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Hoffrichter CARAT II User Manual

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Quality makes the Difference
User's Manual
Ventilator
as of device software 2.300

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Summary of Contents for Hoffrichter CARAT II

  • Page 1 Quality makes the Difference User's Manual Ventilator as of device software 2.300...
  • Page 2 SERIAL NUMBER Every HOFFRICHTER GmbH device is supplied with a serial number for traceability purposes. Please enter your device's serial number here. You will fi nd the serial num- ber on the rating plate on the back of the device.

  • Page 3: Table Of Contents

    CONTENTS Scope of Delivery ................7 General ....................8 Informationen on User's Manual ............8 Symbols on the Rating plate..............8 Symbols used in this User's Manual ..........9 Safety Information ................10 General Safety Instructions .............. 10 Installation Requirements and Transport .......... 13 Instructions Before Commissioning ..........14 Electrical Safety ................
  • Page 4 Service Display ................29 Display Real Time Monitoring ............29 Technology of the Device ..............32 Main Assemblies ................32 Functional Description ..............36 Ventilation Modes ................38 PCV Mode ..................38 PSV Mode ..................39 SIMV Mode ..................40 VCV Mode ..................
  • Page 5 Alarm Parameters on the “Display of Extended Parameters” ..53 Commissioning ................54 Setting up the Ventilator ..............54 Using the Functional Bag (Optional Accessory) ........ 54 Power Supply ................. 54 Connecting a Single Line Patient Circuit .......... 55 Connecting a Double Line Patient Circuit ......... 55 Turning the Ventilator On ..............
  • Page 6 Cleaning and Disinfection ..............73 Device Surface ................73 Air Filter ..................73 Patient Circuit and Mask ..............74 Oxygen Sensor ................74 Humidifi er ..................74 Bacterial Filter ................. 74 Preparing the device when changing patient ........75 Preparation procedure 1 - Manual Preparation ......75 Validated preparation procedure 2 - KR1000 (Keredusy) ....

  • Page 7: Scope Of Delivery

    2 adapter for power supply bacterial fi lter User's Manual and Short Manual Spare fi lter cassette Ventilator CARAT II Mains cable Connector Power supply Patient Double line patient circuit Inspiration part Connector Spare Inspira- coarse fi...

  • Page 8: General

    GENERAL INFORMATIONEN ON USER'S MANUAL Read this user's manual through carefully before using the ventilator for the fi rst time. Follow the safety and cleaning instructions in particular. Keep the manual in a safe place close to the device so that you can refer to it immediately if necessary.

  • Page 9: Symbols Used In This User's Manual

    SYMBOLS USED IN THIS USER'S MANUAL Important information is denoted by symbols in this user's manual. Be sure to follow these instructions in order to avoid accidents, personal injury and material damage. In addition, the local accident prevention regulations and general safety regulations in force in the area of use must be observed.

  • Page 10: Safety Information

    SAFETY INFORMATION GENERAL SAFETY INSTRUCTIONS • Settings on the ventilator may only and exclusively be made by qualifi ed and trained medical personnel under the supervision of a physician. The ventilator may only be operated by persons who have com- pletely read and fully understood these User's Manual and have familiarized themselves with the system before putting it into operation.
  • Page 11 • Before being reused on a different patient, all parts coming into contact with the respiratory gas must be treated hygienically • The directions given in these user's manual and the applicable regulations of the particular hospital or nursing home must be adhered to while hygienically treating and cleaning the ventilator.
  • Page 12 • Do not steam-sterilize the system in the autoclave. • Replace fi lters and other parts which are connected to the patient at regular intervals. Dispose of the parts replaced according to the regulations for used medi- cal material and/or according to local environment protection rules.

  • Page 13: Installation Requirements And Transport

    INSTALLATION REQUIREMENTS AND TRANSPORT • To ensure reliable operation, place the Ventilator on a safe and plane base. The air inlet on the rear of the system as well as all venting slots must not be covered or blocked. • The display of the ventilator as well as the alarm LEDs must not be covered and must be permanently visible.

  • Page 14: Instructions Before Commissioning

    INSTRUCTIONS BEFORE COMMISSIONING • Whenever the device is put into operation, a func- tional check must be performed beforehand (see page 78). • Any ventilator that is not functioning properly may pose a risk to the patient or operator. If the system fails to start properly or if the self-tests performed automatically on system start fail to be completed successfully, it is not permitted to continue operation...

  • Page 15: Electrical Safety

    Electromagnetic fi elds that exceed 10 V/m may adversely affect the operation of the ventilator. • Please pull off the power plug to disconnect CARAT II from external power supply. • Disconnect the power plug before cleaning the ventilator.

  • Page 16: Indended Use

    The system can be connected to a low- pressure gas source for ventilation with an increased oxygen concentra- tion. In addition, it is also possible to combine CARAT II with a humidifi er. If the CARAT II ventilator is operated with a single line patient circuit, it must not be used as a life-supporting device.

  • Page 17: Contraindications

    CONTRAINDICATIONS The following conditions may be a contraindication for non-invasive ven- tilation: • Severe cardiac arrhythmia • Severe hypotension • Severe epistaxis • Pneumothorax or pneumomediastinum • Pneumoencephalus • Cranial trauma • Status after cranial or brain surgery • Acute infl ammation of the paranasal sinuses, middle ear infection or a perforated ear drum •...

  • Page 18: Description Of The Device

    DESCRIPTION OF THE DEVICE FRONT VIEW Handle LED „Alarm“ LED „External power supply“ Tube connector Alarm key for inspiration LED „Internal power supply“ Connector O sensor ON/OFF key Connector control tube Connector Multi Functional Key measuring tube (MFK) esc | mode key Tube connector Modus LED´s for expiration...

  • Page 19: Back View

    BACK VIEW Handle Filter cassette Main switch Rating plate Oxygen inlet Cover valve membrane Oxygen outlet Power socket Figure 2: Ventilator back view Description of the Device...

  • Page 20: Displays

    DISPLAYS DISPLAY LAYOUT CARAT II is provided with a Standard display which is activated in the normal and standby modes of the ventilator as well as with a display of Extended Parameters, a Service display and a display Real Time Monitoring.

  • Page 21: Pressure Bargraph

    PRESSURE BARGRAPH The pressure bargraph indicates the pressure course during ventilation. The arrows indicate the set IPAP or PS (upper arrow) and the set PEEP (lower arrow). The currently achieved maximum pressure of the last spon- taneous breath is indicated by the peak mark (horizontal bar). ACTUAL VALUES The actual values indicate the currently measured values listed below: Single line patient circuit...

  • Page 22: Symbol Field

    SYMBOL FIELD Acoustic alarm off This symbol indicates that the acoustic alarm has been muted for 2 min. Any new alarm will also be suppressed acoustically until the 2-min interval has elapsed. By pressing the Alarm key the acoustic alarm can be disactivated before the alarm appears.

  • Page 23: Remaining Battery Capacity

    REMAINING BATTERY CAPACITY The battery symbol represents and indicates in percent the remaining capacity of the internal battery. This value is only for reference purposes. To obtain as accurate a value as possible, ventilation should be activated for approx. 1 minute to permit calculation of the battery capacity. If a DC voltage source is connected to the ventilator, the battery is charged automatically (indicated by a see-saw battery symbol).

  • Page 24: Standard Display

    STANDARD DISPLAY The Standard display is intended for displaying and changing the most important ventilation and alarm parameters which are always based on the ventilation mode currently selected.  see section “Ventilation Modes” and section “Alarm Parameters” IPAP and PEEP Pressure bargraph Actual values Ventilation...

  • Page 25: Display Of Extended Parameters

    DISPLAY OF EXTENDED PARAMETERS On the display of Extended Parameters, additional presetting can be made for the ventilator. This display also displays the alarm limits which are inde- pendent of the ventilation mode and can be changed. Figure 4: Display of Extended Parameters for all respiration modes, if the sensor is connected TIME...

  • Page 26: Display Screen

    DISPLAY SCREEN Using this menu item, it can be selected one of the following screens, which are displayed while ventilation is in progress and backlighting is darkened: Standard screen (STD) Figure 5: Standard screen (STD) XXL screen (XXL) Screen displaying the actual values in enlarged size, but not displaying the setting parameters - appropriately used in hospitals.

  • Page 27: Alarm Volume

    Patient screen (PAT) Screen displaying minimum information without actual values, nor dis- playing the setting parameters - appropriately used in home care. Figure 7: Patient screen (PAT) ALARM VOLUME The alarm volume can be set to values ranging from 10 to 100 %, In incre- ments of 10 %.

  • Page 28: Extended Alarm Parameters

    EXTENDED ALARM PARAMETERS The following alarm parameters can be set in the display of Extended Parameters: Alarm parameter Adjustment range Settings steps Accuracy 1.0 % Leakage OFF, 5 - 50 % 1.0 % Max. Insp. Time 1 - 10 sec 1.0 s 1.0 s Pressure Difference 1 - 10 hPa...

  • Page 29: Service Display

    This function can only be used in standby operation. In addition to this, the service screen offers the authorized service personnel the possibility of executing various tests and calibrations on the CARAT II. Figure 8: Service screen DISPLAY REAL TIME MONITORING The display Real Time Monitoring shows during running ventilation pressure-, fl...
  • Page 30 Figure 9: Display Real Time Monitoring PSV-Mode with double line pati- ent circuit Figure 10: Display Real Time Monitoring PCV-Mode with double line pati- ent circuit Figure 11: Display Real Time Monitoring PCV-Mode with single line pati- ent circuit Description of the Device...
  • Page 31 The current display can be frozen by pressing the multi functional key. Pressing again the multi functional key the real time monitoring will con- tinue with the next inspiration. The scaling of the curves and the time axis can be changed. To change the scaling, select the symbol by turning the MFK and confi...

  • Page 32: Technology Of The Device

    TECHNOLOGY OF THE DEVICE MAIN ASSEMBLIES The CARAT II ventilator consists of the following assemblies:: • Blower • Pneumatic block • Power supply (internal battery, switched-mode power supply unit) • Power management • Controller (control and operating unit) • External interfaces...
  • Page 33 Blower The blower is installed in a sound-absorbing box and delivers a maximum pressure of 50 hPa with a fl ow of 250 l/min. On its air inlet side, the blower is provided with an air fi lter cassette with a coarse fi lter and a fi ne fi lter (micro fi...
  • Page 34 Pneumatic block The pneumatic block is the connection assembly for the double line or single line patient circuit and consists of the following units: • Inspiration unit with fl ow sensor, check valve and standardized tube connector (M 22) • Pressure connection port (ø...
  • Page 35 Controller (control and operating unit) The control unit controls the blower and the valves, in order to implement the ventilation modes set. The control unit is also provided for the detection of alarm situations. In addition, the control unit exchanges data with the oper- ating controller and the power management.

  • Page 36: Functional Description

    FUNCTIONAL DESCRIPTION The operating principle of the CARAT II ventilator is based on a control mech- anism which, in a closed control loop, adjusts the capacity of the blower to the air output required for therapy. The blower output is controlled by the signal of the airway pressure and by the signal of the inspiration fl...
  • Page 37 Alarms Alarm conditions are continuously checked. If occurring, an alarm is indi- cated by an acoustic and a visual signal. As soon as the alarm condition is eliminated, the acoustical signal is turned off; the visual alarm is still shown on the display until it is acknowledged. In doing so, the cause of the alarm, the settings of the device, the time of the alarm and the current measured values at the time of the alarm are stored.

  • Page 38: Ventilation Modes

    VENTILATION MODES PCV MODE PCV - Pressure Controlled Ventilation Pressure controlled or pressure controlled assisted ventilation Pressure controlled ventilation In this ventilation mode, ventilation is exclusively controlled by the device. Spontaneous breathing on the patient’s part is not possible. To ensure exclusively controlled ventilation, the inspiration trigger must be set to “OFF”.

  • Page 39: Psv Mode

    PSV MODE PSV - Pressure Supported Ventilation Pressure supported ventilation is intended to support spontaneous breath- ing and to initiate machine ventilation whenever spontaneous breathing is missing. The pressure support (PS) as well as the positive end-expiratory pressure (PEEP) defi nes the range of pressure for ventilating the patient. The trigger thresholds of the inspiration trigger and the expiration trigger can be adjusted to the patient’s requirements.

  • Page 40: Simv Mode

    SIMV MODE SIMV - Synchronous Intermittent Mandatory Ventilation The SIMV mode provides a combination of pressure controlled machine ventilation and pressure assisted spontaneous breathing. Machine ventilation is based on a defi ned respiratory rate (SIMV frequency) and a defi ned inspiration time. The inspiratory pressure (IPAP) as well as the end-expiratory pressure (PEEP) defi...

  • Page 41: Vcv Mode

    VCV MODE VCV - Volume Controlled Ventilation Volume controlled ventilation or volume controlled assisted ventilation Volume controlled ventilation In this ventilation mode, ventilation is exclusively controlled by the system. Spontaneous breathing on the patient’s part is not possible. To ensure exclusively controlled ventilation, the inspiration trigger must be set to “OFF”.

  • Page 42: Parameters

    PARAMETERS VENTILATION PARAMETERS VENTILATION PARAMETERS ON THE “STANDARD DISPLAY” The ventilation parameters listed below are displayed on the left-hand side of the Standard display and can be changed within the appropriate adjustment ranges. The particular display of the changeable parameters depends on the ventilation mode selected.

  • Page 43: Settings In The Psv Mode

    SETTINGS IN THE PSV MODE Parameter Adjustment range Settings steps Accuracy 4 to 50 hPa 0.5 hPa 1,0 hPa or 5 % of value PEEP 0 to 20 hPa 0.5 hPa 1,0 hPa or [PEEP  PS – 3 hPa] 5 % of value Frequency 4 to 50 bpm;...

  • Page 44: Settings In The Simv Mode

    SETTINGS IN THE SIMV MODE Parameter Adjustment range Settings steps Accuracy IPAP 4 to 50 hPa 0.5 hPa 1,0 hPa or 5 % of value 4 to 50 hPa 0.5 hPa 1,0 hPa or 5 % of value PEEP 0 to 20 hPa 0.5 hPa 1,0 hPa or [PEEP <...

  • Page 45: Settings In The Vcv Mode

    SETTINGS IN THE VCV MODE Parameter Adjustment range Settings steps Accuracy Volumen 0.05 to 2 l 0.01 l 0,03 l or [V < 1,5 l/sec x Insp. time] 20 % of value PEEP 0 to 20 hPa 0.5 hPa 1,0 hPa or 5 % of value Frequency 4 to 50 bpm...

  • Page 46: Description Of Ventilation Parameters

    DESCRIPTION OF VENTILATION PARAMETERS IPAP IPAP (= Inspiratory Positive Airway Pressure) is the therapeutically pressure in the PCV and SIMV modes, which is administered to the patient with each ventilator stroke during inspiration. The set IPAP value is not summed up to the set PEEP, but represents the maximum inspiratory pressure.

  • Page 47: Apnea Time

    In between the ventilator strokes, the patient can increase his/her frequency by means of spontaneous inspiration. APNEA TIME In the PSV mode, an apnea time can be set if it is intended to permit respi- ratory pauses between the patient’s spontaneous breathing efforts. The apnea time serves to set the delay time which, after having elapsed, will ini- tiate ventilator strokes in the event of respiratory pauses.

  • Page 48: Ramp

    RAMP PCV / PSV /SIMV In the pressure controlled ventilation modes, the ramp settings limit the increase in pressure in the inspiration phase. This pressure increase is not set as a time parameter, but is implemented by setting the course of the fl...

  • Page 49: Inspiration Trigger

    INSPIRATION TRIGGER The inspiration trigger specifi es the extent of the patient’s inspiration efforts required to obtain pressure or volume support from the ventilator in case of spontaneous breathing. Pressure trigger If a single line patient circuit is used, the pressure trigger is activated. An inspiration is triggered when the patient generates a certain negative pressure in the tubing system by his/her own inhalation efforts, i.e.

  • Page 50: Trigger Lock

    TRIGGER LOCK The trigger lock is especially applicable in the ventilation of patients with obstructive pulmonary diseases (e.g., COPD). In these patients, fl uctua- tions often occur during the expiration phase. This leads to the device registering spontaneous respiration and the inspiration trigger is released too soon.

  • Page 51: Additional Pressure

    ADDITIONAL PRESSURE To ensure the minimum volume, it is possible to specify an additional pres- sure which can be added to the IPAP or PS pressure if the minimum volume fails to be reached. The value of the set additional pressure is a maximum value.

  • Page 52: Alarm Parameters

    ALARM PARAMETERS ALARM PARAMETERS ON THE “STANDARD DISPLAY” The alarm parameters listed below are displayed on the left-hand side of the Standard display and can be changed within the appropriate adjust- ment ranges. The particular display of the changeable parameters depends on the ventilation mode selected.

  • Page 53: Alarm Parameters On The "Display Of Extended Parameters

    ALARM PARAMETERS ON THE “DISPLAY OF EXTENDED PARAMETERS” The alarm parameters listed below are displayed in the left lower area of the display of Extended Parameters and can be changed within the appro- priate adjustment ranges. These parameters are displayed independently of the ventilation mode selected.

  • Page 54: Commissioning

    POWER SUPPLY To operate the CARAT II with external power supply, connect the supplied power supply unit to the DC socket on the rear of the ventilator and to the power cord. Then connect the ventilator to a 100 - 250 V AC (-20 % / +10 %), 50 - 60 Hz voltage source via the mains cable.

  • Page 55: Connecting A Single Line Patient Circuit

    When a nasal or full face mask is used for noninvasive ventilation, this mask must not contain any expiration opening. If the CARAT II ventilator is operated with a single line patient circuit, it must not be used as a life-supporting device.

  • Page 56: Turning The Ventilator On

    On device start, the patient circuit may already be connected to the ven- tilator, but not to the patient yet. Turn the CARAT II ventilator on via the main switch on the rear of the sys- tem. It will then emit an acoustic signal tone. The display of the ventilator indicates the serial number, the software version, the therapy counter and the operation hours.

  • Page 57: Oxygen Supply

    Please be absolutely sure to observe the instructions for use issued by the manufacturer or dealer deliver- ing the oxygen. • The CARAT II ventilator allows FiO measurement via the O sensor which is optionally available as an accessory part. We recommend using this O sensor only.

  • Page 58: O 2 Measurement

    • Oxygen supply should be stopped before the ventila- tion is interrupted. We also recommend that you run the ventilator without supplying oxygen for several ventilatory periods before starting and after complet- ing the ventilation process. • In case of an oxygen leak, the oxygen source must be closed on the spot.

  • Page 59: Behavior Of The Device Without Osensor

    BEHAVIOR OF THE DEVICE WITHOUT O SENSOR Unless an O sensor is connected to the CARAT II ventilator, or if the O sensor is removed with the ventilator on, the following message will be displayed: If this message is confi rmed with “NO”, the device will automatically enable the Standard display.

  • Page 60: Operation

    OPERATION TURNING THE DEVICE ON AND OFF Turn the ventilator on and off by actuating the main switch on the rear of the device. After the ventilator has been turned on, the device performs an automatic hardware test.  see section “System start (initialization)” The ventilator can only be switched off, if the respiration has been termi- nated before.

  • Page 61: End Of Ventilation

    If the ON/OFF key will not released the respiration continues. ENABLING AND DISABLING THE SAFETY LOCK The CARAT II ventilator is provided with a safety lock as a protection against inadvertent or unauthorized readjustment of the ventilation and alarm parameters. Once the safety lock is enabled, all settings on the Standard display and display of Extended Parameters are disabled.

  • Page 62: Function Of The Esc | Mode Key

    FUNCTION OF THE esc | mode KEY The esc | mode key has two functions. On one hand the function “esc” (escape) to cancel unwanted entries, and on the other hand the function “mode” to change ventilation modes. ESCAPE By pressing the esc | mode key, not yet confi rmed entries can be cancelled. If a parameter is selected and changed but has not yet been confi...

  • Page 63: Changing The Ventilation Mode With Ventilation Running

    CHANGING THE VENTILATION MODE WITH VENTILATION RUNNING The mode can only be changed if the Standard display is shown and none of the parameters is selected. If necessary, press the esc | mode key. The ventilation mode currently selected is indicated by the appropriate mode LED emitting steady light.

  • Page 64: Changing Displays

    CHANGING DISPLAYS The display can only be changed if none of the parameters is selected. If necessary press the esc | mode key. It can be moved among the displays by pressing and holding the MFK (> 1.5 sec), in the following order: •...

  • Page 65: Functional Assignment Of The Control Elements

    FUNCTIONAL ASSIGNMENT OF THE CONTROL ELEMENTS Control element Function Actuation ON/OFF key Press briefl y Ventilation on Ventilation off Press and hold (> 3 sec) Alarm key Mutes the alarm tone in Press briefl y case of a ventilation alarm Acknowledges the venti- Press briefl...

  • Page 66: Alarms And Error Messages

    Alarm limits may only be set by qualifi ed and skilled personnel under the supervision of a physician. The alarms of the CARAT II ventilator are either defi ned alarms or alarms that are adjustable in relation to the particular ventilation mode. All of the adjustable alarms are preserved when CARAT II is turned off and will again be active on device restart.

  • Page 67: Saving Alarms

    by pressing the Alarm key e.g. before the tube system is shortly discon- nected to carry out the suction of the patient. After the alarm cause has been removed, the alarm tone can also be reactivated within the two min- utes by pressing the Alarm key once more.

  • Page 68: Adjustable Alarms

    ADJUSTABLE ALARMS Before changing alarm parameter settings, check the patient’s con- dition. If an adjustable alarm parameter (on the Standard display) results in an alarm, then it is simultaneously highlighted by a black bar. Alarm / Priority Cause Delay Message Pressure HIGH Pressure higher than the set...

  • Page 69: Defined Alarms And Error Messages

    Alarm / Priority Cause Delay Message Min. Volume Tidal volume lower than the set 3 successive breaths not reached min. volume DEFINED ALARMS AND ERROR MESSAGES ERROR MESSAGES OF THE HARDWARE TEST ON DEVICE START Message Cause Remedy Parameter Error Invalid parameters / Invalid parameters and settings have checksum error...

  • Page 70: Defined Power Supply Alarms

    DEFINED POWER SUPPLY ALARMS Alarm / Priority Cause Remedy Message Int. Battery HIGH Battery The battery needs recharging; discharged discharged 1 minute until the power supply fails completely; ventilation pos- sible only with external power supply Error Int. Battery MEDIUM Battery defective Device service required Int.
  • Page 71 Alarm / Priority Cause Remedy Message Stenosis HIGH Measured tidal vol- Check the patient curcuit and ume less than 30 ml the tube for occlusion Constant fl ow over a period of 15 sec. High HIGH Pressure higher than Device service required Pressure 60 hPa/device error ...

  • Page 72: Additional Messages

    ADDITIONAL MESSAGES Message Cause Battery Operation The device was disconnected from external power supply and is now operated by the internal battery; confi rm message by pressing alarm key Safety Mode No spontaneous breathing on the patient’s part; mini- mum frequency ensured by device; in PSV modes only Saving Data Data are saved after actuation of the main switch Device is switching off...

  • Page 73: Cleaning And Disinfection

    • Disconnect the power plug before cleaning the ventilator. • We do not recommend standard sterilization methods for the CARAT II ventilator. • Do not use aggressive abrasive or other cleaners (e.g. acetone) for cleaning the ventilator. • Do not immerse the ventilator in water or solvent.

  • Page 74: Patient Circuit And Mask

    PATIENT CIRCUIT AND MASK Clean and disinfect reusable patient circuits and masks according to the manufacturer’s instructions. If worn or damaged strongly, the patient circuit or the mask must be replaced. Dispose of any patient circuits that are not suitable for re-use. OXYGEN SENSOR Do not place the optional oxygen sensor in cleaning solution nor sterilize it.

  • Page 75: Preparing The Device When Changing Patient

    PREPARING THE DEVICE WHEN CHANGING PATIENT Before using the ventilator on a different patient, clean and disinfect it to such an extent that it is free from any human pathogens. Please ensure that all tools used, such as measuring instruments and test lung, are free from human pathogens.

  • Page 76: Validated Preparation Procedure 2 - Kr1000 (Keredusy)

    • Disinfect all the parts of the housing and the connections with a suitable agent, e.g., Mikrozid® Liquid. • Dispose of the fi lter cassette and replace it with a new one. • Reassemble the device. • After reprocessing, carry out a safety-related check according to this User’s Manual (see page 80).

  • Page 77: Using Bacterial Filters

    USING BACTERIAL FILTERS If the device is intended for use by more than one patient (e.g., in opera- tion in clinics), a suitable bacterial fi lter (e.g., MEDISIZE BARR-VENT S) at the inspiration port and the expiration port should continuously be used to protect the device from contamination by human pathogens.

  • Page 78: Functional Check

    FUNCTIONAL CHECK Whenever the ventilator is put into operation, the alarms must be checked for proper functioning beforehand. The patient circuit to be used as well as a test lung (max. Tidal vol- ume = 1000 ml, Compliance = 25 ml/mbar) are required for the functional check.
  • Page 79 Alarm “Frequency too high” Set the “Inspiration Trigger” ventilation parameter to 3 and the “Max. Fre- quency“ alarm parameter to 20 bpm. Simulate spontaneous breathing with more than 20 bpm using the test lung, until the acoustic alarm is initiated. The LED ”Alarm”...

  • Page 80: Maintenance And Safety-Related Check

    MAINTENANCE AND SAFETY-RELATED CHECK In order to ensure the operating safety of the CARAT II ventilator, a safety-related test or maintenance must be carried out at the pre- scribed intervals. Every six months, the CARAT II ventilator must be subjected to a safety- related check to be carried out by the authorized service agency.

  • Page 81: Exchange Of The Valve Membrane (Expiration)

    EXCHANGE OF THE VALVE MEMBRANE (EXPIRATION) A change of the valve membrane is necessary: • change of the patient • if the device runs without bacterial fi lter In order to change the valve membrane do as follows: 1. Open the cover on the bottom of the device. 2.

  • Page 82: Operation By External Power Supply And Battery

    If the CARAT II ventilator is connected to a 100 - 250 V AC (-20 %, +10 %), 50/60 Hz voltage source via the power supply unit, the LED “external power supply”...
  • Page 83 Battery test In order to ensure the operating safety of the CARAT II ventilator, a battery test must be carried out at the prescribed intervals. To check the functionality of the internal battery, a battery test must be carried out monthly.

  • Page 84: Operation By The External Battery

    At full capacity and factory settings, the AKKUPACK uni BASE enables CARAT II to operate for up to 8 hours. Using AKKUPACK uni BASE together with AKKUPACK uni PLUS doubles operation time to up to 16 hours.

  • Page 85: Disposal

    DISPOSAL DEVICE The ventilator must not be disposed of with the household waste. Please contact the relevant customer services department to fi nd out how to dis- pose of the device properly. Proper disposal saves natural resources and prevents harmful substances being released into the environment.

  • Page 86: Accessories

    5 pack fi ne fi lter 0000 4951 2 adapter for bacterial fi lter 0000 4933 Adapter for oxygen connection, straight 4100 0104 User's manual 5000 0103 Short manual 0000 4851 For ordering of accessories, please contact a HOFFRICHTER service partner. Accessories...

  • Page 87: Optional

    0000 3442 Silicone NIPPV full face mask, size L 0000 3438 Silicone NIPPV full face mask, size XL 0000 3462 Silicone NIPPV-PSU full face mask, size L (autoclavable) 0000 3439 For ordering of accessories, please contact a HOFFRICHTER service partner. Accessories...

  • Page 88: Technical Data

    TECHNICAL DATA Voltage suppllies Mains power 100 ... 250 V AC (-20 %, +10 %), 50 ... 60 Hz DC power 24 V DC / 5 A Internal battery power Lithium ion battery, 28,8 V (nominal voltage) / 2.25 Ah / 3 W External battery power AKKUPACK uni BASE 24 V (nominal voltage) / 8,8 Ah...
  • Page 89 Specifi cations and Performance Max. stable pressure limit 60 hPa Min. stable pressure limit 0 hPa Max. working pressure 50 hPa Min. working pressure 0 hPa Maximum fl ow 250 l/min Measured values Parameter Display range Increments Measurement Accuracy of the display Pressure 0.0 to 99.9 hPa 0.1 hPa...
  • Page 90 Maximum Minute Volume PCV mode (IPAP = 50, PEEP = 0) R5 / C50 45 l/min R5 / C20 33 l/min R20 / C20 26 l/min R20 / C50 30 l/min VCV mode limited to 90 l/min Sound pressure range of audible alarm signal Lowest value (at 1 m distance) 64 dBA, setting 10 % Highest value (at 1 m distance)
  • Page 91 Technical Requirements for Accessories (CE mark required!) Pressure < 1000 hPa Flow < 15 l/min Bacterial Filter Connections 22 / 15 mm cone (acc. to EN1281-1) Resistance < 2.3 hPa with 60 l/min Compressible volume < 66 ml Internal volume <...

  • Page 92: Manufacturer's Declaration On Electromagnetic Compatibility

    MANUFACTURER'S DECLARATION ON ELECTROMAGNETIC COMPATIBILITY Guidance and manufacturer's declaration – electromagnetic emissions The CARAT II ventilator is intended for use in the electromagnetic environment specifi ed below. The user of the CARAT II ventila- tor should assure that it is used in such an environment.
  • Page 93 1/2 cycle cal commercial or hospital environment. If the input lines acc. to IEC 61000-4-11 cycle user of the CARAT II ventilator requires contin- ued operation during power mains interruption, 40 % U (60 % dip 60 % dip in U...
  • Page 94 fi xed RF transmitters, an electromagnetic side survey should be considered. If the mea- sured fi eld strength outside the location in which the CARAT II ventilator is used exceeds the compliance level, the CARAT II ventilator should be observed to verify normal operation.
  • Page 95 Recommended separation distances between portable and mobile RF communication equipment and the CARAT II The CARAT II ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the CARAT II ventilator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CARAT II ventilator as recommended below, according to the maximum output power of the communications equipment.

  • Page 96: Disclaimer

    DISCLAIMER HOFFRICHTER GmbH is not liable 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, •...
  • Page 97 NOTES ................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... Notes...
  • Page 98 NOTES ................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... Notes...
  • Page 99 NOTES ................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... Notes...
  • Page 100 HOFFRICHTER GmbH Mettenheimer Straße 12 / 14 19061 Schwerin Germany Phone: +49 385 39925 - 0 Fax: +49 385 39925 - 25 E-Mail: info@hoffrichter.de www.hoffrichter.de CARAT II-eng-260112-16 Art. no.: 5000 0103...

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