Hill-Rom Synclara PSC1 User Manual
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Hill-Rom Synclara PSC1 User Manual

Cough system
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Draft_E_2019-Apr-29_Cleaned
Synclara™ Cough System
Model PSC1
User Manual
Product No. PSC1
Rx only: Federal USA law restricts this device to sale by or on the order of a
physician.
194921 REV E

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Summary of Contents for Hill-Rom Synclara PSC1

  • Page 1 Draft_E_2019-Apr-29_Cleaned Synclara™ Cough System Model PSC1 User Manual Product No. PSC1 Rx only: Federal USA law restricts this device to sale by or on the order of a physician. 194921 REV E...
  • Page 2 Draft_E_2019-Apr-29_Cleaned...
  • Page 3 The Synclara™ Cough System, Model PSC1 may be covered by one or more patents. See the Internet address above. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications. Manufactured by: HILL-ROM SERVICES PRIVATE LIMITED...
  • Page 4 Bluetooth® is a registered trademark of Bluetooth Sig, Inc. Hill-Rom® is a registered trademark of Hill-Rom Services, Inc. Synclara™ is a trademark of Hill-Rom Services PTE Ltd . Replace this manual (194921) if it is damaged and/or can not be read.

  • Page 5: Table Of Contents

    Draft_E_2019-Apr-29_Cleaned Table of Contents Revision ............i Intended Use .
  • Page 6 Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy in Manual Mode......28 Start a Therapy in Manual Mode ......29 Advanced Synclara™...
  • Page 7 Draft_E_2019-Apr-29_Cleaned Install the Control Unit on the Cart and Stand Assembly . . 69 Move the Stand ......... 70 Install the Control Unit on a Medical Rail or IV pole .
  • Page 8 Draft_E_2019-Apr-29_Cleaned Classification and Standards ....... . . 93 Essential Performance ........93 Federal Communications Commission (FCC) Compliance Statement .

  • Page 9: Intended Use

    Draft_E_2019-Apr-29_Cleaned Intended Use INTENDED USE The Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, as a result of high spinal cord injuries, neuromuscular deficits, or severe fatigue associated with intrinsic lung disease.

  • Page 10: Indications For Use

    Draft_E_2019-Apr-29_Cleaned Important Information shifts to supply negative exsufflatory pressure (Exhale) with the intended goal of rapidly deflating the lungs to simulate a high expiratory flow which stimulates an effective cough. After exhale, the system moves into a paused state and maintains a positive pressure flow to the patient, if programed.

  • Page 11: Relative Contraindications

    Draft_E_2019-Apr-29_Cleaned Important Information ELATIVE ONTRAINDICATIONS When you use the Synclara™ Cough System, patients with these conditions should be carefully evaluated before a decision is made to use the therapy: • Inability to tolerate the increased work of breathing • Hemodynamic instability •...

  • Page 12: Symbols And Acronyms

    Draft_E_2019-Apr-29_Cleaned Symbols and Acronyms SYMBOLS AND ACRONYMS OCUMENT YMBOLS This manual contains different typefaces and symbols to make the content easier to read and understand: • Standard text—used for regular data. • Boldface text—emphasizes a word or phrase. • NOTE:—sets apart special data or important instruction clarification. •...
  • Page 13 Draft_E_2019-Apr-29_Cleaned Symbols and Acronyms Symbol Definition Rating for ingress protection in accordance with IEC 60259 Unique Device Identification information Type B equipment with an F-type applied part, according to EN 60601-1 Class II equipment (double insulated), according to EN60601-1 Manufacturer or distributor complies with the Waste Electric and Electronic Equipment Directive 2002/96/EC Manufacture date...
  • Page 14 Draft_E_2019-Apr-29_Cleaned Symbols and Acronyms Symbol Definition Single patient use Physician prescription required (for US only) Safe Working Load—this includes weight of control unit and accessories such as patient circuits Mass of the medical equipment Mass of the medical equipment including the mass of the control unit, accessories, patient circuits, and the pole clamp assembly Warning—Read the User Manual for safety...

  • Page 15: Common Screen Symbols

    Draft_E_2019-Apr-29_Cleaned Symbols and Acronyms OMMON CREEN YMBOLS The following symbols may or may not be shown on the touchscreen. Symbol Description The system is connected to the AC power and not powered by the battery. The system is powered by the battery. The system is connected to a WiFi network.

  • Page 16: Acronyms

    Draft_E_2019-Apr-29_Cleaned Symbols and Acronyms Symbol Description Heart rate of the patient. Blood oxygen saturation level of the patient. Strength of the cough flow. Tidal volume delivered to the patient during the therapy. CRONYMS Acronym Meaning Highest Programed Pressure Pressure Ceiling Positive Airway Pressure Peak Cough Flow SpO2...

  • Page 17: Safety Instructions

    READ ALL INSTRUCTIONS BEFORE USING Training shall be provided by a Hill-Rom qualified trainer or respiratory therapist before the user uses the system for therapy delivery. WARNING: Obey all warnings throughout the manual and also those below to help prevent injury and/or equipment damage: •...
  • Page 18 • Warning—Do not connect any equipment or accessories to the USB port on the system, except for Hill-Rom approved accessories (See “Accessories” on page 59). The USB port on the back of the system is only for retrieving information as described in this user manual.
  • Page 19 Draft_E_2019-Apr-29_Cleaned Safety Instructions WARNING: (Warnings continued) Obey all warnings throughout the manual and also those below to help prevent injury and/or equipment damage: • Warning—Do not allow any metallic conductive objects to contact the battery terminals. Do not short circuit a battery or throw it into the fire;...
  • Page 20 Synclara™ Cough System, Model PSC1, contact Hill-Rom: • In the USA, call Hill-Rom at 800-426-4224. • Outside of the USA, contact your distributor or local Hill-Rom representative, or go to www.respiratorycare.hill-rom.com. SAVE THESE INSTRUCTIONS Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 21: Features

    Draft_E_2019-Apr-29_Cleaned Features FEATURES ONTROL Front Item Description Item Description Control unit Therapy port Touchscreen Nebulizer port (Not applicable for Synclara™ Cough System) Power On/Off button Therapy port cap Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 22: Back

    Draft_E_2019-Apr-29_Cleaned Features Back Item Description Item Description Patient circuit hook USB port Handle Foot switch port (optional) Replaceable battery Fuse holder (optional) Ventilation fan Air inlet filter Power inlet Nebulizer filter (Not applicable for Synclara™ Cough System) Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 23: Synclara™ Cough System Single Patient Use Circuit

    Draft_E_2019-Apr-29_Cleaned Features ™ C YNCLARA OUGH YSTEM INGLE ATIENT IRCUIT Item Description Item Description Bio-filter Adapter, 22 mm x 22 mm Breathing hose Face mask (optional) Mouthpiece Flexible tracheostomy adapter (optional) Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 24: Assemble And Connect The Patient Circuit

    • In the USA, call Hill-Rom at 800-426-4224. • Outside the USA, contact your distributor or local Hill-Rom representative, or go to www.respiratorycare.hill-rom.com. Connect the correct patient circuit. See page 17. Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 25: Connect The Synclara™ Patient Circuit

    Draft_E_2019-Apr-29_Cleaned Assemble and Connect the Patient Circuit ™ P ONNECT THE YNCLARA ATIENT IRCUIT WARNING: Warning—The patient circuit is for single patient use only. Always use a new patient circuit when using the system on a new patient. Failure to do so could cause cross contamination.

  • Page 26: Set Up And Power On The Control Unit

    Draft_E_2019-Apr-29_Cleaned Set up and Power on the Control Unit • Flexible tracheostomy adapter (I)— Insert and gently twist the tracheostomy adapter (I) into the free end (D) of the breathing hose. b. Connect the other end of the flexible tracheostomy adapter to the tracheostomy tube (patient’s own).

  • Page 27: Power Off The Control Unit And Store The System

    Press and hold the Power button on the control unit for 5 seconds. The Hill-Rom screen shows. To start a therapy, see “Synclara™ Therapy” on page 19 or “” on page 39.

  • Page 28: About The Home Menu

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy BOUT THE Item Description Item Description Automatic Therapy mode B Manual Therapy mode Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 29: About The Options Menu

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy BOUT THE PTIONS Item Option Description Home—Go to the Home menu. Advanced View—See an advanced view of a therapy summary. Care Plan—Access the preset therapy settings. Device Settings—Access the device control settings, enable clinical access, retrieve logs, and configure connections to accessories (available only if enabled).

  • Page 30: Start A Therapy

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy TART A HERAPY NOTES: • Always use the settings prescribed by the physician. • Avoid operating the touchscreen with wet fingers as this will reduce the screen response. Synclara™ therapy is available in both automatic and manual modes. Select the preferred therapy mode—...

  • Page 31: Synclara™ Therapy In Automatic Mode

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy adapter from the tracheostomy tube or endotracheal tube to permit the patient to breathe freely through the tracheal tube. At the same time, coach the patient to make spontaneous cough efforts to expel any mucus. Follow the steps that apply to the prescribed therapy modes: •...

  • Page 32: Start A Therapy In Automatic Mode

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy Start a Therapy in Automatic Mode NOTES: • Before you start a therapy, make sure you have connected the appropriate patient circuit to the system. “Connect the Synclara™ Patient Circuit” on page 17. • Make sure the patient circuit is put into position on the patient. See Step 4 on page 17.
  • Page 33 Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy NOTE: To modify a preset therapy plan, see page 50. Press Start. The therapy begins. During the therapy, follow these guidelines: • During the Inhale stage, have the patient breathe normally as directed by the clinician until his/her lungs fill to capacity. •...

  • Page 34: Adjust The Patient Synchrony And End With Sigh Settings

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy NOTE: Note the number of treatment sessions carried out with the connected patient circuit. Number of times the patient circuit has been used Maximum number of treatment sessions the patient circuit can be used Press Back to go to the automatic therapy screen.

  • Page 35: Access The Advanced View

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy Press Options. To enable Patient Synchrony— Slide the setting to ON. b. Select the preferred level of sensitivity: Low, Medium or High. To enable End with Sigh— Slide the setting to ON. b. Press the setting to change the Pressure or Time.

  • Page 36: Synclara™ Therapy In Manual Mode

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy ™ T YNCLARA HERAPY IN ANUAL Basic View in Manual Mode Item Description Item Description Therapy controls Start/stop control Pressure meter/digital Flow control manometer Heart rate and pulse Flutter (Pressure oscillation) oximeter readings control (available only if a pulse oximeter is connected).

  • Page 37: Start A Therapy In Manual Mode

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy Start a Therapy in Manual Mode NOTES: • Before you start a therapy, make sure you have connected the appropriate patient circuit to the system. “Connect the Synclara™ Patient Circuit” on page 17. • Make sure the patient circuit is put into position on the patient. See Step 4 on page 17.
  • Page 38 Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy • If required, press Flow to toggle between different intensities of air movement during the therapy. Press Start. When pressure is ready for therapy, the Inhale control is lighted. Press and hold the Inhale control to activate the Inhale stage. Or, press and hold the Exhale control to activate the Exhale stage.
  • Page 39 Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy NOTE: On custom configured systems with the foot switch option— • To activate the Inhale stage, press and hold +. • To activate the Exhale stage, press and hold - • Release the control to deactivate each stage. Activate Activate Exhale...

  • Page 40: Advanced Synclara™ Therapy Settings

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy ™ T DVANCED YNCLARA HERAPY ETTINGS These settings allow you to create, modify, rename, and/or delete a preset therapy. Create a New Preset Therapy Plan NOTE: Available only if Clinical Access is enabled. See page 42. Press Automatic. Swipe the Options tab left, and press the Care Plan menu control.
  • Page 41 Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy At each cycle, select the preferred option to adjust its settings: Inhale (Blue) Exhale (Orange) PAP (Green) You can adjust these settings for each cycle: • Duration of therapy session • Therapy pressure • Enable, disable, or adjust Flutter. •...
  • Page 42 Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy 11. To adjust Flutter and Frequency, press the setting to change it. Press the keypad control and enter the required setting, or use the + or – control to adjust the setting. b. Press Save to save the changes. Or, press Cancel.

  • Page 43: Modify A Preset Therapy Plan

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy 14. Select the new Care Plan and press Start. The therapy begins. Modify a Preset Therapy Plan NOTE: Available only if Clinical Access is enabled. See page 42. Press Automatic. Swipe the Options tab left, and press the Care Plan menu control.
  • Page 44 Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy Swipe right or left to select a cycle. At each cycle, select the preferred option to adjust its settings: Inhale (Blue) Exhale (Orange) PAP (Green) You can adjust these settings for each cycle: • Duration of the therapy session •...
  • Page 45 Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy 13. To adjust Flutter and Frequency, press the setting to change it. Press the keypad control and enter the required setting, or use the + or – control to adjust the setting. b. Press Save to save the changes. Or, press Cancel.

  • Page 46: Rename A Preset Therapy Plan

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy Rename a Preset Therapy Plan NOTE: Available only if Clinical Access is enabled. See page 42. Select the plan to rename. Press and hold the therapy plan until the on-screen keyboard shows. Use the on-screen keyboard to enter any 5 alphanumeric characters, and press Enter.

  • Page 47: Delete A Preset Therapy Plan

    Draft_E_2019-Apr-29_Cleaned Synclara™ Therapy Delete a Preset Therapy Plan NOTE: Available only if Clinical Access is enabled. See page 42. Press Automatic. Swipe the Options tab left, and press the Care Plan menu control. Select the plan to delete. Press Edit. When prompted, press Delete.

  • Page 48: Device Settings

    Draft_E_2019-Apr-29_Cleaned Device Settings DEVICE SETTINGS Swipe the Options tab left, and press the Device Settings menu control. The Device Settings screen shows. You can view or adjust these settings: • Screen brightness • Date and time • 12 hour or 24 hour clock format •...

  • Page 49: Adjust Date And Time Settings

    Draft_E_2019-Apr-29_Cleaned Device Settings DJUST ATE AND IME SETTINGS Press Device to access the Date-Time settings. At the Device screen, move the slider to select the preferred setting for each item. To change the time zone, press Modify. b. Scroll up or down to select the correct time zone, and press Save.

  • Page 50: Enable Or Disable Clinical Access

    Draft_E_2019-Apr-29_Cleaned Device Settings NABLE OR ISABLE LINICAL CCESS Clinical Access allows facility-authorized persons to access and configure these advanced features: • Adjustment of the maximum pressure ceiling setting available to the user. • Modification of the preset therapy settings. • Import of the device settings •...

  • Page 51: Set The Pressure Ceiling Limit

    Draft_E_2019-Apr-29_Cleaned Device Settings NOTE: To prevent unauthorized persons from adjusting the settings made, disable Clinical Access after you have made the settings. Press Control, then slide Clinical Access to OFF. Press the Home menu control to exit. ET THE RESSURE EILING IMIT The Pressure Management feature allows facility-authorized persons to...
  • Page 52 Draft_E_2019-Apr-29_Cleaned Device Settings NOTE: The pressure management settings show: • Pressure Ceiling (PC)—the maximum therapy pressure that can be selected by the user in manual mode or when modifying a preset plan. • Highest Programed Pressure (HPP)—the highest therapy pressure that has been programed in both automatic and manual modes in this system.

  • Page 53: Connect A Barcode Reader Or Pulse Oximeter

    Draft_E_2019-Apr-29_Cleaned Device Settings ONNECT A ARCODE EADER OR ULSE XIMETER NOTES: • Available only if Clinical Access is enabled. See page 42. • For Bluetooth® detection, have the barcode reader or pulse oximeter within one meter (3') of the system. Power on the control unit and the device for pairing.

  • Page 54: Connect To Awifi Network

    Draft_E_2019-Apr-29_Cleaned Device Settings NOTE: To prevent unauthorized persons from adjusting the settings made, disable Clinical Access after you have made the settings. Press Device, then press Control. Slide Clinical Access to OFF. When complete, press the Home menu control to exit. WIFI N ONNECT TO A ETWORK...
  • Page 55 Draft_E_2019-Apr-29_Cleaned Device Settings Depending on the networks available, the scan will take a few minutes. When complete, a list of wireless networks shows. Select the network to join. Use the on-screen keyboard to enter the Password. To confirm the entries, press Proceed. To cancel, press Cancel.

  • Page 56: Connect To A Public Network

    Draft_E_2019-Apr-29_Cleaned Device Settings Connect to a Public Network NOTES: • After initial connection, the WiFi will automatically connect when the Synclara™ Cough System is turned on and within WiFi range. • Data will transmit automatically at the end of the therapy session, or when the Synclara™...

  • Page 57: Connect To An Enterprise Network

    Draft_E_2019-Apr-29_Cleaned Device Settings • If the connection is unsuccessful, an error message shows. Press Return to go to the previous screens and make your entries again. To view the status of the connection, press Status. Press the Home menu control to exit. Connect to an Enterprise Network Swipe the Options tab left, then press the Options menu control.

  • Page 58: Configure Network Settings

    Draft_E_2019-Apr-29_Cleaned Device Settings Select the network to join. When prompted, use the on-screen keyboard to enter the UserID and Password. To confirm, press Proceed. To cancel, press Cancel. 10. When the connection is successful, a green check mark shows next to the access point name.
  • Page 59 • If the test is unsuccessful, try again later. • If the test continues to fail, contact Hill-Rom. Press Return to exit the test connection screen. To connect to the server, slide WiFi to OFF, then ON again. The network settings entered are submitted to the server.

  • Page 60: Test The Connection To Visiview™ Health Portal

    If the test is complete, a confirmation screen shows. • If the test is unsuccessful, try again later. • If the test continues to fail, contact Hill-Rom. Press the Home menu control to exit. Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 61: Test The Connection To Electronic Medical Records (Emr)

    If the test is complete, a confirmation screen shows. Press Return to exit. • If the test is unsuccessful, try again later. • If the test continues to fail, contact Hill-Rom. Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 62: Retrieve Logs

    Draft_E_2019-Apr-29_Cleaned Device Settings To confirm the settings entered, slide WiFi to OFF, then ON again. Press the Home menu control to exit. ETRIEVE You can retrieve both the therapy log and the error log from this system. NOTES: • Before you start, format the USB drive to FAT16 or FAT32 format on your computer.

  • Page 63: Retrieve The Error Log

    Draft_E_2019-Apr-29_Cleaned Device Settings To export all the therapy logs, connect a USB drive to the port on the back of the control unit. At Therapy Log, press Export. Exporting begins. When the export is complete, a confirmation screen shows. Press Return to go to the Data screen. NOTE: To prevent unauthorized persons from adjusting the settings made, disable...
  • Page 64 Draft_E_2019-Apr-29_Cleaned Device Settings Select the date and time of the session on the left hand panel. Errors that occurred at that time show on the right panel. Press Back to go to the Data screen. To export the Error Log, connect the USB drive to the port on the back of the control unit.

  • Page 65: Import And Export Device Settings

    Draft_E_2019-Apr-29_Cleaned Device Settings MPORT AND XPORT EVICE ETTINGS You can export the settings from one system and import the settings into another system. NOTES: • Before you start, format the USB drive to FAT16 or FAT32 format on your computer. This action deletes all information currently stored on the USB drive.

  • Page 66: View The Firmware Version And System Information

    Draft_E_2019-Apr-29_Cleaned Device Settings NOTE: To prevent unauthorized persons from adjusting the settings made, disable Clinical Access after you have made the settings. Press Device, then press Control. Slide Clinical Access to OFF. IEW THE IRMWARE ERSION AND YSTEM NFORMATION Swipe the Options tab left, and press the Device Settings menu control.

  • Page 67: Accessories

    Draft_E_2019-Apr-29_Cleaned Accessories ACCESSORIES Item Part Number Replaceable Battery 194566S See page 60. Pulse Oximeter, Bluetooth® 196694 See page 64. Foot Switch (for control of 204405 Synclara™ therapy and on custom configured systems). See page 65. WiFi Module, USB 198658 Pole Clamp Assembly M08235 See page 66.

  • Page 68: Replaceable Battery

    181995 Carrying Case M08083 EPLACEABLE ATTERY Use only the Hill-Rom approved battery (194566S). The Synclara™ Cough System can be powered by a Lithium-ion battery when AC power is not available. A fully charged new battery can support 9 sessions of a typical Synclara™...

  • Page 69: Install The Battery

    Caution—Do not open, crush, puncture, incinerate, immerse in water, or heat over 140°F (60°C) the battery. • Caution—Use only the Hill-Rom approved battery (194566S). • Caution—Fully charge the battery to 100% before the first time use. Allow for up to 8 hours to fully charge the battery.
  • Page 70 Draft_E_2019-Apr-29_Cleaned Accessories Unlocked Fully Locked When the replaceable battery is installed in the control unit, the battery symbol shows on the touchscreen. Symbol Battery status The battery charge is low. The battery is charging. The battery is 25% charged. The battery is 50% charged. Synclara™...

  • Page 71: Charge The Battery

    Draft_E_2019-Apr-29_Cleaned Accessories Symbol Battery status The battery is 75% charged. The battery is fully charged. The control unit has lost communication with the battery and is not powered by the battery. To check the battery charge, press the button beside the LED indicator on the battery.

  • Page 72: Pulse Oximeter

    Draft_E_2019-Apr-29_Cleaned Accessories ULSE XIMETER NOTE: Use only the Hill-Rom approved pulse oximeter (196694). The pulse oximeter is connected to the Synclara™ Cough System by Bluetooth®. The pulse oximeter monitors the patient’s blood oxygen level and heart rate (pulse). When the pulse oximeter is connected, you can view the readings collected from the patient on the control unit touchscreen.

  • Page 73: Foot Switch

    WITCH WARNING: The foot switch port is available only on custom configured systems. Warning—Use only the approved Hill-Rom foot switch (204405). The use of a different foot switch could cause the control unit to operate incorrectly, resulting in patient injury.

  • Page 74: Mobile Stand And Pole Clamp Assembly

    Draft_E_2019-Apr-29_Cleaned Accessories OBILE TAND AND LAMP SSEMBLY Install the Stand Lock the casters. to prevent the stand base from moving. Install the pole with cart into the stand base. Lay the stand base on its side. Install the screw and washer to secure the stand base to the pole. Turn the hex wrench clockwise to tighten the screw.
  • Page 75 Draft_E_2019-Apr-29_Cleaned Accessories Install the top pole into the stand base. Make sure the groove is aligned with its opening in the bottom pole. Use the hex wrench to tighten the pole connection. Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 76: Install The Tray And Pole Clamp

    Draft_E_2019-Apr-29_Cleaned Accessories Install the Tray and Pole Clamp Note the guide on the back of the tray. Turn the tray over, and attach the pole clamp to the tray with the supplied parts from the kit. Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 77: Install The Control Unit On The Cart And Stand Assembly

    Draft_E_2019-Apr-29_Cleaned Accessories Install the Control Unit on the Cart and Stand Assembly Find the preferred position to install the tray. Turn the knob on the pole clamp clockwise to hold the tray in position on the cart. Put the control unit on the tray. Make sure the screw holes on the bottom of the control unit are aligned with the screw holes on the tray.

  • Page 78: Move The Stand

    Draft_E_2019-Apr-29_Cleaned Accessories Move the Stand CAUTION: Obey these cautions to help prevent equipment damage: • Caution—Do not apply force or pull the control unit when it is connected to the oxygen source. • Caution—Do not pull the control unit using the breathing hose or circuit tubing.
  • Page 79 Draft_E_2019-Apr-29_Cleaned Accessories Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 80: Replacement Parts/Kits

    Draft_E_2019-Apr-29_Cleaned Replacement Parts/Kits REPLACEMENT PARTS/KITS Description Part number Adapter, in-line 22 mm x 22 mm C10038 Bio-filter 206680 Battery cover 194779 Breathing hose: 120 cm (47") long, 22 mm ID 206681 Face mask: 15 mm OD—infant 188339 Face mask: 22 mm ID—adult large 188343 Face mask: 22 mm ID—adult medium 188342...

  • Page 81: Cleaning And Disinfecting

    Draft_E_2019-Apr-29_Cleaned Cleaning and Disinfecting CLEANING AND DISINFECTING WARNING: When you clean and disinfect the system, obey these warnings to help prevent injury and/or equipment damage: • Warning—The potential for electrical shock exists with electrical equipment. Failure to follow facility protocols may cause death or serious injury.

  • Page 82: Clean The Control Unit, Stand With Cart, And Foot Switch

    Draft_E_2019-Apr-29_Cleaned Cleaning and Disinfecting CAUTION: To help prevent equipment damage, obey these cautions: • Caution—Do not use harsh cleansers/detergents, heavy duty grease removers, solvents such as toluene, xylene, or acetone, and do not use scouring pads (you may use a soft-bristle brush). •...

  • Page 83: Clean The Pulse Oximeter

    Draft_E_2019-Apr-29_Cleaned Cleaning and Disinfecting Clean the control unit, mobile stand with cart, and foot switch, as follows: Power off the control unit. Disconnect the control unit from the power source. Disconnect the patient circuit from the control unit. Put the therapy port cap over the therapy port.
  • Page 84 Draft_E_2019-Apr-29_Cleaned Cleaning and Disinfecting • Warning—Clean the patient circuit between each therapy session for the same patient. • Warning—If the circuit and/or bio-filter are damaged or visibly soiled, replace them. See “Replacement Parts/Kits” on page 72. NOTE: Each patient circuit is for use by a single patient and intended for 30 days of treatment or a maximum of 90 treatment sessions.

  • Page 85: Disinfect

    Draft_E_2019-Apr-29_Cleaned Cleaning and Disinfecting Examples of Typical Damage of the Bio-filter Each of the following three pictures show examples of possible damage. These pictures do not show all possible types of damage. Soiled Filter: Mucus or liquid is attached to the membrane.

  • Page 86: Maintenance

    Draft_E_2019-Apr-29_Cleaned Maintenance MAINTENANCE WARNING: Warning—To prevent injury and/or equipment damage, do not do maintenance when the system is in use. NLET ILTER Examine the inlet filter every month, and clean it as necessary. Replace the inlet filter every twelve (12) months. To clean the filter, do as follows: Power off the control unit.

  • Page 87: Fuse

    Draft_E_2019-Apr-29_Cleaned Maintenance If a fuse needs to be replaced, do as follows: Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 88: Expected Life

    If service is necessary, use this contact information: • In the USA, call a Hill-Rom representative at: 800-426-4224. • Outside the USA, contact your distributor or a local Hill-Rom representative or go to www.respiratorycare.hill-rom.com. NOTE: When contacting a Hill-Rom representative regarding the Synclara™...

  • Page 89: Troubleshooting

    Make sure the power cord is fully plugged into an AC power. • Examine the fuse. If necessary, replace the fuse (see page 79). • If the problem continues, contact a Hill-Rom representative. • If the control unit is powered by a battery: •...

  • Page 90: Information Indicators

    Draft_E_2019-Apr-29_Cleaned Troubleshooting NFORMATION NDICATORS Information indicators provide the caregiver with audible indicators and visual indicators. Audio Alerts Beeps provide audible indications of the status of the system. Alert Pattern Status One beep Indicates that an activity is successful. Three beeps Indicates that attention is needed, and you should look at the touchscreen.

  • Page 91: Warning Messages

    001, 002, 003, 004, Power off the control unit, then power it on 005, 006, 008, 032 again. Make sure only the Hill-Rom approved battery (194566S) is used. Press return after reading the on-screen message. Make sure the battery is correctly installed in the control unit.

  • Page 92: Caution Messages

    Draft_E_2019-Apr-29_Cleaned Troubleshooting Caution Messages Caution messages show on-screen to let you know that an issue has occurred. Follow the on-screen instructions to troubleshoot the issue. If an error code shows, see “Solutions for Cautious Messages” on page 84. Solutions for Cautious Messages Error Code Do this: 007, 013, 020...
  • Page 93 3. If the same message shows, power off the control unit and let it cool down for at least 30 minutes. Power on the control unit. 1. Make sure only the Hill-Rom approved battery (194566S) is used. 2. Press return after you read the on-screen message.
  • Page 94 See “Replacement Parts/Kits” on page 4. Press return after you read the on-screen message. 1. Make sure only the Hill-Rom approved bio- filter (206680) is used. For instructions on how to connect the filter correctly, see page 2. Press return after you read the on-screen message.
  • Page 95 In most instances, you may have to restart the system. If the problem continues, contact Hill-Rom: • In the USA, call Hill-Rom at 800-426-4224. • Outside of the USA, contact your distributor or local Hill-Rom representative, or go to www.respiratorycare.hill-rom.com. Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 96: Storage And Handling

    Draft_E_2019-Apr-29_Cleaned Storage and Handling STORAGE AND HANDLING To store or transport the Synclara™ Cough System, do the following: Put the therapy port cap over the therapy port. Put the control unit in the carrying case. Put the patient circuit components into a clean plastic bag. Pack the power cord, replaceable battery, patient circuit, and other accessories into the compartments of the carry case.

  • Page 97: Shipping And Packaging

    • Request and get a return material authorization (RMA) number from Hill-Rom. You will get a return kit in the mail. Clean and disinfect the unit. Make sure it is dry before you pack it. See “Clean the Control Unit, Stand with Cart, and Foot Switch” on page 74.

  • Page 98: Specifications

    Draft_E_2019-Apr-29_Cleaned Specifications SPECIFICATIONS RODUCT DENTIFICATION Product Number Description PSC1 Synclara™ Cough System, Model PSC1 PECIFICATIONS RODUCT Feature Description Inhale Pressure 0 to 70 cmH2O Exhale Pressure -70 to 0 cmH2O PAP Pressure 0 to 30 cmH2O Sigh Pressure 0 to 30 cmH2O Per Stage Duration 0 - 5 seconds Flutter Pressure...

  • Page 99: Power Requirements

    Draft_E_2019-Apr-29_Cleaned Specifications Weight 26.9 lb (12.2 kg) OWER EQUIREMENTS Condition Range Line voltage 100 - 240 V AC Supply frequency 50 - 60 Hz Supply current 2.0 - 1.0 A Mode of operation Non-continuous: 5 minutes ON/ 20 minutes OFF at CHFO pressure setting of 65 cmH2O and above.

  • Page 100: System Cool Down

    Draft_E_2019-Apr-29_Cleaned Specifications YSTEM CAUTION: Caution—Failure to follow the system cool down guidelines below could cause equipment damage. Condition Cool Down Period System operates continuously for At least 20 minutes 5 minutes, at CHFO pressure setting of 65 cmH2O and above. IRELESS OMMUNICATION The Synclara™...

  • Page 101: Classification And Standards

    Draft_E_2019-Apr-29_Cleaned Specifications Feature Dimension Security Authentication/ WPA/WPA2-Personal, WEP 64/128 bits Encryption LASSIFICATION AND TANDARDS Classification Standards Safety Standards ANSI/AAMI ES60601-1: 2005 + C1: 09 + A2: 10 + A1: 12 ANSI/AAMI HA60601-1-11:2015 CAN/CSA-C22.2 No. 60601-1: 14 CAN/CSA-C22.2 No. 60601-1-11:15 IEC 60601-1: 2005 + A1: 2012 EN 60601-1: 2006 + A12:2014 IEC 60601-1:1988 + A1:1991 + A2:1995 IEC 60601-1-11: 2015-01...

  • Page 102: Federal Communications Commission (Fcc) Compliance

    Draft_E_2019-Apr-29_Cleaned Specifications (FCC) C EDERAL OMMUNICATIONS OMMISSION OMPLIANCE TATEMENT <This section is pending further updates from C&S. To be updated in Phase 3 after certification submission.> NOTES: • This system may not cause harmful interference, • This system must accept any interference received, including interference that may cause undesired operation.
  • Page 103 Draft_E_2019-Apr-29_Cleaned Specifications To see the FCC ID of this system— Swipe the Options tab left, and press the Device Settings menu control. The device information screen shows. Find the FCC ID in the system information. Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

  • Page 104: Electromagnetic Compatibility Guidance

    Draft_E_2019-Apr-29_Cleaned Specifications LECTROMAGNETIC OMPATIBILITY UIDANCE The Synclara™ Cough System, Model PSC1 is suitable for the electromagnetic environment settings specified in the tables that follow. WARNING: Warning—The Synclara™ Cough System, Model PSC1 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Synclara™...
  • Page 105 Draft_E_2019-Apr-29_Cleaned Specifications Guidance and Manufacturer's Declaration—Electromagnetic Immunity The Synclara™ Cough System, Model PSC1 is intended for use in the electromagnetic environment specified below. The customer or user of the Synclara™ Cough System, Model PSC1 should make sure it is used in such an environment. IEC 60601 Compliance Electromagnetic...
  • Page 106 Draft_E_2019-Apr-29_Cleaned Specifications Guidance and Manufacturer's Declaration—Electromagnetic Immunity The Synclara™ Cough System, Model PSC1 is intended for use in the electromagnetic environment specified below. The customer or user of the Synclara™ Cough System, Model PSC1 should make sure it is used in such an environment. IEC 60601 Compliance Electromagnetic...
  • Page 107 Draft_E_2019-Apr-29_Cleaned Specifications a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast can not be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, the electromagnetic site used should be considered.

  • Page 108: Electromagnetic Immunity To Wireless Communications

    Draft_E_2019-Apr-29_Cleaned Specifications LECTROMAGNETIC MMUNITY TO IRELESS OMMUNICATIONS The Synclara™ Cough System, Model PSC1 is intended for use in the electromagnetic environment specified below. The customer or user of the Synclara™ Cough System, Model PSC1 should make sure it is used in such an environment. Sides Tested Frequency Test Severity Level...
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