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CARAT II pro Patient 1.000 ENG_2014-07-16_01

1. o Q 50 100 ii V 0 0 200 0 400 0 600 AN O B 22 33 Figure 37 Flow Volume Loop 78 Chapter 6 Device operation ACTIVATING A VENTILATION SET How to call up to the set settings 1 Navigate to Parameter in the home screen by turning the MFK SUL 2 Press the MFK Set 2 Set 3 Mode IPAP PEER Frequency Time Inspiration Ramp Minimum Volume Sigh Function High Inspiration Volume Figure 38 Parameter screen NOTICE PCV 20 0 hPa 5 0 hPa 12 bpm 2 0s 371 Off Off 1 001 The active setting is highlighted in green and has a check mark M Chapter 6 Device operation 79 To activate a ventilation set 1 3 4 80 Navigate to the ventilation set you wish to activate by turning the MFK acne er Mode PSV IPAP 20 0 hPa BEER 5 0 hPa Frequency 12 bpm Time Inspiration 2 0s Press the MFK twice Mode PSV IPAP 20 0 hPa BERR 5 0 hPa Frequency 12 bpm Time Inspiration 2 0s Change the setting to Yes by turning the MFK Mode PSV IPAP 20 0 hPa BREER 5 0 hPa Frequency 12 bpm Time Inspiration 2 0s Press the MFK to confirm the new setting Chapter 6 Device operation DISPLAY OF STORED ALARMS How to call up the alarm log screen 1 Navigate to Alarm log in the home screen by turning the MFK 2 Press the MFK 38 You can move between the alarm entries by turning th
2. 08 88 Chapter 6 Device operation How to call up to the statistical values 1 Navigate to the home screen by turning the MFK to System 2 Press the MFK 5 25 Median 75 95 25 wi 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 01 02 03 04 05 06 Feb 14 v Ss a Ss NN A e lees Figure 41 Statistics screen 1 ventilation parameter Chapter 6 Device operation 89 STARTING VENTILATION AWARNING The expiration valve air outlet has to be open during running ventilation Make sure that the opening is not blocked as the expired air will be unable to escape and will affect the ventilation process 1 Switch on the device using the main power switch on the rear of the device 2 Press the ON OFF key o Ventilation begins STOPPING VENTILATION 1 Press the ON OFF key B Measurements Graphs nei Stop Ventilation 60 Flow min Stop Ventilation Figure 42 Stop ventilation 2 Navigate to Yes by turning the MFK 3 Press the MFK 90 Chapter 6 Device operation CHAPTER 7 ALARMS AND MESSAGES This chapter describes alarms and messages their cause and what measures need to be taken in case of an alarm event Chapter 7 Alarms and messages 91 GENERAL INFORMATION A CAUTION The device must be operated so that the alarm is audible and visible by the user Audible alarms can be forwarded using t
3. Chapter 7 Alarms and messages 97 Table 4 Adjustable alarms Alarm Priority Audible LED alarm Cause Time delay alarm Status High MEDIUM caf Yellow Measured frequency is for 3 breaths in Frequency flashes higher than the High a row Frequency Low MEDIUM caf Yellow Measured frequency for 3 breaths in Frequency flashes is lower than the High a row Frequency High MEDIUM caf Yellow Tidal volume is higher for 3 breaths in Inspiration flashes than the High Inspira a row Volume tion Volume Low MEDIUM caf Yellow Tidal volume is lower for 3 breaths in Inspiration flashes than the Low Inspira a row Volume tion Volume High MEDIUM caf Yellow Ventilation minute vol for 3 breaths in Minute flashes ume is higher than the a row Ventilation High Minute Ventila tion Low MEDIUM caf Yellow Ventilation minute vol for 3 breaths in Minute flashes ume is lower than the a row Ventilation Low Minute Ventila tion High MEDIUM caf Yellow Expiration volume is for3 breaths in Expiration flashes higher than the High a row Volume nspiration Volume Low MEDIUM caf Yellow Expiration volume is for3 breaths in Expiration flashes lower than the Low arow Volume nspiration Volume Low SpO MEDIUM Cba Yellow Measured SpOs is None flashes ower than the set Low Spo 98 Chapter 7 Alarms and messages FIXED ALARMS The fixed alarms are technically conditional
4. Error detected Selecting this icon results in a list of all current errors see Error messages on page 15 Internal battery fully charged Internal battery being charged 1 bar 20 of charge EEES200 8B 70 Chapter 6 Device operation ENABLING A SCREEN The following screens are accessible from the home screen Monitoring screen Monitoring measurements numerical and graphs Parameter screen Ventilation and alarm parameters of the active ventilation mode Alarm log screen Display of alarms with time stamp and measurements System screen System settings calibrations counters and device information Statistics screen Statistical evaluation reports Service screen System calibration and tests for service work PIN code protected Boo Monitoring Parameter Alarm Log System Statistics Service e fg ee A Selected screen icon Figure 31 Home screen Chapter 6 Device operation 71 To enable a screen 1 Navigate to the desired screen by turning the MFK The selected screen icon gt Black Icon not selected Blue 2 Press the MFK to activate the selected screen NOTICE During active ventilation the device will switch to the monitoring screen 2 minutes after the last completed operation If ventilation is not active the device will switch over to the home screen after 2 minutes 72 Chapter 6 Device operation MONITORING In the monitoring screen the ventilatio
5. Device type 9LV203 HOFFRICHTER GmbH Mettenheimer Stra e 12 14 19061 Schwerin Germany Telephone 49 385 39925 0 Fax 49 385 39925 25 Email info hoffrichter de www hoffrichter de fA oD HOFFRICHTER User s manual for patients as of device software 1 000 User s manual CARATII pro for patients CARAT II pro Patient 1 000 ENG_2014 07 16_01 Article no 5000 0626 a CARAT II pro User s manual for patients 2014 HOFFRICHTER GmbH All rights reserved The content published in this user s manual is the sole property of the HOFFRICHTER GmbH All forms of reproduction editing distribution and any kind of exploita tion even in part require the prior written consent of the HOFFRICHTER GmbH The HOFFRICHTER GmbH reserves the right to amend or replace this user s manual without prior notice Please ensure that you are always working with the most current version of this user s manual Should you have any questions please contact the ventilation device provider or check our information at www hoffrichter de The respiratory device may only be operated and maintained by trained personnel The following documents are available for CARAT II pro in addition to this user s manual e User s manual for CARAT II pro for physicians and medical professionals e Brief instructions for CARAT II pro e Service manual e Hygiene concept e Maintenance plan Please read first this user s manual carefully and
6. Quality makes the Difference m 0x12 Primary Alarm Not Working A Software version B Error message Figure 10 Start screen If no errors were detected during the hardware test or the errors have been confirmed the display will switch to the standby screen The current level of battery charge will be displayed on the standby screen Figure 11 Standby screen 5 Switch on the ventilator by the main switch See page 62 42 Chapter 4 Commissioning OPERATION WITH INTERNAL BATTERY NOTICE To prevent the internal battery from discharging the device should stay con nected to the mains power during standby times In order to ensure the full function of the battery the battery must be main tained in accordance with the section Battery maintenance on page111 With a fully charged battery the device can be operated up to 4 hours on the fac tory default settings Table 1 Operating time with battery power and factory default settings Battery power level Time Alarm 100 10 199 min 10 0 39 min Low Internal Battery O complete power loss 1 min Internal Battery Empty The internal battery enables operation of at least 1 hour at maximum power con sumption Information about the battery charge level is indicated by the battery LED and by touching the battery icon A CAUTION If the alarm Low Internal Battery appears the ventilator must immediately be connected to an alternative power source
7. Device settings and counter Yes No Update files No Yes Initialization files No Yes Measurement parameters No Yes approx 50 days at Pressure volume flow FiO a recording rate of 20 values per second 114 Chapter 15 Appendix ERROR MESSAGES Table 11 Error messages during operation and at device start up Error message Error SpO2 sensor Cause Communication to SpO2 measuring module not possible Correction Device must be serviced SpOx2 sensor defective Replace SpO2 sensor SD card is full No storage space avail able on the SD card Insert blank SD card Flash Not Working No access to the flash Device must be serviced An older parameter set is on the device Current parameter set is incorrect The device uses the old parameter set and can con tinue to be utilized Default parameters are on the device No valid parameter set available or they are faulty The device uses the default parameter set and can continue to be uti lized The flow sensor shows an error Flow sensor is defective Device must be serviced The FiO2 sensor shows an error FiO sensor is defective Check FiO2 sensor connection Recalibrate FiOosensor Replace FiO sensor Error Pressure Sensor Defective pressure sensor Device must be serviced Calibration File Damaged Calibration data for sensors is damaged Device must be serviced Eve
8. Service intervals OVervieW ssssessssrirssreesttrrrrrrressttnrrerreesserrrent 110 Table 10 Data MaNaQeMENt ll lll lll ll nl ln lll nun laid 114 Table 11 Error messages during operation and at device start up ee 115 Table 12 Error messages during operation and at device start up seee 116 10 List of tables CHAPTER 1 INTRODUCTION This chapter contains general information on the use and operation of the ventilator Chapter 1 Introduction 11 SCOPE OF DELIVERY Illustration Name CARAT II pro Ventilator Switched mode power supply Mains cable Disposable double line patient circuit for adults with pressure measuring tube _ 180 cm 22 mm op Adapter for bacterial filter SD card Straight FiO2 connection adapter Carrying case 12 Chapter 1 Introduction Illustration Name Spare filter cassette complete open with filters Spare coarse filter 1 pack 2 ea Spare fine filter 1 pack 5 ea User s manual for the patient Brief instructions Final inspection certificate Chapter 1 Introduction 13 SYMBOLS PACKAGING SYMBOLS Meaning European Article Number Article number rT Serial number A M oO 8 CE Declaration of Conformity Transport and store package with arrows pointing up at all times Fragile contents Protect from moisture a Humidity range during storage and tra
9. The alarm LED may take on 3 different statuses to signify the current alarm priority e Red flashes rapidly 2 Hz gt high priority alarm e Yellow flashes 0 5 Hz gt medium priority alarm e Turquoise glows steadily gt low priority alarm If multiple alarms are triggered simultaneously or in quick succession the alarm with the highest priority will be displayed first More information on alarm LEDs is available on page 35 ALARM OUTPUT IN THE TOOLBAR Alarms are shown in the toolbar by the Alarm active icon and displayed with an alarm message The icon s color indicates the alarm priority e Red icon gt high priority alarm e Yellow icon gt medium priority alarm e Turquoise icon gt low priority alarm If multiple alarms are triggered simultaneously or in quick succession the alarm with the highest priority will be displayed first LX 1 45 Low Frequency A Alarm active icon B Alarm Figure 44 Alarm output in the toolbar 94 Chapter 7 Alarms and messages ALARM OUTPUT AS A TEXTBOX 120 seconds after the last performed operation the alarms will also display in a textbox as well The textbox will disappear as soon as you press the alarm key The textbox color corresponds to the highest priority alarm e Red textbox gt high priority alarm e Yellow textbox gt medium priority alarm e Turquoise textbox gt low priority alarm If multiple alarms occur at the same time the alarms are sorted and displayed i
10. Navigate to Monitoring in the home screen by turning the MFK i 2 Press the MFK 3 Navigate to Graphs by turning the MFK Measurements Loops 24 RAPER e70 P aE 15 18 21 24 s 22 33 A Automatic scaling is on o2 2 Figure 33 Monitoring screen graphs Chapter 6 Device operation 75 Freezing the real time curve 1 Press the pause symbol ff Measurements Loops p 24 po min Figure 34 Monitoring screen freeze graphs 2 Press the start symbol to restart the real time curve P 76 Chapter 6 Device operation DISPLAY LOOPS Depending on your settings you may display the following loops graphically in Loops while ventilation is running e Flow Volume Loop e Volume Pressure Loop Flow Volume Loop Flow 100 l min 50 pe 50 100 il y 0 0 200 0 400 0 600 I Current breath Last breath Figure 35 Flow Volume Loop Volume Pressure Loop 0 800 0 600 0 400 0 200 p 25 hPa Current breath Last breath Figure 36 Volume Pressure Loop Chapter 6 Device operation 77 How to call up to Loops 1 Navigate to Monitoring in the home screen by turning the MFK N 2 Press the MFK 3 Navigate to Loops by turning the MFK Measurement Graphs Flow 100 l min
11. and water traps _ 180 cm 22 mm 00007996 Disposable single line circuit for children with an expiratory valve pressure measuring and control tube _ 180 cm 15 mm 00014923 Disposable double line circuit for children with pressure measuring tube _ 180 cm 15 mm 00004928 CPAP Silicon nasal mask size S 00004960 CPAP Silicon nasal mask size M 00003440 CPAP Silicon nasal mask size L 00003434 124 Chapter 15 Appendix Name Article number CPAP Silicon full face mask size S 00003441 CPAP Silicon full face mask size M 00003436 CPAP Silicon full face mask size L 00003437 Figure PPV Silicon full face mask size S PPV Silicon full face mask size M PPV Silicon full face mask size XL 0003462 PPV PSU Silicon full face mask size L autoclavable 00003439 N O N O NIPPV Silicon full face mask size L O N O N Bacterial filter 00004932 FiO measurement set consisting of FiO sensor T adapter FiO2 sensor adapter FiO2 sensor connecting cable with screw connector 00004944 FiO2 sensor OOM108 1 23000018 T adapter 23000019 Chapter 15 Appendix 125 Name Figure Article number FiO sensor adapter ey 23000020 w DU FiOz sensor connecting cable with screw connector 00014116 FiOz connection adapter angled 41000087 02 Cover for expiration tube connection 42100449 USB cable PC c
12. e In order to disconnect the device from the mains supply the plug must be pulled e Before cleaning the device the plug must be disconnected from the electrical outlet e The use of accessories or power supplies not approved by us for the ventilator can increase the emission of elec tromagnetic radiation reduce interference immunity or can lead to an increased patient leakage current e During certain examinations or treatments mutual interfer ence between the ventilator and other medical devices may occur Please observe the information regarding electro magnetic compatibility and monitor the devices with regard to error free and proper operation e Do not reach for the device under any circumstances if it falls into water e Do not try to open the device Maintenance and repairs may only be performed by personnel authorized by HOF FRICHTER GmbH 24 Chapter 2 Safety warnings INSTALLATION REQUIREMENTS AND TRANSPORT e For operation the device must be placed on a safe and level base e The air inlet at the rear of the device as well as all ventilation slots must not be blocked e Please ensure the device is operated in an area where there is sufficient and clean ambient air e The display and the alarm LED s must not be covered and must be visible at all times e No objects must be placed on the device e The system must never be stored or transported at ambient temperatures under 20 C and over 6
13. filter s or use another humidifier Then rerun the calibration Calibrate Tube Ok FiO2 Monitoring Internal Finish calibration Calibrate FiO Sensor Alarm Volume 3 Brightness Display 50 Brightness LEDs 10 Brightness MFK 10 7 Press the MFK to exit the tube calibration process Chapter 4 Commissioning 53 CONNECTING THE ALARM BOX OR THE NURSE CALL Connect the alarm box to the device as shown in Figure 19 A Alarm box B Remote alarm nurse call connection C Alarm box cable Figure 19 Connecting alarm box Alarm boxes are available as an accessory see page 127 An on site nurse call can also be connected to the remote alarm nurse call con nection point as well You will need a cable with a RJ10 plug to do this The cables are available as an accessory see page 127 Additional information on alarm boxes and forwarding alarms is available in the section Forwarding alarms on page96 54 Chapter 4 Commissioning SpO SENSOR CONNECTION Connect the SpOz2 sensor to the device as shown in Figure 20 The toolbar will then show the a icon If the sensor is connected to the patient the oxygen saturation and heart rate are displayed in the monitoring screen if ventilation is in progress it will also show in the parameter screen A SpOz finger clip sensor B SpOz2 sensor connection Figure 20 Connecting the SpO2 sensor Chapter 4 Commissioning 55 INSERTING THE SD CARD Insert the SD card i
14. filter thoroughly with clear water Let the filter dry completely in the air Insert the cleaned filter back into the filter cassette Slide the filter cassette into the device Instead of cleaning the filter you can insert a new one or replace the entire filter cassette with a new one Chapter 8 Cleaning and disinfection 107 REPLACING THE FINE FILTER The white fine filter cannot be cleaned It must be replaced with a new one 1 Pull the filter cassette from the device Remove the coarse filter olack Remove the fine filter white and replace it with a new one Insert the coarse filter back into the cassette Slide the filter cassette into the device or oN CHANGING THE FILTER CASSETTE 1 Pull the filter cassette from the device 2 Pull apart the filter cassette and the filter frame cover 3 Reassemble the replacement cassette and the filter frame cover 4 Slide the filter cassette into the device 108 Chapter 8 Cleaning and disinfection CHAPTER 9 ROUTINE CHECKS AND MAINTENANCE WORK Routine checks and scheduled maintenance are necessary in order to maintain safe functioning of the device This chapter describes which and when tests and maintenance works must be performed NOTICE You must not perform any testing or maintenance work while the patient is still connected to the device Provide an alternative ventilation system for the patient during that time Chapter 9 Routine checks and maintenan
15. this user s manual before undertaking and have familiarized themselves with the device Disregarding these instructions can lead to life threatening situations for the patient e In cases of emergency an alternative ventilation option such as a second ventilator or an emergency ventilation bag must be available at all times and for use by the attending person e For patients who are unable to breathe independently or are completely dependent on the ventilation system additional monitoring depending on and adapted to the disability is recommended e The device must only be used on the responsibility and prescription of the physician e The device must only be used on patients whose clinical record requires its application e Please take the utmost care to ensure that the patient remains connected to the tubing circuit during ventilation e The device must not be used with flammable anesthetics or ambient air that contains explosive gases This may cause fires or explosions e Before being used again on another patient all parts that come into contact with respiratory gas must be hygienically prepared e The directions given in this user s manual and the applicable regulations of the hospital or nursing home must be adhered to when hygienically preparing and cleaning the device e We recommend the use of the tube systems tested and approved for use by the manufacturer Using other tube systems may lead to aberrant resu
16. well The device must be completely dry before commissioning CLEANING THE TUBE CIRCUIT A CAUTION A heavily worn or damaged tube system should be disposed of correctly and replaced by a new one The tube circuit supplied is intended for use on one patient only It must not be cleaned and used for other patients When using other tube circuits the manu facturer s instructions must be observed Tube circuits not designed for reuse must be disposed of properly CLEANING THE MASK CAUTION A heavily worn or damaged mask must not be reused and should be dis posed of correctly Disconnect the mask from the tube circuit Clean the mask with mild soapy water Do not use any other agents Rinse the mask thoroughly with clear water Let the mask dry completely in the air PON gt 106 Chapter 8 Cleaning and disinfection CLEANING THE HEADGEAR 1 Disconnect the headgear from the mask 2 Clean the headgear as described in the headgear manufacturer s users manual CLEANING REPLACING THE FILTER A Filter frame cover B Filter cassette C Fine filter white D Coarse filter black Figure 48 Filter cassette structure CLEANING THE COARSE FILTER OO oe DNS T Pull the filter cassette from the device Remove the coarse filter olack from the filter cassette Clean the filter with mild soapy water Do not use any other agents Rinse the
17. 0 C e The device must not be exposed to direct sunlight e Due to possible electromagnetic interference the ventilator may not be placed directly next to other devices in which the electromagnetic radiation is not CE compliant and or the limits values exceed 10 V m If this is unavoidable then the ventilator operation must be monitored for trouble free and correct operation e Do not locate the device near water containers baths Chapter 2 Safety warnings 25 INSTRUCTIONS BEFORE COMMISSIONING An malfunctioning device can endanger the patient or operator Should the appliance not start properly or if the device s automatically carried out self tests should fail you must stop operating the device In such cases the service provider must be informed Locate the device in such a way that the mains plug is easily accessible and can be unplugged quickly in the event of a potential hazard Do not use the device if the housing or the cable of the device or the power supply are damaged USING OF OXYGEN 26 Please be sure to observe the user s manual of the manu facturer or distributor from whom you obtain the oxygen If the patient is supplied with oxygen via the device the FiO2 should be measured CARAT II pro offers a FiO measurement via the optional FiO sensor We recommend using this particular sensor exclusively The FiO sensor contains a caustic liquid Avoid skin or eye contact if there is a sensor
18. 4 CHAPTER 10 sissiteasecataazeaesinatsaesaseaesnassdiabs isdusaaszodestaassastatabanened 113 adan e T R 113 Data manageme San 114 Eien e ETERA TERE TETE TERE ETE TETE TETE TET 115 TECHNICA Cala s smer a E R 117 Replacement parts and aCcessorieS ssesssttrtttttttttrtrtttttttttrrrtttterrenrrnnt 121 Manufacturer s declaration on electromagnetic compatibility 128 Bioro PE T A 129 DISCIAIMGR wndictaletdcatalebaradalatdaatAlebaladalabdaabalabaladaletdnahdoabacalalatahebagataaaiatetanedans 130 Table of contents 7 LIST OF FIGURES Figure T JRAtING PII Eesaia edadia 15 Figure 2 Connections at the front side of the device wo ee 30 Figure 3 Connections at the rear side of the device wo eres 31 FIQUIE4 CONTOIGIEMENIS sec cciiecncccerenececereneccncssnetapednaedconednnadnnadenadnnednneranasts 33 PIQUIC s CED CISDIAYS teneran aa i ana AAN ATTEN 35 aeo LEE GEVICE SIDES A 37 TEELE E E e SIGS E I A A I A I T N I T A 37 Foures Seng Wp Mhe GEVICE issnin asss is naana a nan a a ES A A Aa 40 Figure 9 Mains connection via power supply UNit eee eee eeceeeeeeeeeeeeeeeeeeeees 41 Foure T0 Sten SEE s in anainn aaa annaa AAA 42 Figure 11 STANGDY SOTEN ossaa EEEE EEE 42 Figure 12 AKKUPACK uni BASE right AKKUPACK uni PLUS left 45 Figure 13 Connecting AKKUPACK uni BASE ree 46 Figure 14 Connecting a single line patient circuit eccerre 48 Figure 15 Connecting a double line patient Circuit ee 49 Figure 16 Connec
19. E BATTERIES During storage charge the batteries every 6 months up to 100 capacity by operating the devices via mains supply Chapter 9 Routine checks and maintenance work 111 PERFORM THE BATTERY QUICK TEST The battery quick test must be carried out monthly as follows 1 Make sure that the battery is fully charged 100 2 Disconnect the device from the mains and operate the device for 1 hour on battery power 3 The test is positive if after 1 hour the battery capacity is gt 10 and the alarm Low Internal Battery has not sounded If the battery capacity has fallen below 10 and the alarm Low Internal Battery has sounded the batteries must be replaced by an authorized service technician REPLACE THE BATTERIES The batteries must be replaced every 2 years by an authorized service technician The procedure is described in the CARAT pro service manual 112 Chapter 9 Routine checks and maintenance work CHAPTER 10 APPENDIX Chapter 15 Appendix 113 DATA MANAGEMENT The device has an internal memory to recording data We recommend operat ing the device with an SD card to save larger amounts of data More information about SD cards are available on page 56 The following data will be saved Table 10 Data management Data and parameters Alarms and events with date and time stamp Inside the device Yes approx 15 000 entries SD card Yes approx 15 000 entries Statistics Yes No
20. G A CAUTION Use only the original HOFFRICHTER functional bag We recommend using our functional bag for transporting the CARAT II pro on wheelchairs walkers or in transport vehicles The functional bag is available as an accessory see page 127 Figure 25 Functional Bag When using the device in the functional bag the following instructions must be observed to ensure safe and trouble free operation e Set the alarm sound to level 3 e Make sure that all alarm messages are visible through the viewing window and that the air vents of the bag are not blocked The air supply for the device must be guaranteed at all times e Use the bag in such a way that the device is protected from overheating dust and water e All accessories connected such as tube filter supply lines etc must be arranged so that they cannot cause any malfunctions of the device Chapter 4 Commissioning 61 SWITCHING THE DEVICE ON NOTICE The tube circuit may be connected when the device is started up but it may not yet be connected to the patient yet If you are using oxygen therapy during ventilation please note the section Using oxygen from page 57 To switch on the device 1 Press the main power switch on the back of the device position I OI T Figure 26 Switching on the device 2 The home screen see page 71 will be displayed SWITCHING THE DEVICE OFF 1 Stop the ventilation 2 Switch off the power with th
21. ING TUNCHONAl DAG bircticctcececececeuecececceedecectendececsnndscadseadetaddtndetaadtadetadaanande 61 Switching TINE CL EVICS OM secre ecseciecincsecieiecinsncnciesmsecncisisaininisnsaiscaisajaciaanacaciaaiinnacnnacndse 62 Switching TNE device Off sasasdesasnandeaginqnteanasas te anasands dnanaads dusnas AA RA AA 62 CHAPTER cache ctecentsianentceaesetantestscanasacecsascarinetiseuauianalancieaseas 63 VENTILATION MODES icscccsecceccccccssccbackbecccs eats cicacabactbackbacubaeadeckcacabectbeckbeetbead 63 CHAPTER stscisinssdenctianrtisnonicertdensnnanrianniiedupsbasetnaaciasneacduoacbia 65 DEVICE OPERATION jiisiisciiivisasiavinstiastisiiavteastiastnastiastessbhasbessteastnssteastirebees 65 KOY LOCK EE e2hehee inthis dndednchie indedadndeduchie indedsdndedncede indedadndedacede indedadnands 65 User ProtleS marenie a E E OE O E E 65 Menu Stuc ti aaa A a es amneueneneeaas ca aieneas 66 Basic OP SEATON onse E E eeneeenanaainnn eaneeenan anna 66 BASIC SClSSM AAV OUI merenan aa a a a E Aa N aA E 68 EXplanatlon Of TOOIDAMICONS roesini ninna na ASENA EAR 69 Enabling g Sora Sasiia 71 Montani sessa 73 Activating a Ventilation Sel oo i lll ll ll ll ll ll nl nln Gn lll allie 79 Display Of stored alani S iccccisiciccncnecerinesescnenmer reser ieebenmenseerrnerens 81 MOV SISM SCUINGS E E E E EA ET E E E E EE 82 SEE E A E E E E E E EE 88 SAER E E E E E E E E E E E 90 SOPPINI VENIAM aaa A A aaatas 90 CHAPTER 7 ssscesicssisscniasesnsnauscccanenemaneuinesesanenanc
22. Meaning Clinic mode active Home mode active Alarm active A Red icon gt High priority alarm IN Yellow icon gt Medium priority alarm Al Turquoise icon gt Low priority alarm os Audio alarm paused The audible alarm has been paused for 2 min The audible alarm of even a new alarm event will also be paused for 2 min The audible alarm may be deactivated by pressing the alarm key before an alarm event occurs Pressing the key again reactivates the audible alarm in case an alarm event has occurred i P O1 Counter Audio alarm paused counter Indicates how much longer the audible alarm will be paused Key lock activated The functions of all controls are disabled except for the ON OFF and alarm key FiO sensor connected FiIO2 Monitoring setting has been set to External in the system screen Measurement of oxygen concentration is performed with an external FiO2 Monitoring unit Oxygen is supplied ERROR Spontaneous breathing detected The device has detected spontaneous breathing by the patient This trig gered the inspiration trigger The icon will remain visible during inspiration and will shut off with the beginning of the expiration Chapter 6 Device operation 69 Meaning Trigger lock On Trigger lock momentarily active SD card is inserted into the device No SD card inserted into the device SpOs sensor connected PC is connected via the USB port
23. RCUIT Connect the tube circuit to the device according to Figure 15 Note When using a bacterial filter please read the instructions of use of this filter If water should collect in the tubes we recommend the use of water traps Double line patient circuits with water traps are available as an accessory see page 124 Should you be using a tube circuit without pressure measuring tube the used cir cuit must be calibrated see page 52 A Patient side connection B Pressure measuring tube C Expiration tube D Inspiration tube E H Bacterial filters F G Adapters for bacterial filters Figure 15 Connecting a double line patient circuit Chapter 4 Commissioning 49 CONNECTING A HUMIDIFIER A humidifier is used to humidify the breathing air If you use a humidifier be sure to follow the manufacturer s user s manual The humidifier is integrated into the inspiration section It should be positioned below the patient and the device so that no water can accumulate in the patient s lungs or in the device If water accumulates in the tube circuit we recommend using water traps The respective tube circuits with water traps are available at HOFFRICHTER see page 124 Note When using a bacterial filter please read the instructions of use of this filter Single line patient circuit Connect the tube circuit to the humidifier and the device as shown in Figure 16 When using a tube circuit without pressure measuring tube the used tub
24. SE The AKKUPACK uni BASE enables the device to be operated independently of the mains power supply The battery pack is optionally available as an accessory see page 126 To supply the battery pack with power use the power cable and the power supply unit of the ventilator If the battery pack is connected to the ventilator the power LED glows green At full capacity and factory settings the AKKUPACK uni BASE enables TRENDvent to operate for up to 8 hours Using AKKUPACK uni BASE together with AKKU PACK 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 Figure 12 AKKUPACK uni BASE right AKKUPACK uni PLUS left Chapter 4 Commissioning 45 CONNECTING EXTERNAL BATTERY AKKUPACK uni BASE Connect the AKKUPACK uni BASE to the device according to Figure 13 ADC port B DC cable for ventilation C DC out device connection D AKKUPACK uni BASE Figure 13 Connecting AKKUPACK uni BASE 46 Chapter 4 Commissioning CONNECTING THE TUBE CIRCUIT The following decsribes it is described how to connect the tube circuit to the device We recommend the use of bacterial filters in particular for clinic operations when using the device for more than one patient AWARNING Tubes and cables must always be positioned so that they cannot wrap around the neck or limbs of the patient thus avoiding the risk of stra
25. TOUCH SCREEN OPERATION The following operations can be initiated with the touch screen ae Monitoring Parameter Alarm Log System Statistics Service ea gea Screen selection Graphs Calibrate Tube FiO2 Monitoring Internal Calibrate FiO Sensor Alarm Volume Brightness Display Brightness LEDs 0 Brightness MFK 0 Language English Pressure Unit hipa Display Time Insp Seconiis 3 Parameter selection Measurements 8 a A 7 d ey a 12 18 a 24 27 30 SUA a t D S S s 2 16 M oA TT OO a Select tab Freeze real time curve on the monitoring screen Measurements Graphs MFK to Continue SES EeEwew a z a A ea ee 7 ed Continue real time curve Show errors on the monitoring screen if present Measurements Pressure eerie t 6 i te th a EE Ger ie Open settings window 24 c Battery State charging Show battery state Chapter 6 Device operation 67 BASIC SCREEN LAYOUT N ee Monitoring Parameter Alarm Log System Statistics Service DA 1 45 Low Frequency e ae B C A Pressure bar during running ventilation B Screen content C Toolbar D Active ventilation mode Figure 30 Basic screen layout 68 Chapter 6 Device operation EXPLANATION OF TOOLBAR ICONS Icon IDI
26. The alarm will continue until the battery charge has exceeded 10 Recharging a fully discharged battery takes approximately 3 5 hours The device is fully functional during recharging If the device switched on without having a connection to the mains supply an audi ble alarm will sound the alarm message Battery Operation will appear and the alarm LED will flash yellow The battery LED glows depending on state of charge Chapter 4 Commissioning 43 POWER FAILURE NOTICE During a power failure the battery capacity display must be monitored and an alternative power source kept ready For further details on the battery state display please refer to page 36 If the power supply is interrupted by a power failure the device is supplied with power via the internal battery Power failure and thus the switch to the internal battery is indicated by an alarm sound as well as by the message Power Failure In addition the alarm LED flashes yellow and the power LED glows yellow The battery LED glows accord ing to the state of charge When the power supply returns the device is supplied with power from the mains supply and the internal battery is charged and the power LED glows green again 44 Chapter 4 Commissioning OPERATION WITH EXTERNAL BATTERY IMPORTANT Only the HOFFRICHTER AKKUPACK uni BASE may be used for the external power supply Before initial commissioning please read the user s manual for AKKUPACK uni BA
27. able 00005291 AKKUPACK uni BASE Ventilation 00011100 AKKUPACK uni PLUS 00011099 SpOz finger clip sensor cable length 2 m 00005292 SpO adhesive sensor for adults and children finger and toe ay cable length 2 m A D 00005294 LS QI 126 Chapter 15 Appendix Name Article number Extension cable for SpOz2 sensor cable length 1 m 00005293 Figure Remote alarm box complete including accessories 00014122 Remote alarm box without accessories 00004834 Cable for remote alarm box 00014115 Cable for nurse call 00014117 Functional bag 00004879 EASYset PC software Chapter 15 Appendix 127 MANUFACTURER S DECLARATION ON ELECTROMAGNETIC COMPATIBILITY The CARAT II pro must be commissioned in accordance with the provisions in these user s manual Wireless home network devices mobile phones cordless phones and their base stations walkie talkies etc can affect the CARAT II pro Close proximity to these devices should therefore be avoided Example A distance of 3 25 m has to be maintained for a typical mobile phone with a maximum output power of 2 W to preserve an electromagnetic immunity of 10V m 128 Chapter 15 Appendix DISPOSAL Proper disposal saves natural resources and prevents harmful substances being released into the environment DEVICE The device must not be disposed of with the household waste Please Ds contact the relevant custom
28. alarms Alarm conditions are built into the device and are non adjustable by the user Table 5 Fixed Alarms Alarm Priority Audible State ofthe Cause Correction alarm alarm LED Error HIGH ccc cc Red Defective battery Device must be Internal flashes serviced Battery Overcur HIGH Ccc Red Motor currenttoo Restart the rent fuse Cc flashes high device in the event of a recur rence the device must be serviced Stenosis HIGH caf af Red No flow for more Check tube cir flashes than 3 breaths cuit and tubing for obstructions Error HIGH ccc cc Red Communication Restart the Internal flashes with the control device in the Communi unit has been event of a recur cation interrupted for rence the device more than 10s must be ser viced Disconnect HIGH caf af Red Inspiration and Connect the flashes or expiration inspiratory and lines of the tube or expiration line circuit are not to the device connected to the device Internal HIGH Ccc Red Battery empty Battery must be Battery Cc flashes Current state of recharged maxi Empty charge of the bat mum 1 minute tery 0 left until com plete mains fail ure ventilation process will only be possible with external power supply Chapter 7 Alarms and messages 99 Table 6 Fixed Alarms Alarm Priority Audible State ofthe Cause Correction alarm alarm LED Over MEDIUM caf Yellow Over pressure Device must Pressure flashes detected be serv
29. allation requirements and transport ece cece eeeeee cette ee eeeeeeeeeeeeeeseaaaeeeeeeees 25 Instructions before COMMISSIONING sssri i rire 26 JSING OF OVO aaa ala alaaanaada nite 26 Safety related test ee naiinis aan aiaiai a 27 CHAPTER 3 gt siccasiesiesasdavesantnaiasnnisaasteskdaasestacanixassiveadiasapinsnndenaudad 29 DESCRIPTION OF DEVICE oii ccssctesedetedcdecsssucctec ed sdescssecedetvdesesststecedetetvteesisss 29 Front Side CONNECTING POINTS 0 nr En rire 30 near SIS COMMMEC LIC POM arrede ena RE 31 CONKOrSIEMEN Siss sinnini A LEEN 33 CE DAISPISY Sienie ee a e a i ada eaa e id eed e T 35 Movable and removable housing parts 0 i rire 37 CHAPTER 4 eccaiaenasinstscesasciscbneradscscaessaisancbausasinsaaessasaisaiausaeeceads 39 COMMISSIONING ssi cssesc civics cis sece snc ciee cess tec selene essen a NREN A NENEN EESHA 39 SSS ULI URS MO deC aeae RER 40 OWE SUP LY nmre nan E ondnsasadenanea stds saaingeenanea monaainemnede 40 Connecting the tube CirCuit i cceceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeteeetees 47 Calibrating Ihe TUbC CIRCUIL siti tiatiasisiniadatianiieninntieninntinlintiltunttctcentedes 52 Connecting the alarm box or the nurse Call eeeceeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 54 POs SENSO CONNECTION sed csiadd aa adided deliadiadacalladadliliaal hada Madalaldanadalalebare 55 Moennig ME S DONG a eieaa aa aa A EEEE 56 RemoviNG the SD Caldari naea ven EEEE E NEEE EAEE TARNA 56 BnG OVO hee 57 Table of contents 5 Using
30. andard Electromagnetic compat ibility Requirements and tests IEC 60601 1 2 2007 modified e DIN EN 60601 1 4 Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems IEC 60601 1 4 1996 A1 1999 e Medical electrical equipment Part 1 8 General requirements for basic safety and essential performance Collateral Standard General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601 1 8 2006 A1 2012 e DIN EN ISO 10651 6 only for use with the single line circuit Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6 Home care ventilatory support devices ISO 10651 6 2004 e DIN EN ISO 10651 2 only for use with the double line patient circuit Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2 Home care ventilators for ventilator depend ent patients ISO 10651 2 2004 120 Chapter 15 Appendix REPLACEMENT PARTS AND ACCESSORIES NOTICE Make sure to follow all general safety guidelines when using replacement parts and accessories page 22 For ordering of replacement parts and accessories please contact a HOFFRICH TER service partner REPLACEMENT PARTS Name Figure Article number Disposable double line circuit for adults with pressure meas urin
31. ce work 109 OVERVIEW Table 9 Service intervals overview When O What By whom Before commissioning Safety related test Provider Service Weekly Clean replace the coarse filter User Patient see page 107 Visually check of the fine filter User Patient Monthly or Replace fine filter User Patient before if heavily see page 108 contaminated Monthly Battery quick test see page 112 User Provider Every 6 months during Charge battery to 100 User Provider in storage see page 111 Every 6 months without Replace the valve membrane Provider Service bacterial filter expiration Every 12 months Maintenance 1 Provider Service refer to the service manual Safety related test Provider Service Every 2 years Maintenance 2 Provider Service refer to the service manual After 15 000 h blower Maintenance 5 Provider Service run time or every 5 years refer to the service manual 110 Chapter 9 Routine checks and maintenance work BATTERY MAINTENANCE The batteries in CARAT II pro are powerful lithium ion batteries To obtain the full capacity of the batteries it is important to charge and maintain them on a regular basis The number of charging cycles of lithium ion batteries is limited Therefore after a certain time the batteries must be replaced and disposed Tips for disposal can be found on page 129 MAINTENANCE REPLACEMENT INTERVALS 1 month 6 months 2 years CHARGING TH
32. e MFK 04 07 13 134 Low Internal Battery 04 07 13 2316 LOW Inspiration Volume 05 07 13 22 LOW Pressure 05 07 13 soa Power Failure 05 07 13 I 9713 High Minute Ventilation Stenosis 08 07 13 03 24 LOW Inspiration Volume 12 07 13 r oo10 Disconnection 12 07 13 0412 Check Expiration Outlet 18 07 13 2218 LOW Pressure IN E 22 33 A Alarm priority B Selected alarm Figure 39 Alarm log screen For more information on the alarms refer to chapter Alarms and messages start ing on page 91 Chapter 6 Device operation 81 SYSTEM SETTINGS In the system screen basic device settings calibrations and tightness check can be made Selecting the system screen device information can be obtained s Adjustable Menu item Explanation Home profile Calibrate Tube Calibrating the connected tube circuit see ff page 52 FiOQ2 Monitoring Setting if oxygen concentration measure ments are to be taken with internal FiO monitoring or with external FiO2 monitoring Calibrate O2 Sensor Calibrating the FiO2 sensor see page 59 vA Alarm Volume Volume of the primary alarm sound Brightness Display Brightness of the display v Brightness LEDs Brightness of the alarm LED power LED Vv and battery LED Brightness MFK Background lighting brightness of the y multifunctional key Language Setting the device language Pressure Unit Setting th
33. e circuit must be calibrated page 52 A Patient side connection B Expiration valve C Ventilation tube D Connecting tube for inspiration E Bacterial filter F Adapter for bacterial filter G Control tube H Pressure measuring tube Humidifier J Air outlet Figure 16 Connecting the humidifier single line patient circuit 50 Chapter 4 Commissioning Double line patient circuit Connect the tube circuit to the humidifier and the device according to Figure 17 When using a tube circuit without pressure measuring tube the used tube circuit must be calibrated see page 52 T he A Patient side connection B Pressure measuring tube C Expiration tube D Connecting tube for inspiration E H Bacterial filters F G Adapters for bacterial filters Humidifier J Inspiration tube Figure 17 Connecting the humidifier double line patient circuit Chapter 4 Commissioning 51 CALIBRATING THE TUBE CIRCUIT NOTICE The tube calibration must be performed only by using a tube system with out measuring tube A tube calibration should be performed after an interruption in the power supply on off switching when running on battery power and if changes have been made to the circuit system These may include connecting and disconnecting of the fol lowing components for example e Bacterial filter humidifier tube circuit mask FiO2 sensor water trap etc If you do not perform a tube calibration the stored standard calibratio
34. e device pressure unit Display Time Insp Setting to etablish whether the inspiration time can be set in seconds or as I E ratio in the parameter screen Date and Time Date and time settings V Number of Ventilation Sets Setting to etablish how many ventilation _ sets is displayed in the parameter screen User Profile Setting the user profile Clinic full access to all settings v Home restricted access to the settings Tightness Check Here you can perform a tightness check The tightness check serves to detect leaks in the tube circuit Recent Ventilation Hours Ventilation hours since the last reset Ventilation Hours Total Total ventilation hours can be reset with PC software 82 Chapter 6 Device operation Menu item Standby Hours Adjustable Explanation Home profile Hours during which the device was turned on without ventilation hours Blower Service in Number of hours after which the blower must be replaced SW Version Software version of the device Serial Number Serial number of the device Chapter 6 Device operation 83 SYSTEM SETTING CHANGES How to call up to the system settings 1 Navigate to the home screen by turning the MFK to System 2 Press the MFK Calibrate Tube FiO2 Monitoring Internal Calibrate FiO Sensor Alarm Volume 3 Brightness Display 50 Brightness LEDs 10 Brightness MFK 10 Language English Pressure Unit hPa Di
35. e main power switch on the rear panel position O a eae C Figure 27 Switching off the device 62 Chapter 4 Commissioning CHAPTER 5 VENTILATION MODES The device has three types of ventilation modes e Mandatory ventilation modes where the device performs the respiratory work for the patient completely e Augmented ventilation modes where the device performs part of the respiratory work alternating or over lapping with the patient s breathing rate e Spontaneous ventilation modes where the patient does the respiratory work with the support of the device The patient determines the frequency Respiratory work Respiratory work Device Patient AVCV P SIMV V SIMV Augmented lt n Ora O53 0E S p o n t a n e o u s Figure 28 Ventilation modes overview Chapter 5 Ventilation modes 63 Table 2 Overview ventilation modes Mode Description Mandatory ventilation modes PCV Pressure Controlled Ventilation APCV Assisted Pressure Controlled Ventilation VCV Volume Controlled Ventilation AVCV Assisted Volume Controlled Ventilation Augmented ventilation modes P SIMV Pressure Controlled Synchronized Intermittent Mandatory Ventilation V SIMV Volume Controlled Synchronized Intermittent Mandatory Ventilation Spontaneous ventilation modes CPAP Continious Positive Airway Pressure PSV Pressure Supported Ventilation PSV S Pressure Supported Ventilation Spontaneo
36. ed with the alarm key TO TEMPORARILY MUTE AUDIO ALARMS AUDIO ALARM PAUSED Audio alarms can be muted for 2 minutes by pressing the alarm key audio alarm paused If this function is enabled the audible alarm created by new alarm events will also be suppressed as well The alarm LED will visibly indicate an alarm event even when the audible alarm has been temporarily suppressed If the cause of the alarm is not corrected the audible alarm will sound again after two minutes The audio alarm may also be suppressed by pressing the alarm key even before an alarm event occurs e g before the tube circuit is temporarily disconnected for suctioning the patient The audio alarm can be reactivated after correcting the alarm cause even within the two minute period by pushing the alarm key again The Audio alarm paused J icon will indicate when the audio alarm is temporar ily switched to mute The counter tracks the time until the audio alarm will sounds again LA 1 45 Low Frequency A Audio alarm paused icon B Audio alarm paused counter Figure 43 Alarm displays in the toolbar NOTICE The Internal Battery Empty audible alarm cannot be set to pause while the device is in battery operation Chapter 7 Alarms and messages 93 VISIBLE ALARM OUTPUT Visible alarms are displayed as follows e via the alarm LED e in the toolbar e asa textbox e lighting up the multifunctional key ALARM OUTPUT VIA THE ALARM LED
37. er services department to find out how to dispose of the device etc properly aa BATTERIES Replaced batteries must be disposed in accordance with the respective local laws Please contact the relevant customer services department to find out how to dispose of the device etc properly PACKAGING The packaging is taken back by the distributor but it can alternatively A be disposed of separately with the normal household waste FiO2 SENSOR The FiO sensor must not be disposed of with the household waste SI Please contact the relevant customer services department to find out how to dispose of the device etc properly a Chapter 15 Appendix 129 DISCLAIMER HOFFRICHTER GmbH accepts no liability 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 for pusposes other than stipulated in the user s manual or the hygiene and cleaning instructions stipulated in the user s manual have not been complied with Statutory guarantee rights remain unaffected by this disclaimer 130 Chapter 15 Appendix
38. ere cardiac arrhythmia e Severe hypotension e Severe epistaxis e Pneumothorax or pneumomediastinum e Pneumoencephalus e Cranial trauma e Status after cranial or brain surgery e Acute inflammation of the paranasal sinuses middle ear infection or a perfo rated ear drum e Aspiration hazard In individual cases the attending physician must decide on the therapy Chapter 1 Introduction 19 SIDE EFFECTS The following undesired side effects may occur in connection with artificial respiration Invasive ventilation e Complications due to tube tracheal cannula Mask ventilation e Pressure points and skin defects in the face e Eye irritation due to leaks e Gastric inflation e Aspiration e Sinusitis e 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 20 Chapter 1 Introduction CHAPTER 2 SAFETY INFORMATION This chapter contains safety instructions on the following topics e General safety instructions e Electrical safety e Installation and transport e Commissioning e Use of oxygen e Safety related test Chapter 2 Safety warnings 21 GENERAL SAFETY INSTRUCTIONS e Only qualified trained specialist medical staff under the supervision of a physician may make adjustments to the ventilator The device must only be used by persons who have fully read and understood
39. g tube _ 180 cm 22 mm 00007969 Bacterial filter adapter 00004933 Straight FiO2 connection adapter 41000104 SD card 2 GB 11200010 Mains cable 31100023 Switched mode power supply 00014206 Filter cassette complete open 00002145 Chapter 15 Appendix 121 Name Article number Filter cassette complete closed 00002146 Figure Filter cassette complete open with filters 00002038 Filter cassette complete closed with filters 00002058 Filter cassette cover 42101301 Coarse filter 1 pack 2 ea 00014950 Course filter 00002993 Fine filter 1 pack 5 ea 00014951 Fine filter 00002994 User s manual for CARAT II pro for physicians and medical professionals 50000625 User s manual for CARAT II pro for patients 50000626 122 Chapter 15 Appendix Name Article number Brief instructions for CARAT II pro 50000645 Figure Carrying case 00004875 Chapter 15 Appendix 123 ACCESSORIES Name Figure Article number Disposable single line circuit for adults with an expiratory valve and the pressure measuring and control tube _ 180 cm 22 mm 00014967 Disposable single line circuit for adults with an expiratory valve and the pressure measuring and control tube plus water trap _ 180 cm 22 mm 00014995 Disposable double line circuit for adults with pressure meas uring tube
40. h Standby Hours 622h 86 Chapter 6 Device operation 6 Press the MFK Date and Time 13 02 14 10 36 Year 2014 Number Ventilation Sets 3 Month 2 User Profile Home Day Tightness Check Hour 10 Recent Ventilation Hours 65h Minute 36 Ventilation Hours Total 342 h Standby Hours 622 h 7 Change the setting by turning the MFK Date and Time 13 02 1410 36 Year 2014 Number Ventilation Sets 3 Month 2 User Profile Home Day Tightness Check Hour 10 Recent Ventilation Hours 65h Minute 36 Ventilation Hours Total 342 h Standby Hours 622 h 8 Press the MFK to confirm the new setting Chapter 6 Device operation 87 STATISTICS The statistics screen contains statistical evaluations of the following ventilation parameters e Minute volume e Frequency s SpO2 Leak Rate Tidal Volume I E Ratio The evaluation of the ventilation parameters is based on percentiles Percentiles are the dispersion measurement of the statistical data distribution during ventila tion sessions An example based on frequency zo genera ea during 95 of the day s therapy duration the frequency was lt 24 bom tern mm during 75 of the day s therapy duration the frequency was lt 22 bpm 20 15 during 50 of the day s therapy duration the frequency was lt gt 15 bpm E during 25 of the day s therapy duration the frequency was lt 12 bpm ppe during 5 of the day s therapy duration the frequency was lt 10 bpm
41. he nurse call or the alarm box The CARAT Il pro ventilator is equipped with fixed and adjustable alarms relating to the respective ventilation modes There are 3 alarm priorities Alarm priority A What action is required HIGH Immediate action is required Monitor the patient and the cause of the alarm closely MEDIUM Fast action is required for medium priority alarms Correct the cause of the alarm LOW User attention is requested for low priority alarms Low priority alarms indicate a change at normal device operation Check the cause of the alarm ALARM SOUND TEST A hardware test is performed with each device start up The primary and sec ondary alarm sound transmitters are tested see page 41 Both alarm sound transmitters must emit a short beep in sequence Otherwise an error message is issued and the device must be returned for servicing 92 Chapter 7 Alarms and messages AUDIBLE ALARM OUTPUT AUDIO ALARMS Audio alarms are issued in a sequence of beeps Alarm tones differ depending on alarm cause and priority For more information please see page 97 If the alarm sound equipment is defective and emits no sound the audible alarms will be triggered by a second alarm sound transmitter which emits only a simple audible alarm NOTICE An audio alarm will switch off when the alarm event is no longer fulfilled and the priority has been lowered but the alarm will stay in active until it has been confirm
42. iced throughout 3 or check if the breaths or 15s alarm may have been triggered by the patient coughing Battery MEDIUM Ccc Yellow Mains power sup Restore mains Operation flashes ply has failed the power supply device is running on battery power Low MEDIUM Ccc Yellow Device operat Battery must be Internal flashes ing on battery recharged Battery power supply Alarm remains battery charge until the battery lt 10 charge is gt 10 Mains MEDIUM Ccc Yellow Power supply Restore mains Failure flashes from the mains power supply AC connection has failed Check MEDIUM caf Yellow Expiratory flow Check control Expiration flashes during inspiration tube connection Outlet detected or expi on the device ration flow toolow and the tube during expiration circuit Check expiration outlet Check LOW ec Turquoise Measurement Check for kinks Measuring glows tube kinked or not in the measuring Tube steadily connected to the tube device Check measur ing tube at the device 100 Chapter 7 Alarms and messages MESSAGES MESSAGE DISPLAY IN THE TOOLBAR Messages are displayed in the toolbar When an alarm occurs the alarm is dis played instead of the message since the alarm has a higher priority PCV A Minimum Volume Not Reached A Message Figure 47 Messages in the toolbar MESSAGES OVERVIEW Table 7 Messages Messages Cause Time delay Back up Frequency Active Device operates in PSV mode patient None has no spontaneous b
43. in its entirety before first using the ventilator In particular follow all safety and cleaning instructions Keep the instructions in close proximity to the device for immediate re ference if necessary Every HOFFRICHTER GmbH device is supplied with a serial number for tracea bility purposes Please enter your device s serial number here You will find the serial number on the rating plate on the bottom of the device Please always quote the serial number for all queries and complaints The device complies with the requirements of Directive 93 42 EEC TABLE OF CONTENTS CHAPTER 1 scscdcarssiuatticsassansaneridacnibastsbasnisnusuiatnddasaaeasssiaaracicaaas 11 INTRODUC TION cee sce occa naie aeaeaie EEEE EEE EEEE EEEE EEEE EE REEERE EEE 11 SCOPE of GEIIVENY re oieri niren eieaa E AEE NAE AREER 12 SVOI S enan EEEE E 14 iniiae Ee UE NNER err rceteenen perce pcmtrnen eect ech ernon rarer ecrCeen cnr ere ecr rennet 19 COMMAINGICATIONS Sa scresciaisieitadcieddtaisanintadtindd tained tudaiedetaieieitadniaietateimncbennedgen 19 Side 210 eee eee eee 20 CHAPTER 2 sisdiaiissaseatacasaasbabeaitsbipin ieacdaasbabesibiagisinaazauebeiasstinslodes 21 SAFETY INFORMATION a cccccccccccctecccccceccccceccecccrecteccccecteccegevecccesectecccceceecceee 21 General safety INStrUCtiONS cece cece eetttee tere eee ee ean aeaeeeeeeeeeeaaaaaaeeeeeeeeeeaaa 22 Elecmiecalsato iy aagana er ttt terrace ere rrReee ncn ete AEAEE EAEEREN 24 Inst
44. ing the oxygen source rear of unit Chapter 4 Commissioning 57 MEASURING OXYGEN CONCENTRATION The oxygen concentration may be inconsistent when feeding in a fixed value oxy gen flow FlowOz The inspirational oxygen concentration FiO2 can vary depend ing on pressure ventilation pattern of the patient mask or leakage The oxygen concentration should therefore always be measured with a FiO2 sensor when oxy gen is being supplied See accessories on page 125 The FiO2 sensor must be calibrated for exact results See page 59 In addition the device will allow you to measure the inspiratory oxygen concen tration FiO with an external monitoring device during oxygen therapy under the supervision of a physician The FiO monitoring device should be connected according to the manufacturer s instructions before commissioning the ventilator It must also be equipped with an alarm system which is able to detect an alarm event for unacceptably high oxygen content The measuring of the oxygen con centration with an external FiO monitoring device must be set up in the system screen by a physician The factory default is set to a measuring with a FiO sen sor FiO monitoring Internal STARTING THE SUPPLY OF OXYGEN A DANGER Use only certified and clean oxygen sources 1 Switch the device on 2 Start ventilation and wait for several respiratory cycles 8 Start supplying the oxygen STOPPING THE SUPPLY OF OXYGEN 1 Stop the sup
45. king pressure OhPa Max flow 175 l min Operating conditions Temperature range 5 C to 40 C 41 F to 104 F Relative humidity 10 95 non condensing Air pressure range 600 hPa 1100 hPa Storage and transport conditions Temperature range lt 1 day lt 1 month lt 6 months gt 6 months 20 C to 60 C 20 C to 55 C 20 C to 45 C 20 C to 35 C 68 F to 140 F 68 F to 131 F 68 F to 118 F 68 F to 95 F a Chapter 15 Appendix 117 Storage and transport conditions Relative humidity 5 95 non condensing Air pressure range 250 hPa 1100 hPa Storage conditions Store in a dry vibration free place in an upright position store device and accessories in their origi nal packaging Sound pressure range of audible alarm signal at 1 m distance Lowest value 55 dBA Level 1 Medium value 60 dBA Level 2 Highest value 65 dBA Level 3 Pressure at 60 min Inspiratory resistance of the Single line patient circuit Double line patient circuit device at the patient con nection port 2 8hPa 2 9hPa Expiratory resistance of the Single line patient circuit Double line patient circuit device at the patient con nection port 3 9hPa 4 2 hPa Total resistance of the system lt 6hPa Technical requirements for accessories Oxygen inlet Connection type Quick connect coupling Pressure lt 1000 hPa Fl
46. leak Replace the sensor The oxygen supplied must not exceed a pressure of 1000 hPa and a flow of 151 min The oxygen must be dosed using an external flow meter When supplying oxygen please ensure that only dry gas FiOz is used Increased residual moisture 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 FiO2 connection and external FiO source must be absolutely airtight Otherwise leakage losses may occur during ventilation The oxygen supply should be stopped before the ventilation is interrupted We further recommend that after stopping the ventilation the device is allowed to run for several respira tory cycles without an oxygen supply Chapter 2 Safety warnings e In the event of an oxygen leak the oxygen supply should be closed off immediately The room must be ventilated immediately At the same time any sparks fire or potential flammable sources in the vicinity of the device must be avoided e Oxygen supports combustion Therefore observe the fire protection regulations applicable for using oxygen Please 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 SAFETY RELATED TEST e In order to ensure the operating safe
47. lts e Manufacturer tested and approved accessories are recom mended for the device If other accessories are used this may lead to insufficient ventilation or the use of hazardous materials may lead to further secondary complications 22 Chapter 2 Safety warnings When a nasal or full face mask is used for noninvasive ven tilation this mask must not contain any expiration opening If used with a single line patient circuit the controlled expira tion 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 oper ated in such a way that all adjustable alarms are activated and adjusted to the patient Alarms must not be ignored They indicate conditions that require an immediate action An annual safety related test and maintenance is required for the ventilator In case of exessive agitation on the part of the patient there is a risk of hyperventilation in all ventilation modes with inspiration triggering The device must not be steam sterilized in an autoclave Filters and other parts that are connected to the device must be regularly replaced Please dispose of the used parts according to the regulations for used medical material and or the local environmental protection rules The connection of accessories or other components to the respiratory system of the ventilator can lead to increased expirat
48. n order of priority 24 bPa no i J Alarm Q Stenosis Leakage Low Pressure High Inspiration Volume Q Flow Vmin Press fA to Continue seer eE 6 9 12 15 18 24 27 30 s A Textbox Figure 45 Alarm output in the textbox Chapter 7 Alarms and messages 95 ALARM OUTPUT VIA THE MULTIFUNCTIONAL KEY The backlighting of the MFK either glows steadily or flashes in the event of an alarm depending on the alarm priority only when MFK brightness gt O ALARM LOG The device stores the last 50 alarm events When additional alarms occur the old est entry will be overwritten You can view the alarms in the alarm log screen For more information please refer to page 54 Alarms are permanently stored even during a complete power failure FORWARDING ALARMS Alarms can be forwarded by using a nurse call or the ALARMBOX optionally available alarm box This allows even better monitoring of the device at the home or clinic The use of the remote alarm box or a nurse call is especially recom mended when several ventilators are used in one room as this allows the device generating the alarm to be eas ily identified The alarms will be forwarded without delay to the nurse call or the alarm box Instructions on how to connect the HOFFRICHTER alarm HOFFRICHTER box or nurse call can be found on page 54 Figure 46 Alarm box NOTICE The alarm box is an op
49. n and off with the main switch For more information refer to page 62 34 Chapter 3 Description of device LED DISPLAYS A oo H FFRICHTER 21 Alarm LED Figure 5 LED displays The alarm LED lights flashes in the event of an alarm It also provides infor mation on the alarm priority Color Status light Priority Red Flashes HIGH Yellow Flashes MEDIUM Turquoise Glows steadily LOW 22 Power LED The power LED gives information on the status of the power supply Color Status light Status Green Glows steadily Mains operation Yellow Glows steadily Unacknowledged power failure White Flashes Device shuts down None Off Confirmed AC power failure or no mains voltage battery power Chapter 3 Description of device 35 23 36 Battery LED The battery LED provides information on the state of the internal battery charge Color Status light Battery charge state Green Glows steadily gt 60 Yellow Glows steadily gt 20 lt 60 Red Glows steadily gt 0 lt 20 White Flashes Device shuts down Chapter 3 Description of device MOVABLE AND REMOVABLE HOUSING PARTS m e v we Figure 6 Left device side Figure 7 Right device side 24 Handle pull out The handle may be pulled out for device transport 25 Bottom flap Valve membrane expiration is l
50. n data is used for the tube calibration After starting the ventilation a message box see Fig ure 18 is displayed Although the ventilation is continued however the pressure measurement may be incorrect A tube calibration is therefore recommended Attention Tubeless Pressure Measurement Stored Calibration Data are used Press the MFK to Continue Figure 18 Measurement without pressure tube message box To calibrate the tube circuit 1 Disconnect the tube circuit from the patient The patient side connection of the tube circuit must be unobstructed and left open to the air during tube calibration a mask may be connected 2 Navigate to System in the home screen by turning the MFK 3 Press the MFK 52 Chapter 4 Commissioning 4 Navigate to Calibrate Tube by turning the MFK Calibrate Tube FiO2 Monitoring Internal Calibrate FiO Sensor Alarm Volume 3 Brightness Display 50 Brightness LEDs 10 Brightness MFK 10 5 Press the MFK Tube calibration begins Calibrate Tube Run FiO2 Monitoring Internal Calibrate FiO Sensor Alarm Volume 3 Brightness Display 50 Brightness LEDs 10 Brightness MFK 10 6 If the calibration was successful OK will appear after a few seconds If the calibration was not successful Error will display In the event of an error check the entire system Resistance in the overall system may be too high You may for example have to exchange the bacterial
51. n external power source power supply or external bat tery pack it will always use this source first and then switch to the internal battery as needed In each case the used power source being drawn on will be indicated by the power LED or battery LED 40 Chapter 4 Commissioning MAINS OPERATION 1 Insert the power supply plug into the DC connector socket 2 Connect the mains cable to the power supply 8 Insert the mains cable plug into the power socket 100 240 V 50 60 Hz A Power socket B Mains cable C Power supply D Power supply plug E DC connector socket Figure 9 Mains connection via power supply unit 4 The device boots and performs the following hardware tests e Testing the primary and secondary alarm sounds Both alarm sounds give a short beep one by one e Checking of other hardware components If errors are detected during the hardware test they will be displayed at the bottom left of the screen Each error must be confirmed by pressing the MFK Then the system switches to the home screen see page 71 If the error message System locked appears a serious error has occurred The device should not be put into oper ation In this case contact your service provider All error messages listed in the Table 11 on page 115 All three LEDs will glow white during the booting process This allows the user to determine if the LEDs are working correctly Chapter 4 Commissioning 41 SW Version 1 000 HOFFRICHTER
52. n nn nn EE Erinn 77 FIQUIE 3 2 FIOW VOIUME LOOD viaiiicinccsrcnasceeccenevenedenevanednnadnnndnaadanndnnedenedenenennnes 78 Figure 38 Farameter SCIEN sescieccccacecadacncecadacnceendadnenendadadecadadnendadadadedadadnnnanens 79 Figure 39 Alarm OJ SCIECN 0 EE EE EE rE rire 81 PIQUE 4 OF SYSLSIMES CHEM s tactvastntaiwindaladeisdnladwisdaladoisdaladwisdaladosdaladesdaladaidaieatt 84 8 List of figures Figure 41 Statistics screen 1 ventilation parameter sssssesseeeeeeeerereererrrrrrereeee 89 FIQUIS 42 SLOP VERO Meeris eaea eden td ea dd ty td te td data et ol ontd od ol oded od ob oded od boned oeeeds 90 Figure 43 Alarm displays in the toolbar srianan a as 93 Figure 44 Alarm OUTPUTIN THE TOMBE ecce a e 94 Figure 45 Alarm output in the textbox enssenesananannn n 95 Foure 46 ALAM DOX ecc cntaciia cctcntacnmmatin ccnmuntnccmmamacanedees 96 Figure 47 Messages in the TOO al nesie as 101 Figure 48 Filter Cassette StIructulet c cis 107 List of figures 9 LIST OF TABLES Table 1 Operating time with battery power and factory default settings 43 Table 2 Overview ventilation MOCES cccccceceeeeeeeeeeeeeeeaaeeeeeeeeeeeeeanaaaenteeees 64 Table 3 Adjustable alar MS scssi sinini aiaiai a 97 Table 4 Adjustable Alar Sissis ana inana 98 Tables Fixed Alann Seians EELEE 99 Table 6 Fixed AlaScore 100 Ie c E 6 ots E crete cere er A rece ere rece ere reer A A 101 Table 8 Cleaning intervals OVErVVICW 00 aaa 104 Table 9
53. n parameters are shown in real time The monitoring screen is divided into three sections e Measurements e Graphs e Loops MEASUREMENTS DISPLAY The Measurements section displays the following ventilation parameters when ventilation is running Pressure p Inspiration volume V Expiration volume Ve Minute ventilation MV Frequency f Inspiration to expiration ratio I E FiO2 concentration FiO2 only using a FiO2 sensor Oxygen saturation SpOz only using an SpOz2 sensor Heart rate HR only using an SpO2 sensor NOTICE The measured values are displayed on the parameter screen during active ventilation Chapter 6 Device operation 73 How to call up to the data 1 Navigate to Monitoring in the home screen by turning the MFK N 2 Press the MFK 19 8 hPa Graphs l Loops 12 CILS p bem 0 570 6 840 0 570 Mv l v 60 98 76 Fio gt q 1 25 HR z a il A Pressure B Frequency IE ratio D Heart rate E Expiration volume F SpO saturation G Minute ventilation H FiO concentration I Inspiration volume Figure 32 Monitoring screen data 74 Chapter 6 Device operation GRAPHS DISPLAY Depending on your settings Curves will graphically display the following venti lation parameters during running ventilation Pressure p Flow V Volume V Oxygen FiO2 How to call up to the graphs 1
54. ngulation A CAUTION Make sure that the bacterial filter is installed as shown in the illustrations When using bacterial filters and a tube circuit without pressure measuring tube a tube calibration must be performed Otherwise the pressure meas urement values may be incorrect NOTICE Please be sure to replace the bacterial filter daily and follow the manufac turer s user s manual When a nasal or full face mask is used for noninvasive ventilation the mask must not contain any expiration opening Chapter 4 Commissioning 47 CONNECTING A SINGLE LINE PATIENT CIRCUIT CAUTION If the CARAT II pro ventilator is operated with a single line patient circuit it must not be used as a life supporting device Connect the tube circuit to the device according to Figure 14 Note When using a bacterial filter please read the instructions of use of this filter If water collects in the tubes we recommend the use of water traps Single line patient circuits with water traps are available as an accessory see page 124 Should you be using a tube circuit without pressure measuring tube the circuit in use must be calibrated see page 52 A Patient side connection B Expiration valve C Ventilation tube D Bacterial filter E Adapter for bacterial filter F Pressure measuring tube G Control tube H Air outlet Figure 14 Connecting a single line patient circuit 48 Chapter 4 Commissioning CONNECTING A DOUBLE LINE PATIENT CI
55. njuries or death CAUTION This symbol denotes hazardous situations that may lead to light or severe injuries ATTENTION This symbol denotes situations that may lead to material damage or dam age to the device NOTICE This symbol denotes information tips and instructions for the efficient cor rect use of the device 18 Chapter 1 Introduction INTENDED USE NOTICE The use of the device contrary to its intended use can endanger the health of the patient CARAT II pro is used for continuous or intermittent respiratory support and for the ventilation of patients The device is suitable for adults and children from a tidal volume of 50 ml and higher and is designed for home or clinical applications CARAT II pro has both pressure and volume controlled ventilation modes The ven tilation can be invasive e g using a tracheostoma or non invasive using a mask CARAT II pro has the technical prerequisites to allow it to run with a single line patient circuit with exhalation valve or with a double line patient circuit as required The device can be connected to a low pressure source of oxygen for ventilation with increased oxygen concentration There is also the option to combine CARAT II pro with an external humidifier CONTRAINDICATIONS A WARNING Ventilation may be contraindicated for certain pre existing conditions The following conditions may be a contraindication for non invasive ventilation e Sev
56. nsport A 4 Hele a 1100 hPa Air pressure range during storage and transport Q 250 hPa 55 C Temperature range for storage and transport up to 1 month Y 8 fo 45 C Temperature range for storage and transport up to 6 months 35 C Temperature range for storage and transport longer than 6 months nD 8 fo CAUTION CAUTION Device contains lithium ion batteries Lithium ion Batteries DO NOT LOAD OR TRANSPORT PACKAGE IF DAMAGED T E 5 14 Chapter 1 Introduction SYMBOLS ON THE RATING PLATE The rating plate is on the back of the device Ventilator Type 9LV203 HOFFRICHTER Quality makes the Difference m m m m CARAT Ii pro Made in Germany Li lon ICR 18650 14 8V 4400mAh 65 12Wh SN EAG1300001 ry HOFFRICHTER GmbH A dl A IP22 pee chwerin 0123 Germany Figure 1 Rating plate Symbol Meaning Observe the warning and safety instructions in the user s manual Protection class II protective insulation BF application part gt 0 amp Protect against e solid foreign objects with diameters from 12 5 mm e access to hazardous parts with a finger e falling dripping water as long as the housing is tilted up to15 y N N Serial number F 23 CE Declaration of Conformity Manufacturer Do not dispose of the device with the household waste Please contact the relevant customer services de
57. ntlog File Damaged Event read data failed Device must be serviced Primary Alarm Not Working Primary alarm sound unit is defective Device must be serviced Secondary Alarm Not Working Secondary alarm sound transmitter is defective Device must be serviced No Alarm Available Primary and second ary alarm sound units are defective Device must be serviced Chapter 15 Appendix 115 Table 12 Error messages during operation and at device start up Error message 7 Cause O Correction Booting Error Boot failed Device must be serviced Fatal Error Fatal error occurred Device must be serviced Maintenance 5 necessary Maximum blower run times Device must be serviced reached 116 Chapter 15 Appendix TECHNICAL DATA The manufacturer reserves the right to make technical changes without notice Power supply Mains operation 100 240 VAC 20 10 50 60 Hz DC operation 12VDC 10A0r24VDC 5A Internal battery operation Lithium ion battery 14 8 V nominal voltage 4 4 Ah 65 12 Wh External battery operation AKKUPACK uni BASE PLUS 20 26 V nominal voltage 5A Maximum power consumption 75W Electrical protection class Class II Specifications and performance Dimensions W x D x H 304 x 253 x 160 mm Weight 4 72kg Max stable limit pressure 60 hPa Min stable limit pressure OhPa Max working pressure 50 hPa Min wor
58. nto the SD card slot until it clicks into place as shown in Fig ure 21 The toolbar will then show the ej icon Figure 21 Inserting SD card SD and SDHC cards up to 32 GB may be used More information on SD cards is available on page 114 REMOVING THE SD CARD ATTENTION Remove the SD card only when the device is turned off and is disconnected from the main power supply to ensure that the data storage of the SD card is not damaged The device is completely shut down when the power and battery LEDs no longer flash after the device has been turned off Gently press the card into the SD card slot and remove the card Figure 22 Removing SD card 56 Chapter 4 Commissioning USING OXYGEN A WARNING Before using oxygen the safety instructions must be read as of page 26 ATTENTION Oxygen may only be supplied during active ventilation The supply of oxygen is possible in all ventilation modes Please note that any changes to the ventilation parameters as e g pressure E frequency will lead to a change of the FiO concentration CONNECTING THE OXYGEN SOURCE ATTENTION Only the oxygen connection adapter supplied may be used to connect oxygen Otherwise there is a risk that the back stop in the connection is damaged Connect the oxygen source to the device as shown in Figure 23 TSAN SPOG A Oxygen connection B Oxygen connection adapter straight C Tube from the oxygen source Figure 23 Connect
59. ocated under the bottom flap 26 Filter cassette The filter cassette contains the two air filters coarse and fine filter For information on how to replace and clean the filter refer to page 107 Chapter 3 Description of device 37 38 Chapter 3 Description of device CHAPTER 4 COMMISSIONING Before commissioning the device read the safety information as from page 21 onwards Before commissioning the ventilation system ventilator tube humidifier etc check all connections for leaks as well as the stability of the connected accessories Never operate the device without the air filter Only use Original HOFFRICHTER Filters If the device was previously in an environment where the air temperature was not the same as in the new operating location allow approximately 1 hour until the temperatures have evened out before commissioning Chapter 4 Commissioning 39 SETTING UP THE DEVICE Place the device on a flat and stable surface Make sure that the device is placed securely and that the air inlet at the rear of the device is not blocked a if co le SS Figure 8 Setting up the device POWER SUPPLY The ventilator may be supplied by three different power sources e Mains connection via switched mode power supply unit e Internal battery e External battery pack optional accessory The ventilator automatically detects which power sources are available If the device is connected to a
60. ory pressure at the patient connection opening Please ensure that the total resistance of the ventilation system does not exceed 6 hPa with a flow of 60 l min for adults and 30 l min for children Any modification to the device poses a threat to its reliability and is accordingly not permitted Masks may only be used on the prescription of a physician and after training by qualified medical staff Masks may only be used after training by qualified medical staff The intake of medicines and possible contraindications and side effects associated with the use of the prescribed mask should be clarified Please note the operating transport and storage conditions Chapter 2 Safety warnings 23 e Temperatures lower than 5 C and higher than 40 C can impair the function of the device e Please be sure to check the ventilation and alarm parameter settings after all servicing work e Please ensure that no water has accumulated in the pressure measuring tube during ventilation ELECTRICAL SAFETY e Only the supplied power supply unit may be used for operat ing the ventilator e Respiratory therapy may be contraindicated for certain pre existing conditions e The device must never be located near other devices or equipment such as defibrillators diathermy units mobile phones microwaves remote controlled toys etc Electro magnetic fields that exceed 10 V m may adversely affect the operation of the ventilator
61. ow lt 15 l min Bacterial filter Connections 22 15 mm cone according to EN1281 1 Resistance lt 2 3 hPa at 60 l min Compressible volume lt 66 ml Internal volume lt 200 ml 118 Chapter 15 Appendix Measured values Parameter Display area Display Measurement Accuracy increments Pressure O 100hPa 0 1 hPa 0 0 1 0 hPa or 5 of the 100 hPa measured value Pressure O 60 hPa 15 Pa 0 0 1 0 hPa or 5 of the bar 100 hPa measured value Volume 0 2 51 0 011 Calculated 0 03 or 20 of the from flow measured value measurements Flow O 200 l min 11 200 4 l min 200 l min Oxygen 0 100 1 0 100 5 Frequency 0 99 bpm 1 bpm Calculated 1 bom from period duration of inspi ration expira tion in 0 002 s LE 1 0 1 1 25 0 1 Calculated 0 2 from period duration of inspi ration expira tion in 0 002 s MV minute 0 251 0 1 Calculated 0 03 or 20 of the volume from flow measured value measurements SpOs 35 100 1 35 100 2 at 70 100 3 at 50 70 Not defined lt 50 Pulse 30 240 bpm 1 bom 380 240 bpm 2bpm or 2 Leak Rate O 230 l min 1 l min 0 230 l min 10 l min All flow and volume values are measured at 25 C 77 F and 1030 hPa Chapter 15 Appendix 119 STANDARDS The device complies with the following standards e DIN EN 60601 1 2 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral st
62. partment to find out how to properly dispose of the device XKE ss Chapter 1 Introduction 15 SYMBOLS ON THE DEVICE Symbol Meaning Connecting points 4 6 Inspiration tube connection 62 Expiration tube connection Control tube connection t 3 JL Pressure measuring tube connection O FiO sensor connection DC DC connection SpO _ _ Sp0z sensor connection Com Com interface A Remote alarm nurse call connection eo USB interface O 3 FiO gt connection O gt output p I SD card slot 16 Chapter 1 Introduction Symbol Meaning Operation Alarm key ON OFF key A Safe key N Home key k Escape key LEDs Alarm LED Mains LED Battery LED Chapter 1 Introduction 17 SYMBOLS USED IN THIS USER S MANUAL Important information is denoted by symbols in this user s manual Please ensure that you follow these instructions in order to avoid accidents personal injury and material damage In addition the local accident prevention regulations and general safety regula tions in force in the area of use must be observed A This symbol denotes general safety instructions Follow these instructions to avoid accidents personal injury or material damage A DANGER This symbol denotes hazardous situations that lead to serious injuries or death AWARNING This symbol denotes hazardous situations that may lead to serious i
63. patient Disposable No No Every change of double line patient circuit In accordance with manufacturer instructions Mask Daily No Every change of patient In accordance with manufacturer instructions Adapter for AS With every Every change of bacterial filters needed new patient patient EN Oxygen connection AS No Every change of OD adapter needed patient Carrying case AS No Every change of needed patient 104 Chapter 8 Cleaning and disinfection Table 8 Cleaning intervals overview Component Name Clean Disinfect Replace Filter cassette As With every without filter needed new patient Course filter Weekly No Instead of cleaning when patient changes Fine filter No No Monthly if severely contaminated or for a patient change N FiO2 sensor AS No In accordance needed with manufacturer Ss instructions Bacterial filters No No Daily and when ever patient changes Chapter 8 Cleaning and disinfection 105 CLEANING THE DEVICE Domestic use For cleaning the surface of the device use a cloth moistened with soapy water Then wipe with a cloth moistened with clear water in order to remove any remain ing of the soapy water The device must be completely dry before commissioning Clinical use AWARNING Disinfect the device surface on a regular basis or when there is any possi bility of contamination We recommend sch lke wipes Similar disinfectant wipes are also acceptable as
64. ply of oxygen at the oxygen source 2 Continue ventilation for a number of respiratory cycles 3 Stop ventilation 58 Chapter 4 Commissioning CALIBRATING THE FiO SENSOR Calibration is done in relation to the ambient air with an assumption of an oxygen content of 21 Automatic calibration when the device is switched on recommended When the device is switched on and you connect the FiOz2 sensor to the device the FiO2 sensor will be calibrated automatically The FiO2 value readout will be dis played in the monitoring screen Automatic calibration during running ventilation If the FiOz sensor is disconnected and reconnected during ventilation then the oxygen supply is interrupted for at least 30 seconds so that the oxygen content in the FiO therapy air is reduced After successful calibration the oxygen supply is restored and the FiO values will be displayed in the monitoring screen again Manual calibration A manual calibration may be performed in the system screen at any time During continuous oxygen therapy we recommend manual calibration of the FiO2 sen sor once a week To calibrate the FiO sensor 1 Make sure that the ventilator has been switched off 2 Install the FiO2 sensor according to Figure 24 Tip Plug and screw the straight plug of the connecting line A to the device and then connect the right angled to with the FiOz2 sensor A Connecting line B FiO sensor C Housing gas duct DT adapter E Tube circ
65. reath and is ventilated at the set frequency Minimum Volume Not Reached Measured minimum volume lower 3 breaths than set Minimum Volume in a row Chapter 7 Alarms and messages 101 102 Chapter 7 Alarms and messages CHAPTER 8 CLEANING AND DISINFECTION Before cleaning the device remove the power plug from the power supply If ventilation is running insert a spare coarse filter for the duration of the cleaning or insert a complete replacement filter cassette into the device Hygienically preparing and cleaning the device must be performed according to the user s manual and the applicable regulations of the hospital or nursing home The device cannot be sterilized by using standard sterilization methods Do not use any aggressive or abrasive cleaning agents e g acetone Do not immerse the device in water or solvents Follow the accessory manufacturer s instructions for cleaning and disinfection Chapter 8 Cleaning and disinfection 103 OVERVIEW The following overview table describes the cleaning intervals of articles delivered by HOFFRICHTER For articles by other manufacturers please follow their clean ing instructions Table 8 Cleaning intervals overview Component Name Clean Disinfect Replace CARAT II pro AS With every dig Ventilator needed new patient Power supply AS With every i unit needed new patient Mains cable AS With every needed new
66. ress briefly Confirm no longer active alarms Stored alarms press briefly Mute the audible alarm for 2 min Active alarms Press briefly audio alarm pause Cancel the audible alarm suppression Audio alarm paused Press briefly When multiple events occur at the same time only one event is confirmed each time the key is pressed and in the order they are listed above 15 E ON OFF key Function Action Start ventilation Press briefly Stop ventilation Refer to page 90 Chapter 3 Description of device 33 16 Multifunctional key MFK Function Action Select another parameter Turn Set parameters Turn Confirm parameter selection Press briefly Confirm modified parameter value Press briefly Open adjustment window for graphs and loops in the Press briefly monitoring screen The MFK is backlit only when MFK brightness gt 0 The color of the light depends on the operating status or the alarm priority of the currently displayed alarm The backlight intensity of the MFK can be adjusted in the system screen 17 Home key Function Action Return to the home screen Press briefly 18 Escape key Function Action Exit the current screen Press briefly Leave selected parameter Press briefly Cancel Press briefly 19 6l Safe key Function Action Activate key lock Press briefly and confirm with MFK Deactivate key lock Press briefly and confirm with MFK 20 Main switch Switch the device o
67. slot card here can be inserted here a ee 023 FiO connection During oxygen input the oxygen source is connected here Use the supplied oxygen connection adaptor for this purpose Refer to page 57 Chapter 3 Description of device 31 10 11 12 13 32 O2 FiO output Oxygen monitoring This is the exit for excess oxygen from the oxygen valve of the unit when ven tilation has been turned off Pressure monitoring Excess oxygen pressure is exhausted to the outside from this exit during oxy gen therapy This is the case when the pressure is higher than 1 hPa above the set ventilation pressure setting In volume controlled modes the value also opens when the measured breathing volume is more than 10 higher than the set value e lt USB interface Connection of PC A PC may be connected here with a USB cable optional accessory In order to be able to communicate with the device the PC software EASYset must be installed on the PC Connection of remote alarm nurse call An alarm box optional accessory or a nurse call system may be connected here Refer to page 54 RS232 interface service interface Accessories connection Chapter 3 Description of device CONTROL ELEMENTS Figure 4 Control elements 14 6 Alarm key The alarm key has several functions Function Condition Action Confirm all current alarms Active alarms P
68. splay Time Insp Seconds Pev a Hza Figure 40 System screen 84 Chapter 6 Device operation To change the system settings e g alarm volume 1 Navigate to the desired parameter by turning the MFK Calibrate O2 Sensor Alarm Volume 3 Brightness Display 50 Brightness LEDs 10 2 Press the MFK Calibrate O2 Sensor Alarm Volume 3 Brightness Display Brightness LEDs 10 8 Change the setting by turning the MFK Calibrate O Sensor Alarm Volume 3 Brightness Display Brightness LEDs 10 4 Press the MFK to confirm the new setting Chapter 6 Device operation 85 DATE AND TIME CHANGES To change the date and time 1 Navigate to System in the home screen by turning the MFK 2 Press the MFK 3 Navigate to Date and Time by turning the MFK Date and Time 13 02 14 10 36 Number Ventilation Sets 3 User Profile Home Tightness Check Recent Ventilation Hours 65h Ventilation Hours Total 342 h Standby Hours 622 h 4 Press the MFK Date and Time 13 02 1410 36 Year 2014 Number Ventilation Sets 3 Month 2 User Profile Home Day 13 Tightness Check Hour 10 Recent Ventilation Hours 65h Minute 36 Ventilation Hours Total 342 h Standby Hours 622 h 5 Navigate to the desired parameter by turning the MFK Date and Time 13 02 1410 36 1 Year 2014 Number Ventilation Sets 3 Month 2 User Profile Home Day 13 Tightness Check Hour 10 Recent Ventilation Hours 65h Minute 36 Ventilation Hours Total 342
69. ting the humidifier single line patient circuit ee 50 Figure 17 Connecting the humidifier double line patient circuit ee 51 Figure 18 Measurement without pressure tube message DOX ee 52 Figure 19 CONNECTING alami DOX csscaccieas aaaceidnaetata snaar aaa 54 Figure 20 Connecting the SPO2 SENSOF i ee 55 PIQUE 2 12 INSEMING SD Candis s ausctsauaatuanaeanseasacansuieacaavedcauansuncauansencauaumetnseaeaats 56 FIQUIE 22 REMOVING SD CONG iienaa a EEEE EEEE 56 Figure 23 Connecting the oxygen source rear Of unit eee 57 Figure 24 Connecting the FiO sensor single line patient circuit example 59 Figure 252 FUNCTIONAL BaGiisccccccnncctcsnecenenescanenanecadaandenni taunnndedanennendananadenninde 61 Figure 26 Switching on the AeVICE oo iii 62 Figure 27 Switching off the CeVICE rr rr nn rire 62 Figure 28 Ventilation Modes OVEFVIEW oo rr rr rr iii 63 Figure 29 User prolile in the toolbar aieitieisdelsanicdelaniidoleanandeduanneaetaacanaeiadnides 65 Figure 30 Basic sereen IAVOUT isisao Manel Manna Manandaniannieuns 68 aee SL eee E erent tetee rr tntrr teeter eer teen reenter 71 Figure 32 Monitoring Screen data ccceeceeeeeeeeeeeeeetteeeeeeeeeeeetenneeeeeeeeetiea 74 Figure 33 MOnItOFING SCrEEN ape siiicideccnsecrencntrenenenenerenanetenenaneranenannadtaatd 75 Figure 34 Monitoring screen freeze graphs oo ee 76 Figure 35 FlOW VOIUME LOOD ninani eSEE EEE EEEE EEEE 77 Figure 36 Volume PreSSUre LOOD w
70. tional accessory to facilitate remote output of the alarm It does not replace monitoring of the ventilator s primary alarm sound 96 Chapter 7 Alarms and messages ALARM OVERVIEW ADJUSTABLE ALARMS The adjustable alarms are physiologically conditional alarms The alarm limits can only be set by the physician in the parameter screen Table 3 Adjustable alarms Alarm Priority Audible LED alarm Cause Time delay alarm Status Apnoea HIGH caf af Red Set time Apnoea None flashes Alarm has been exceeded High FiO gt MEDIUM Cha Yellow The FiO measured None flashes is higher than the set High FiO LowFiO2 MEDIUM Cba Yellow The FiO measured None flashes is lower than the set Low FiO High MEDIUM caf Yellow Double line circuit for 3 breaths in Leak Rate flashes Difference between arow expiration and inspi ration volume is higher then the set Leak Rate value Single and double line for 3 breaths in circuit when V gt 2 541 a row High MEDIUM caf Yellow Pressure is higher than for 3 breaths in Pressure flashes the set High Pressure a row Tolerance HIGH caf af Red Pressure is higher than for 10 breaths flashes the set High Pressure ina row Tolerance Low MEDIUM caf Yellow Pressure is lower than for 3 breaths in Pressure flashes the set Low Pressure a row Tolerance HIGH caf af Red Pressure is higher than for 10 breaths flashes the set High Pressure in a row Tolerance
71. ty of the device a safety related test or maintenance must be carried out at the prescribed intervals Chapter 2 Safety warnings 27 28 Chapter 2 Safety warnings CHAPTER 3 DESCRIPTION OF DEVICE This chapter describes the connections operation and display elements of the device Chapter 3 Description of device 29 FRONT SIDE CONNECTING POINTS A D H FFRICHTER Figure 2 Connections at the front side of the device 1 30 amp Connection of tube circuit inspiration The single line patient circuit or the inspiration section of a double line patient circuit is connected here Refer to page 48 and page 49 Connection of FiO2 sensor cable Connect the FiO2 sensor cable here for measuring the oxygen concentration Refer to page 59 Connection of pressure measuring tube Refer to page 48 and page 49 S Connection of tube circuit expiration The expiration section of a double line patient circuit will be connected here Refer to page 49 EA Connection of control tube Refer to page 48 Chapter 3 Description of device REAR SIDE CONNECTING POINTS 5 ae o7 a DCO eee Gi Figure 3 Connections at the rear side of the device 6 Dc DC connection he power supply plug is connected here Refer to page 41 4 Wn me 3 N Connection of SpOs sensor SpOz2 sensor can be connected here page 55 gt SD card
72. uit Figure 24 Connecting the FiO sensor single line patient circuit example Chapter 4 Commissioning 59 3 Navigate to the system screen using the MFK Ej Press the MFK 4 Navigate to Calibrate FiO2 Sensor by turning the MFK Calibrate Tube FiOz Monitoring Internal Calibrate FiO Sensor Alarm Volume 3 Brightness Display 50 Brightness LEDs 10 Brightness MFK 10 5 Press the MFK Calibration begins 6 If the calibration was successful OK will appear after a few seconds If the calibration was not successful Error will display In the event of an error repeat the calibration If the calbration is still unsuccessful replace the FiO2 sensor Calibrate Tube 21 Ok FiO2 Monitoring Internal Finish calibration Calibrate FiO Sensor Alarm Volume 3 Brightness Display 50 Brightness LEDs 10 Brightness MFK 10 7 Press the MFK to end the FiO sensor calibration Depending on environmental conditions and the storage time the sensor may take up to 15 minutes after connecting to reach signal stability again NOTICE FiO sensors have a limited service life The service life of the sensors is approx 1 year at a oxygen concentration for about 40 After that the FiO2 sensor must be replaced by a new one The sensor should not be storaged more than 6 month For the longest possible sensor service life we recom mend storage at 5 C to 30 C 60 Chapter 4 Commissioning USING THE FUNCTIONAL BA
73. unisaunanenaemencis 91 ALARMS AND MESSAGES eerren 91 GENEL MATONMMATON easicannsstanineeanannnasavannnaaacasnundavnnnnpancadanndeunnanaanatanndnannanannaalts 92 Alarm Sound TSU ssie uta tatacecnchcna tected etaantaa ukecndes otnantuanteradecttnestuancetnente 92 Audible alarm output audio AlarMS cccecceceeeeeeeeeeeeeeeaaaeeeeeeeeeeeeaaaaaeeeeees 93 Visiblealarrmi OUTOUE sirmione aeaa aa aaaea RES 94 Ae o E A A E 96 FOrWarciiG clei iSeis avs aaavaccatadvacaatea acaatea acaatemvacsuied acsuiem acuuiedvacsaiedvacnaieneacuate 96 Alar OVEMMIOW inaianei on EAEAN EAEAN 97 Messag S aa 101 CHAPTER scx simeecisnyesoteasascresniiscrcactaaasseapioeasaremutes 103 CLEANING AND DISINFECTION cceceeeseeeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeeeeeeenees 103 OVENI ON cis cseca ceernets aaa nancassnn A chs dunn anaenentaanhdainanananeuaannan 104 Cleaning Ne cle lo comer ener eee ree ree rene ree EOE pea Oe pee pee pane pear cert te renee ee renee rey 106 6 Table of contents CIE ARING THE TUBS CIRCUIT sossssninn cots dats dors dah dod date cody dade cedncntedndse ts 106 Cleaning NENA K oerset a slosndecddoindscddnindscddeiadacddecelacddadsbacddacacacddacsdodes 106 Cleaning ne neadgo ai aio a a s 107 Cleaning Replacing the iaf sssrcaceriiiiii i 107 CHAPTER 9 pects destacoenecece sense nesenscccnn uanadeancreamensasauieecnneae 109 ROUTINE CHECKS AND MAINTENANCE WORK cccccceeeesseeeeeeeeeeeeees 109 NVGO nee E EEN 110 Battery Maintenance esisi Ea 11
74. us 64 Chapter 5 Ventilation modes CHAPTER 6 DEVICE OPERATION This chapter decribes the device operation in more detail KEY LOCK The key lock function is designed to protect against the accidental changing of device settings It deactivates all control functions except e ON OFF key to start ventilation e ON OFF key MFK to stop the ventilation e Alarm key LOCK UNLOCK KEYS 1 Press the Safe key Flashes on the toolbar for about 5s 2 Press the MFK during that time USER PROFILES The device can operated in 2 different profiles Clinic and Home The user has access to all device settings in the clinic mode In contrast the ventilation and alarm parameters cannot be set up in the home mode The currently active user profile displays in the toolbar Ay Clinic fj Home Figure 29 User profile in the toolbar Chapter 6 Device operation 65 MENU STRUCTURE e Home screen m Ay Monitoring screen m Measurements p Vj Ve MY f I E FiO2 SoOs HF I Graphs p V V FiO2 Loops V Flow Loop p V Loop E Parameter screen Set 1 m Set 2 Set 3 a Alarm log screen EE g System screen m g Statistics screen K Service screen BASIC OPERATION Use the control elemtents on the right or the touch screen to operate the device OPERATING WITH CONTROL ELEMENTS The control elements functions are described starting with page 33 66 Chapter 6 Device operation

CARAT II pro Patient 1.000 ENG_2014-07-16_01

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