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Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)

Synclara™ Therapy

BOUT THE

OME

ENU

Item

Description

Item

Description

Automatic Therapy mode B

Manual Therapy mode

Draft_E_2019-Apr-29_Cleaned

Summary of Contents for Synclara PSC1

Page 1: ...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 Draft_E_2019 Apr 29_Cleaned...

Page 2: ...Draft_E_2019 Apr 29_Cleaned...

Page 3: ...ritten permission from Hill Rom Services Inc Hill Rom The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of Hill Rom The informa...

Page 4: ...is a trademark of Hill Rom Services PTE Ltd Replace this manual 194921 if it is damaged and or can not be read For product support or to order additional copies of this manual 194921 contact your dist...

Page 5: ...Instructions 9 Features 13 Control Unit 13 Front 13 Back 14 Synclara Cough System Single Patient Use Circuit 15 Assemble and Connect the Patient Circuit 16 Connect the Synclara Patient Circuit 17 Set...

Page 6: ...e Reader or Pulse Oximeter 45 Connect to a WIFI Network 46 Connect to a Local WIFI Network 46 Connect to a Public Network 48 Connect to an Enterprise Network 49 Configure Network Settings 50 Test the...

Page 7: ...t Filter 78 Fuse 79 Expected Life 80 Service calls 80 Troubleshooting 81 Control Unit Does Not Power On 81 On screen Help 81 Information Indicators 82 Audio Alerts 82 Notification Messages 82 Warning...

Page 8: ...1 REV E Classification and Standards 93 Essential Performance 93 Federal Communications Commission FCC Compliance Statement 94 Electromagnetic Compatibility Guidance 96 Electromagnetic Immunity to Wir...

Page 9: ...It is important that you read and strictly obey the safety aspects contained in this manual NOTE To identify the revision of your system see the serial number label on the back of the control unit IM...

Page 10: ...DICATIONS FOR USE The Synclara Cough System is indicated for but is not limited to patients with these conditions Muscular dystrophy Spinal muscular atrophy Amyotrophic lateral sclerosis Spinal cord i...

Page 11: ...iddle ear pathology POSSIBLE ADVERSE CONDITIONS When using the Synclara Cough System patients may experience one or more of these effects Increased work of breathing leading to hypoventilation and hyp...

Page 12: ...or actions that may have an effect on patient safety A WARNING identifies situations or actions that may have an effect on patient or user safety To ignore a warning could cause patient or user injur...

Page 13: ...t 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 D...

Page 14: ...pment 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 information for the battery...

Page 15: ...system is connected to a WiFi network The system is transmitting data to the connected WiFi network The system is connected to a cellular network A Bluetooth device is connected to the system A USB d...

Page 16: ...en saturation level of the patient Strength of the cough flow Tidal volume delivered to the patient during the therapy Acronym Meaning HPP Highest Programed Pressure PC Pressure Ceiling PAP Positive A...

Page 17: ...y Warning We recommend your first use of this product be in a supervised setting such as a doctor s office or at home with a clinical trainer Warning This system should only be used by trained persons...

Page 18: ...n the control unit Warning Do not use the system near flammable chemicals or products including flammable anesthetics Warning Keep the hoses tubings and power cord away from toddlers and children to a...

Page 19: ...or other hazard Warning Do not use this system without a bio filter Warning Do not use the system in a dusty environment Warning This product contains chemicals known to the State of California to ca...

Page 20: ...Caution Use the Synclara Cough System only with the Hill Rom approved pulse oximeter 196694 The data from the pulse oximeter is for information purposes only Caution Use the Synclara Cough System only...

Page 21: ...REV E 13 Features FEATURES CONTROL UNIT Front Item Description Item Description A Control unit D Therapy port B Touchscreen E Nebulizer port Not applicable for Synclara Cough System C Power On Off bu...

Page 22: ...scription Item Description F Patient circuit hook K USB port G Handle L Foot switch port optional H Replaceable battery optional M Fuse holder I Ventilation fan N Air inlet filter J Power inlet O Nebu...

Page 23: ...E 15 Features SYNCLARA COUGH SYSTEM SINGLE PATIENT USE CIRCUIT Item Description Item Description A Bio filter D Adapter 22 mm x 22 mm B Breathing hose E Face mask optional C Mouthpiece F Flexible tra...

Page 24: ...y protocols Warning Do not attempt to sterilize the circuit for reuse NOTES Each patient circuit is for use by a single patient and intended for 30 days of treatment or a maximum of 90 treatment sessi...

Page 25: ...smaller end of the bio filter B 2 Align the larger end of the bio filter C with the therapy port on the control unit 3 Gently turn the bio filter C to secure it to the therapy port NOTE Make sure the...

Page 26: ...the following before use Allow the control unit to warm up in an ambient environment of 68 F 20 C for at least 45 minutes when removed from a storage temperature of 4 F 20 C or colder Allow the contr...

Page 27: ...ynclara Therapy on page 19 or on page 39 POWER OFF THE CONTROL UNIT AND STORE THE SYSTEM When the therapy is complete do these steps 1 Press and hold the Power button for 5 seconds If the system is op...

Page 28: ...Synclara Cough System Model PSC1 User Manual 196286 REV E Synclara Therapy ABOUT THE HOME MENU Item Description Item Description A Automatic Therapy mode B Manual Therapy mode Draft_E_2019 Apr 29_Clea...

Page 29: ...anced view of a therapy summary C Care Plan Access the preset therapy settings D Device Settings Access the device control settings enable clinical access retrieve logs and configure connections to ac...

Page 30: ...ent Make sure the patient maintains a tight seal on the face mask or mouthpiece during the therapy Face mask Tightly but comfortably cover the mouth and nose of the patient Make sure the narrow end of...

Page 31: ...the prescribed therapy modes Automatic mode see Synclara Therapy in Automatic Mode on page 23 Manual mode see Synclara Therapy in Manual Mode on page 28 SYNCLARA THERAPY IN AUTOMATIC MODE Basic View i...

Page 32: ...r pairing instructions see page 45 The last used preset therapy is selected If required press the Flow control to toggle between different intensities of air movement to deliver during the therapy 2 T...

Page 33: ...tracheal tube If you see or suspect that there is mucus and the patient can not spontaneously expel it you may pause the therapy and help the patient to clear the mucus If necessary use suctioning de...

Page 34: ...lable in Synclara Automatic mode Patient Synchrony allows the system to synchronize cough cycles with the patient s breath pattern When enabled the therapy starts in Pause stage When the patient s inh...

Page 35: ...4 To enable End with Sigh a Slide the setting to ON b Press the setting to change the Pressure or Time c Press the keypad control and enter the required setting or use the or controls to adjust the s...

Page 36: ...in Manual Mode Item Description Item Description A Therapy controls E Start stop control B Pressure meter digital manometer F Flow control C Heart rate and pulse oximeter readings available only if a...

Page 37: ...der For pairing instructions see page 45 The manual therapy screen shows the last used therapy settings 2 Use the or control to select the pressure settings Or press the setting and use the keypad con...

Page 38: ...s During the Inhale stage have the patient breathe normally or as directed by the clinician until his her lungs fill to capacity During the Exhale stage have the patient attempt to cough or huff Betwe...

Page 39: ...e each stage 6 When the therapy is complete press Stop The therapy summary shows NOTE Note the number of treatment sessions carried out with the connected patient circuit 7 Press Back to go to the ini...

Page 40: ...Plan NOTE Available only if Clinical Access is enabled See page 42 1 Press Automatic 2 Swipe the Options tab left and press the Care Plan menu control 3 Select an empty preset plan and press Create 4...

Page 41: ...tic form of chest physiotherapy to assist the patient loosen and remove secretions 7 Press the setting to change it 8 Press the keypad control and enter the required setting or use the or control to a...

Page 42: ...ave to save the changes Or press Cancel 12 To confirm all settings press Done The new therapy plan is added to the Care Plan menu NOTE To prevent unauthorized persons from adjusting the settings made...

Page 43: ...Access is enabled See page 42 1 Press Automatic 2 Swipe the Options tab left and press the Care Plan menu control 3 Select a preset therapy plan and review the therapy settings 4 Press Edit 5 When pro...

Page 44: ...f therapy pressure as a pneumatic form of chest physiotherapy assisting in loosening and removing secretions 9 Press the setting to change it 10 Press the keypad control and enter the required setting...

Page 45: ...ng or use the or control to adjust the setting b Press Save to save the changes Or press Cancel 14 To confirm all settings press Done 15 Press Back to go to the initial therapy screen NOTE To prevent...

Page 46: ...me 2 Press and hold the therapy plan until the on screen keyboard shows 3 Use the on screen keyboard to enter any 5 alphanumeric characters and press Enter The new name is saved NOTE To prevent unauth...

Page 47: ...ab left and press the Care Plan menu control 3 Select the plan to delete 4 Press Edit 5 When prompted press Delete The initial care plan screen shows and the selected preset therapy is removed NOTE To...

Page 48: ...tings screen shows You can view or adjust these settings Screen brightness Date and time 12 hour or 24 hour clock format Wireless connection WiFi Bluetooth Internet connection Logs and firmware upgrad...

Page 49: ...for each item a To change the time zone press Modify b Scroll up or down to select the correct time zone and press Save 3 When complete press the Home menu control to exit 1 Press Device and press La...

Page 50: ...g of Bluetooth devices such as a barcode reader or pulse oximeter Upgrade of the system firmware See the service manual for details NOTE Import of the Health Level 7 HL7 standard file 1 Press Device a...

Page 51: ...it defined in the device settings WARNING Warning To avoid patient injury this setting should only be configured by facility authorized persons NOTE To prevent unauthorized persons from adjusting the...

Page 52: ...his system 2 Press the or controls to select the required PC setting NOTES Each press of the control increases decreases the PC setting by five 5 units The PC ranges between 5 70 cmH2O and is limited...

Page 53: ...g for Barcode Detection to ON 4 Press Connect 5 Slide the setting for Bluetooth to ON 6 Select SpO2 to add a pulse oximeter or Barcode to add a barcode reader To automatically detect and pair the Blue...

Page 54: ...djusting the settings made disable Clinical Access after you have made the settings Press Device then press Control Slide Clinical Access to OFF 8 When complete press the Home menu control to exit 1 S...

Page 55: ...yboard to enter the Password 9 To confirm the entries press Proceed To cancel press Cancel 10 When the connection is successful a green check mark shows next to the access point name If the connection...

Page 56: ...o not connect to a public WiFi if any log on Terms and Conditions must be accepted to use that public WiFi 1 Swipe the Options tab left then press the Options menu control 2 Press the Device Settings...

Page 57: ...he status of the connection press Status 9 Press the Home menu control to exit 1 Swipe the Options tab left then press the Options menu control 2 Press the Device Settings menu control 3 Press Connect...

Page 58: ...r the UserID and Password 9 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 NOTE To enter specific server se...

Page 59: ...the keypad 5 To test the entries made press Test Connections 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...

Page 60: ...he connection to VisiView portal before you start the therapy 1 After the Synclara Cough System is connected to a WiFi network press Settings 2 Slide the server option to Visiview 3 To test the connec...

Page 61: ...clara Cough System is connected to the WiFi network press Settings 2 Slide the server option to EMR 3 Press on each of the empty field and use the on screen keypad to enter the settings for Server IP...

Page 62: ...See page 42 Retrieve the Therapy Logs 7 To confirm the settings entered slide WiFi to OFF then ON again 8 Press the Home menu control to exit 1 Swipe the Options tab left and press the Options menu c...

Page 63: ...turn to go to the Data screen 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 Clini...

Page 64: ...g connect the USB drive to the port on the back of the control unit 8 At Error Log press Export Exporting begins When the export is complete a confirmation screen shows 9 Press Return to go to the Dat...

Page 65: ...Access is enabled See page 42 1 Swipe the Options tab left and press the Options menu control 2 Press the Device Settings menu control 3 Press Data Not all options are available at the same time 4 Con...

Page 66: ...TION 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 1 Swipe...

Page 67: ...attery See page 60 194566S Pulse Oximeter Bluetooth See page 64 196694 Foot Switch for control of Synclara therapy and on custom configured systems See page 65 204405 WiFi Module USB 198658 Pole Clamp...

Page 68: ...essions of a typical Synclara therapy WARNING Obey these warnings to help prevent patient injury and or equipment damage Warning Do not ship the battery with over a 30 charge Warning If the battery ch...

Page 69: ...e 72 For disposal of the battery consult your local regulations to safely discard or recycle the battery If you return the control unit for repairs do not return the battery unless specifically reques...

Page 70: ...n 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...

Page 71: ...stration shown 1 Plug the power cord into the back of the control unit 2 Plug the other end of the power cord into the applicable power outlet The battery is 75 charged The battery is fully charged Th...

Page 72: ...lse 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...

Page 73: ...to operate incorrectly resulting in patient injury The foot switch can only be used for control of the Synclara therapy 1 Connect the foot switch to the control unit a Hold the connector of the foot s...

Page 74: ...LY Install the Stand 1 Lock the casters to prevent the stand base from moving Install the pole with cart into the stand base 2 Lay the stand base on its side 3 Install the screw and washer to secure t...

Page 75: ...User Manual 196286 REV E 67 Accessories 5 Install the top pole into the stand base Make sure the groove is aligned with its opening in the bottom pole 6 Use the hex wrench to tighten the pole connect...

Page 76: ...User Manual 196286 REV E Accessories Install the Tray and Pole Clamp 1 Note the guide on the back of the tray 2 Turn the tray over and attach the pole clamp to the tray with the supplied parts from t...

Page 77: ...position to install the tray 2 Turn the knob on the pole clamp clockwise to hold the tray in position on the cart 3 Put the control unit on the tray Make sure the screw holes on the bottom of the cont...

Page 78: ...t equipment damage obey these cautions and make sure the mounting structure complies with these recommendations Caution Make sure the diameter of the pole for mounting the pole clamp assembly is betwe...

Page 79: ...Synclara Cough System Model PSC1 User Manual 196286 REV E 71 Accessories Draft_E_2019 Apr 29_Cleaned...

Page 80: ...ge 188343 Face mask 22 mm ID adult medium 188342 Face mask 22 mm ID adult small 188341 Face mask 22 mm ID child 188340 Face mask 22 mm ID adult regular inflatable 183158 Foam air inlet filter 203923 F...

Page 81: ...solvents or detergents Harmful cleaning solutions may cause skin rash and or irritation upon contact Warning Use cleaning and disinfectant products in accordance with the manufacturer s instructions...

Page 82: ...bleach as your primary everyday cleaner disinfectant The system has been tested for compatibility with the following cleaning and disinfecting solutions Compatible cleaning and disinfecting solutions...

Page 83: ...LEAN THE PULSE OXIMETER CAUTION To help prevent equipment damage obey these cautions and cleaning instructions Caution Clean the pulse oximeter between patient to patient use or when visibly soiled Ca...

Page 84: ...ct the mouthpiece face mask adapters handset breathing hose and bio filter 3 Examine the inside of the bio filter for any damage and or soilage If there is soilage or damage replace the bio filter imm...

Page 85: ...mage DISINFECT When there is visible soilage and also between patient use we recommend that you disinfect the unit with an EPA registered US only tuberculocidal disinfectant Dilute and use the disinfe...

Page 86: ...sary Replace the inlet filter every twelve 12 months To clean the filter do as follows 1 Power off the control unit 2 Remove the inlet filter from the back of the control unit NOTE If the filter is da...

Page 87: ...Synclara Cough System Model PSC1 User Manual 196286 REV E 79 Maintenance FUSE If a fuse needs to be replaced do as follows Draft_E_2019 Apr 29_Cleaned...

Page 88: ...WARNING Warning Only authorized persons should service the Synclara Cough System Service by unauthorized persons could cause personal injury or equipment damage If service is necessary use this contac...

Page 89: ...gain 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 uni...

Page 90: ...n the next action required Follow the on screen instructions Alert Pattern Status One beep Indicates that an activity is successful Three beeps Indicates that attention is needed and you should look a...

Page 91: ...ng Messages on page 83 Solutions for Warning Messages Error Code Do this 001 002 003 004 005 006 008 032 Power off the control unit then power it on again 009 1 Make sure only the Hill Rom approved ba...

Page 92: ...it on 011 1 Make sure the power cord is fully plugged into the electrical inlet on the back of the control unit If necessary disconnect the power cord from the control unit and then connect it 2 Make...

Page 93: ...approved battery 194566S is used 2 Press return after you read the on screen message 3 Make sure the battery is correctly installed in the control unit If necessary remove the battery and install it R...

Page 94: ...Hill Rom approved bio filter 206680 is used For instructions on how to connect the filter correctly see page 16 2 Press return after you read the on screen message 024 1 Make sure a tight seal is main...

Page 95: ...ad the on screen message 029 1 Press return after you read the on screen message 2 Power off the control unit and leave the system to warm up in a warmer environment for at least 5 minutes Power on th...

Page 96: ...onents into a clean plastic bag 4 Pack the power cord replaceable battery patient circuit and other accessories into the compartments of the carry case 5 Close the carry case to secure the product ins...

Page 97: ...in its original packing material When the system has reached the end of its useful life discard the system in accordance with local and federal standards SHIPPING FOR REPAIR When the control unit is...

Page 98: ...Pressure 0 to 30 cmH2O Sigh Pressure 0 to 30 cmH2O Per Stage Duration 0 5 seconds Flutter Pressure 1 to 10 cmH2O Flutter Frequency 5 to 20 Hz Pressure Accuracy 5 cmH2O Flutter Frequency Accuracy 1 Hz...

Page 99: ...nuous 5 minutes ON 20 minutes OFF at CHFO pressure setting of 65 cmH2O and above Fuse rating Fuse 4 A H 250 V Feature Description Lithium ion Battery A new and fully charged battery can support 9 sess...

Page 100: ...erates continuously for 5 minutes at CHFO pressure setting of 65 cmH2O and above At least 20 minutes Feature Dimension Bluetooth Specification Optional Configuration Bluetooth compliance Bluetooth V4...

Page 101: ...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 EN 60601 1 11 2015 IEC 6...

Page 102: ...ass B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates...

Page 103: ...196286 REV E 95 Specifications To see the FCC ID of this system 1 Swipe the Options tab left and press the Device Settings menu control The device information screen shows 2 Find the FCC ID in the sy...

Page 104: ...nt and result in improper operation Guidance and Manufacturer s Declaration Electromagnetic Emissions The Synclara Cough System Model PSC1 is intended for use in the electromagnetic environment specif...

Page 105: ...line s to line s 1 kV line s to line s Mains power quality should be that of a typical home environment 2 kV line s to earth Not applicable Voltage dips short interruptions and voltage variations on p...

Page 106: ...diatedRFIEC 61000 4 3 10 V m 80 MHz to 2 7 GHz 10 V m 80 MHz to 800 MHz 800 MHz to 2 7 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufac...

Page 107: ...events electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the system as recommended below according to the maximum...

Page 108: ...FM 5 kHz 1 kHz 0 3 Front back left right 710 9 V m 50 PM 217 Hz 0 3 Front back left right 745 9 V m 50 PM 217 Hz 0 3 Front back left right 780 9 V m 50 PM 217 Hz 0 3 Front back left right 810 28 V m 5...

Page 109: ...Draft_E_2019 Apr 29_Cleaned...

Page 110: ...Draft_E_2019 Apr 29_Cleaned...

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