ventilator The use of accessories or power supplies which are not approved by us for the device may lead to increased emission of electromagnetic radiation or reduced resistence to interference During certain examinations or treatments mutual interference between the ventilator and other medical devices may occur Observe the information regard ing electromagnetic compatibility and monitor the devices with regard to error free and proper opera tion Do not reach for the device under any circumstances should it f
61. on are described in detail in the Instruc tion on dealing with validated respirators for the Desinfection System KR 1000 The number of preparation cycles for the device is limited to 10 After reprocessing carry out a safety related check according to this User s Manual see page 80 76 Cleaning and Disinfection USING BACTERIAL FILTERS If the device is intended for use by more than one patient e g in opera tion in clinics a suitable bacterial filter e g MEDISIZE BARR VENT S at the inspiration port should continuously be used to protect the device from contamination by human pathogens The bacterial filter must be changed daily On a change of patient carry out the following steps e Replace the bacterial filters e Disinfect all the parts of the housing and the connections with a suit able agent e g Mikrozid Liquid e Change the coarse filter and the fine filter and disinfect the surface of the filter cassette You can also replace the entire filter cassette with a new one IMPORTANT If there is any doubt it should be assumed that the device is con it should hygienically prepared according the chapter Preparing the device when changing patient auf Seite 75 Using Bacterial Filters 77 FUNCTIONAL CHECK A CAUTION Whenever the ventilator is put into operation the alarms must be checked for proper functioning beforehand The patient circuit to be
62. onditions which require immediate action The ventilator must be subjected to the technical safety check every six months and to inspection and maintenance measures once a year In case of extraordinary efforts on the patient s part there may be the risk of hyperventilation in all ventila tion modes with inspiration triggering Do not steam sterilize the system in the autoclave Replace filters and other parts which are connected to the patient at regular intervals Dispose of the parts replaced according to the regulations for used medi cal material and or according to local environment protection rules Safety Information 11 The connection accessories other components at the ventilator may increase the pressure at the patient connection during the expiration cycle Please ensure that the total resistance of the patient circuit and the accessories used does not exceed 6 hPa with a flow of 60 l min on adults and 30 l min on children Any modification to the device poses a threat to its serviceability and is not permitted Only use masks that have been prescribed for your treatment by a physician Only use the mask after instruction by a qualified medical person and clarify in particular the intake of medicines and possible contraindications and side effects associ ated with the use of the mask Please note the operating transport and storage conditions If temperatures fall below 5 or rise abo
63. or Messages of the Hardware Test on Device Start 69 Defined Power Supply Alarms ee 70 Miscellaneous Defined Alarms ette 70 Additional Messages uti 72 Cleaning and Disinfection eese 73 Device SUI TaCe een e UU ea e an 73 Contents 5 AIE RAN ANNIE ELLE T9 Patient Gireuit ard Masks rs ertet ede ine 74 VIOS lt 74 H rnidifier 74 Bacterial Filter en 74 Preparing the device when changing 75 Preparation procedure 1 Manual 75 Validated preparation procedure 2 KR1000 Keredusy 76 Using Bacterial Filters eere 77 Functional reete rre erre ree rire eror rrr 78 Maintenance and Safety related 80 Operation by External Power Supply and Battery 81 Operation by External Power Supply 81 Operation by the Internal 81 Operation by the External 83 BIEDLICIM 84 Bem UM 84 Packaging eie toe re toe cove oe o e ee ne ee
64. or in the VCV mode Set the value of the max pres sure alarm parameter lower than the maximum pressure reached After 15 seconds an audible signal will be emitted and the text field will display the message Volume too low Alarm Volume too low Operate the ventilator in the PSV mode Set the value of the min volume alarm parameter higher than the volume measured Set the minimum volume ventilation parameter to OFF After 3 breaths an acoustic signal will be emit ted and the text indication field will display the message Volume too low Alarm Volume too high Operate the ventilator in the PSV mode Set the value of the max volume alarm parameter lower than the volume currently measured Set the minimum volume ventilation parameter to OFF After 3 breaths an acoustic signal will be emitted and the text indication field will display the message Vol ume too high NOTICE If one of the tests described above cannot be carried out please contact your responsible service technician Functional Check 79 MAINTENANCE AND SAFETY RELATED CHECK IMPORTANT In order to ensure the operating safety of the CARAT ventilator a safety related test or maintenance must be carried out at the pre scribed intervals Every six months the CARAT ventilator must be subjected to a safety related check to be carried out by the authorized service agency The safety related check comprises e a visual check for outside damage of the ve
65. r the responsi bility of and on prescription by the physician The ventilator may only be used on patients whose clinical picture requires its application Please take utmost care to ensure that the patient remains connected to the tubing system during ventilation It is not permitted to operate the ventilator with flam mable anesthetics or room air containing explosive gases This may cause fire or explosion Before being reused on a different patient all parts coming into contact with the respiratory gas must be treated hygienically The directions given in these user s manual and the applicable regulations of the particular hospital or nursing home must be adhered to while hygienically treating and cleaning the ventilator We recommend to use the ventilator with the tubing system tested and released by the manufacturer Any use of other tubing systems may yield different results 10 Safety Information When a nasal or full face mask is used for noninvasive ventilation this mask must not contain any expiration opening When using with a single line patient circuit the con trolled expiration valve must not meet any resistance during exhalation and must allow quick ventilation of the ventilation tube system In order to ensure patient safety the device must be operated in such a way that all adjustable alarms are activated and adjusted to the patient Never ignore any audible alarm signals Such signals indicate c
66. ration time IMPORTANT The volume setting is directly connected to the set max pressure see page 52 If the Max Pressure selected is too low there is a possibility that the set volume is not reached In this case the Vol ume too low alarm is triggered 1 only available for volume controlled assisted ventilation Parameters 45 DESCRIPTION OF VENTILATION PARAMETERS IPAP IPAP Inspiratory Positive Airway Pressure is the therapeutically pressure inthe PCV and SIMV modes which is administered to the patient with each ventilator stroke during inspiration The set IPAP value is not summed up to the set PEEP but represents the maximum inspiratory pressure PS PS Pressure Support is the pressure administered to the patient in the PSV mode which supports the patient in his her own spontaneous inspi ration or the inspiratory pressure which is administered with the ventila tor stroke when the patient s own breathing fails In the SIMV mode PS is exclusively intended as pressure support of the patient s spontaneous inspiration The set PS value is not summed up to the set PEEP but rep resents the maximum inspiratory pressure VOLUME The volume is the adjustable inspiration volume which is administered to the patient on each inspiration in the VCV mode PEEP PEEP Positive End Expiratory Pressure is the positive pressure which is available to the patient at the end of each expiration and befor
67. remains switched on and the respiration is continued The alarm remains active until the main switch is set back to l or the respiration is terminated If the respiration is terminated and the device is switched off via the main switch the message appears Data is being saved Device will be Switched off After successful data storing the device switches itself off IMPORTANT If you turn off the ventilator all parameters set will be preserved START AND END OF VENTILATION START OF VENTILATION Start ventilation by actuating the ON OFF key While ventilation is in prog ress the actual values indicate all values currently measured 60 Operation END OF VENTILATION After short pressing of the ON OFF key a signal tone sounds and in the display appears the message Press and hold for 3 sec to turn Ventilation off By pressing of the ON OFF key for approx 3 sec the signal tone silences the display message disappears and the respiration stops Afterwards a short signal tone sounds If the ON OFF key will not released the respiration continues ENABLING AND DISABLING THE SAFETY LOCK The CARAT ventilator is provided with a safety lock as a protection against inadvertent or unauthorized readjustment of the ventilation and alarm parameters Once the safety lock is enabled all settings on the Standard display and display of Extended Parameters are disabled The Service dis play and the display Real Time Mo
68. ructions described in the user s manual have not been complied with Statutory guarantee rights remain unaffected by this Disclaimer 95 HOFFRICHTER GmbH Mettenheimer Stra e 12 14 19061 Schwerin Germany Phone 49 385 39925 0 Fax 49 385 39925 25 E Mail info hoffrichter de www hoffrichter de CARAT I eng 291111 15 Art no 50000102
69. s also possible to set the positive endexpiratory pressure PEEP The inspiration flow ramp can be selected as constant flow or as decelerating flow Volume controlled assisted ventilation In its ventilation parameters the volume controlled assisted ventilation is equal to the exclusively controlled ventilation By setting an inspiration trigger however the patient can stop expiration by inspiration efforts once he reaches the trigger threshold and initiate the additional respiratory strokes As is the case with exclusively controlled ventilation these additional respiratory strokes are only controlled by the device The inspiration time is defined The patient can only shorten the expiration time by his own breathing efforts thus increasing the set frequency In the VOV mode the alarm parameters that can be set are the maximum and minimum pressures It is also possible to set the maximum frequency In the assisted ventilation mode it is particularly important to define the maximum frequency because the patient may increase the frequency by his own breathing efforts Ventilation Modes 41 PARAMETERS VENTILATION PARAMETERS VENTILATION PARAMETERS ON THE STANDARD DISPLAY The ventilation parameters listed below are displayed on the left hand side of the Standard display and can be changed within the appropriate adjustment ranges The particular display of the changeable parameters depends on the ventilation mode selected Th
70. ssible between the ventila tor strokes if the trigger thresholds for inspiration and expiration triggers are reached During inspiration spontaneous breathing is supported by a pressure PS that can be selected beforehand and is independent of the IPAP The length of the spontaneous breaths and the inspiration time are exclusively defined by the patient The ventilator strokes are adjusted to spontaneous breathing in terms of time If for example a spontaneous inspiration occurs shortly before a SIMV period is started within a spe cific expected time window 2 seconds the device initiates the ventilator Stroke synchronously with the patient s own breathing already at that time In the SIMV mode the alarm parameters that can be set are the maximum and minimum volumes as well as the maximum frequency 40 Ventilation Modes VCV MODE VOV Volume Controlled Ventilation Volume controlled ventilation or volume controlled assisted ventilation Volume controlled ventilation In this ventilation mode ventilation is exclusively controlled by the system Spontaneous breathing on the patient s part is not possible To ensure exclusively controlled ventilation the inspiration trigger must be set to OFF The ventilatory period is based on the set respiratory rate and requires a defined EE ratio The inspiration volume is defined such that the corre sponding pressure is based on the condition of the lung compliance and resistance It i
71. stem and can be read via the PC software The alarm cause the device settings and the alarm time are saved More over the pressure and the flow curves are displayed from 1 min before until 1 min after the alarm It is also possible to output alarms of medium and high priority via the remote alarm function Operation during power failure IMPORTANT During a power failure the battery capacity display must be moni tored and an alternative power source kept ready For further details on the display of the battery capacity please refer to page 82 When the power supply is interrupted by a power failure the device is supplied with power via the internal battery The switch to the internal bat tery is indicated by an alarm sound as well as by the text display Battery Operation In addition the Alarm LED and the Internal power supply LED are lit Pressing the alarm button switches the alarm off and switches the text display to date and time When the mains power supply returns the device is supplied with power from the mains supply and the internal battery is charged The Internal power supply LED goes out and the External power supply LED is lit Technology of the Device 37 VENTILATION MODES PCV MODE PCV Pressure Controlled Ventilation Pressure controlled or pressure controlled assisted ventilation Pressure controlled ventilation In this ventilation mode ventilation is exclusively controlle
72. structions for use issued by the manufacturer or dealer deliver ing the oxygen The CARAT ventilator allows FiO2 measurement via the O2 sensor which is optionally available as an accessory part We recommend using this O2 sensor The oxygen sensor contains a caustic liquid Avoid skin or eye contact if there is a sensor leak The pressure of the supplied oxygen must not exceed a value of 1000 hPa its flow must not exceed 15 1 min The oxygen must be metered out via an external flow meter During oxygen supply using the device s O2 connec tion no humid oxygen may be used Damp air may lead to device defects If necessary a humidifier can be connected between the air outlet of the device and the patient The connection between the O2 connection and external O2 source must be absolutely airtight Other wise leakage losses may occur during ventilation Oxygen Supply 57 Oxygen supply should be stopped before the ventila tion is interrupted We also recommend that you run the ventilator without supplying oxygen for several ventilatory periods before starting and after complet ing the ventilation process In case of an oxygen leak the oxygen source must be closed on the spot The room must immediately be ventilated At the same time any sparks fire or potential sources of fire in the vicinity must be avoided Oxygen supports combustion Therefore observe the fire protection regulations applicable for us
73. ting Pressure increase time 1 1 7 sec 2 1 0sec 3 0 6 sec 4 0 4 sec 1 5 0 3 sec The values specified are reference times and vary in relation to the pressure range set and to the condition of the patient s lung While setting the ramp in the volume controlled mode the course of the inspiration flow can be selected as constant flow stage 1 oras decelerating flow stage 2 4 48 Parameters Figure 13 Pressure increase time in seconds with an IPAP of 20 hPa and a PEEPof 5 hPa INSPIRATION TRIGGER The inspiration trigger specifies the extent of the patient s inspiration efforts required to obtain pressure or volume support from the ventilator in case of spontaneous breathing Pressure trigger If a single line patient circuit is used the pressure trigger is activated An inspiration is triggered when the patient generates a certain negative pressure in the tubing system by his her own inhalation efforts i e when the pressure has dropped by the currently set value In addition it will be checked it there is a positive flow Trigger stage Pressure trigger 1 0 2hPa 2 0 5hPa 3 0 8hPa 4 1 0hPa 5 1 5hPa IMPORTANT Please always take utmost care and always consider the patient s Clinical picture when setting the trigger stages in order to prevent the risk of auto triggering Automatic trigger The automatic trigger can be activated independently from the selection of the tube system If the s
74. tion of selecting adjustment of either the inspiration time or the I E ratio In the SIMV mode the inspi ration time is the only adjustable parameter The inspiration time defines the duration of inspiration in seconds When setting this parameter the frequency selected must be taken into consideration If a defined inspira tion time is set the I E ratio is calculated in relation to the frequency The ratio is the ratio of inspiration to expiration content the total respi ratory cycle If a defined E ratio is set the inspiration time depends on the currently set frequency Parameters 47 RAMP PCV PSV SIMV In the pressure controlled ventilation modes the ramp settings limit the increase in pressure in the inspiration phase This pressure increase is not set as a time parameter but is implemented by setting the course of the flow curve in the inspiration phase i e by limiting the flow increase The resistance and the compliance of the patient s lungs are also taken into consideration so that the varying conditions of different patients lungs will also result in varying pressure increase times When setting an individual ramp the currently specified inspiration time in which the increase in pres sure should be reached must be taken into consideration For example the following table provides an overview of the change in the pressure increase time with various ramp settings in case of a healthy lung Ramp set
75. transmitter manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency range is essential Note2 The ISM frequency bands for industrial scientific and medical applications between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHZ to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Note3 The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range from 80 MHz and 2 5 GHz are intended to reduce the probability that mobile portable communication facilities can cause interference when they are accidentally brought into the range of the patient For this reason the additional factor of 10 3 is applied in the calculation of the recommended safety clearances in these frequency ranges Note 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 94 Manufacturer s Declaration on Electromagnetic Compatibility DISCLAIMER HOFFRICHTER GmbH is not liable for consequences in terms of safety reliability and performance of the product if e interventions modifications extensions calibration repairs and maintenance are carried out by persons not authorized by us e other manufacturers accessories and spare parts are used that have not been approved by us for use on the product e the product is used other than as described in the user s manual or e the hygiene and cleaning inst
76. umes as well as the maximum frequency In the assisted ventilation mode it is particularly important to define the maxi mum frequency because the patient may increase the frequency by his own breathing efforts 38 Ventilation Modes PSV MODE PSV Pressure Supported Ventilation Pressure supported ventilation is intended to support spontaneous breath ing and to initiate machine ventilation whenever spontaneous breathing is missing The pressure support PS as well as the positive end expiratory pressure PEEP defines the range of pressure for ventilating the patient The trigger thresholds of the inspiration trigger and the expiration trigger can be adjusted to the patient s requirements The adjustable frequency is set in the background As long as the patient reaches or exceeds this fre quency by spontaneous breathing the ventilator reacts with the pressure support to each spontaneous inspiration following the patient s breath ing If the background frequency fails to be reached the device assumes machine ventilation until it registers the next spontaneous breath To permit respiratory pauses between the patient s breathing efforts an apnea time can be set to delay the start of the ventilator strokes The rise in pressure between PEEP and PS can be selected by setting a ramp which defines the course of the flow curve The tidal volume is automatically adjusted to the lung s condition compliance and resistance To ensure a minimu
77. under the cover Display Connector RS232 interface under the cover Figure 1 Ventilator front view 18 Description of the Device BACK VIEW Handle Filter cassette Main switch Rating plate Oxygen inlet Cover valve mem brane no function Oxygen outlet Power socket Figure 2 Ventilator back view Description ofthe Device 19 DISPLAYS DISPLAY LAYOUT CARAT I is provided with a Standard display which is activated in the normal and standby modes of the ventilator as well as with a display of Extended Parameters a Service display and a display Real Time Monitoring While parameter selection is inactive you can select the displays in the following order by pressing and holding the multi functional key MFK for gt 1 5 sec e Standard display e Display of Extended Parameters e Service display e Display Real Time Monitoring e Standard display The display of Extended Parameters and the Service display will be left automatically after 30 seconds without any entry and change to the Stan dard display The display Real time Monitoring will be left automatically only in case if an alarm occurs These displays can be closed manually by pressing the esc mode key The left hand side of the displays differ in their function and displays gt see page 24 to page 29 The right hand side is identical in the Standard display the display of Extended Parameters and the Service display and is subdivided i
78. ve 50 C proper functioning of the ventilator may be impaired 12 Safety Information INSTALLATION REQUIREMENTS AND TRANSPORT To ensure reliable operation place the Ventilator on a safe and plane base The air inlet on the rear of the system as well as all venting slots must not be covered blocked The display of the ventilator as well as the alarm LEDs must not be covered and must be permanently visible Do not place any objects onto the ventilator The housing of the ventilator does not provide any protection against ingress of water The system must never be stored or transported at an ambient temperature below 10 or above 50 C The system must not be exposed to direct solar radiation Due to electromagnetic interference the ventilator must not be set up in the immediate vicinity of other devices If this is unavoidable the ventilator must be monitored with respect error free proper operation Do not put the device near water containers baths Safety Information 13 INSTRUCTIONS BEFORE COMMISSIONING Whenever the device is put into operation a func tional check must be performed beforehand see 78 Any ventilator that is functioning properly may pose a risk to the patient or operator If the system fails to start properly or if the self tests performed automatically on system start fail to be completed successfully it is not permitted to continue operati

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