Hoffrichter CARAT II pro User Manual Download Page 70

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Chapter 4: Commissioning

3. Navigate to the system screen using the MFK

. Press the MFK.

4. Navigate to "Calibrate FiO

Sensor" by turning the MFK.

22:33













PCV

Calibrate Tube

Calibrate O

Sensor

FiO

-Monitoring Internal

Alarm Volume

Night Screen

Meaurements

Timer Screen Change

Brightness Display

Brightness LEDs

Brightness MFK 20

Language English

min

5. Press the MFK. Calibration begins.
6. If the calibration was successful, "OK" will appear after a few seconds. If the cali-

bration was not successful, "Error" will display. In the event of an error, repeat
the calibration. If the calbration is still unsuccessful, replace the FiO

sensor.

22:33













PCV

Calibrate Tube

Calibrate O

Sensor

FiO

-Monitoring Internal

Alarm Volume

Night Screen

Meaurements

Timer Screen Change

Brightness Display

Brightness LEDs

Brightness MFK 20

Language English

min

21% Ok

Finish calibration

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.

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

FiO

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.

Summary of Contents for CARAT II pro

Page 1: ...ator Device type 9LV203 HOFFRICHTER GmbH Mettenheimer Straße 12 14 19061 Schwerin Germany Telephone 49 385 39925 0 Fax 49 385 39925 25 Email info hoffrichter de www hoffrichter de CARAT II pro Klinik ENG_2019 11 22_12 0 User s manual CARAT II pro for physicians and medical professionals 5 0 0 0 0 6 2 5 ...

Page 2: ......

Page 3: ...e 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 availa...

Page 4: ... 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 CE mark and number of the notified body The medical device complies with the relevant requirements of th...

Page 5: ...tworks 30 Safety related test 30 CHAPTER 3 31 DESCRIPTION OF DEVICE 31 Front side connecting points 32 Rear side connecting points 33 Control elements 35 LED displays 37 Movable and removable housing parts 39 CHAPTER 4 41 COMMISSIONING 41 Setting up the device 42 Power supply 42 Connecting the tube circuit 49 Setting an alarm to detect disconnection of the tube system 55 Calibrating the tube circu...

Page 6: ...s 93 Ventilation parameters pescription 95 Description of alarm parameters 103 CHAPTER 6 107 DEVICE OPERATION 107 Key lock 107 User profiles 107 Menu structure 109 Basic operation 109 Basic screen layout 112 Explanation of toolbar icons 113 Enabling a screen 115 Monitoring 117 To change ventilator and alarm parameters 126 Activating a ventilation set 129 Changing a ventilation mode during ventilat...

Page 7: ...g the filter 165 Using the device for more than one patient 167 CHAPTER 9 169 ROUTINE CHECKS AND MAINTENANCE WORK 169 Overview 170 Safety related test SRT 171 Replacing the valve membrane expiration 172 Battery maintenance 173 CHAPTER 10 175 APPENDIX 175 Instructions for ventilation outSIde of a clinical setting 176 Technical specifications for the device 176 Data management 179 Error messages 180...

Page 8: ...ure measur ing tube 51 Figure 17 Connecting a double line patient circuit with pressure measur ing tube 51 Figure 18 Connecting the humidifier single line patient circuit 52 Figure 19 Connecting the humidifier double line patient circuit 53 Figure 20 Using HME filter double line patient circuit with pressure measur ing tube 54 Figure 21 Measurement without pressure tube message box 58 Figure 22 Co...

Page 9: ...24 Figure 56 Monitoring screen change the loop 125 Figure 57 Parameter screen 126 Figure 58 Parameter screen 129 Figure 59 Alarm log screen 132 Figure 60 System screen 134 Figure 61 Circuit configuration tightness check single line patient circuit 139 Figure 62 Circuit configuration tightness check double line patient circuit 139 Figure 63 Statistics screen 1 ventilation parameter 143 Figure 64 St...

Page 10: ...Table 7 Adjustable alarms 155 Table 8 Fixed Alarms 157 Table 9 Messages 160 Table 10 Cleaning intervals overview 162 Table 11 Service intervals overview 170 Table 12 Data management 179 Table 13 Error messages during operation and at device start up 180 Table 14 Setting ranges and control accuracy of ventilation parameters 185 Table 15 Setting ranges and control accuracy of alarm parameters 186 Ta...

Page 11: ...Chapter 1 Introduction 11 Chapter 1 INTRODUCTION This chapter contains general information on the use and operation of the ventilator ...

Page 12: ...ration Name CARAT II pro Ventilator Switched mode power supply Mains cable Disposable double line patient circuit for adults with pressure measuring tube L 180 cm 22 mm Adapter for bacterial filter SD card Straight FiO2 connection adapter Carrying case ...

Page 13: ...duction 13 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 ...

Page 14: ...port up to 6 months 20 C 35 C Temperature range for storage and transport longer than 6 months HANDLE WITH CARE IF DAMAGED KEEP UPRIGHT LITHIUM ION RECHARGEABLE BATTERIES INSIDE No lithium metal Do not damage or mishandle this package If package is damaged batteries must be quarantined inspected and repacked For additional emergency information call 49 385 39925 0 ENTHÄLT WIEDERAUFLADBARE LITHIUM ...

Page 15: ...ctive insulation BF application part IP22 Protect against solid foreign objects with diameters from 12 5 mm access to hazardous parts with a finger falling dripping water as long as the housing is tilted up to15 Serial number CE mark and number of the notified body The medical device com plies with the relevant requirements of the EU Directive 93 42 EEC for medical devices Manufacturer Do not disp...

Page 16: ...manual Connecting points Inspiration tube connection Expiration tube connection Control tube connection Pressure measuring tube connection FiO2 sensor connection DC DC connection SpO2 SpO2 sensor connection Com Com interface Remote alarm nurse call connection USB interface O2 O2 connection ...

Page 17: ...Chapter 1 Introduction 17 Symbol Meaning O2 O2 output SD card slot Operation Alarm key ON OFF key Safe key Home key Escape key LEDs Alarm LED Mains LED Battery LED ...

Page 18: ...rved This symbol denotes general safety instructions Follow these instructions to avoid accidents personal injury or material damage This symbol denotes hazardous situations that lead to serious injuries or death This symbol denotes hazardous situations that may lead to serious injuries or death This symbol denotes hazardous situations that may lead to light or severe injuries This symbol denotes ...

Page 19: ... to the patient The ventilation can be invasive e g via a tracheostomy or non invasive via a mask Ventilation is based on ventilation parameters which are set using the controls Ventilation can be monitored on the display using the measurements and graphs If the alarm parameters which have been set and stored in the device are breached visual and acoustic alarms are emitted If the prescribed venti...

Page 20: ... always be used in accordance with the physician s individual diagnosis CONTRAINDICATIONS Ventilation may be contraindicated for certain pre existing conditions The following conditions may be a contraindication for non invasive ventilation Severe cardiac arrhythmia Severe hypotension Severe epistaxis Pneumothorax or pneumomediastinum Pneumoencephalus Cranial trauma Status after cranial or brain s...

Page 21: ...cts on the cardio vascular system USER QUALIFICATIONS The ventilation and alarm parameters must only be set by qualified specialist staff under the supervision of a physician Nursing staff and patients should be instructed in the operation and handling of the device It is essential that these persons are familiar with operation of the device and that they have read and understood the entire user s...

Page 22: ...22 Chapter 1 Introduction ...

Page 23: ...ings 23 Chapter 2 SAFETY INFORMATION This chapter contains safety instructions on the following topics General safety instructions Electrical safety Installation and transport Commissioning Use of oxygen Safety related test ...

Page 24: ... emergency ventilation bag must be available at all times and for use by the attending person 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 The device must only be used on the responsibility and prescription of the physician The device must only be used on pa...

Page 25: ...r 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 After changing any ventilation or alarm parameters the tubing system or the system configuration e g humidifier filter oxygen addition etc the effectiveness of ventilation and alarms should be checked Every two years a safety...

Page 26: ...an impair the function of the device Please be sure to check the ventilation and alarm parameter settings after all servicing work Please ensure that no water has accumulated in the pressure measuring tube during ventilation ELECTRICAL SAFETY Only the supplied power supply unit may be used for operat ing the ventilator Only the CARAT pro and a humidifier should be connected to a multiple socket Ad...

Page 27: ...nt leakage current 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 Do not reach for the device under any circumstances if it falls into water Do not try to open the device Maintenance...

Page 28: ...ect sunlight Use of this device next to other equipment or with other equipment in a stacked form should be avoided as this could result in an abnormal operation If use is still neces sary in the manner described above this device and the other devices should be observed to make sure they are working properly Do not locate the device near water containers baths ...

Page 29: ...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 FiO2 measurement via the optional FiO2 sensor We recommend using this particular sensor exclusively The FiO2 sensor contains a caustic liquid Avoid skin or eye contact if there is a sensor leak Replace the sensor The oxygen supplied mu...

Page 30: ...gs 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 INTEGRATION INTO IT NETWORKS Integrating the device into an IT network that also includes other devices can lead to previously unknown risks The user is therefore responsible for assessing and eval...

Page 31: ...Chapter 3 Description of device 31 Chapter 3 DESCRIPTION OF DEVICE This chapter describes the connections operation and display elements of the device ...

Page 32: ...ine patient circuit is connected here Refer to page 50 and page 51 2 Connection of FiO2 sensor cable Connect the FiO2 sensor cable here for measuring the oxygen concentration Refer to page 69 3 Connection of pressure measuring tube Refer to page 50 and page 51 4 Connection of tube circuit expiration The expiration section of a double line patient circuit will be connected here Refer to page 51 5 C...

Page 33: ...vice 6 DC connection The power supply plug is connected here Refer to page 42 7 SpO2 Connection of SpO2 sensor A SpO2 sensor can be connected here page 60 8 SD card slot An SD card an be inserted here 9 FiO2 connection During oxygen input the oxygen source is connected here Use the supplied oxygen connection adaptor for this purpose Refer to page 65 ...

Page 34: ...trolled modes the value also opens when the measured breathing volume is more than 10 higher than the set value 11 USB interface Connection of PC A PC may be connected here with a USB cable optional accessory Refer to page 64 In order to be able to communicate with the device the PC soft ware easySET must be installed on the PC Only devices conforming to IEC 60601 1 and IEC 60950 1 may be connecte...

Page 35: ...onger active alarms Stored alarms Press briefly Mute the audible alarm for 2 min audio alarm pause Active alarms Press briefly 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 ON OFF key Function Action Start ventilation Press briefly S...

Page 36: ...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 Safe key Function Action Activate key lock Press brie...

Page 37: ...s Red Flashes HIGH Yellow Flashes MEDIUM Turquoise Glows steadily LOW White Glows steadily Device boots 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 Glows steadily Device boots White Flashes Device shuts down None Off Confirmed AC power failure o...

Page 38: ...attery LED provides information on the state of the internal battery charge Color Status light Battery charge state Green Glows steadily 60 Yellow Glows steadily 20 60 Red Glows steadily 0 20 White Glows steadily Device boots White Flashes Device shuts down ...

Page 39: ...y be pulled out for device transport 25 Bottom flap Valve membrane expiration is located under the bottom flap which must be replaced before every change of patient or maintenance work Refer to page 172 26 Filter cassette The filter cassette contains the two air filters coarse and fine filter For infor mation on how to replace and clean the filter refer to page 165 ...

Page 40: ...40 Chapter 3 Description of device ...

Page 41: ...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 ...

Page 42: ...ched mode power supply unit Internal battery External battery pack optional accessory The ventilator automatically detects which power sources are available If the device is connected to an 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 indi...

Page 43: ...s give a short beep one by one 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 115 If the error message System locked appears a serious error has occurred The device should not be put into oper ation In t...

Page 44: ...r 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 90 charging Figure 11 Standby screen 5 Switch on the ventilator by the main switch see page 74 ...

Page 45: ...settings Battery power level Time Alarm 100 10 199 min 10 0 39 min Low Internal Battery 0 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 If the alarm Low Internal Battery appears the ventilator must imm...

Page 46: ...lure 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 ...

Page 47: ...ry see page 197 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 CARAT II pro to operate for up to 8 hours Using AKKUPACK uni BASE together with AKKU PACK uni PLUS doubles operation time to up to 16 hou...

Page 48: ...TERY AKKUPACK uni BASE Connect the AKKUPACK uni BASE to the device according to Figure 13 0 I A K K U PA C K un i B A S E D B A C A DC port B DC cable for ventilation C DC out device connection D AKKUPACK uni BASE Figure 13 Connecting AKKUPACK uni BASE ...

Page 49: ... the neck or limbs of the patient thus avoiding the risk of strangulation 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 Please be sure to replace the bacterial filter daily and follow the ma...

Page 50: ...ation 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 with pressure measuring tube Should you be using a tube circuit without pressure measuring tube Figure 15 the circuit in use must be calibrated see page 55 D PA T I E N T A C B E A Bacterial filter B Expiration val...

Page 51: ...be D Inspiration tube E H Bacterial filters F G Adapters for bacterial filters Figure 16 Connecting a double line patient circuit with pressure measuring tube Should you be using a tube circuit without pressure measuring tube Figure 17 the circuit in use must be calibrated see page 55 B C PA T I E N T A A Bacterial filter B Expiration tube C Inspiration tube Figure 17 Connecting a double line pati...

Page 52: ...acterial 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 18 When using a tube circuit without pressure measuring tube the used tube circuit must be calibrated page 55 I PA T I E N T C A B H J F E D G A Patient side connection B Expiration valve C Ventilation tube D Connecting tube for...

Page 53: ...nnect the tube circuit to the humidifier and the device according to Figure 19 When using a tube circuit without pressure measuring tube the used tube circuit must be calibrated see page 55 H PA T I E N T C D B A I F E G A Patient side connection B Pressure measuring tube C Expiration tube D Connecting tube for inspiration E Bacterial filter F Adapter for bacterial filter G Hydrophobic filter H Hu...

Page 54: ...bserve the manufacturer instruction and follow the respective and recommended replacement intervals Connect all components according to Figure 20 Should you be using a tube cir cuit without pressure measuring tube the circuit in use must be calibrated see page 55 PA T I E N T B D F E A C A Patient side connection B HME filter C Expiration tube D Inspiration tube E Pressure measuring tube F Pressur...

Page 55: ...nection test both at the patient end and at the ventilation device Adjust the alarm settings accordingly If the alarm is not reliably activated alternative monitoring must be carried out Table 2 Alarms for detecting a disconnection Tube system Pressure controlled modes Volume controlled modes Single line patient circuit Min Pressure Apnoea Alarm High Inspiration Volume High Minute Ventilation Low ...

Page 56: ...acterial filter humidifier tube circuit mask FiO2 sensor etc 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 cali bration a mask may be connected 2 Navigate to System in the home screen by turning the MFK 3 Press the MFK 4 Navigate to Calibrate Tube by turning the ...

Page 57: ...hecalibration was not successful Error will display In the event of an error check the entire sys tem Resistance in the overall system may be too high You may for example have to exchange the bacterial filter s or use another humidifier Then rerun the calibration 22 33 PCV Calibrate Tube Calibrate O2 Sensor FiO2 Monitoring Internal Alarm Volume 3 Night Screen Meaurements Timer Screen Change 2 Brig...

Page 58: ...ressure Measurement Stored Calibration Data are used Press the MFK to Continue Figure 21 Measurement without pressure tube message box The message box is disappeared by pressing der MFK Although the ventilation is continued however the pressure measurement could be distorted It is there fore recommended performing a tube calibration 1 Valve and leakage tube system 22 mm l 1 80 m Altitude approx 44...

Page 59: ...Figure 22 Connecting alarm box Alarm boxes are available as an accessory see page 197 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 197 Additional information on alarm boxes and forwarding alarms is available in the section Forwarding alarms on ...

Page 60: ...s 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 In the case of a malfunction abnormal operation dashes are displayed instead of the measured value 0 I A B A SpO2 finger clip sensor B SpO2 sensor connection Figure 23 Connecting the SpO2 sensor ...

Page 61: ... into the SD card slot until it clicks into place as shown in Fig ure 24 The toolbar will then show the icon 0 I Qua lity mak es the Diffe renc e Figure 24 Inserting SD card SD and SDHC cards up to 32 GB may be used More information on SD cards is available on page 179 ...

Page 62: ...2 0 Ramp 3 Minimum Volume Off Sigh Function Off High Inspiration Volume 1 00 hPa hPa bpm s l PCV 60 Remove SD Card Secured SD Card Removal Yes No Figure 25 Removing the SD card safely 2 Navigate to Yes by turning the MFK 3 Press the MFK 4 While this message box is displayed data is still being written on the SD card and the SD card cannot be removed Information SD Card Removal In Process Please wa...

Page 63: ... remove the card 0 I Figure 26 Removing SD card If you would like to remove the SD card after powering off the device please note the following 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 powered off if the power and battery LED do not flash ...

Page 64: ...The detailed procedure is described in the CARAT pro service manual Connect the PC according to Figure 27 to the device You will need a USB cable with a type B plug see page 197 If a communication to easySET exists will displayed in the toolbar 0 I PC D B A C A USB interface B USB type B plug C USB cable PC cable D USB type A plug Figure 27 Connecting a PC ...

Page 65: ...rameters as e g pressure I E frequency will lead to a change of the FiO2 concentration CONNECTING THE OXYGEN SOURCE 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 28 0 I C B A A Oxygen connection B Oxygen connection adapter straight C Tube ...

Page 66: ...g device should be connected accord ing 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 concentration with an external FiO2 monitoring device must be set up in the system screen The factory default is set to a measuring with a ...

Page 67: ...etting by turning the MFK setting to External 22 33 PCV Calibrate Tube Calibrate O2 Sensor FiO2 Monitoring Internal Alarm Volume 3 Night Screen Meaurements Timer Screen Change 2 Brightness Display 20 Brightness LEDs 20 Brightness MFK 20 Language English min Calibrate Tube Calibrate O2 Sensor FiO2 Monitoring External Alarm Volume 3 Night Screen Meaurements Timer Screen Change 2 Brightness Display 2...

Page 68: ...an oxygen sources 1 Switch the device on 2 Start ventilation and wait for several respiratory cycles 3 Start supplying the oxygen STOPPING THE SUPPLY OF OXYGEN 1 Stop the supply of oxygen at the oxygen source 2 Continue ventilation for a number of respiratory cycles 3 Stop ventilation ...

Page 69: ...at the oxygen content in the FiO2 therapy air is reduced After successful calibration the oxygen supply is restored and the FiO2 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 FiO2 sensor...

Page 70: ...ll unsuccessful replace the FiO2 sensor 22 33 60 PCV Calibrate Tube Calibrate O2 Sensor FiO2 Monitoring Internal Alarm Volume 3 Night Screen Meaurements Timer Screen Change 2 Brightness Display 20 Brightness LEDs 20 Brightness MFK 20 Language English min 21 Ok Finish calibration 7 Press the MFK to end the FiO2 sensor calibration Depending on environmental conditions and the storage time the sensor...

Page 71: ... 5 7 9 11 13 15 FiO2 Flow O2 l min f 15 bpm MV 2 5 l min MV 5 0 l min MV 7 5 l min MV 10 0 l min 100 80 60 40 20 0 3 5 7 9 11 13 15 FiO2 Flow O2 l min f 20 bpm MV 2 5 l min MV 5 0 l min MV 7 5 l min MV 10 0 l min 1 The measurement has been performed using a test lung PEEP 3 mbar resistance 20 mbar l s tidal volume max 1000 ml Depending on the condition of the patient s lung the oxygen concentratio...

Page 72: ...min MV 7 5 l min MV 10 0 l min Example 100 80 60 40 20 0 3 5 7 9 11 13 15 FiO2 Flow O2 l min f 25 bpm 78 11 11 l min MV 2 5 l min MV 5 0 l min MV 7 5 l min MV 10 0 l min At an oxygen flow rate of 11 l min and a minute ventilation of approximately 6 l min an oxygen concentration of approximately 78 can be reached ...

Page 73: ...using the device in the functional bag the following instructions must be observed to ensure safe and trouble free operation Set the alarm sound to level 3 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 Use the bag in such a way that the device is protected from...

Page 74: ...entilation please note the section Using oxygen from page 65 To switch on the device 1 Press the main power switch on the back of the device position I Figure 31 0 I I 0 Switching on the device 2 The home screen see page 115 will be displayed SWITCHING THE DEVICE OFF 1 Stop the ventilation 2 Switch off the power with the main power switch on the rear panel position 0 0 I Figure 32 Switching off th...

Page 75: ...ted ventilation modes where the device performs part of the respiratory work alternating or over lapping with the patient s breathing rate Spontaneous ventilation modes where the patient does the respiratory work with the support of the device The patient determines the frequency Respiratory work Device Respiratory work Patient Augmented M a n d a t o r y S p o n t a n e o u s Figure 33 Ventilatio...

Page 76: ...ressure PEEP defines the range of pressure for ventilating the patient The rise in pressure can be selected by setting a ramp defining the form of the flow curve The inspiration volume is automatically adjusted to the condition of the lung com pliance and resistance To ensure a minimum volume it is possible to specify a value and to optionally increase the pressure IPAP Additional Pressure to reac...

Page 77: ...Chapter 5 Ventilation modes 77 20 10 0 0 5 10 15 20 25 IPAP PEEP t s P 6 s 6 s 6 s Ⓜ Ⓜ Ⓜ Ⓜ t s V IPAP 20 hPa PEEP 8 hPa I E 1 2 2 s 4 s f 10 bpm Ⓜ Mandatory ventilation Figure 34 PCV mode diagram ...

Page 78: ...ger threshold and initiate the next inspira tion phase As in the case with exclusively controlled ventilation these additional respiratory strokes are only controlled by the device The inspiration time is defined The patient can only shorten the expiration time by his own breathing efforts thus increasing the set frequency rate Important settings Tips Alarm limit High Inspiration Volume Alarm limi...

Page 79: ... 10 0 0 5 10 15 20 25 IPAP PEEP t s P 6 s 6 s 6 s 6 s Ⓜ Ⓜ Ⓜ t s V Ⓐ Ⓐ IPAP 20 hPa PEEP 8 hPa I E 1 2 2 s 4 s f 10 bpm Spontaneous breathing Ⓜ Mandatory ventilation Ⓐ Pressure controlled assisted ventilation Figure 35 APCV mode diagram ...

Page 80: ...set as a backup frequency As long as the patient reaches or exceeds this frequency the ventilator reacts with the pressure support to each spontaneous inspiration following the patient s breathing If the backup frequency fails to be reached the device assumes mechanical ventilation until it registers the next spontaneous breath To permit respiratory pauses between the patient s breathing efforts a...

Page 81: ...Volume Adjustable Additional Pressure to reach the minimum volume Adjustable Trigger Lock of the inspiration trigger Adjustable Apnoea Time Adjustable minimum Ti Min and maximum Ti Max inspiration time 20 10 0 0 5 10 15 20 25 IPAP PEEP t s P Ⓐ Ⓜ t s V Ⓐ Ⓐ IPAP 20 hPa PEEP 8 hPa Spontaneous breathing Backup frequency Apnoea time Expiration time Apnoea time Expiration time Ⓜ Mandatory ventilation Ⓐ ...

Page 82: ...as those of the PSV mode Inspiration triggers are only actuated by the patient s spontaneous breathing since there is no frequency setting The apnoea time is an alarm parameter Apnoea Alarm Important settings Tips Alarm limit High Inspiration Volume Alarm limit Low Inspiration Volume Alarm limit High Expiration Volume Alarm limit Low Expiration Volume Alarm limit High Frequency Alarm limit Low Fre...

Page 83: ...entilation modes 83 20 10 0 0 5 10 15 20 25 PS PEEP t s P Ⓐ Ⓐ t s V Ⓐ Ⓐ PS 20 hPa PEEP 8 hPa Spontaneous breathing t Apnoea time Apnoea alarm Ⓐ Pressure controlled assisted ventilation Figure 37 PSV S mode diagram ...

Page 84: ...ance and resistance The mechanical ventilation cannot influence by the patient spontaneous breathe Spontaneous breathing on the patient s part is possible between the ventilator strokes if the trigger thresholds for inspiration and expiration triggers are reached During inspiration spontaneous breathing is supported by a pressure PS that can be selected beforehand and is independent of the IPAP Th...

Page 85: ...y Adjustable Trigger Lock of the inspiration trigger Minimum Ti Min and maximum Ti Max inspiration times are adjust able 0 5 10 15 20 25 20 10 0 IPAP PS PEEP t s P 10 s t 10 s t texp Ⓟ Ⓜ Ⓜ t s V Ⓐ IPAP 20 hPa PS 12 hPa PEEP 8 hPa Frequency 6 bpm Spontaneous breathing Expected time window 5 s Ⓜ Mandatory ventilation Ⓟ Pressure supported ventilation Ⓐ Pressure controlled assisted ventilation Figure ...

Page 86: ...requires a defined I E ratio The inspiration volume is defined such that the corresponding pressure is based on the condition of the lung compliance and resistance It is also possible to set the positive end expiratory pressure PEEP The inspiration flow Flow Ramp can be selected as constant flow as decele rating flow or as accelerating decelerating flow Important settings Tips Max Pressure Min Pre...

Page 87: ...Chapter 5 Ventilation modes 87 20 10 0 0 5 10 15 20 25 PEEP t s P 6 s 6 s 6 s Ⓜ Ⓜ Ⓜ Ⓜ t s V PEEP 8 hPa V 1 l I E 1 2 2 s 4 s f 10 bpm Ⓜ Mandatory ventilation Figure 39 VCV mode diagram ...

Page 88: ...r the patient can stop expiration by inspi ration efforts once he reaches the trigger threshold and initiate the additional breathes This additional breathes are only controlled by the device The inspiration time is defined by the device The patient can only shorten the expiration time by his own breathing efforts thus increasing the set frequency Important settings Tips Max Pressure Min Pressure ...

Page 89: ...lation modes 89 20 10 0 0 5 10 15 20 25 PEEP t s P Ⓜ Ⓐ Ⓜ Ⓜ Ⓐ t s V 6 s 6 s 6 s 6 s PEEP 8 hPa V 1 l I E 1 2 2 s 4 s f 10 bpm Ⓜ Mandatory ventilation Ⓐ Volume controlled assisted ventilation Figure 40 AVCV mode diagram ...

Page 90: ...etermined and selectable pressure PS which is independent from the IPAP Only the patient can predefine the length of the ventilations as well as the duration of the inspiration The mechanical breaths are adjusted to spontaneous breathing in terms of time If for example a spontaneous inspiration occurs shortly before a SIMV period is started within a specific expected time window 5 seconds the mech...

Page 91: ...PEEP t s P 10 s t 10 s Ⓟ Ⓟ Ⓟ Ⓜ Ⓜ t s V t texp Ⓐ PS 12 hPa PEEP 8 hPa Frequency 6 bpm Spontaneous breathing Expected time window 5 s Ⓜ Mandatory ventilation Ⓟ Pressure supported ventilation Ⓐ Volume controlled assisted ventilation Figure 41 V SIMV mode diagram ...

Page 92: ...itive Airway Pressure Main features Pressure controlled Independent respiration In the CPAP mode the device provides continuous positive pressure The patient must be able to breathe spontaneously 20 10 0 Druck t P Pressure 8 hPa Figure 42 CPAP mode diagram ...

Page 93: ...rview of the ventilation and alarm parameter adjustable Parameter PCV APCV PSV PSV S P SIMV VCV AVCV V SIMV CPAP Tidal Volume Pressure IPAP PS PEEP Frequency Apnoea Alarm Time Inspiration Ti Max Ti Min I E Ramp Flow Ramp Inspiration Trigger Expiration Trigger Trigger Lock SMART Function Minimum Volume Additional Pressure Sigh Function Max Pressure Min Pressure Apnoea Alarm ...

Page 94: ...V S P SIMV VCV AVCV V SIMV CPAP High Frequency Low Frequency High Inspiration Volume Low Inspiration Volume High Expiration Volume Low Expiration Volume High Minute Ventilation Low Minute Ventilation Leak Rate High FiO2 Low FiO2 High SpO2 Low SpO2 High Heart Rate Low Heart Rate High Pressure Tolerance Low Pressure Tolerance ...

Page 95: ...echanical ventilation during inspiration and exxpiration IPAP PCV PSV PSV S APCV P SIMV IPAP Inspiratory Positive Airway Pressure is the ventilation pressure in the PCV APCV PSV PSV S and P SIMV mode which is applied to the patient with each breath during inspiration The set IPAP value is not summed up to the set PEEP but it represents the maximum inspiratory pressure PS P SIMV V SIMV PS Pressure ...

Page 96: ... the patient can increase the frequency by means of spontaneous inspiration APNOEA TIME PSV The apnoea time is intended to provide an additional time interval for patient who can spontaneously breaths after the mandatory period has expired The apnea time begins at the end of the inspiration period The device begins ventilation if there are no patient breaths for the duration of the apnoea time If ...

Page 97: ... inspiration phase The pressure increase time ia determined by set ting the ramp level which stored as a flow curve The pressure increase time also depends on the resistance and the compliance of the patient s lung When setting a ramp the currently set inspiration time must be taken into con sideration The following examples shows the change in the pressure increase time depend ing on various ramp...

Page 98: ...rt from the ventilator in the case of spontaneous breathing Please always consider the patient s clinical record when setting the trigger levels in order to avoid the risk of auto triggering Once the set inspiratory trigger threshold see Table 5 is reached the device starts the inspiratory phase Table 5 Thresholds inspiratory trigger Level Volume threshold value Flow change in 30 ms 1 5 ml 20 1 2 ...

Page 99: ...ion t V 20 40 80 Expiration trigger threshold Figure 43 Flow trigger setting a percentage value TRIGGER LOCK APCV PSV PSV S AVCV P SIMV V SIMV The trigger lock is especially applicable in the ventilation of patients with obstruc tive pulmonary diseases e g COPD In these patients fluctuations often occur during the expiration phase This leads to the device registering spontaneous res piration and t...

Page 100: ...s lead to a breath triggering in the absence of effort by the patient during expiration Without SMART Function The inspiration trigger is initiated by artefacts t s V ml Volume curve Trigger activity t s Trigger threshold Trigger threshold V ml Artefacts Spontaneous breathing IPAP 20 hPa Inspiration trigger Level 9 Triggered by artefacts Trigger by patient spontaneous breathing Figure 44 Inspirati...

Page 101: ...ng to the following conditions A time period T is calculated depending on the IPAP and starting with the expi ration period If the inspiration trigger threshold is reached an additional IPAP dependent time period t is calculated If a patient effort meets the trigger con dition within this time period t an inspiration trigger will initiate If this is not the case the device supposes an artefact and...

Page 102: ... volume controlled mode and the sigh function is activated 150 of the set volume is administered in the inspiration phase at each 100th breath If using a pressure controlled mode the IPAP is increased so that approx 150 of the messured tidal volume of the previously breath is reached This may help to reo pen or keep open any collapsing pulmonary alveolar If in the P SIMV and V SIMV modes the 100th...

Page 103: ...han the Low Frequency setting the Low Frequency alarm will be triggered HIGH INSPIRATION VOLUME PCV APCV PSV PSV S P SIMV CPAP If the measured tidal volume is higher than the High Inspiration Volume setting the High Inspiration Volume alarm will be triggered LOW INSPIRATION VOLUME PCV APCV PSV PSV S P SIMV CPAP If the measured tidal volume is lower than the Low Inspiration Volume setting the Low I...

Page 104: ...Minute Ventilation setting the Low Minute Ventilation alarm will be triggered LEAK RATE PCV APCV PSV PSV S VCV AVCV P SIMV V_SIMV CPAP Double line patient circuit If the difference between the expiration and inspiration volume is higher then the Leak Rate setting the Leak Rate alarm will be triggered Single line patient circuit If the inspiration volume is higher than 2 54 l the Leak Rate alarm wi...

Page 105: ...n the High Heart Rate setting the High Heart Rate alarm will be triggered LOW HEART RATE PCV APCV PSV PSV S VCV AVCV P SIMV V SIMV CPAP If the measured pulse frequency is lower than the Low Heart Rate setting the Low Heart Rate alarm will be triggered HIGH PRESSURE TOLERANCE PCV APCV PSV PSV S VCV AVCV P SIMV V SIMV CPAP If the measured pressure is higher than the set pressure plus the setting Hig...

Page 106: ...106 Chapter 5 Ventilation modes ...

Page 107: ...ilation Alarm key LOCK UNLOCK KEYS 1 Press the Safe key Flashes on the toolbar for about 5 s 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 t...

Page 108: ...on 2 002 Serial Number EAG1300001 10 36 h h h h 4 Press the MFK 22 33 Date and Time 13 02 14 Number Ventilation Sets 3 User Profile Clinic Tightness Check Recent Ventilation Hours 65 Ventilation Hours Total 342 Operating Counter 622 Blower Service in 14658 SW Version 1 000 Serial Number EAG1300001 10 36 h h h h 5 Change the setting by turning the MFK 22 33 PCV Date and Time 13 02 14 Number Ventila...

Page 109: ...V V FiO2 Loops V Flow Loop p V Loop Parameter screen Set 1 Set 2 Set 3 Alarm log screen System screen Statistics screen 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 35 ...

Page 110: ... 6 9 12 15 18 21 24 27 30 p hPa Flow l min V l t s 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 Error Error FiO2 Sensor Primary Alarm Not Working Press the MFK to Continue 60 22 33 PCV Measurements Loops Graphs 24 18 12 6 0 0 3 6 9 12 15 18 21 24 27 30 p hPa Flow l min V l t s 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 600 300 0 300 600 0 3 6 9 ...

Page 111: ...0 hPa hPa bpm s l PCV 60 Remove SD Card Secured SD Card Removal Yes No Switching on night screen 22 33 Set 1 Set 2 Set 3 Mode PCV IPAP 20 0 PEEP 5 0 Frequency 12 Time Inspiration 2 0 Ramp 3 Minimum Volume Off Sigh Function Off High Inspiration Volume 1 00 hPa hPa bpm s l PCV 60 Switching off night screen 22 33 PCV 60 p hPa f bpm I E 6 840 MV l 0 570 VI l l VE l Leck l min SpO2 HR bpm FiO2 bpm 15 1...

Page 112: ...C SCREEN LAYOUT 22 33 1 45 Low Frequency PCV Monitoring Statistics Parameter Alarm Log System Service A B D C 60 A Pressure bar during running ventilation B Screen content C Toolbar D Active ventilation mode Figure 47 Basic screen layout ...

Page 113: ...of all controls are disabled except for the ON OFF and alarm key A FiO2 sensor is connected and FiO2 Monitoring setting has been set to Internal in the system screen The FiO2 Monitoring setting has been set to External in the system screen Measurement of oxygen concentration is performed using an external FiO2 Monitoring unit A FiO2 sensor is connected the FiO2 Monitoring setting has been set to I...

Page 114: ...erted into the device No SD card inserted into the device Sp O2 SpO2 sensor connected PC is connected via the USB port Error detected Selecting this icon results in a list of all current errors see Error messages on page180 Internal battery fully charged 1 bar 20 of charge green bar charge level 60 yellow bar charge level 20 60 red bar charge level 0 20 Internal battery being charged ...

Page 115: ... 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 22 33 PSV Monitoring Statistics Parameter Alarm Log System Service 60 A A Selected screen icon F...

Page 116: ...reen CHANGING THE TIMER SCREEN The factory default setting of Time Screen Change is 120 seconds The device switches 120 seconds after the last operation to the following screens to the monitoring screen measured values during ventilation or to the home screen in standby mode This time can be set in the system screen A screen switch can be disabled by setting the Timer Screen Change parameter to Of...

Page 117: ...ction displays the following ventilation parameters when ventilation is running Pressure p Inspiration volume VI Expiration volume VE Minute ventilation MV Frequency f Inspiration to expiration ratio I E FiO2 concentration FiO2 only using a FiO2 sensor Oxygen saturation SpO2 only using an SpO2 sensor Heart rate HR only using an SpO2 sensor The measured values are displayed on the parameter screen ...

Page 118: ...0 VI l VE l Leck l min SpO2 HR bpm FiO2 15 19 8 12 1 1 5 0 570 Measurements Loops Graphs C A B 60 PSV A configured neasuring value B configured measuring value configured sensor not connected C no configured measuring value Figure 49 Monitoring screen data factory setting Figure 49 shows the factory default configuration The measured value can also be configured as follows ...

Page 119: ... Loops Graphs 60 19 8 hPa PSV 2 Navigate to the measured value box that you would like to configure by tur ning the MFK Press the MFK to activate the measured value box 3 Change the measured value by turning the MFK 22 33 p hPa f bpm I E 6 840 MV l 0 570 VI l VE l Leck l min SpO2 HR bpm FiO2 15 19 8 12 1 1 5 0 570 Measurements Loops Graphs 60 19 8 p hPa Settings Measuring Value Pressure PSV 4 Pres...

Page 120: ...How to call up to the graphs 1 Navigate to Monitoring in the home screen by turning the MFK 2 Press the MFK 3 Navigate to Graphs by turning the MFK 22 33 PCV Measurements Loops Graphs 24 18 12 6 0 0 3 6 9 12 15 18 21 24 27 30 p hPa Flow l min V l t s 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 A 60 A Automatic scaling is on Figure 50 Monitoring scr...

Page 121: ... s 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 Settings Graph 1 Graph 2 Type Pressure Auto Scale On Graph 3 Time A 60 A Automatic scaling is on Figure 51 Monitoring screen change the parameters 2 You can switch between Graph 1 Graph 2 Graph 3 and Time by turn ing the MFK 3 Press the MFK 4 Navigate to the desired line by turning the MFK 5 Press the ...

Page 122: ... PCV Measurements Loops Graphs 24 18 12 6 0 0 3 6 9 12 15 18 21 24 27 30 p hPa Flow l min V l t s 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 60 Figure 52 Monitoring screen freeze graphs 2 Press the start symbol to restart the real time curve ...

Page 123: ... Volume Loop Volume Pressure Loop Flow Volume Loop 22 33 PCV Measurement Loops Graphs 100 50 0 50 100 0 0 200 0 400 0 600 l min Flow V l 60 Current breath Last breath Figure 53 Flow Volume Loop Volume Pressure Loop 22 33 PCV Measurements Loops Graphs 0 800 0 600 0 400 0 200 0 0 5 10 15 20 25 l V p hPa 60 Current breath Last breath Figure 54 Volume Pressure Loop ...

Page 124: ...up to Loops 1 Navigate to Monitoring in the home screen by turning the MFK 2 Press the MFK 3 Navigate to Loops by turning the MFK 22 33 PCV Measurement Loops Graphs 100 50 0 50 100 0 0 200 0 400 0 600 l min Flow V l 60 Figure 55 Flow Volume Loop ...

Page 125: ...e display 22 33 PCV Measurement Loops Graphs 100 50 0 50 100 0 0 200 0 400 0 600 l min Flow V l Settings Type Flow Volume Auto Scale On 60 Figure 56 Monitoring screen change the loop 2 Navigate to the desired line by turning the MFK 3 Press the MFK to activate the line 4 Change the parameter by turning the MFK 5 Press the MFK to confirm the setting ...

Page 126: ... to the ventilator and alarm parameters 1 Navigate to Parameter in the home screen by turning the MFK 2 Press the MFK 22 33 Set 1 Set 2 Set 3 Mode PCV IPAP 20 0 PEEP 5 0 Frequency 12 Time Inspiration 2 0 Ramp 3 Minimum Volume Off Sigh Function Off High Inspiration Volume 1 00 hPa hPa bpm s l PCV 19 8 p 12 f bpm hPa 6 840 MV 1 1 5 I E 0 570 VI l l 0 570 VE l 76 HR 98 SpO2 bpm 60 FiO2 15 Leck l min ...

Page 127: ... 3 Navigate to the desired ventilation or alarm parameter by turning the MFK 22 33 Set 1 Set 2 Set 3 Abhängigkeiten PCV Mode PCV IPAP 20 0 EPAP 5 0 Frequency 12 Time Inspiration 2 0 Ramp 3 Minimum Volume Off Sigh function Off High Inspiration Volume Off hPa hPa bpm s Dependencies 60 4 Press the MFK The value is highlighted 22 33 Set 1 Set 2 Set 3 Dependencies PCV Mode PCV IPAP 20 0 EPAP 5 0 Freque...

Page 128: ...by turning the MFK 22 33 Set 1 Set 2 Set 3 Dependencies PCV Mode PCV IPAP 20 0 EPAP 5 0 Frequency 14 Time Inspiration 2 0 Ramp 3 Minimum Volume Off Sigh function Off High Inspiration Volume Off hPa hPa bpm s 60 6 Press the MFK to confirm the new setting ...

Page 129: ...mp 3 Minimum Volume Off Sigh Function Off High Inspiration Volume 1 00 hPa hPa bpm s l PCV 60 Figure 58 Parameter screen The active setting is highlighted in green and has a check mark To activate a ventilation set 1 Navigate to the ventilation set you wish to activate by turning the MFK Set 1 Set 2 Set 3 hPa hPa bpm s s s s Activate Set No Mode PSV IPAP 20 0 PEEP 5 0 Frequency 12 Time Inspiration...

Page 130: ...EEP 5 0 Frequency 12 Time Inspiration 2 0 Ti Max 4 0 Ti Min 1 0 Apnoea Time 10 60 3 Change the setting to Yes by turning the MFK 22 33 Set 1 Set 2 Set 3 hPa hPa bpm s s s s Activate Set Yes Mode PSV IPAP 20 0 PEEP 5 0 Frequency 12 Time Inspiration 2 0 Ti Max 4 0 Ti Min 1 0 Apnoea Time 10 60 4 Press the MFK to confirm the new setting ...

Page 131: ...20 0 PEEP 5 0 Frequency 12 Time Inspiration 2 0 Ramp 3 Minimum Volume Off Sigh Function Off High Inspiration Volume 1 00 hPa hPa bpm s l PCV 60 4 Set the desired ventilation mode by turning the MFK 5 Press the MFK High FiO2 Off Low FiO2 Off Low SpO2 Off High Pressure Tolerance 3 0 Low Pressure Tolerance 3 0 Confirm Settings hPa hPa Mode Change Press to Cancel 6 Make sure the ventilation and alarm ...

Page 132: ...Inspiration Volume Low Pressure Power Failure High Minute Ventilation Stenosis Low Inspiration Volume Disconnection Check Expiration Outlet Low Pressure 04 07 13 22 35 04 07 13 23 16 05 07 13 02 24 05 07 13 05 04 05 07 13 21 55 06 07 13 02 46 08 07 13 03 24 12 07 13 00 10 12 07 13 04 12 18 07 13 22 18 PCV A B A Alarm priority B Selected alarm Figure 59 Alarm log screen For more information on the ...

Page 133: ...ast operation and set Time Screen Change Brightness Display Brightness of the display Brightness LEDs Brightness of the alarm LED power LED and battery LED Brightness MFK Background lighting brightness of the multifunctional knob Language Setting the device language Pressure Unit Setting the device pressure unit Volume Unit Setting the volume unit Display Time Insp Setting to etablish whether the ...

Page 134: ... must be replaced SW Version Software version of the device Serial Number Serial number of the device 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 22 33 PCV Calibrate Tube Calibrate O2 Sensor FiO2 Monitoring Internal Alarm Volume Night Screen Measurements Timer Screen Change 2 Brightness Display 20 Brightnes...

Page 135: ... 3 min 60 2 Press the MFK 22 33 PCV Calibrate Tube Calibrate O2 Sensor FiO2 Monitoring Internal Alarm Volume 3 Night Screen Measurements Timer Screen Change 2 Brightness Display 20 Brightness LEDs 20 Brightness MFK 20 Language English min 60 3 Change the setting by turning the MFK 22 33 PCV Calibrate Tube Calibrate O2 Sensor FiO2 Monitoring Internal Alarm Volume 1 Night Screen Measurements Timer S...

Page 136: ...mo notturno Misurazioni Modifica schermo timer 2 Luminosità Display 20 Luminosità LEDs 20 Luminosità MFK 20 Lingua Italiano min 60 3 Change the language setting by turning the MFK 22 33 PCV Calibrare circuito paziente Calibrare Sensore O2 Monitoraggio FiO2 Interno Volume Allarme 3 Schermo notturno Misurazioni Modifica schermo timer 2 Luminosità Display 20 Luminosità LEDs 20 Luminosità MFK 20 Lingu...

Page 137: ...ess the MFK 22 33 PCV Year 2016 Month 2 Day 13 Hour 10 Minute 36 Date and Time 13 02 14 Number Ventilation Sets 3 User Profile Clinic Tightness Check Recent Ventilation Hours 65 Ventilation Hours Total 342 Operating Counter 622 Blower Service in 14658 SW Version 1 000 Serial Number EAG1300001 10 36 h h h h 60 5 Navigate to the desired parameter by turning the MFK 22 33 PCV Year 2016 Month 2 Day 13...

Page 138: ...Blower Service in 14658 SW Version 1 000 Serial Number EAG1300001 10 36 h h h h 60 7 Change the setting by turning the MFK 22 33 PCV Year 2016 Month 2 Day 28 Hour 10 Minute 36 Date and Time 13 02 16 Number Ventilation Sets 3 User Profile Clinic Tightness Check Recent Ventilation Hours 65 Ventilation Hours Total 342 Operating Counter 622 Blower Service in 14658 SW Version 1 000 Serial Number EAG130...

Page 139: ...ck 1 Connect the tube circuit to the device D C E B A A End cap supplied with the tube circuit B Expiration valve C Control tube D Ventilation tube E Pressure measuring tube Figure 61 Circuit configuration tightness check single line patient circuit C B D A A End cap supplied with the tube circuit B Pressure measuring tube C Expiration section D Inspiration section Figure 62 Circuit configuration ...

Page 140: ...ersion 2 002 Seriennummer EAG1300001 10 36 h h h h Läuft Test beenden 22 7 p 0 Flow l min hPa The pressure is gradually inceased to the maximum pressure by the device Observe the flow value If the flow value exceeds 5 l min during the tightness check there is a leak in the tube circuit In that case check the entire circuit for leaks in tubes and at tube connections As long as the flow remains unde...

Page 141: ... ventilation hours 1 Navigate to System in the home screen by turning the MFK 2 Press the MFK 3 Navigate to Recent Ventilation Hours by turning the MFK 22 33 60 PCV Date and Time 13 02 14 Number Ventilation Sets 3 User Profile Clinic Tightness Check Recent Ventilation Hours 65 Ventilation Hours Total 342 Operating Counter 622 Blower Service in 14658 SW Version 1 000 Serial Number EAG1300001 10 36 ...

Page 142: ...istical data distribution during ventila tion sessions An example based on frequency 25 20 15 10 0 08 f bpm during 95 of the day s therapy duration the frequency was 24 bpm and 5 was 24 bpm during 75 of the day s therapy duration the frequency was 22 bpm and 25 was 22 bpm during 50 of the day s therapy duration the frequency was 15 bpm and during 50 15 bpm during 25 of the day s therapy duration t...

Page 143: ...Navigate to the home screen by turning the MFK to System 2 Press the MFK 22 33 PCV 25 20 15 10 0 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 f bpm Jan 16 Feb 16 5 25 75 50 95 60 Figure 63 Statistics screen 1 ventilation parameter ...

Page 144: ... 000 2 000 0 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 MV l f bpm Jan 16 Feb 16 5 25 75 95 50 Settings Percentile 2 Frequency Percentile 1 Minute Ventilation 60 Figure 64 Statistics screen 2 ventilation parameter 2 You can switch between Percentile 1 and Percentile 2 by turning the MFK 3 Press the MFK to activate the line 4 Change the parameter by tu...

Page 145: ...ertheless all important functions such as the pressure bar and toolbar are very easy to read The night screen is displayed both in standby mode and during ventilation NIGHT SCREEN LAYOUT SETTING The following night screen layouts can be set in the system screen Measurements Light with moon Dark without moon 22 33 PCV 60 p hPa f bpm I E 6 840 MV l 0 570 VI l l FiO2 bpm SpO2 HR bpm 19 8 12 1 1 5 22 ...

Page 146: ...creen by turning the MFK and then press the MFK 4 Change the parameter by turning the MFK to Measurements Light or Dark 5 Press the MFK to confirm the setting SWITCHING THE NIGHT SCREEN ON AND OFF To switch on the night screen Touch in the toolbar see page 111 To switch off the night screen Touch in the toolbar see page 111 or press any control element except Safe key ...

Page 147: ... device using the main power switch on the rear of the device 2 Press the ON OFF key Ventilation begins STOPPING VENTILATION 1 Press the ON OFF key 22 33 PCV Measurements Loops Graphs 24 18 12 6 0 0 3 6 9 12 15 18 21 24 27 30 p hPa Flow l min V l t s 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 Stop Ventilation Stop Ventilation Yes No 60 Figure 68 S...

Page 148: ...148 Chapter 6 Device operation ...

Page 149: ...Chapter 7 Alarms and messages 149 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 ...

Page 150: ...UM 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 Alarms will lowered in the priority when the alarm event is no longer fulfilled The alarm will stay in active until it has been confirmed with the alarm key ALARM SO...

Page 151: ...n 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 correct...

Page 152: ...ses to signify the current alarm priority Red flashes rapidly 2 Hz high priority alarm Yellow flashes 0 5 Hz medium priority alarm Turquoise glows steadily 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 37 ALARM OUTPUT IN THE TOOLBAR Alarms are ...

Page 153: ...s to the highest priority alarm Red textbox high priority alarm Yellow textbox medium priority alarm Turquoise textbox low priority alarm If multiple alarms occur at the same time the alarms are sorted and displayed in order of priority 22 33 PCV Measurements Loops Graphs 24 18 12 6 0 0 3 6 9 12 15 18 21 24 27 30 p hPa Flow l min V l t s 600 300 0 300 600 0 3 6 9 12 15 18 21 24 27 30 600 300 0 300...

Page 154: ...WARDING ALARMS Alarms can be forwarded by using a nurse call or the 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 ...

Page 155: ...an the set Low FiO2 None High Leak Rate MEDIUM c a f Yellow flashes Double line circuit Difference between expiration and inspi ration volume is higher then the set Leak Rate value for 3 breaths in a row Single and double line circuit when VI 2 54 l for 3 breaths in a row High Pressure MEDIUM c a f Yellow flashes Pressure is higher than the set High Pressure Tolerance for 3 breaths in a row HIGH c...

Page 156: ...hes Ventilation minute vol ume is higher than the High Minute Ventila tion for 3 breaths in a row Low Minute Ventilation MEDIUM c a f Yellow flashes Ventilation minute vol ume is lower than the Low Minute Ventila tion for 3 breaths in a row High Expiration Volume MEDIUM c a f Yellow flashes Expiration volume is higher than the High Expiration Volume for 3 breaths in a row Low Expiration Volume HIG...

Page 157: ...an 3 breaths Check tube cir cuit and tubing for obstructions Error Internal Communi cation HIGH c c c c c Red flashes Communication with the control unit has been interrupted for more than 10s Restart the device in the event of a recur rence the device must be ser viced Disconnect HIGH c a f a f Red flashes Inspiration and or expiration lines of the tube circuit are not connected to the device Con...

Page 158: ...IUM C c c Yellow flashes Device operat ing on battery power supply battery charge 10 Battery must be recharged Alarm remains until the battery charge is 10 Mains Failure MEDIUM C c c Yellow flashes Power supply from the mains AC connection has failed Restore mains power supply Check Tube System MEDIUM c a f Yellow flashes Expiratory flow during inspiration detected or expi ration flow too low duri...

Page 159: ...he device Check SpO2 sensor 2 MEDIUM C b a Yellow flashes SpO2 sensor disconnected from the decice Connect the SpO2 sensor to the device SpO2 sensor disconnected from the patient Connect the SpO2 sensor to the patient 1 The alarm message is only possible if at least one of alarms High FiO2 or Low FiO2 is enabled 2 The alarm message is only possible if at least one of alarms High SpO2 Low SpO2 High...

Page 160: ...PCV Monitoring Statistics Parameter Alarm Log System Service Minimum Volume Not Reached A A Message Figure 73 Messages in the toolbar MESSAGES OVERVIEW Table 9 Messages Messages Cause Time delay Back up Frequency Active Device operates in PSV mode patient has no spontaneous breath and is ven tilated at the set frequency None Minimum Volume Not Reached Measured minimum volume lower than set Minimum...

Page 161: ...acement 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 acces...

Page 162: ...ator As needed With every new patient Power supply unit As needed With every new patient Mains cable As needed With every new patient Disposable double line circuit No No Every change of patient In accordance with manufacturer instructions Mask Daily No Every change of patient In accordance with manufacturer instructions Adapter for bacterial filters As needed With every new patient Every change o...

Page 163: ...e without filter As needed With every 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 FiO2 sensor As needed No In accordance with manufacturer instructions PA T I E N T Bacterial filters No No Daily and when ever patient changes ...

Page 164: ...ell The device must be com pletely dry before commissioning CLEANING THE TUBE CIRCUIT 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 de...

Page 165: ...4 Filter cassette structure CLEANING THE COARSE FILTER 1 Pull the filter cassette from the device 2 Remove the coarse filter black from the filter cassette 3 Clean the filter with mild soapy water Do not use any other agents 4 Rinse the filter thoroughly with clear water 5 Let the filter dry completely in the air 6 Insert the cleaned filter back into the filter cassette 7 Slide the filter cassette...

Page 166: ...ilter black 3 Remove the fine filter white and replace it with a new one 4 Insert the coarse filter back into the cassette 5 Slide the filter cassette into the device 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...

Page 167: ...stistant bacteria or contamination due to a reportable infectious disease is suspected the device must be packaged with the appropriate labeling and disinfected accordingly Before using the device for another patient you must complete the following pro cedures Component What action is required Bacterial filters Replace Mask Replace or recondition according to the manufacturer s guide lines if poss...

Page 168: ...168 Chapter 8 Cleaning and disinfection ...

Page 169: ...ance are necessary in order to maintain safe functioning of the device This chapter describes which and when tests and maintenance works must be performed 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 ...

Page 170: ...d Replace fine filter see page 166 User Every 6 months Battery quick test see page 174 User Provider Every 6 months during in storage Charge battery to 100 see page 173 User Provider Every 6 months without bac terial filter Replace the valve membrane expi ration see page 172 Provider Service Every 2 years Maintenance 2 refer to the service manual Provider Service Safety related test see page 171 P...

Page 171: ...y related test every two years carried out by an authorized service technician The safety related check comprises a visual check for outside damage of the ventilator a functional check and a visual inspection of the accessories according to manufacturer s instruc tions tube circuit FiO2 sensor etc All measures to be performed for the safety related check are described in the CARAT pro service manu...

Page 172: ...ottom flap B Valve cover C Valve membrane Figure 75 Replacing valve membrane expiration Replace the valve membrane as follows 1 Turn the device over and place it on a soft surface 2 Remove the bottom flap 3 Turn the valve cover to the left and lift it off 4 Replace the valve membrane with a new one Make sure it is placed into the correct position 5 Reinstall the valve cover and the bottom flap ...

Page 173: ...he batteries must be replaced and disposed when the battery quick test fails or at the latest after 2 years Tips for disposal can be found on page 201 Regularly check the charge state of the batteries Operate the device via main power so that the batteries are always fully charged MAINTENANCE REPLACEMENT INTERVALS 6 months 2 years STORAGE USAGE Battery quick test Charge Replacement Replacement CHA...

Page 174: ...ged 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 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 4 Charge the batteries up t...

Page 175: ...Chapter 10 Appendix 175 Chapter 10 APPENDIX ...

Page 176: ...al support with a pressure accuracy of 2 of the scale value 8 of the actual measured value sounding of an alarm when inspiration pressure is exceeded and alert by remote alarm the volume controlled mechanical support with a volume accuracy of 20 for a tidal volume above 100 ml or at a minute volume above 3 l min sounding of an alarm when the alarm parameter Low Inspiration Volume is not met or whe...

Page 177: ...see sec tion Manufacturer s declaration on electromagnetic compatibility on page198 IMPORTANT COMPONENTS The CARAT II pro ventilator comprises the following components Motherboard Tube circuit Programming board display and membrane keyboard PC USB Accessories RS232 Remote alarm nurse call Power supply Power management Control and operating unit Communication Blower Internal battery SpO 2 measureme...

Page 178: ... valve Air inlet Oxygen output Air outlet Blower Pressure sensor Pressure sensor Oxygen valve Flow sensor 2 way valve NO1 Non return valve Pressure switch Flow sensor Oxygen connection Tube circuit connection Expiration FM22 Tube circuit connection Inspiration M22 Pressure measuring tube connection ø 3 5 mm Ambient air Control tube connection ø 4 5 mm 1 Figure 77 Pneumatic block diagram 1 normally...

Page 179: ... page 61 The following data will be saved Table 12 Data management Data and parameters Inside the device SD card Alarms and events with date and time stamp Yes approx 15 000 entries Yes approx 15 000 entries Statistics Yes No Device settings and counter Yes No Update files No Yes Initialization files No Yes Measurement parameters Pressure volume flow FiO2 No Yes approx 50 days at a recording rate ...

Page 180: ...2 sensor is defective Check FiO2 sensor connection Recalibrate FiO2sensor Replace FiO2 sensor Error Pressure Sensor Defective pressure sensor Device must be serviced Calibration File Damaged Calibration data for sensors is damaged Device must be serviced Eventlog File Damaged Event read data failed Device must be serviced Primary Alarm Not Working Primary alarm sound unit is defective Device must ...

Page 181: ...rror FiO2 Sensor Primary Alarm Not Working Press the MFK to Continue To hide the error list press the MFK The default parameters are not loaded If ventilation is active it continues to run with the user defined settings However the device can no longer be operated Press Yes If there are other errors an error list is displayed Error Error FiO2 Sensor Primary Alarm Not Working Press the MFK to Conti...

Page 182: ... class Class II Specifications and performance Dimensions W x D x H 304 x 253 x 160 mm Weight 4 72 kg Max stable limit pressure 60 hPa Min stable limit pressure 0 hPa Max inspiratory working pressure 50 hPa Min inspiratory working pressure 4 hPa Max flow at 50 hPa 180 l min Max flow at 4 hPa 250 l min Operating conditions Temperature range 5 C to 40 C 41 F to 104 F Relative humidity 10 95 non cond...

Page 183: ...e patient circuit Double line patient circuit 2 9 hPa 3 7 hPa Expiratory pressure of the device at the patient con nection port at 60 l min Single line patient circuit Double line patient circuit 2 1 hPa 5 0 hPa Measurement conditions Device with single line patient circuit art no 00014967 without any accessories Device with double line patient circuit art no 00007969 without any accessories Appli...

Page 184: ... 100 1 0 100 5 Frequency 0 99 bpm 1 bpm Calculated from period duration of inspi ration expira tion in 0 002 s 1 bpm I E 1 0 1 1 25 0 1 Calculated from period duration of inspi ration expira tion in 0 002 s 0 2 MV minute volume 0 25 l 0 1 l Calculated from flow measurements 0 03 l or 20 of the measured value1 SpO2 35 100 1 35 100 2 at 70 100 3 at 50 70 Not defined 50 Pulse 30 240 bpm 1 bpm 30 240 ...

Page 185: ... PS 4 50 hPa 0 5 hPa 1 0 hPa or 5 of the measured value PEEP 0 20 hPa PEEP IPAP 3 hPa 0 5 hPa 1 0 hPa or 5 of the measured value Frequency 4 50 bpm 1 bpm 1 bpm Apnoea Time 0 60 s 1 s 1 s Time Inspiration 0 3 8 s 0 1 s 0 1 s Ti Max 1 10 s 0 1 s 0 1 s Ti Min 0 4 5 s 0 1 s 0 1 s I E 4 00 1 1 4 00 0 1 0 1 Ramp Level 1 5 1 level Flow Ramp Level 1 5 1 level Inspiration Trigger Level 1 10 auto 1 level Ex...

Page 186: ...racy of alarm parameters Parameter Setting range Setting incre ments Accuracy Apnoe Alarm Off 1 60 s 1 s 1 s High Frequency Off 10 120 bpm 1 bpm 1 bpm Low Frequency Off 1 50 bpm 1 bpm 1 bpm High Inspiration Volume Off 0 2 2 5 l 0 01 l 0 03 l or 20 of the measured value Low Inspiration Volume Off 0 1 2 l 0 01 l 0 03 l or 20 of the measured value High Expiration Volume Off 0 2 2 5 l 0 01 l 0 03 l or...

Page 187: ...f 70 100 min 1 greater then Low SpO2 1 1 Low SpO2 Off 70 100 min 1 lower than High SpO2 1 1 High Heart Rate Off 60 200 bpm min 10 bpm grea ter then Low Heart Rate 1 bpm 1 bpm Low Heart Rate Off 30 90 bpm min 10 bpm lower then High Heart Rate 1 bpm 1 bpm High Pressure Tolerance 1 10 hPa 0 5 hPa 1 0 hPa or 5 of the measured value Low Pressure Tolerance 1 10 hPa 0 5 hPa 1 0 hPa or 5 of the measured v...

Page 188: ...t 1 PSV Set 2 P SIMV Set 3 IPAP 20 hPa 20 hPa 20 hPa PEEP 5 hPa 5 hPa 5 hPa Frequency 12 bpm 12 bpm 12 bpm Time Inspiration 2 s 3 s 2 s Ti Max 4 s 4 s Ti Min 0 4 s 0 4 s Apnoea Time 10 s Ramp 3 3 3 Inspiration Trigger 3 3 Expiration Trigger 30 30 Trigger Lock Off Off SMART Function On On Minimum Volume Off Off Sigh Function Off Off Off ...

Page 189: ...w Inspiration Volume 0 2 l 0 2 l 0 2 l High Expiration Volume 1 l 1 l 1 l Low Expiration Volume 0 2 l 0 2 l 0 2 l High Minute Ventilation Off Off Off Low Minute Ventilation Off Off Off Leak Rate Off Off Off High FiO2 Off Off Off Low FiO2 Off Off Off High SpO2 Off Off Off Low SpO2 Off Off Off High Heart Rate Off Off Off Low Heart Rate Off Off Off High Pressure Tolerance 3 hPa 3 hPa 3 hPa Low Pressu...

Page 190: ... Volume 3 1 3 1 Night Screen Measurements Measurements Light Dark Timer Screen Change 2 min Off 20 s 20 min 20 s 100 s 20 s 2 min 20 min 1 min Brightness Display 100 5 100 5 Brightness LEDs 100 5 100 5 Brightness MFK 100 5 100 5 Language English Deutsch English and others Pressure Unit hPa hPa mbar cmH2O Volume Unit l l ml Display Time Insp Seconds Seconds I E Number of ventilation sets 3 1 3 1 ...

Page 191: ...rt 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 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 ...

Page 192: ...ries please contact a HOFFRICH TER service partner REPLACEMENT PARTS Name Article number Figure Disposable two hose system with optionally usable pressure measuring hose and Velcro fastener L 180 cm 22 mm 00014972 Bacterial filter adapter 00004933 Straight FiO2 connection adapter 41000104 SD card 2 GB 11200010 Mains cable 31100023 Switched mode power supply 00014207 Filter cassette complete open 0...

Page 193: ...0002038 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 ...

Page 194: ...194 Chapter 10 Appendix Name Article number Figure Brief instructions for CARAT II pro 50000645 Carrying case 00004875 ...

Page 195: ...Velcro fastener L 180 cm 22 mm 00014972 Disposable single tube system with exhalation valve control line and optionally usable pressure measuring tube L 150 cm 15 mm 00014971 Disposable two hose system with optionally usable pressure measuring hose and Velcro fastener L 150 cm 15 mm 00014973 Pressure measurement adapter 00004943 Bacterial filter 00004932 PA T I E N T SpO2 finger clip sensor cable ...

Page 196: ...03439 Cirri Comfort Full Face Mask NIPPV 00003489 00003490 00003491 FiO2 measurement set consisting of FiO2 sensor T adapter FiO2 sensor adapter FiO2 sensor connecting cable with screw connector 00004944 FiO2 sensor OOM103 1 23000018 T adapter 23000019 FiO2 sensor adapter 23000020 Name Article number Figure FiO2 sensor connecting cable with screw connector 00014116 FiO2 connection adapter angled 4...

Page 197: ...00449 USB cable PC cable 00005291 AKKUPACK uni BASE Ventilation 00011100 AKKUPACK uni PLUS 00011099 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 ...

Page 198: ...w The user of the CARAT II pro ventilator should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions acc to CISPR 11 Group 1 The CARAT II pro ventilator uses RF energy only for its internal function Therefore RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions acc to...

Page 199: ...ity should be at least 30 Radiated RF disturbances acc to IEC 61000 4 3 10 V m 80 MHz 2 7 GHz 80 AM at 1kHz 10 V m Portable and mobile communications equipment including cables and antennas should be used no closer to any part of the CARAT II pro home ventilator than the recommended separation distance of 0 3 m 27 V m 385 MHz PM 18Hz 27 V m 28 V m 450 MHz FM 5Hz 1kHz sinus 28 V m 9 V m 710 745 780...

Page 200: ...equency of the transmitter Recommended safety distance 0 3 m Power frequency 50 60 Hz magnetic field acc to IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines acc to IEC 61000 4 11 95 dip in UT for 0 5 ...

Page 201: ...ERIES 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 be disposed of separately with the normal household waste FiO2 SENSOR The FiO2 sensor must not be disposed of with the h...

Page 202: ...nd maintenance are carried out by persons not authorized by us other manufacturers accessories and spare parts are used that have not been approved by us for use on the product 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 b...

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