Sophysa PRESSIO PSO-4000 Instructions For Use Manual
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Sophysa PRESSIO PSO-4000 Instructions For Use Manual

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PRESSIO
2 ICP MONITOR PSO‑4000
Instructions for Use
NT500_EN_US
Rev003_2020-11

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Summary of Contents for Sophysa PRESSIO PSO-4000

  • Page 1 ® PRESSIO 2 ICP MONITOR PSO‑4000 Instructions for Use NT500_EN_US Rev003_2020-11...
  • Page 2 This page is intentionally left blank.

  • Page 3: Table Of Contents

    Table of Contents 1. Figure ......................5 2.
  • Page 4 17. Technical Specifications ................... 22 17.1.

  • Page 5: Figure

    After reading these instructions carefully, the operator will be The patient is not the expected operator. able to: For more information, go to www.sophysa.com, or contact – Connect cables Sophysa at contact@sophysa.com, or +33(0)1 69 35 35 00. – Connect Catheter – Zero Catheter 3. Intended Use ®...

  • Page 6: Precautions

    Catheter (supplied separately) using the cath- eter extension cable. The Monitor may be connected to a patient bedside monitor (not supplied by Sophysa) which centralizes the measure- ments from various medical devices. If the Monitor is con- [8] Battery indicator light (orange) [9] Power button...

  • Page 7: Power Cable

    Power inlet The battery indicator light flashes when the battery is being charged, or when it is low. To recharge the battery, connect The Monitor should be connected to 100-240 V, 50-60 Hz the Monitor to the mains power. single phase alternating current mains power with ground, using the power cable provided.

  • Page 8: Catheter Extension Cable

    WARNING To avoid any risk of electric shock, the Monitor must only be connected to mains power with protective grounding. WARNING Do not allow any of the power connectors to come into contact with liquid. WARNING Do not remove the grounding electrode from the circuit. CAUTION Electrical isolation of the Monitor is achieved by discon- necting the power cable from the power inlet, on the...
  • Page 9 5.4.3. Action Bar NOTE With a fully charged battery, the Monitor can operate for approximately 6 hours, in normal operation. 5.4.2. Physiological Display The action bar provides access to display options and con- 5.4.2.1. Intracranial Pressure (ICP) figuration menus. It locks automatically after 5 minutes of inactivity to prevent accidental entry to the menus by touching the touch screen and changing the parameters.
  • Page 10 5.4.3.7. Locking and Unlocking the Action Bar The scrolling speeds are expressed in millimeters per second (mm/s) or in centimeters per hour (cm/h). Press and hold the button to unlock the action bar and 5.4.3.3. Pressure Scale for the ICP curve to access the configuration settings menu.

  • Page 11: Initial Installation

    Monitor does not emit 3 beeps when starting, dis- Monitor. connect the Monitor and contact Sophysa Custom- er Service at contact@sophysa.com, or contact your local distributor. The touch screen lights up, and the time zone options appear: Remove the tie and label from the battery connectors.

  • Page 12: Setting-Up The System

    Catheter Extension Cable. For more information, contact Sophysa Customer Serv- WARNING ice at contact@sophysa.com, or contact your local dis- Do not clean the Monitor or the Catheter, nor disinfect tributor. the cables, when in use on the patient. 8.2. PREREQUISITES WARNING Put on gloves and keep them throughout the procedure.

  • Page 13: Cleaning Procedure

    8.3. CLEANING PROCEDURE 8.4. DISINFECTION PROCEDURE The purpose of this procedure is to remove any soiling and The purpose of this procedure is to remove any microorgan- visible residues on the external surfaces of the Monitor, in- isms present on the Catheter Extension Cable. cluding the touchscreen, its cables and accessories.

  • Page 14: Connecting Cables

    Catheter dongle [26] with the blue ar- emit 3 beeps, disconnect the Monitor and contact So- row on the catheter extension cable connector [27]. physa Customer Service at contact@sophysa.com, or contact your local distributor. Power on the Monitor as follows: Affix the Monitor to a pole or rail.

  • Page 15: Implanting The Catheter

    Press “Alarm”. The alarm settings screen displays. CAUTION Select: Keep the sensor immersed in sterile saline solution – ON to activate the alarms. during the zeroing procedure. Zeroing the sensor in – OFF to deactivate the alarms. conditions other than those recommended may cause inaccurate pressure readings.

  • Page 16: Changing The Monitor

    to be displayed along with other physiological parameters on If the patient bedside monitor displays 29, 30 or the patient bedside monitor. 31 mmHg, return to the Monitor touch screen and press NOTE If the patient bedside monitor has not been calibrated, The following message displays: Sending 60 mmHg the Monitor sends a warning value of 360 mmHg to the signal to patient monitor.

  • Page 17: Advanced Functions

    10. Advanced Functions 10.1. HISTORY 10.1.3. Zoom Press the button to select a different zoom value, or to NOTE The cumulative memory for the history is 15 days. Be- deactivate the zoom. yond 15 days, the history data will be deleted on a first- in, first-out (FIFO) basis.

  • Page 18: Data Acquisition

    The mini USB port makes it possible to obtain raw data from “Internal Historical Records” or “Catheter History”. the Catheter in the form of ASCII values, to analyze them with third-party software (not supplied by Sophysa). Press the default button, and select the export for-...

  • Page 19: Maintenance

    Charge the battery no less frequently than every 2 months, to System will function as intended if the maintenance of preserve the battery service life. the monitors has not been carried out by Sophysa or by a third party duly authorized by Sophysa. CAUTION ®...

  • Page 20: Catheter Extension Cable

    Consult the Instructions for Use Keep away from liquids CE Conformity Marking Fragile, handle with care Date of recalibration 15.2. CATHETER EXTENSION CABLE The Monitor must only be used with Sophysa cables, ® Catheter kits and accessories from the Pressio Symbol Meaning range.
  • Page 21 Failure of the real Return the equipment to Defective catheter Change the catheter ex- is displayed on the implantation dura- time clock. Sophysa. extension cable. tension cable. patient bedside tion after 1 day or monitor. Defective Catheter. Change the Catheter if metering blocked.

  • Page 22: Technical Specifications

    SYMPTOMS POSSIBLE CAUSES SUGGESTED ACTIONS SYMPTOMS POSSIBLE CAUSES SUGGESTED ACTIONS turn the Monitor to after- Power the Monitor off sales service. and on. If the Power button does If error codes “E001”, not answer, unplug the “E002” or “E005” ap- power cable, remove the pear: battery cover and dis-...
  • Page 23 Measuring and display specifications Externalization specifications to a patient monitor Item Specification Item Specification bedside Display range -40 mmHg to +150 mmHg Sensitivity Standard YSI 400 monitor Unit mmHg Resolution 0.1 °C (0.1 °F) Resolution +1 mmHg Accuracy Assigned output range +/- 0.2 °C from 25.0 °C to 45.0 °C Accuracy +/-2% of the reading from 0 to...

  • Page 24: Specifications Concerning Alarms

    History of exports and imports specifications Restarting monitoring following a power cut or powering off Item Specification Battery ICP and Restarting Restarting Restarting status ICT moni- ICP and ICP moni- ICT moni- History of averages Interval of 20 s for the toring ICT moni- toring on...
  • Page 25 17.2.2. Technical alarms Techni- Alarm Priori- Sound indica- Visual indi- cal pa- condi- sponse tors cators rameter tion time Techni- Alarm Priori- Sound indica- Visual indi- cal pa- condi- sponse tors cators Average High Prompt Three-pulse The mes- rameter tion time measure- ICP out-...

  • Page 26: Electromagnetic Compatibility

    The user might need to take Use of accessories, transducers and cables other than mitigation measures, such as relocating or re-orienting those specified or provided by Sophysa could result in the equipment. increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result 18.1.

  • Page 27: Guidance And Manufacturer's Declaration Tables

    – the ICP curve can show temporary peaks of high ampli- Guidance and manufacturer’s declaration – Electromagnetic im- tude. munity – If an electrostatic discharge occurs near the Monitor, tem- The Monitor is intended to be used in the electromagnetic environ- porary error “E001”, “E002”...

  • Page 28: References

    Guidance and manufacturer’s declaration – Electromagnetic im- Guidance and manufacturer’s declaration – Electromagnetic im- munity munity Surges line- ±0.5 kV, ±1 kV ±0.5 kV, ±1 kV The quality of the Voltage dips 0 % U ; 0.5 cy- 0 % U ;...
  • Page 29 Availability may vary according to country. Page 29 of 30...
  • Page 30 Sophysa USA 503 E Summit Street, Suite 5 Crown Point IN 46307 Tel.: +1 219 663 7711 Fax: +1 219 663 7741 contact@sophysa.us www.sophysa.com ® Pressio is a registered trademark of Sophysa. ©2020 Sophysa. All rights reserved. NT500_EN_US Rev003_2020-11...

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