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SynCardia Systems, LLC 
Companion 2 Driver System Operator Manual

 

 

Page 121 of 132 

Chapter 22.  Companion 2 Driver System Specifications  

 

22.1  Safety Standards 

The  Companion 2 Driver System, as part of the SynCardia  TAH-t 
Companion 2 Driver  System, has been thoroughly tested pursuant the 
requirements of European safety standard IEC  60601-1: 2006.  This 
standard requires making the following declarations and stating the type 
and degree of protection for listed hazards. See the following pages for 
more specific safety and testing classification information.  

 

Table 22-1 

–

 Declaration Concerning General Safety Standards

 

Type 

 

Degree of Protection 

 

Mode of Operation  

Continuous  

Method of Sterilization  

100% EtO for TAH-t and all sterile 
accessories (e.g., Drivelines) 

Type of protection against electrical 
shock  

Class I (grounded) and internally powered  

Degree of protection against electric 
shock  

Type BF (Body Floating)  

Degree of safety of application in the 
presence of a flammable anesthetic 
mixture with air or with oxygen or 
nitrous oxide  

Equipment not suitable for use in the 
presence of a flammable anesthetic 
mixture with air or with oxygen or nitrous 
oxide  

Degree of protection against harmful 
ingress of water and foreign 
materials 

Driver: IP30 
Driver Caddy: IP32 
Hospital Cart: unrated 

 

 

MEDICAL EQUIPMENT 
WITH RESPECT TO ELECTRIC SHOCK, 
FIRE AND MECHANICAL HAZARDS ONLY 
IN ACCORDANCE WITH IEC 60601-1 

 

Содержание Companion 2 Driver System

Страница 1: ...tificial Heart TAH t is an Investigational Device Limited by United States Law to Investigational Use CAUTION In the United States the use of the SynCardia 70cc TAH t for destination therapy is invest...

Страница 2: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 2 of 132...

Страница 3: ...Companion 2 Driver Operation Cautions 69 Chapter 13 Power Management 73 Chapter 14 Alarms and Notifications 81 Chapter 15 Switching from Primary Companion 2 Driver to Backup Companion 2 Driver 97 Chap...

Страница 4: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 4 of 132...

Страница 5: ...re 8 4 System Check Menu Screen 38 Figure 8 5 Set Date Time 40 Figure 8 6 New Patient Setup Screen 41 Figure 8 7 Patient File Copy Screen 43 Figure 8 8 Parameter Adjustment Window 44 Figure 8 9 Adjust...

Страница 6: ...on Screen 91 Figure 16 1 Wire Ties around CSS Hose Barb Connectors 100 Figure 16 2 Metal Hose Barb Connectors Loosened but Still Connected to the Cannulae 100 Figure 16 3 Inserting the Companion 2 Dri...

Страница 7: ...Responses 81 Table 14 2 Alarm Configuration Default Settings and Ranges 92 Table 14 3 Notifications 94 Table 22 1 Declaration Concerning General Safety Standards 121 Table 22 2 Declaration and Guidan...

Страница 8: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 8 of 132...

Страница 9: ...ation For more information on the TAH t see the SynCardia temporary Total Artificial Heart TAH t Instructions for Use with the Companion 2 Driver System for the 50cc or 70cc TAH t as appropriate The 5...

Страница 10: ...ion 2 Driver System The Companion 2 Driver System Figure 1 3 is a multi component electro mechanical unit designed to provide pneumatic power to the implanted 50cc or 70cc TAH t The Companion 2 Driver...

Страница 11: ...ich the Driver docks It is intended for use in the hospital during the TAH t implant procedure and subsequent recovery phase o The Driver docks into the Hospital Cart by placing the Driver straight in...

Страница 12: ...res o The Driver docks into the Caddy by placing the Driver straight into the center of the Caddy so that the docking connectors mate The Driver must always be put into the Driver Caddy with the Exter...

Страница 13: ...Hand Pump is designed for emergency use when a backup Driver is not immediately available The Companion Drivelines connect to the CPC connectors on the Hand Pump Clinical operators should pump at 110...

Страница 14: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 14 of 132...

Страница 15: ...ion therapy for patients who are ineligible for cardiac transplantation and for whom clinical indices indicate a remote likelihood of becoming eligible for a transplant is investigational 2 2 50cc TAH...

Страница 16: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 16 of 132...

Страница 17: ...m or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging CT scan 10 cm Patients who cannot be adequately anticoagulated on the 70cc TAH...

Страница 18: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 18 of 132...

Страница 19: ...r by x ray after catheter insertion and repeat an x ray immediately if any unexplained sudden drop in cardiac output occurs A percutaneously inserted central catheter may migrate into the inflow valve...

Страница 20: ...the Companion 2 Driver versus the Circulatory Support Console CSS with the TAH t for patients who received circulatory rescue intervention e g extracorporeal membrane oxygenation ECMO or intra aortic...

Страница 21: ...ver with a backup Companion 2 Driver in the event of system failure Connect the backup Companion 2 Driver as quickly as possible This procedure is for emergency use only See Chapter 15 in this manual...

Страница 22: ...es is established 5 14 The level of anticoagulation will vary depending on the patient s coagulation status Clinical experience has shown that typically patients supported with the 70cc TAH t require...

Страница 23: ...at is regulated to cause the left and right TAH t ventricle diaphragms to move upward and expel blood into the arterial and pulmonary systems In diastole vacuum is applied by speed regulated vacuum bl...

Страница 24: ...can be loaded onto the Driver through this unidirectional USB interface A Key Switch on the front panel of the Driver allows the device to be manually stopped and started When the Driver Key Switch i...

Страница 25: ...1 Display Screen The color LCD display and touch screen is the mechanism by which all adjustable device operating parameters may be adjusted and device outputs monitored and displayed The primary I C...

Страница 26: ...ironment and Chapter 10 Operating Modes Ambulatory Mode The Power Status Window displays battery charge status for both external Batteries and shows a plug icon when the device is powered by an extern...

Страница 27: ...ied to the Driver A yellow external power LED indicates the Driver is operating from battery power Battery LED Solid green indicates the battery is charged and has at least 20 of capacity The LEDs fla...

Страница 28: ...approximately one minute to update the estimated battery support time based on Driver settings 6 5 1 Connection to External Power The Driver should be connected to external wall power via the Hospital...

Страница 29: ...de is Battery 1 The Battery on the right side is Battery 2 Two fully charged Batteries provide a minimum of 60 minutes of support with each Battery providing a minimum of 30 minutes of support Actual...

Страница 30: ...icate a fully charged Battery with each light representing approximately 20 capacity 6 5 3 Emergency Battery The Emergency Battery is an independent internal rechargeable lithium ion battery that does...

Страница 31: ...mmended that the external air pressure for the Companion 2 Driver be between 50 to 80 PSI 3 5 to 5 5 Bar If the external air pressure is below this range it will not impact the Driver functionality ho...

Страница 32: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 32 of 132...

Страница 33: ...ver Settings is available 8 1 Preparation for Use O R Mode 8 1 1 Dock the Driver without External Batteries into the Hospital Cart If necessary this may be done with the help of another trained user 8...

Страница 34: ...creen is non responsive after the graphical user interface is presented on the display dock the Driver into the Hospital Cart to recalibrate the Driver touch screen This is performed by following the...

Страница 35: ...splay 2 Select MENU then O R MODE Figure 8 1 Figure 8 1 Menu Selection in Ambulatory Mode 3 A dialogue box called ENTER PASSWORD will request that you enter the O R Mode password 3228 and press CONFIR...

Страница 36: ...Alarm indicator has a solid X over the speaker to indicate that audible alarms are muted A reminder audible signal will be generated every two hours to indicate that the system is in O R Mode All vis...

Страница 37: ...touch screen select MENU SETUP and either DRIVER SCREEN CALIBRATION or CART SCREEN CALIBRATION 3 The onscreen prompts will direct you to touch four places in succession on the screen to be calibrated...

Страница 38: ...required from initial power on to when the system begins to run at the default start up settings 5 Verify that that the Driver compressors began to run within 10 seconds and note the results on the fo...

Страница 39: ...d 12 The power management system and indicators are manually verified Complete the steps and document the results on the System Check Form See Chapter 13 Power Management for any additional informatio...

Страница 40: ...ent data should be downloaded Press CANCEL if you would like to exit the new patient file screen 5 Enter the patient information in the pop up window using the touch keyboard that appears Select the w...

Страница 41: ...EDIT Figure 8 6 New Patient Setup Screen 10 Patient File Information Patient data log files record information pertaining to the operation of the Driver and any alarms that occurred in a comma separa...

Страница 42: ...n the Alarm log This information remains stored even if power to the Driver is removed See Chapter 14 Alarms and Notifications for additional information on alarms 11 Copy Patient File The steps for c...

Страница 43: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 43 of 132 Figure 8 7 Patient File Copy Screen...

Страница 44: ...e The following actions may be required during the procedure 8 2 1 Adjustment of Operation Parameter The Parameter Adjustment Window of the user interface is shown in Figure 8 8 below Figure 8 8 Param...

Страница 45: ...d Hold Increment Rate Beats per minute BPM 40 40 is single pulse mode 150 1 10 Systole Percent 40 60 1 1 Left Pressure mmHg 120 280 1 5 Right Pressure mmHg 40 150 1 5 Left Vacuum mmHg 0 30 1 5 Right V...

Страница 46: ...to 40 in O R Mode Turning the rate down any further suspends pumping action and allows single pulse actuations to be used which are helpful in de airing the TAH t 1 To set the Driver to single pulse...

Страница 47: ...rease the Rate select RATE and press and hold the increment button to increase the Rate to 120 BPM Multiple alarms will be displayed when transitioning out of single pulse mode These alarms will clear...

Страница 48: ...acceptable partial fill is between 50 and 60 cc The fill capacity of each 50cc ventricle is 50cc acceptable partial fill is between 30 and 40 cc 8 2 4 Flip Screen The surgeon may request to see the c...

Страница 49: ...the main screen display to view a larger pressure waveform graph The left pressure is shown with a red line and the right pressure waveform is shown with a blue line It may be necessary to increase or...

Страница 50: ...lag is reduced to approximately 10 to 20 of the pressure waveform length 4 Partial Fill Adjustment The TAH t is intended to operate with a partial fill An acceptable partial fill for the 70cc TAH t is...

Страница 51: ...ricle and blue for the right ventricle Always assure partial filling of the ventricles by observing the displayed fill volume of the ventricles and flow waveform on the screen An acceptable partial fi...

Страница 52: ...is full filling See Figure 8 13 If the flow remains above zero as shown in Figure 8 14 the device is operating in a partial fill condition Note If the Flow Waveform indicates a full fill condition th...

Страница 53: ...o the instantaneous Cardiac Output display to see if the current Cardiac Output is greater than or less than the hourly average cardiac output Figure 8 15 Reset Average Hourly Cardiac Output 8 2 6 Cha...

Страница 54: ...Ambulatory Mode 8 2 8 Setup of Backup Driver The Driver will begin operating at default settings when power is applied and the key switch is set to the ON position The Driver will begin to pump as so...

Страница 55: ...LLC Companion 2 Driver System Operator Manual Page 55 of 132 3 Change to I C U Mode by selecting MENU I C U MODE and enter the password 9722 4 Press the LOCK Icon in the lower right corner to unlock...

Страница 56: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 56 of 132...

Страница 57: ...ended to be used by trained hospital personnel who have a need to modify device operation to respond to potential changes in patient conditions such as decreasing pressure when patient edema decreases...

Страница 58: ...ure 9 2 Unlocked screens revert to locked status after 30 seconds of no activity Figure 9 2 I C U Mode Screen Unlocked 9 2 Adjustment of Parameters 9 2 1 Operating parameters can be adjusted once the...

Страница 59: ...parameters are adjusted as follows 1 Unlock the LOCK icon by selecting it 2 Press the RATE button on the LCD screen 3 Select or to increase or decrease the rate 4 Select to enter the change or X to ca...

Страница 60: ...old Increment Rate Beats per minute BPM 90 150 1 10 Systole Percent 40 60 1 1 Left Pressure mmHg 120 280 1 5 Right Pressure mmHg 40 150 1 5 Left Vacuum mmHg 0 30 1 5 Right Vacuum mmHg 0 30 1 5 Actual...

Страница 61: ...ate and Time if necessary Any other changes of device settings require that the Operating Mode be changed to I C U Mode or O R Mode When power is applied and the key switch is set to the ON position t...

Страница 62: ...mma separated file CSV that can be opened with most spreadsheet applications The Patient File information includes performance data pressure and flow waveforms and alarm history data The following per...

Страница 63: ...ter 14 Alarms and Notifications for additional information on alarms 10 2 Adjustments 10 2 1 Copy Patient File The steps for copying files to any 8GB or larger USB 1 0 2 0 compliant mass memory device...

Страница 64: ...ent File Copy Screen 10 2 2 Set Date and Time Set the Date and Time for the Driver if needed by pressing MENU SETUP DATE TIME Select each item that requires modification and use the or button to chang...

Страница 65: ...pleting the following steps 1 Select MENU MODE and O R MODE 2 Enter the O R Mode password 3228 and press CONFIRM to change to O R Mode 10 2 4 Change to I C U Mode Change the operating mode to I C U Mo...

Страница 66: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 66 of 132...

Страница 67: ...m silenced Audible Alarm Disabled or Refer to instruction manual booklet IP30 Protected against objects 2 5mm dripping water at 15 tilt External Battery 1 Year of manufacture External Battery 2 SN Ser...

Страница 68: ...ousehold Waste Do Not Incinerate Do Not Crush 4ICR19 65 5 IEC 61960 battery designation The alpha and numeric characters represent the following 4 Number of cell packs connected in series in the batte...

Страница 69: ...m Investigate and correct the cause of any alarm 12 3 Use of Backup Driver A SynCardia approved Driver must be available as a backup to be used in the event of a failure of the primary Driver 12 4 Mai...

Страница 70: ...ons 12 9 Removal of Key During Operation Remove the key from the Key Switch when the Driver is in operation The key cannot be removed when the Driver is switched OFF 12 10 Driver Storage Requirements...

Страница 71: ...Do not leave Batteries in vehicles in direct sunlight or in other places where the temperature may rise above 40 C 104 F Do not let Batteries get wet Do not drop Batteries or subject them to shock Do...

Страница 72: ...of 132 Both external Batteries in the Driver are fully charged Additional fully charged External Batteries are available The Companion 2 Driver is docked in either a Hospital Cart or Driver Caddy A b...

Страница 73: ...charged Batteries provide a minimum of 60 minutes of support The External Batteries will charge while installed in a Driver that is docked into a Hospital Cart or Driver Caddy connected to a wall out...

Страница 74: ...or Manual Page 74 of 132 Figure 13 1 Locking Connector on the Power Cord Figure 13 2 Connecting External Power with the Hospital Cart Figure 13 3 Connecting External Power with the Companion Driver Ca...

Страница 75: ...o not use any electrical outlets that are controlled by wall switches 13 1 3 Disconnecting external power and switching to battery power Make sure that two charged Batteries are inserted into the Driv...

Страница 76: ...en using battery power the Driver uses power from both External Batteries The Driver is able to run with a single External Battery but this is not recommended 13 2 3 When a Battery has less than 30 mi...

Страница 77: ...ll eventually lose power and emergency power will become necessary 13 3 Battery Removal When the External Batteries are in use the Power Status Window shows the Battery Symbols and the remaining suppo...

Страница 78: ...op of the battery out of the Driver Figure 13 7 Figure 13 7 Battery Latch 13 3 2 The Power Status Window indicates that a Battery has been removed or is not functioning correctly by showing the Batter...

Страница 79: ...ver and push the Battery towards the Driver An audible snap indicates that the latch has secured the Battery to the Driver Correct battery installation can be verified by the Batteries appearing as sh...

Страница 80: ...Power Status Window as shown in Figure 13 10 Figure 13 10 Battery Power Status Window Showing Emergency Battery in Use 13 3 7 If no power sources are connected to the system and the Emergency Battery...

Страница 81: ...are active during this time Table 14 1 Alarm Messages and Responses Alarm Message Visual Indicators Audible Signal Corrective Action Dual Compressor Malfunction Alarm Bar Flashing Red Alarm Indicator...

Страница 82: ...t partial fill conditions from Driver displayed wave forms Assess patient conditions that may contribute to a low Cardiac Output If alarm persists replace Driver with a SynCardia approved backup Drive...

Страница 83: ...th fully charged Batteries If condition persists replace Driver with a SynCardia approved backup Driver Notify SynCardia at 1 866 771 9437 Cardiac Output Imbalance low Alarm Bar Red Alarm Indicator LE...

Страница 84: ...866 771 9437 High Internal Temperature Alarm Bar Red Alarm Indicator LED Red 10 beeps every 5 seconds 70 80 dBA Make sure that the Driver is not close to a heat source and that the sides of the unit...

Страница 85: ...charge on battery fuel gauge If alarm persists replace Driver with a SynCardia approved backup Driver Notify SynCardia at 1 866 771 9437 Rate Incorrect Alarm Bar Flashing Yellow Alarm Indicator LED Fl...

Страница 86: ...Driver Right Vacuum Incorrect alarm settings are appropriate Section 14 4 If alarm persists replace Driver with a SynCardia approved backup Driver Notify SynCardia at 1 866 771 9437 External Battery...

Страница 87: ...ator LED Flashing Yellow 3 beeps every 30 seconds 70 80 dBA Verify Driver settings are achieving full eject partial fill conditions from Driver displayed wave forms Assess patient conditions that may...

Страница 88: ...will be displayed in the Alarm Bar and be highlighted in the Alarm Status Screen Any active lower priority alarms will also be highlighted in the Alarm Status Screen For instance a low cardiac output...

Страница 89: ...Alarm History The Alarm History Log will indicate the dates and times of alarm events Figure 14 2 Figure 14 2 Alarm History Screen The Alarm History can be viewed by touching the Alarm Status Bar and...

Страница 90: ...tory but may be adjusted for individual patients The Alarm settings may be accessed from the O R Mode and I C U Mode by selecting MENU ALARMS and ALARM SETTINGS Figure 14 3 Figure 14 3 Alarm Settings...

Страница 91: ...g priority order Alarms are prioritized based on the potential harm to a patient and the time or delay in which that harm would be experienced based on the detected fault Where the alarm limits are us...

Страница 92: ...5 L min 0 to 90 60 6 Low Right Cardiac Output 0 to 20 10 1 5 L min 5 L min 1 3 5 L min 0 to 90 60 7 Single Compressor Malfunction N A N A N A N A N A N A 0 3 8 Emergency Battery Error N A N A N A N A...

Страница 93: ...Incorrect 0 to 20 10 1 mmHg 5 mmHg 1 5 mmHg 0 to 30 1 25 Right Vacuum Incorrect 0 to 20 10 1 mmHg 5 mmHg 1 5 mmHg 0 to 30 1 26 External Battery Error N A N A 71 C N A N A N A 0 0 27 Low External Batt...

Страница 94: ...ower Status Window Icon overlays the External Battery Icon Numerical display of the estimated remaining battery support time 10 beeps every 2 5 seconds Connect Driver to an external power source wall...

Страница 95: ...ry Mode Notification Display shall indicate it is in Ambulatory Mode No audible signal No action required if the device is in use on an Ambulatory patient otherwise switch to OR Mode if in use during...

Страница 96: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 96 of 132...

Страница 97: ...r the Driver Exchange Turn the backup Driver key switch to the ON position The Driver will operate on internal battery power Note The backup Driver will begin operating at the previously set settings...

Страница 98: ...ed are fully charged If not connect the backup Driver to wall power 15 2 4 Determine if there are any alarms If there are alarms see Chapter 14 Alarms and Notifications to correct them 15 2 5 Remove t...

Страница 99: ...lways inserted into the red Driveline 16 2 Preparation for the Driver Exchange 16 2 1 Prepare the Companion 2 Driver as indicated in Section 8 2 8 Setup of Backup Driver including the System Check If...

Страница 100: ...CONNECT OR REMOVE YET Figure 16 2 Metal Hose Barb Connectors Loosened but Still Connected to the Cannulae CAUTION Before disconnecting the Drivelines of the CSS Console you must have the Drivelines of...

Страница 101: ...lue Cannula by pulling and then immediately insert the CPC connector of the blue Companion 2 Driveline into the blue Cannula Figure 16 3 Figure 16 3 Inserting the Companion 2 Drivelines into the Cannu...

Страница 102: ...ynCardia Systems LLC Companion 2 Driver System Operator Manual Page 102 of 132 16 3 7 It is recommended that the CSS Console Drivelines be retained or disposed of in accordance with hospital procedure...

Страница 103: ...marked Driveline 17 2 Preparation for of the CSS Console and Drivelines for Driver Exchange 17 2 1 Prior to switching to the CSS Console the Console should be prepared in the following manner Ensure t...

Страница 104: ...nnectors from each of the Companion Drivelines that mate with the CPC connectors of the cannulae of the TAH t 17 3 3 Immediately insert the CPC connectors of the CSS Console Drivelines into the CPC co...

Страница 105: ...reparation to Perform Switch from Companion 2 Driver to Freedom Driver Both primary and backup Freedom Drivers must be tested at the Hospital prior to use following the checklist for the Freedom Drive...

Страница 106: ...wering up the Freedom Driver there is a malfunction of the Driver The patient must not be switched from the Companion 2 Driver to the Freedom Driver CAUTION When performing a switch from the Companion...

Страница 107: ...to Cannulae via the CPC Connectors 1 DO NOT DISCONNECT THE CANNULA FROM THE DRIVELINE YET With the Wire Cutter Tool provided in the Tool Kit cut the Wire Tie under the metal release button of the CPC...

Страница 108: ...disconnecting the Drivelines of the Companion 2 Driver you must have the Drivelines of the Freedom Driver within reach 3 Perform steps 4 and 5 simultaneously in order to disconnect the Drivelines of...

Страница 109: ...ase button Pull the blue Cannula away from the blue Companion 2 Driveline Immediately insert the blue Cannula into the blue Freedom Driveline Insert until a click is heard Lightly tug on the connectio...

Страница 110: ...ies The loop in the Wire Tie makes it easier to cut if it is necessary to change to another Driver Figure 18 5 Inserting Wire Tie under Metal Release Button of CPC Connector 7 Insert the Companion 2 D...

Страница 111: ...o the Companion 2 Driver System assemble the following materials Companion 2 Driver with power ON Velcro Scissors Wire Cutter tool from Patient Tool Kit Male and Female CPC connectors and Wire Ties fr...

Страница 112: ...ltaneously 19 3 2 1 Unplug the red Cannula from the Freedom Driver Driveline and connect the Quick Connect to the Companion 2 red color coded Driveline Quick Connect 19 3 2 2 Unplug the blue Cannula f...

Страница 113: ...not expose the Driver to temperatures higher than 40 C 104 F or lower than 4 5 C 40 F for long periods of time 20 2 2 To prevent a high temperature alarm do not block the air inlets on the sides of th...

Страница 114: ...ser to replace the Air Filters This alarm will appear in a yellow banner as Filter Maintenance Required Figure 20 1 Figure 20 1 Yellow Banner Alarm for Filter Maintenance Required 20 4 2 To access the...

Страница 115: ...Figure 20 3 Driver Side Panel with Filter Cover Removed CAUTION Do not touch the moving fan 20 4 4 Place a clean filter over the fan opening and reinstall the Filter Cover Repeat this process on the o...

Страница 116: ...Operator Manual Page 116 of 132 Figure 20 4 SETUP Menu 4 Select the FILTER MAINT REQUIRED button 5 This will bring up a verification screen asking Has the filter maintenance been completed see Figure...

Страница 117: ...Companion 2 Driver System Operator Manual Page 117 of 132 6 Once the alarm has been cleared the FILTER MAINT REQUIRED button will be grayed out see Figure 20 6 Figure 20 6 SETUP Menu with Filter Main...

Страница 118: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 118 of 132...

Страница 119: ...ient 21 1 2 Install two external Batteries into the Driver 21 1 3 Connect the Driver to external air If external air is not available the Driver will operate with its internal compressors 21 1 4 Turn...

Страница 120: ...The Driver should be docked into another Hospital Cart or Caddy 21 2 Hospital Cart The Hospital Cart is shipped in a large crate The front door of the crate can be opened and a ramp lowered while the...

Страница 121: ...afety Standards Type Degree of Protection Mode of Operation Continuous Method of Sterilization 100 EtO for TAH t and all sterile accessories e g Drivelines Type of protection against electrical shock...

Страница 122: ...of its internal electrical and electronic functions RF emissions are very low and are unlikely to cause interference in nearby electronic equipment RF emissions CISPR 11 Class A SynCardia Companion 2...

Страница 123: ...elative humidity is at least 30 Electrical fast transient burst IEC 61000 4 4 Mains fast transient of 2 kV Companion 2 Driver with Hospital Cart or Caddy Mains power applied No change in functional op...

Страница 124: ...ponents are intended for use in the electromagnetic environment specified in Table 22 4 The customer or the user of either device should assure that they are used in such an electromagnetic environmen...

Страница 125: ...ance test for minimum installation Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequen cy range Interfer...

Страница 126: ...uirements for safety Collateral standard Electromagnetic compatibility These limits are designed to provide reasonable protection against harmful interference in a typical medical installation These d...

Страница 127: ...43inches handle lowered raised Depth 45 7 cm 18 inches Weight 6 8 kg 15 lbs 22 5 Environmental Conditions 22 5 1 Operating Conditions Operating Temperature Driver Driver Caddy 4 5 to 40 C 40 to 104 F...

Страница 128: ...erating Ranges Rate 40 to 150 bpm single pulse in O R Mode Systole 40 to 60 Left Driver Pressure 120 to 280 mmHg Right Driver Pressure 40 to 150 mmHg Left Vacuum 0 to 30 mmHg Right Vacuum 0 to 30 mmHg...

Страница 129: ...battery terminals External air Driver Side Panel Quick disconnect pneumatic connection 22 9 Classification Companion 2 Driver System Class 1 Equipment Type BF Equipment Driver Ingress Protection IP30...

Страница 130: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 130 of 132...

Страница 131: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 131 of 132 Appendix A Companion 2 Driver System Check Form...

Страница 132: ...SynCardia Systems LLC Companion 2 Driver System Operator Manual Page 132 of 132...

Страница 133: ...the driver Verify system starts pumping within 10 seconds Note If Driver or Batteries have been stored for an extended period there may be an active low battery alarm Pass Fail 3 To access Driver seri...

Страница 134: ...r recognizes the replaced battery Pass Fail 5 Remove Battery 2 from the battery docking port Verify that the display and LED lights indicate that the battery is removed Pass Fail 6 Replace Battery 2 V...

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