RAUMEDIC NeuroSmart Instruction Manual
  1. Manuals
  2. Brands
  3. RAUMEDIC Manuals
  4. Medical Equipment
  5. NeuroSmart
  6. Instruction manual

RAUMEDIC NeuroSmart Instruction Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

RAUMED NeuroSmart Instruction Manual
Instruction manual
®
®
RAUMED
NeuroSmart
REF 095284-001 and
®
®
RAUMED
NeuroSmart
logO
095294-001
Edition with GUI Revision g3.22.
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 1 of 61

Advertisement

Table of Contents
loading

Related Manuals for RAUMEDIC NeuroSmart

Summary of Contents for RAUMEDIC NeuroSmart

  • Page 1 RAUMED NeuroSmart Instruction Manual Instruction manual ® ® RAUMED NeuroSmart REF 095284-001 and ® ® RAUMED NeuroSmart logO 095294-001 Edition with GUI Revision g3.22. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 1 of 61...

  • Page 2: Table Of Contents

    Measuring position selection ..................... 19 3.4.3 Conventional zeroing ......................19 3.4.4 Start telemetric measurement (ICPT) ................20 Adjusting the settings / installing the NeuroSmart ..............22 3.5.1 General adjustment of settings ..................22 3.5.2 Setting the date/time ......................27 3.5.3 Graphic setting ........................
  • Page 3 8.2.2 Storage conditions ......................58 8.2.3 Transport conditions ......................58 Environment and disposal ......................59 Liability and warranty ......................... 59 Appendices ..........................60 Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 3 of 61...
  • Page 4 Intracranial Pressure Arterial Blood Pressure Central Venous Pressure Cerebral Perfusion Pressure CPPopt Optimal Cerebral Perfusion Pres- sure Pressure Reactivity Index Oxygen Reactivity Index Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 4 of 61...

  • Page 5: General Information

    Intended use The NeuroSmart is a diagnostic device and is used for monitoring up to four invasively measured phys- iological pressures and up to two patient temperatures (with alarm function). In addition to measuring and monitoring the aforementioned vital parameters, the NeuroSmart offers long-term storage of the readings.

  • Page 6: Safety Instructions

    The NeuroSmart may only be used on a single patient at the same time. • For the NeuroSmart’s mains operation, only choose a wall socket that can be reached without diffi- culty if the adapter has to be disconnected from the wall socket •...

  • Page 7: Instructions For Cyber And Data Security

    • Please delete all data before sending the NeuroSmart for routine service checks. • Please delete all data at the end of the device’s service life if the NeuroSmart is to be perma- nently shut down. • Only persons/organisations authorised by RAUMEDIC may perform a software/firmware up- date.

  • Page 8: Safety Symbols On The Device

    For the patient connections, the sign means that only accessory parts approved by the manufacturer may be connected to the NeuroSmart, because protection of the medical device against the consequences of a defibrillator’s discharge depends on the use of suit- able cables.

  • Page 9: Safety Symbols On The Packaging

    Important operating functions • Forwarding readings to a patient monitor • Exporting data to the USB stick • Download data to the PC Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 9 of 61...

  • Page 10: Start-Up

    • Are the device or accessories dirty? 3.2.1 Connection diagram The connection diagram with peripheral devices is shown in Figure 1. RAUMEDIC neurosurgical cath- blood pressure transducers eters or can be connected to the inputs P1/T1 and P2/T2. The pO input and thus the oxygen measurement function is not available with REF 095284-001.

  • Page 11: Accessories

    Accessories Table 5: Accessory as defined in Directives 93/42/EEC and 90/385/EEC Article No. Designation 284037-001 Power Adapter NeuroSmart length 2 m (included in delivery) See instruction manual RAUMEDIC neurosurgical catheters (application parts) with print number zwo- 096504-001 NEUROVENT-P-tel, length 35 mm (application part), Directive 90/385/EEC...

  • Page 12: Operating Concept

    RAUMED NeuroSmart Instruction Manual Operating concept The NeuroSmart can be operated with hard keys (buttons) and soft keys. The hard keys are located beneath the display and are shown in Figure 2. Most functions can be handled with the soft keys on the touch display.

  • Page 13: Views In The Main Display Area

    In this way, 1-6 display fields may be shown in the Reading View. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 13 of 61...
  • Page 14 In this way, up to 3 curves may be displayed in the Live Graph View. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 14 of 61...
  • Page 15 CPPopt and PRx can be calculated if the ART and ICP are measured at the same time. ORx can be calculated if the ART, ICP and pO2 are measured at the same time. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03...

  • Page 16: Status Area

    Figure 5: Status area [1] Date and time [2] Patient No.: Patient No. is a number assigned internally by the NeuroSmart. The Patient No. in- creases continuously when a new patient is created. [3] Clinic ID: The Clinic ID is user-assigned when a new patient is created. Alphanumeric characters can be entered for the Clinic ID.

  • Page 17: Commonly Occurring Soft Keys

    (see Figure 3). 3.3.4 Commonly occurring soft keys Soft keys Meaning Select button Plus/Minus button Cancel button Confirm button Confirm Continue button Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 17 of 61...

  • Page 18: Starting A Measurement

    The battery symbol at the top of the display means that the battery is fully charged. With a fully charged battery, the NeuroSmart can be operated without connection to a mains outlet for up to 4 hours (e.g. when transporting a patient) In this case, the green Power On LED flashes (on the bottom left of the operating foil, see Figure 2 No.

  • Page 19: Prepare Invasive Pressure Measurement

    It is not necessary to assign a measuring position for catheters with an internal storage. The measuring positions are automatically detected and assigned by the NeuroSmart. Measuring positions do need to be assigned for catheters (without an internal storage) and blood pressure transducers.

  • Page 20: Start Telemetric Measurement (Icpt)

    • Please observe the instructions in the manuals for the accessories. • Connect the Reader TDT1 readP to the NeuroSmart by inserting the plug with the black mark into the black P-tel socket of the NeuroSmart. See Figure 1. •...
  • Page 21 P-tel. If there are any limitations here, e.g. for the permissible measurement range or for defibrillator protection, then these must be observed without fail. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 21 of 61...

  • Page 22: Adjusting The Settings / Installing The Neurosmart

    RAUMED NeuroSmart Instruction Manual Adjusting the settings / installing the NeuroSmart 3.5.1 General adjustment of settings To access the general Settings menu, please carry out the following steps: <1> Settings then <2> Gen- eral. See Figure 11. In this menu, you can adjust the settings for the system language, scaling, alarm limits, and key sound as explained in more detail below.
  • Page 23 <1> Press the axis of the particular measuring position <2>. An input window appears and the scaling range can be adjusted with the Plus/Minus buttons<3>. Confirm the input. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03...
  • Page 24 <1> Press the axis of the particular measuring position <2> An input window appears and the scaling range can be adjusted with the Plus/Minus button <3> Confirm the input. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03...
  • Page 25 <4> Soft keys are available on the left side of the display that can be used to adjust the displayed chronological range of the trend. The individual soft key has the following functionality. See Table Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03...
  • Page 26 Trend Graph View. The functions for the display in the Trend Graph View are described in the previous section. See Figure 14 and Table 13. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 26 of 61...

  • Page 27: Setting The Date/Time

    The date/time can only be set in the Start Screen mode. The date/time cannot be changed during a measurement. Please use the following procedure to set the date and time. <1> Switch on the NeuroSmart. When the Start screen appears (see Figure 6), <2> press the Settings button. <3> Date and time can now be adjusted with the Select buttons [1-3].

  • Page 28: Graphic Setting

    To do this, please perform the following steps. <1> Setting <2> Channel <3> Colours <4> Select measuring position <5> Assign colour for the meas- uring position. See Figure 17. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 28 of 61...

  • Page 29: Alarm System

    Figure 17: Assign colours to measuring positions Alarm system The alarm system in the NeuroSmart is subdivided into two categories, medium and high-priority alarms. Furthermore, there are low-priority informative messages that alert you to certain device statuses. See Table 14. At the same time, a distinction is made between physiological and technical alarms.
  • Page 30 [3] flash). For a medium-priority physiological alarm, the symbols are accordingly yellow. See Table 15. Table 15: Indication on the display when an alarm is activated High-priority alarm activated Medium-priority alarm activated Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 30 of 61...
  • Page 31 2 minutes to 10 minutes under “Settings” in the password-protected area. Attention: Readings recorded while AUDIO PAUSED is active are not used to calculate PRx, ORx, or CPPopt. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 31 of 61...

  • Page 32: Operator Settings (Admin)

    (see Operator settings, section 3.6.1), then all acoustic alarms are suppressed until this button is pressed again or until the NeuroSmart is switched off. The alarm suppression status is permanently indicated by a criss-crossed flashing bell symbol displayed in the Info area, see Figure 19.

  • Page 33: Setting Physiological Alarm Limits

    Figure 21 and Figure 22. Caution: ALARM LIMITS set to extreme values can make the ALARM SYSTEM unusable. If the NeuroSmart is not continuously operated by clinical personnel, we recommend selecting the “Default” alarm limits. Table 16 Shows the default settings for the physiological alarms and their setting ranges.
  • Page 34 [2] If you do not want to make any change but wish to quit the menu, tap the “Cancel” button. See Figure 21. Figure 21: Adjust the alarm limits and alarm activation for the individual measuring positions. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 34 of 61...
  • Page 35 At the same time, the clinic-specific alarm limits are saved under the name "Clinic" and can be selected as shown in Figure 6. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 35 of 61...
  • Page 36 1 second during oxygen partial pressure measurement, this would result in a maximum delay to the alarm condition of 16 s (15 s + 1 s). Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03...

  • Page 37: Technical Alarms

    RAUMED NeuroSmart Instruction Manual The following alarm conditions are defined for the NeuroSmart's pressure values and temperature val- ues: The alarm is triggered if the limit value is exceeded or fallen below for 6 seconds within a 10- second interval.

  • Page 38: Analogue Forwarding Of Measured Parameters

    6 minutes. Analogue forwarding of measured parameters The NeuroSmart device has two types of analogue outputs. The first type of forwarding is pressure forwarding with the Out1/Out2 outputs, which can be connected to the invasive pressure input of a patient monitor.

  • Page 39: Forwarding Pressures And Temperature

    Figure 24: Forwarding 1 A pressure of 0 mmHg and/or temperature of 35°C is now output. See Figure 25 (A). Figure 25: Forwarding 2 Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 39 of 61...

  • Page 40: Expanded Parameters Orx, Prx, Cppopt

    NeuroSmart. Quit the forwarding dialogue with the “Confirm” button. If necessary, the value measured with the NeuroSmart can deviate from the value shown by the patient monitor. For this, please observe the patient monitor instruction manual, which contains the tolerances of the IBP input.

  • Page 41: Calculation Methodology For Prx, Orx And Cppopt

    ORx: The Oxygen Reactivity Index is the correlation between oxygen partial pressure (pO2) and Cere- bral Perfusion Pressure (CPP), whereby CPP is the difference between ART and ICP. ������ = ������ − ������ Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 41 of 61...

  • Page 42: Set The Calculation Of Prx, Orx, Cppopt

    CPPopt is calculated from past measurement data. You can select the CPPopt calculation time in which the CPPopt value should be calculated. The following time options are available: 4h, 6h, 8h, 12h. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03...

  • Page 43: View Expanded Parameters

    CPPopt calculation time that has been set, the data from the previous measurement is still used for the current CPPopt calculation. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03...

  • Page 44: Error Messages And Troubleshooting

    RAUMED NeuroSmart Instruction Manual Error messages and troubleshooting If an error occurs, the NeuroSmart shows an info message. Press the flashing speech bubble read the associated info message. The info messages with corresponding error code and troubleshoot- ing recommendation are listed in Table 18.
  • Page 45 The zero calibration could not be car- Ensure stable pressure and repeat zero balance. ried out. The pressure has changed more than 2 mmHg. Please check this and repeat the zero calibration. Table 20: Technical error message (NeuroSmart internal) Error Error description Troubleshooting code Internal error in pressure channel P1/P2.
  • Page 46 ROVENT P-tel. A measuring process can not be carried out. Please contact service The software version of the NEUROVENT P-tel is Contact Service not compatible with the NeuroSmart. Use another NEUROVENT p-tel or contact service. There is an inconsistency in the data of the reader. Contact Service A measuring process can not be carried out.
  • Page 47 Save data to the PC and then delete the data to the PC, otherwise the oldest data will data on the NeuroSmart. basically be overwritten. Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 47 of 61...

  • Page 48: Information If An Error Occurs

    To access the information, please carry out the following steps: <1> Settings; <2> then the “Info” tab; <3> then go to the “Device” tab and select “PTO” or “P-tel”. See Figure 28. Read the NeuroSmart information as shown in Figure 28 (Pos. 1-6) and please forward the information to Service as shown in Table 21.

  • Page 49: Cleaning And Care

    Any liquid coming into contact with the housing must be immediately wiped off using a dry cloth. To disinfect the NeuroSmart, use standard hospital disinfectants such as Lysoformin or Helipur H plus N. Do not use cleaning agents with a phenol base.

  • Page 50: Disinfection

    • Do not allow disinfectant to come into contact with the electrical contacts (take particular care if spraying the disinfectant!). Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 50 of 61...

  • Page 51: Electromagnetic Compatibility

    30 cm (12 inches) from the NeuroSmart’s labelled parts and accessories. If they are too close to the device, its performance may be adversely affected.

  • Page 52: Electromagnetic Emissions

    In the event of concurrent use with a HF surgical device, the measurement may be briefly interrupted. Within 10 seconds after the HF surgical device has been switched off, the NeuroSmart continues the measurement. Before using electric surgical instrument, check whether the blood pressure transducer being used is equipped with suitable safety measures against burns to the patient.

  • Page 53: Electromagnetic Immunity

    RAUMED NeuroSmart Instruction Manual Electromagnetic immunity The NeuroSmart is intended for use in an electromagnetic environment as specified below. The operator or user of the NeuroSmart should ensure that it is used in such an environment. Table 24: Measurement of electromagnetic immunity...

  • Page 54: Inspections, Safety And Measurement Checks

    Under the Medical Devices Operator Ordinance (MPBetreibV), the operator has an obligation to determine body temperatures for medical devices (medical electronic thermometer) and carry out a measurement check at least every two years. The NeuroSmart is a device with an electric tem- perature measurement function.

  • Page 55: Technical Parameters (Specification)

    25 … 45 °C: ±0.1 K (plus sensor deviation ±0.1 K) Accuracy: 15 … 25 °C: ±0.2 K (plus sensor deviation ±0.2 K) Sampling rate: 1 Hz Defibrillator protection Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 55 of 61...
  • Page 56 0 ... + 200 mmHg Accuracy: See accuracy of oxygen sensor Sampling rate: 1 Hz Defibrillator protection Oxygen sensor Fibre optic Light source Green LED Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 56 of 61...
  • Page 57 Accuracy after zero calibration: Output frequency: Max. 100 Hz (depending on measuring position) or 1 Hz (for temperature) Sensitivity: 10 mV/mmHg or 150 mV/°C Defibrillator protection Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 57 of 61...

  • Page 58: Ambient Conditions

    8.2.3 Transport conditions Temperature: -25 °C ... + 60 °C Air humidity: Non-condensing between 15% and 93% Air pressure: 620-1060 hPa Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 58 of 61...

  • Page 59: Environment And Disposal

    The cardboard packing is 100 % recyclable. All parts of the NeuroSmart are labelled and can be separated for recycling or environmentally friendly disposal by specialised companies. The Li-ion type battery and the electronic components comply with the RoHS 2 (2011/65/EU) directive.

  • Page 60: Appendices

    Observance of the procedures specified in directive 93/42/EEC is subject to monitoring by the notified body: TÜV SÜD Product Service Ridlerstraße 65 80339 Munich Ref. No.: 0123 RAUMEDIC AG 0123 Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 60 of 61...
  • Page 61 Observance of the procedures specified in directive 90/385/EEC is subject to monitoring by the notified body: TÜV SÜD Product Service Ridlerstraße 65 80339 Munich Ref. No.: 0123 RAUMEDIC AG 0123 Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany zwo-541EN Rev 3 / 2022-05-03 Page 61 of 61...

This manual is also suitable for:

Neurosmart logo095284-001095294-001

Table of Contents