Hoffrichter CARAT II pro User Manual
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Hoffrichter CARAT II pro User Manual

Ventilator
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Summary of Contents for Hoffrichter CARAT II pro

  • Page 2 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: • User's manual for CARAT II pro for physicians and medical professionals •...
  • Page 3 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 fi nd the serial number on the rating plate on the bottom of the device.

  • Page 4: Table Of Contents

    TABLE OF CONTENTS CHAPTER 1 ................11 INTRODUCTION ...................11 Scope of delivery ...................12 Symbols ......................14 Intended use ....................19 Contraindications ...................19 Side effects ....................20 CHAPTER 2 ................21 SAFETY INFORMATION ................21 General safety instructions ................22 Electrical safety ....................24 Installation requirements and transport ............25 Instructions before commissioning ..............26 Using of oxygen .....................26 Safety-related test ..................27...
  • Page 5 Using the functional bag .................61 Switching the device on .................62 Switching the device off .................62 CHAPTER 5 ................63 VENTILATION MODES .................63 CHAPTER 6 ................65 DEVICE OPERATION ..................65 Key lock......................65 User profi les ....................65 Menu structure ....................66 Basic operation ....................66 Basic screen layout ..................68 Explanation of toolbar icons ................69 Enabling a screen ..................71...
  • Page 6 Cleaning the tube circuit ................106 Cleaning the mask ..................106 Cleaning the headgear .................107 Cleaning / Replacing the fi lter ................107 CHAPTER 9 ................109 ROUTINE CHECKS AND MAINTENANCE WORK ........109 Overview ......................110 Battery maintenance ..................111 CHAPTER 10 ................ 113 APPENDIX ....................113 Data management ..................114 Error messages ....................115 Technical data ....................117...
  • Page 7 LIST OF FIGURES Figure 1: Rating plate ..................15 Figure 2: Connections at the front side of the device ........30 Figure 3: Connections at the rear side of the device ........31 Figure 4: Control elements ................33 Figure 5: LED displays ..................35 Figure 6: Left device side ................37 Figure 7: Right device side ................37 Figure 8: Setting up the device ..............40...
  • Page 8 Figure 41: Statistics screen (1 ventilation parameter) ........89 Figure 42: Stop ventilation ................90 Figure 43: Alarm displays in the toolbar ............93 Figure 44: Alarm output in the toolbar .............94 Figure 45: Alarm output in the textbox ............95 Figure 46: Alarm box ..................96 Figure 47: Messages in the toolbar ...............101 Figure 48: Filter cassette structure ..............107 List of fi...
  • Page 9 LIST OF TABLES Table 1: Operating time with battery power and factory default settings ..43 Table 2: Overview ventilation modes .............64 Table 3: Adjustable alarms ................97 Table 4: Adjustable alarms ................98 Table 5: Fixed Alarms ...................99 Table 6: Fixed Alarms .................100 Table 7: Messages ..................101 Table 8: Cleaning intervals - overview ............104 Table 9: Service intervals - overview ............110...

  • Page 10: Chapter 1

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

  • Page 11: Scope Of Delivery

    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 (L = 180 cm, 22 mm) Adapter for bacterial fi lter SD card Straight FiO...
  • Page 12 Illustration Name Spare fi lter cassette, complete (open) with fi lters Spare coarse fi lter, 1 pack (2 ea) Spare fi ne fi lter, 1 pack (5 ea) User's manual for the patient Brief instructions Final inspection certifi cate Chapter 1: Introduction...

  • Page 13: Symbols

    SYMBOLS PACKAGING SYMBOLS Symbol Meaning European Article Number Article number Serial number CE - Declaration of Conformity Transport and store package with arrows pointing up at all times Fragile contents Protect from moisture! Humidity range during storage and transport 1100 hPa Air pressure range during storage and transport 250 hPa +55°C...

  • Page 14: Figure 1: Rating Plate

    SYMBOLS ON THE RATING PLATE The rating plate is on the back of the device Ventilator Type: 9LV203 Quality makes the Difference CARAT II pro Li-Ion ICR 18650 14.8V; 4400mAh; 65.12Wh DC-INPUT -INPUT EAG1300001 max. 5A max. 15l/min max. 10A...
  • Page 15 SYMBOLS ON THE DEVICE Symbol Meaning Connecting points Inspiration tube connection Expiration tube connection Control tube connection Pressure measuring tube connection sensor connection DC connection sensor connection Com-interface Remote alarm/nurse call connection USB interface connection output SD card slot Chapter 1: Introduction...
  • Page 16 Symbol Meaning Operation Alarm key ON/OFF key Safe key Home key Escape key LEDs Alarm LED Mains LED Battery LED Chapter 1: Introduction...
  • Page 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.

  • Page 18: Intended Use

    (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.

  • Page 19: Side Effects

    SIDE EFFECTS The following undesired side effects may occur in connection with artifi cial respiration: Invasive ventilation: • Complications due to tube / tracheal cannula Mask ventilation: • Pressure points and skin defects in the face • Eye irritation due to leaks •...

  • Page 20: Chapter 2

    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 Chapter 2: Safety warnings...

  • Page 21: General Safety Instructions

    GENERAL SAFETY INSTRUCTIONS • Only qualifi ed, 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 this user’s manual before undertaking and have familiarized themselves with the device.
  • Page 22 • 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.

  • Page 23: Electrical Safety

    • Temperatures lower than + 5 °C and higher than + 40 °C can 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.

  • Page 24: Installation Requirements And Transport

    INSTALLATION REQUIREMENTS AND TRANSPORT • For operation, the device must be placed on a safe and level base. • The air inlet at the rear of the device, as well as all ventilation slots, must not be blocked. • Please ensure the device is operated in an area where there is suffi...

  • Page 25: Instructions Before Commissioning

    • 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 sensor. We recommend using this particular sensor exclusively.

  • Page 26: Safety-Related Test

    • 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, fi re or potential fl ammable sources in the vicinity of the device must be avoided.
  • Page 27 Chapter 2: Safety warnings...

  • Page 28: Chapter 3

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

  • Page 29: Front Side Connecting Points

    FRONT SIDE CONNECTING POINTS Connections at the front side of the device Figure 2: 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 FiO sensor cable Connect the FiO...

  • Page 30: Rear Side Connecting Points

    REAR SIDE CONNECTING POINTS Figure 3: Connections at the rear side of the device DC connection The power supply plug is connected here. Refer to page 41. Connection of SpO sensor A SpO sensor can be connected here. page 55. SD card slot An SD card here can be inserted here.
  • Page 31 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.

  • Page 32: Control Elements

    CONTROL ELEMENTS Control elements Figure 4: Alarm key The alarm key has several functions: Function Condition Action Confi rm all current alarms Active alarms Press briefl y Confi rm no longer active alarms Stored alarms press briefl y Mute the audible alarm for 2 min Active alarms Press briefl...
  • Page 33 16 Multifunctional key MFK Function Action Select another parameter Turn Set parameters Turn Press briefl y Confi rm parameter selection Confi rm modifi ed parameter value Press briefl y Open adjustment window for graphs and loops in the Press briefl y monitoring screen The MFK is backlit (only when "MFK brightness"...

  • Page 34: Led Displays

    LED DISPLAYS LED displays Figure 5: Alarm LED The alarm LED lights/fl ashes in the event of an alarm. It also provides infor- mation on the alarm priority. Color Status (light) Priority Flashes HIGH Yellow Flashes MEDIUM Turquoise Glows steadily Power LED The power LED gives information on the status of the power supply.
  • Page 35 Battery LED The battery 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 % Glows steadily 0 % ... 20 % White Flashes...

  • Page 36: Movable And Removable Housing Parts

    MOVABLE AND REMOVABLE HOUSING PARTS 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 fl ap Valve membrane (expiration) is located under the bottom fl ap. 26 Filter cassette The fi...
  • Page 37 Chapter 3: Description of device...

  • Page 38: Chapter 4

    • Never operate the device without the air fi lter. • 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 39: Setting Up The Device

    SETTING UP THE DEVICE Place the device on a fl at 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. > 10 cm Figure 8: Setting up the device POWER SUPPLY The ventilator may be supplied by three different power sources.

  • Page 40: Figure 9: Mains Connection Via Power Supply Unit

    MAINS OPERATION 1. Insert the power supply plug into the DC connector socket. 2. Connect the mains cable to the power supply. 3. 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.

  • Page 41: Figure 10: Start Screen

    SW-Version 1.000 Quality makes the Difference 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 confi rmed, the display will switch to the standby screen. The current level of battery charge will be displayed on the standby screen.

  • Page 42: Table 1: Operating Time With Battery Power And Factory Default Settings

    OPERATION WITH INTERNAL BATTERY 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.
  • Page 43 POWER FAILURE 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.

  • Page 44: Figure 12: Akkupack Uni Base (Right) / Akkupack Uni Plus (Left)

    OPERATION WITH EXTERNAL BATTERY 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 BASE. The AKKUPACK uni BASE enables the device to be operated independently of the mains power supply.

  • Page 45: Figure 13: Connecting Akkupack Uni Base

    CONNECTING EXTERNAL BATTERY "AKKUPACK uni BASE" Connect the AKKUPACK uni BASE to the device according to Figure 13. A DC port B DC cable for ventilation C DC out (device connection ) D AKKUPACK uni BASE Figure 13: Connecting AKKUPACK uni BASE Chapter 4: Commissioning...

  • Page 46: Connecting The Tube Circuit

    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 fi lters, in particular for clinic operations, when using the device for more than one patient. 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 strangulation.

  • Page 47: Figure 14: Connecting A Single Line Patient Circuit

    CONNECTING A SINGLE LINE PATIENT CIRCUIT 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.

  • Page 48: Figure 15: Connecting A Double Line Patient Circuit

    CONNECTING A DOUBLE LINE PATIENT CIRCUIT Connect the tube circuit to the device according to Figure 15. Note: When using a bacterial fi lter, please read the instructions of use of this fi lter. 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).

  • Page 49: Figure 16: Connecting The Humidifi Er - Single Line Patient Circuit

    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 fi lter, please read the instructions of use of this fi lter.

  • Page 50: Figure 17: Connecting The Humidifi Er - Double Line Patient Circuit

    Double line patient circuit Connect the tube circuit to the humidifi er 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). 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 I Humidifier J Inspiration tube Figure 17: Connecting the humidifi...

  • Page 51: Calibrating The Tube Circuit

    CALIBRATING THE TUBE CIRCUIT 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.
  • Page 52 4. Navigate to "Calibrate Tube" by turning the MFK. Calibrate Tube -Monitoring Internal Calibrate FiO Sensor Alarm Volume Brightness Display Brightness LEDs Brightness MFK 5. Press the MFK. Tube calibration begins. Calibrate Tube Run... -Monitoring Internal Calibrate FiO Sensor Alarm Volume Brightness Display Brightness LEDs Brightness MFK...

  • Page 53: Connecting The Alarm Box Or The Nurse Call

    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.

  • Page 54: Spo 2 Sensor Connection

    SENSOR CONNECTION Connect the SpO sensor to the device as shown in Figure 20. The toolbar will then show the 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.

  • Page 55: Inserting The Sd Card

    INSERTING THE SD CARD Insert the SD card into the SD card slot until it clicks into place as shown in Fig- ure 21. The toolbar will then show the 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.

  • Page 56: Using Oxygen

    USING OXYGEN Before using oxygen, the safety instructions must be read as of page 26. 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, I:E, frequency, will lead to a change of the FiO concentration.
  • Page 57 MEASURING OXYGEN CONCENTRATION The oxygen concentration may be inconsistent when feeding in a fi xed value oxy- gen fl ow (FlowO ). The inspirational oxygen concentration (FiO ) can vary depend- ing on pressure, ventilation pattern of the patient, mask or leakage. The oxygen concentration should therefore always be measured with a FiO sensor when oxy- gen is being supplied (see accessories on page 125).

  • Page 58: Figure 24: Connecting The Fio 2 Sensor (Single Line Patient Circuit Example)

    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 FiO sensor to the device, the FiO sensor will be calibrated automatically.
  • Page 59 3. Navigate to the system screen using the MFK . Press the MFK. 4. Navigate to "Calibrate FiO Sensor" by turning the MFK. Calibrate Tube -Monitoring Internal Calibrate FiO Sensor Alarm Volume Brightness Display Brightness LEDs Brightness MFK 5. Press the MFK. Calibration begins. 6.

  • Page 60: Using The Functional Bag

    USING THE FUNCTIONAL BAG 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).

  • Page 61: Switching The Device On

    SWITCHING THE DEVICE ON 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.

  • Page 62: Chapter 5

    CHAPTER 5 VENTILATION MODES The device has three types of ventilation modes: • Mandatory ventilation modes, where the device performs the respiratory work for the patient completely. • Augmented ventilation modes, where the device performs part of the respiratory work, alternating or over- lapping with the patient's breathing rate.

  • Page 63: Table 2: Overview Ventilation Modes

    Table 2: Overview ventilation modes Mode Description Mandatory ventilation modes Pressure Controlled Ventilation APCV Assisted Pressure Controlled Ventilation 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...

  • Page 64: Chapter 6

    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: • ON/OFF key to start ventilation •...

  • Page 65: Menu Structure

    MENU STRUCTURE • Home screen Monitoring screen Measurements (p, V , MV, f, I:E, FiO , SpO , HF) Graphs (p, V, V, FiO 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...
  • Page 66 TOUCH SCREEN OPERATION The following operations can be initiated with the touch screen: Calibrate Tube -Monitoring Internal Calibrate FiO Sensor Alarm Volume Monitoring Parameter Alarm Log Brightness Display Brightness LEDs Brightness MFK Language English Pressure Unit System Statistics Service Display Time Insp. Seconds 22:33 22:33...

  • Page 67: Basic Screen Layout

    BASIC SCREEN LAYOUT Monitoring Parameter Alarm Log System Statistics Service 1:45 Low Frequency 22:33 A Pressure bar (during running ventilation) B Screen content C Toolbar D Active ventilation mode Figure 30: Basic screen layout Chapter 6: Device operation...

  • Page 68: Explanation Of Toolbar Icons

    EXPLANATION OF TOOLBAR ICONS Icon Meaning Clinic mode active Home mode active Alarm active Red icon High priority alarm Yellow icon Medium priority alarm Turquoise icon Low priority alarm 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.
  • Page 69 Icon Meaning Trigger lock "On" Trigger lock momentarily active SD card is inserted into the device No SD card inserted into the device 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"...

  • Page 70: Enabling A Screen

    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 •...
  • Page 71 To enable a screen: 1. Navigate to the desired screen by turning the MFK. The selected screen icon Black Icon not selected Blue 2. Press the MFK to activate the selected screen. During active ventilation the device will switch to the monitoring screen 2 minutes after the last completed operation.

  • Page 72: Monitoring

    MONITORING In the monitoring screen the ventilation parameters are shown in real-time. The monitoring screen is divided into three sections: • Measurements • Graphs • Loops MEASUREMENTS DISPLAY The "Measurements" section displays the following ventilation parameters when ventilation is running: •...

  • Page 73: Figure 32: Monitoring Screen (Data)

    How to call up to the data: 1. Navigate to "Monitoring" in the home screen by turning the MFK: 2. Press the MFK. Measurements Graphs Loops 1:1,5 19,8 [hPa] [bpm] 0,570 6,840 0,570 [bpm] 22:33 A Pressure B Frequency C I:E ratio D Heart rate E Expiration volume F SpO saturation G Minute ventilation H FiO concentration...

  • Page 74: Figure 33: Monitoring Screen (Graphs)

    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 FiO How to call up to the graphs: 1. Navigate to "Monitoring" in the home screen by turning the MFK: 2.

  • Page 75: Figure 34: Monitoring Screen (Freeze Graphs)

    Freezing the real-time curve: 1. Press the pause symbol Measurements Graphs Loops [hPa] Flow [l/min] -300 -600 -300 -600 22:33 Figure 34: Monitoring screen (freeze graphs) 2. Press the start symbol to restart the real-time curve Chapter 6: Device operation...

  • Page 76: Figure 35: Flow-Volume-Loop

    DISPLAY LOOPS Depending on your settings, you may display the following loops graphically in "Loops", while ventilation is running: • Flow-Volume-Loop • Volume-Pressure-Loop Flow-Volume-Loop Flow [l/min] -100 [ l ] 0,200 0,400 0,600 Current breath Last breath Figure 35: Flow-Volume-Loop Volume-Pressure-Loop 0,800 [l ]...

  • Page 77: Figure 37: Flow-Volume-Loop

    How to call 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. Measurement Graphs Loops Flow [l/min] -100 [l ] 0,200 0,400 0,600 22:33 Figure 37: Flow-Volume-Loop...

  • Page 78: Activating A Ventilation Set

    ACTIVATING A VENTILATION SET How to call up to the set settings: 1. Navigate to "Parameter" in the home screen by turning the MFK 2. Press the MFK. 19,8 Set 1 Set 2 Set 3 Mode [ hPa] [ bpm ] 1:1,5 0,570 IPAP...
  • Page 79 To activate a ventilation set: 1. Navigate to the ventilation set you wish to activate by turning the MFK. Set 1 Set 1 Set 2 Set 2 Set 3 Set 3 Activate Set Mode IPAP 20,0 PEEP Frequency Time Inspiration 2.

  • Page 80: Display Of Stored Alarms

    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. 3. You can move between the alarm entries by turning the MFK. 04.07.13 Low Internal Battery 22:35...

  • Page 81: System Settings

    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. Adjustable Menu item Explanation (Home profi le) Calibrate Tube Calibrating the connected tube circuit (see page 52) -Monitoring Setting, if oxygen concentration measure-...
  • Page 82 Adjustable Menu item Explanation (Home profi le) Standby Hours 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...

  • Page 83: Figure 40: System Screen

    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 -Monitoring Internal Calibrate FiO Sensor Alarm Volume Brightness Display Brightness LEDs Brightness MFK Language English...
  • Page 84 To change the system settings (e.g. alarm volume): 1. Navigate to the desired parameter by turning the MFK. Calibrate O Calibrate O Sensor Sensor Alarm Volume Alarm Volume Brightness Display Brightness Display Brightness LEDs Brightness LEDs 2. Press the MFK. Calibrate O Sensor Alarm Volume...
  • Page 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 User Profile...
  • Page 86 6. Press the MFK. Date and Time Year 2014 13.02.14 10:36 Number Ventilation Sets Month User Profile Home Tightness Check Hour Recent Ventilation Hours Minute Ventilation Hours Total Standby Hours 7. Change the setting by turning the MFK. Date and Time Year 2014 13.02.14...

  • Page 87: Statistics

    STATISTICS The statistics screen contains statistical evaluations of the following ventilation parameters. • Minute volume • Frequency • SpO • 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.

  • Page 88: Figure 41: Statistics Screen (1 Ventilation Parameter)

    How to call up to the statistical values: 1. Navigate to the home screen by turning the MFK to "System": 2. Press the MFK. Median [ bpm ] Jan/14 Feb/14 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 22:33 Figure 41: Statistics screen (1 ventilation parameter) Chapter 6: Device operation...

  • Page 89: Starting Ventilation

    STARTING VENTILATION 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.

  • Page 90: Chapter 7

    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...

  • Page 91: General Information

    The device must be operated so that the alarm is audible and visible by the user. Audible alarms can be forwarded using the nurse call or the alarm box. The CARAT II pro ventilator is equipped with fi xed and adjustable alarms, relating to the respective ventilation modes.

  • Page 92: Audible Alarm Output (Audio Alarms)

    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.

  • Page 93: Visible Alarm Output

    VISIBLE ALARM OUTPUT Visible alarms are displayed as follows: • via the alarm LED • in the toolbar • as a textbox • lighting up the multifunctional key ALARM OUTPUT VIA THE ALARM LED The alarm LED may take on 3 different statuses, to signify the current alarm priority. •...

  • Page 94: Figure 45: Alarm Output In The Textbox

    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: •...

  • Page 95: Alarm Log

    The alarms will be forwarded without delay to the nurse call or the alarm box. Instructions on how to connect the HOFFRICHTER alarm box or nurse call can be found on page 54. Figure 46: Alarm box The alarm box is an optional accessory to facilitate remote output of the alarm.

  • Page 96: Alarm Overview

    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 c a f –...

  • Page 97: Table 4: Adjustable Alarms

    Table 4: Adjustable alarms Alarm Priority Audible LED alarm Cause Time delay alarm Status High MEDIUM c a f Yellow - Measured frequency is for 3 breaths in Frequency fl ashes higher than the "High a row Frequency" MEDIUM c a f Yellow - Measured frequency for 3 breaths in...

  • Page 98: Table 5: Fixed Alarms

    FIXED ALARMS The fi xed alarms are technically conditional alarms. Alarm conditions are built into the device and are non-adjustable by the user. Table 5: Fixed Alarms Alarm Priority Audible State of the Cause Correction alarm alarm LED Error HIGH c c c –...

  • Page 99: Table 6: Fixed Alarms

    Table 6: Fixed Alarms Alarm Priority Audible State of the Cause Correction alarm alarm LED Over MEDIUM c a f Yellow - Over pressure Device must Pressure fl ashes detected be serviced, throughout 3 or check if the breaths or 15s alarm may have been triggered by the patient...

  • Page 100: 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. Minimum Volume Not Reached 22:33 A Message Figure 47: Messages in the toolbar MESSAGES OVERVIEW Table 7: Messages Messages...
  • Page 101 Chapter 7: Alarms and messages...

  • Page 102: Chapter 8

    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 fi lter for the duration of the cleaning or insert a complete replacement fi lter cassette into the device.

  • Page 103: Overview

    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 With every...
  • Page 104 Table 8: Cleaning intervals - overview Component Name Clean Disinfect Replace Filter cassette With every (without fi lter) needed new patient Course fi lter Weekly Instead of cleaning, when patient changes Fine fi lter Monthly, if severely contaminated, or for a patient change sensor In accordance...

  • Page 105: Cleaning The Device

    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 Disinfect the device surface on a regular basis, or when there is any possi- bility of contamination.

  • Page 106: Cleaning The Headgear

    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 1.
  • Page 107 REPLACING THE FINE FILTER The white fi ne fi lter cannot be cleaned. It must be replaced with a new one. 1. Pull the fi lter cassette from the device. 2. Remove the coarse fi lter (black). 3. Remove the fi ne fi lter (white) and replace it with a new one. 4.

  • Page 108: Chapter 9

    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. You must not perform any testing or maintenance work while the patient is still connected to the device.

  • Page 109: Overview

    OVERVIEW Table 9: Service intervals - overview When? What? By whom? Before commissioning Safety-related test Provider/Service Weekly Clean/replace the coarse fi lter User/Patient (see page 107) Visually check of the fi ne fi lter User/Patient Monthly, or Replace fi ne fi lter User/Patient before, if heavily (see page 108)

  • Page 110: Battery Maintenance

    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.
  • Page 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.

  • Page 112: Chapter 10

    CHAPTER 10 APPENDIX Chapter 15: Appendix...

  • Page 113: Data Management

    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 Inside the device...

  • Page 114: Error Messages

    ERROR MESSAGES Table 11: Error messages during operation and at device start-up Error message Cause Correction Error SpO sensor Communication to SpO Device must be serviced measuring module not possible sensor defective Replace SpO sensor SD card is full No storage space avail- Insert blank SD card able on the SD card Flash Not Working...

  • Page 115: Table 12: Error Messages During Operation And At Device Start-Up

    Table 12: Error messages during operation and at device start-up Error message Cause 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 Chapter 15: Appendix...

  • Page 116: Technical Data

    TECHNICAL DATA The manufacturer reserves the right to make technical changes without notice. Power supply Mains operation 100...240 V AC (-20 %, +10 %), 50...60 Hz DC operation 12 V DC / 10 A or 24 V DC / 5 A Internal battery operation Lithium ion battery, 14.8 V (nominal voltage) / 4.4 Ah / 65.12 Wh...
  • Page 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...
  • Page 118 Measured values Parameter Display area Display Measurement Accuracy increments Pressure 0 – 100 hPa 0.1 hPa 0.0 – 1.0 hPa or 5 % of the 100 hPa measured value Pressure 0 – 60 hPa 15 Pa 0.0 – 1.0 hPa or 5 % of the 100 hPa measured value Volume...
  • Page 119 STANDARDS The device complies with the following standards: • DIN EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compat- ibility - Requirements and tests (IEC 60601-1-2:2007, modifi ed) •...

  • Page 120: Replacement Parts And Accessories

    REPLACEMENT PARTS AND ACCESSORIES 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- uring tube (L = 180 cm, 22 mm)
  • Page 121 Course fi lter 00002993 Fine fi lter, 1 pack (5 ea) 00014951 Fine fi lter 00002994 User's manual for CARAT II pro for physicians and medical professionals 50000625 User's manual for CARAT II pro for patients 50000626 Chapter 15: Appendix...
  • Page 122 Name Figure Article number Brief instructions for CARAT II pro 50000645 Carrying case 00004875 Chapter 15: Appendix...
  • Page 123 ACCESSORIES Name Figure Article number Disposable single line circuit for adults with an expiratory valve and the pressure measuring and control tube (L = 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 (L = 180 cm, 22 mm) 00014995...
  • Page 124 Name Figure 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 NIPPV Silicon full face mask, size S 00003461 NIPPV Silicon full face mask, size M 00003442 NIPPV Silicon full face mask, size L 00003438...
  • Page 125 Name Figure Article number sensor adapter 23000020 sensor connecting cable with screw connector 00014116 connection adapter, angled 41000087 Cover for expiration tube connection 42100449 USB cable (PC cable) 00005291 AKKUPACK uni BASE "Ventilation" 00011100 AKKUPACK uni PLUS 00011099 fi nger clip sensor , cable length 2 m 00005292 adhesive sensor for adults and children (fi...
  • Page 126 Name Figure Article number Extension cable for SpO sensor, cable length 1 m 00005293 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"...

  • Page 127: Manufacturer's Declaration On Electromagnetic Compatibility

    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.

  • Page 128: Disposal

    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 contact the relevant customer services department to fi nd out how to dispose of the device, etc.

  • Page 129: Disclaimer

    DISCLAIMER HOFFRICHTER GmbH accepts no liability for consequences in terms of safety, reliability and performance of the product if: • interventions, modifi cations, extensions, calibration, repairs and 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, •...

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