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5388 - Medtronic Manuals: Region

1. Bured suabu L suods y pesuss X uoN A y fend wnuy O a v J mU A A pesuas sequieyy X UON A y fend unuy O a v PJUSA A p 2ed saquieyy X L861 epod Jeyewesed DAN 1997 E H S e1GeL 5388 Technical manual 96 Chapter 5 Tables 5388 Technical manual Table 5 5 Rate and Interval Conversion Chart Rate Int Rate Int Rate Int min 1 ms min ms min ms 30 2000 100 600 390 154 35 1714 110 545 400 150 40 1500 120 500 410 146 45 1333 130 462 420 143 50 1200 140 429 430 140 52 1154 150 400 440 136 54 1111 160 375 450 133 56 1071 170 353 460 130 58 1034 180 333 470 128 60 1000 190 316 480 125 62 968 200 300 490 122 64 938 210 286 500 120 66 909 220 273 510 118 68 882 230 261 520 115 70 857 240 250 530 113 72 833 250 240 540 111 74 811 260 231 550 109 76 789 270 222 560 107 78 769 280 214 570 105 80 750 290 207 580 103 82 732 300 200 590 102 84 714 310 194 600 100 86 698 320 188 610 98 88 682 330 182 620 97 90 667 340 176 630 95 92 652 350 171 640 94 94 638 360 167 650 92 96 625 370 162 98 612 380 158 60 000 ms min 1 or 60 000 min 1 ms Device maintenance 6 Cleaning and Sterilization 98 Safety and Technical Checks 99 Service 100 98 Chapter 6 Cleaning and Sterilization Cleaning and Sterilization Model 5388 Temporary Pacemaker Cleaning The Model 5388 temporary pacemaker can be cleaned using a sponge or c
2. 25 mA for Emergency Asynchronous for Emergency Asynchronous for Emergency 5388 Technical manual Specifications 105 Device Accessories Humidity storage 90 maximum Battery Type 9 V Alkaline type 6LR61 type 6F22E NEDA 1604A Eveready 522 or equivalent 9 V Lithium NEDA 1604LC Ultralife U9VL or equivalent Battery Life 9 days typical 7 days minimum alkaline or 16 days lithium when the rate is 70 min 1 and all other parameters are at the nominal values listed above Operation After Battery 15 seconds typical under the following conditions RATE of Removal 70 min or less A OUTPUT and V OUTPUT of 10 mA or less backlight off and lower screen blank a An NBG code followed by indicates a clinically ineffective pacing mode b 20 25 mA 10 into 200 500 Ohms c Pulse width is measured at the 50 amplitude points of the leading and trailing edges excluding the discharge cycle d When sensing 40 ms wide Haversine waveform for ventricular inputs 30 ms wide Haversine waveform for atrial inputs e When tested with a 1 ms square pulse with sufficient amplitude f Ventricular blanking after an atrial pace is followed by 16 ms of reduced sensitivity During this time the device detects R waves with amplitudes of at least 5 mV or twice the V SENSITIVITY setting whichever is greater 9 Within the ranges of 10 C to 17 C 50 F to 64 F and 33 C to 43 C 92 F to 110 F the specification for
3. Chapter 3 Timing Violations Pacemaker block point reached Adjust RATE or parameters on Menu 2 WARNING Pacemaker block point reached Adjust RATE or parameters on Menu 2 Pacemaker block point reached Adjust RATE or parameters on Menu 2 5388 Technical manual UPPER RATE vs SAV and PVARP The total atrial refractory period TARP which is SAV Interval PVARP cannot be longer than the Upper Rate Interval or the device will reach the 2 1 block point before being limited by the UPPER RATE This condition is prevented by the following formula SAV Interval PVARP lt UPPER RATE Interval During manual adjustment of RATE or the rate dependent parameters the device will limit adjustment at the block point and display the warning message to the left Minimum V A interval The minimum V A interval required by the Model 5388 when operating in DOO mode is 70 ms This condition is preserved using the following formula A V INTERVAL 70 ms lt RATE Interval The minimum V A interval required by the Model 5388 when operating in DVI mode is 180 ms This condition is preserved using the following formula A V INTERVAL 180 ms lt RATE Interval During manual adjustment of RATE or the rate dependent parameters the device will limit adjustment at the block point and display the warning message to the left Note This limit only occurs in DVI or DOO mode In
4. Disposable Pouch Description Procedure for Use The Model 5409 Disposable Pouch is designed to protect and hold the Model 5388 Temporary Pacemaker The pouch consists of a see through plastic pocket mounted on an attachment panel The pouch should be disposed of after one patient use The pouch can be hung from an IV stand Insert the temporary pacemaker into the pouch bottom end first with the front of the pacemaker facing away from the attachment panel Fold the flip over top over itself to secure the temporary pacemaker in the pouch Insert the patient cable connector plugs through the slits in the pouch and insert them into the temporary pacemaker Note To prevent accidental changes of pacemaker controls do not place the Model 5388 Temporary Pacemaker in any area outside of direct observation by medical staff The temporary pacemaker should be placed in an area that minimizes access to device controls by unauthorized personnel such as patients or visitors Disposable Cover Description The Model 5441 Disposable Cover is designed to prevent unathorized access to the controls of the Model 5388 Temporary Pacemaker The cover consists of rigid see through plastic The cover should be disposed of after one patient use A Caution Use of the cover will prevent direct access to the Model 5388 emergency key The Model 5388 should be used only according to labeling and safe handling should still be observed even when the cover
5. Release the SELECT key 5388 Technical manual 92 Chapter 5 Battery Replacement A Caution RAP may result in tachycardia acceleration of existing tachycardia or fibrillation Apply high rates under careful patient monitoring and control Monitor the patient s ECG and blood pressure and ensure defibrillation equipment is immediately available Battery Replacement 5388 Technical manual Replace the battery for each new patient Replace the battery when the low battery indicator appears during device operation see page 33 Use a fresh 9V alkaline or lithium battery Ultralife U9VL Eveready 522 or equivalent Check the battery status at least twice daily Replace alkaline batteries at least once every week when the temporary pacemaker is in continuous use Figure 5 29 Battery Replacement To Replace Battery Note Medtronic does not recommend replacing the battery while the pacemaker is turned on However if during an emergency situation the battery must be replaced while the device is in use ensure that the device is locked see Lock Unlock Key on page 26 then replace the battery Pacing is maintained for 15 seconds typical at 70 min t and nominal outputs see Operation After Battery Removal on page 105 1 Turn device off User guide 93 Battery Replacement Press button on the bottom of the device to open battery drawer Remove old battery and discard Insert fresh battery a
6. 2 Ventricular Use Figure 4 2 The Model 5433A Atrial Use symbol and the Model 5433V Ventricular Use symbol Preparation for use 61 Connector Setup Connector Setup Connecting or disconnecting the Model 5433A or 5433V Patient Cable to or from the Model 5388 A Warning Connect the patient cable to the temporary pacemaker before connecting the leads to the patient cable Z Caution Do not hang the Model 5388 by the cables The attachment ring or bails should be used when mechanical support of the pacemaker is necessary Notes The Patient Cable Models 5433A and 5433V are supplied non sterile They should be cleaned and sterilized according to the instructions in Chapter 6 see Cleaning on page 98 Carefully inspect the patient cable for visible signs of wear or damage To connect the cable to the Model 5388 With the Model 5388 pacemaker turned off fully insert the appropriate atrial or ventricular patient cable connector plug into the appropriate Model 5388 connector receptacle marked A or V until it clicks See Figure 4 3 Note The click verifies that the plug is completely inserted into the receptacle Pull gently on the plug after insertion to ensure a good connection Figure 4 3 Connecting the Model 5433A or 5433V Patient Cable to the Model 5388 Temporary Pacemaker 5388 Technical manual 62 Chapter 4 Connector Setup To disconnect the cable from the Model 5388 1 T
7. After the self test is successfully completed the following occurs Ifthe battery has sufficient power the device begins sensing and pacing in both the atrium and ventricle at the following nominal parameter values Table 3 1 Power on values Base RATE 80 mint A OUTPUT and V OUTPUT 10 mA Atrial pulse width 1 0 msa Ventricular pulse width 1 5 msa A SENSITIVITY 0 5 mV V SENSITIVITY 2 0 mV A TRACKING ON UPPER RATE 110 min 1 PVARP 300 ms A V INTERVAL paced 170 ms a Pulse width is not adjustable For a description of atrial tracking see page 40 c These parameters are set to the automatic rate dependent values see Device Specifications on page 103 Ifthe battery is nearing depletion the low battery indicator is displayed Ifthe battery is depleted the LEDs may come on see Light Emitting Diodes on page 32 while ON is pressed but the device will not operate When the upper screen is locked press the ON key once to unlock the upper screen see Lock Unlock Key on page 26 The backlight comes on and the upper screen parameters may be adjusted The device continues to pace at the currently selected values OFF Key To SHUT DOWN Press again Controls indicators and other features 29 Controls When the device is pacing asynchronously to return the device to demand synchronous pacing Press the ON key once if the asynchronous pacing message see page 30 is d
8. A and V SENSITIVITY on Menu 1 see Menu 1 on page 38 5388 Technical manual 30 Chapter 3 Controls ASYNCHRONOUS PACING To Resume Synchronous Pacing Press PAUSE Key 5388 Technical manual To initiate dual chamber asynchronous pacing press the EMERGENCY ASYNC key once at any time that is while the device is on off in a Menu or locked The device will pace at the following values Table 3 3 Emergency values RATE current setting or 80 min if device was off A OUTPUT 20 mA V OUTPUT 25 mA A SENSITIVITY ASYNC i e no sensing V SENSITIVITY ASYNC i e no sensing A TRACKING UPPER RATE PVARP not applicable A V INTERVAL automatic rate dependent or current manual setting Note If the device is locked when EMERGENCY ASYNC is pressed the upper screen parameters unlock the backlight turns on and the device immediately begins to pace at emergency values The RATE A OUTPUT and V OUTPUT can be adjusted using the three upper dials The A V INTERVAL can be manually adjusted or allowed to adjust automatically with the RATE see A V Interval on page 40 The message to the left appears in the lower screen Note The asynchronous pacing message disappears after one minute The message reappears anytime the ON key is pressed see ON Key on page 28 during asynchronous pacing To resume demand synchronous pacing press the ON key see ON Key on page 28 o
9. DDD Noise Cancelled A Pace A DDD v T Oox G x GGG Restart Upper Rate 4 gt gt gt Interval AV Interval 170 ms PVARP 300 ms VA Interval 580 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 545 ms Blanking After Sense 125 ms If ventricular events are sensed in successive ventricular refractory periods the pacemaker will Inhibit atrial pacing and sensing and Asynchronously pace in the ventricle at the programmed base RATE The pacemaker is essentially in VOO mode Notes A cancelled atrial pace will not start a ventricular safety pace window UPPER RATE does not delay a ventricular pace after a cancelled atrial pace PVARP as well as ventricular refractory is continuously restarted by ventricular refractory sensed events 5388 Technical manual 136 Appendix A Dual Chamber Modes PVC Start Restart PVARP PVARP 400 ms Start PVARP Programmed value backat programmed value o A DDD Vv Start This Upper gt sensed Rate event is treated as Restart Upper Rate p aPVC SAV Interval 170 ms 30 ms 140 ms PVARP 300 ms VA Interval 580 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 545 ms Blanking After Sense 125 ms If the detected ventricular event occurs within the ventricular refractory pe
10. Damaged packages should be returned to Medtronic see back cover for address Registration Card Please complete the registration card and return it to Medtronic Consult the back cover of this manual for the address 5388 Technical manual 12 Chapter 1 Intended Use Intended Use The Medtronic Model 5388 temporary pacemaker is intended to be used in conjunction with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel The Model 5388 can be used where short term demand synchronous or asynchronous pacing is indicated for therapeutic prophylactic or diagnostic purposes Specific indications for temporary cardiac pacing include but are not limited to the following Complete heart block Sinus bradycardia Sick sinus syndrome Bradycardia with congestive heart failure Atrial and or ventricular arrhythmias Cardiac arrest Support management and evaluation of a patient prior to permanent pacemaker implantation Support during permanent pacemaker replacement Cardiac complications during invasive or surgical procedures Support following cardiac surgery Acute myocardial infarction complicated by heart block and High rate burst pacing for treatment of atrial tachyarrhythmias The Model 5388 can be used to determine sensing thresholds of temporary and permanently implanted lead systems When implanting a permanent pacemak
11. Defibrillation 16 Demand synchronous pacing definition 75 dual chamber 75 single chamber 75 to resume from asynchronous 72 Description general 10 Device maintenance 98 to 100 Dial a mode menu M 46 89 Dials 31 Diathermy equipment 17 Dimensions 104 Disposable cover 59 Disposable pouch 22 59 DOO mode definition 118 diagnostic diagram 118 menu M Dial a mode 46 89 pacing setup table 94 Dual chamber modes definitions 118 119 124 137 diagnostic diagrams 118 to 138 Dual chamber pacing asynchronous 76 definition 68 demand 75 DVI mode definition 119 diagnostic diagrams 119 to 124 menu M Dial a mode 46 89 E Electromagnetic interference EMI 16 Electrostatic discharge ESD 20 22 Electrosurgical equipment 17 Emergency connections 78 Emergency pacing 71 nominal values 72 EMERGENCY ASYNC key adjusting RATE OUTPUT 30 emergency pacing values 30 function 29 if upper screen is locked 49 30 Environmental precautions 22 to 23 Equipment diathermy 17 electrosurgical 16 17 line powered 16 magnetic resonance imaging MRI 17 medical telemetry 17 Erratic output sensing 18 F Failures random 18 self test 50 Features functional 49 to 55 physical 46 to 48 safety 11 Fluid incursion precautions 22 G General description 10 H Haversine waveform 105 Heartwires connection to cables 62 connections directly to device 64 device receptacles 47 HIGH OUTPUT adverse effect 24 indicator 37 75 prec
12. Pacemaker diagnostic diagrams definition of symbols 110 to 112 dual chamber modes 118 to 138 single chamber modes 113 to 117 Pacemaker setup indicators 69 Pacing asynchronous contraindication 13 atrial 13 atrial contraindication 13 dual chamber asynchronous 76 dual chamber demand 75 high output asynchronous 30 high rate therapy 13 17 setup table 94 single chamber asynchronous 77 single chamber demand 75 termination of 21 Pacing mode 102 nominal 104 selection 88 to 90 menu M 89 transitions 52 Pacing system analyzer PSA 12 Package contents 11 Parameters A TRACKING 40 A V INTERVAL 43 OUTPUT 74 PVARP 42 RATE 74 SENSITIVITY 39 80 SETTING 44 timing violations 53 UPPER RATE 42 81 Index 143 Patient cable 10 connecting to device 61 fig 61 connecting to lead system 62 description 60 sockets for 47 PAUSE key 31 how to 73 if upper screen is locked 49 precaution 21 30 time limit 74 PAVB period definition 111 Periods blanking 51 refractory 51 Physical features 46 to 48 Pouch disposable 22 59 Power loss of control 18 Power on 28 71 Precautions environmental 22 to 23 pressed 50 PSA pacing system analyzer 12 Pulse width 102 atrial 36 inappropriate variance 18 ventricular 37 PVAB period definition 111 PVARP 42 112 manual adjustments 82 nominal value 104 range increments 103 timing violations vs RATE A V INTERVAL 54 vs SAV UPPER RATE 54 wenckebach response 52 R Random failures 18 Rapid
13. after pace periods m Restart the UPPER RATE interval Start the V A interval and Deliver a pacing stimulus in the ventricle Jid DDD o Programmed lt Upper Rate Programmed lt a Upper Rate gt Restarted SAV Interval 170 ms 30 ms 140 ms PVARP 300 ms VA Interval 580 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 545 ms Blanking After Sense 125 ms If a ventricular sensed event occurs outside of the ventricular refractory and the SAV interval has timed out and the UPPER RATE interval has not timed out and a ventricular pace has been scheduled the pacemaker will Start the PVARP and PVAB after sense period Start the PVVR and PVVB after sense periods 5388 Technical manual 130 Appendix A Dual Chamber Modes Restart the UPPER RATE interval Start the V A interval and Cancel the scheduled ventricular pace fo A DDD Vv o Programmed Upper Rate Programmed t Upper Rate gt Restarted SAV Interval 170 ms 30 ms 140 ms PVARP 300 ms VA Interval 580 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 545 ms Blanking After Sense 125 ms If a ventricular sensed event occurs outside of the ventricular refractory and the SAV interval has not timed out and the UPPER RATE interval has not timed out
14. also unlock the Model 5388 and allow the upper dials to function The lock icon and flashing key icon appear in the middle of the screen if dials are turned while the upper screen is locked Viewing the Patient s Intrinsic Rhythm The recommended method for viewing the patient s intrinsic rhythm is to reduce the pacing rate Another option however is to use the PAUSE key To Pause amp Medtronic 5388 Dual Chamber Temporary Pacemaker Figure 5 6 Pause 5388 Technical manual 74 Chapter 5 Basic Operation Press and hold the PAUSE key Pacing and sensing are suspended for ten seconds unless you release the PAUSE key sooner Note To pause up to ten seconds again release the PAUSE key then press and hold the PAUSE key again This is a safety feature Rate and Output Adjustments 5388 Technical manual Figure 5 7 Rate and Output The upper dials are used to adjust the pacing rate min 1 atrial output mA and ventricular output mA The upper screen displays a numerical value and segmented line graph that reflects the current setting for each dial To Adjust Rate Turn the RATE dial clockwise to increase the rate counterclockwise to decrease the rate Rate range 30 min 1 to 200 min1 Note When the rate is set higher than 120 min 1 the bar size on the segmented line graph gets taller and thicker To Adjust Atrial Output Turn the A OUTPUT dial clockwise to increase atrial ou
15. on NBG codes The phrase MANUAL appears at the top of every Menu screen if one or more of the three rate dependent parameters are manually adjusted see SETTING on page 44 Note Once activated if Menu 1 2 M and the upper screen parameters remain unchanged for over 60 seconds the menu goes blank Menu 3 goes blank five minutes after the last adjustment or RAP delivery This Menu provides access to the Atrial sensitivity A SENSITIVITY Ventricular sensitivity V SENSITIVITY A V Interval A V INTERVAL and Atrial tracking option A TRACKING These parameters are displayed both numerically and graphically A Sensitivity yao V Sensitivity A V Interval A Tracking Controls indicators and other features 39 Lower Screen Parameters that do not apply to the current chambers being paced and sensed are less visible i e grayed out and are not selectable To change grayed out parameters the chambers being paced and sensed i e the pacing mode must first be changed see Model 5388 Pacing Setup Table on page 94 A Atrial SENSITIVITY Unless manually adjusted the atrial sensitivity A SENSITIVITY is set to the nominal value of 0 5 mV When selected the A SENSITIVITY may be adjusted between 0 4 and 10 mV by turning the MENU PARAMETER dial Turn the dial clockwise to increase A SENSITIVITY the mV value decreases and counterclockwise to decrease A SENSITIVITY
16. precaution 19 procedure 85 to 86 safety margin 84 SENSITIVITY 80 loss of control 18 nominal values 104 precaution 20 ranges increments 102 vs corresponding output 81 Service 100 SETTING menu 2 44 resetting manual adjustments 83 Setup indicators 34 OUTPUT 75 76 77 SENSITIVITY 39 40 75 76 Shut down message 71 Single chamber pacing asynchronous 77 demand 75 76 reversion response 52 unipolar lead system 63 Sockets heartwires 47 patient cables 47 Specifications 102 Status line lower screen 38 upper screen 33 to 35 Sterilization environmental precaution 22 patient cables 98 temporary pacemaker 98 Stimulation threshold capture definition 86 precaution 19 procedure 87 safety margin 87 Surgical cables 10 sockets for 47 Synchronous demand pacing transition rules 53 to resume 72 T Table pacing setup 94 Tables NBG code definition 95 rate and interval conversion 96 Tachyarrhythmia 23 Technical checks 99 Technical service 100 Temperature operating 104 stabilization 22 storage 104 Terminating pacing 21 Threshold evaluations 83 to 88 precaution 19 sensing threshold 84 to 86 stimulation threshold 87 to 88 Timing symbols 110 to 112 Timing violations 53 to 55 Transition rules 52 U Unipolar lead systems connecting to patient cables 63 dual chamber 63 precaution 19 Unlocking device 49 UPPER RATE 42 2 1 block point 52 manual adjustments 81 mode transition 53 nominal
17. DDD and DDI modes the RATE vs A V INTERVAL and PVARP block point maintains the 180 ms minimum RATE versus A V INTERVAL and PVARP A window must be provided in dual chamber modes for atrial sensing The formula used to allow for this window is A V INTERVAL PVARP 30 ms lt RATE Interval If the RATE is increased after the rate dependent parameters have been manually adjusted the device will limit increase of the RATE at the block point and display the warning message to the left Turn the RATE down or access Menu 2 and adjust the manually set parameter or set the device to automatic using SETTING see SETTING on page 44 RATE cannot exceed UPPER RATE Adjust RATE or UPPER RATE on Menu 2 Controls indicators and other features 55 Timing Violations RATE versus UPPER RATE The RATE and UPPER RATE can be set to the same value However the RATE cannot be set higher than the UPPER RATE nor can the UPPER RATE be set lower than the RATE If the user tries to set the RATE above the UPPER RATE or vice versa then the message to the left appears in the lower screen Turn the RATE down or access Menu 2 and increase UPPER RATE or set UPPER RATE to automatic using SETTING see SETTING on page 44 5388 Technical manual Preparation for use 4 Battery Installation 58 Disposable Pouch 59 Disposable Cover 59 Cables 60 Connector Setup 61 A A Warning Properly ground all line pow
18. Infarction Pericarditis Body rejection phenomena local tissue reaction Muscle and nerve stimulation and Infection Nerve or muscle stimulation can be caused by pacing lead contact with the nerve or muscle tissue and or by high output settings The stimulation may be controlled by repositioning or replacing the electrode or by reducing the output pulse amplitude Controls indicators and other features Controls 26 Light Emitting Diodes 32 Upper Screen 33 Lower Screen 37 Physical Features 46 Functional Features 49 Timing Violations 53 26 Chapter 3 Controls Controls Lock Unlock Key 5388 Technical manual The dials and keys used to control the functions and parameter settings of the Model 5388 are described below Note All adjustments to the RATE A Atrial OUTPUT and V Ventricular OUTPUT dials take effect within the next two pacing cycles This key allows the user to lock and unlock the upper screen parameter values RATE A OUTPUT and V OUTPUT see Lock Feature on page 49 When the upper screen is unlocked press this key to lock the upper screen parameters at their current settings The backlight will turn off and the lock indicator appears in the upper right hand corner of the upper screen Pressing this key while a lower menu is active causes the device to exit the menu Note If this key is not pressed the device automatically locks the parameters on the upper scr
19. OUTPUT Slowly turn the output dial clockwise until ECG shows consistent capture The pace indicator flashes continuously the sense indicator stops flashing This value is the stimulation threshold 5 Set OUTPUT to a value at least 2 to 3 times greater than the stimulation threshold value This setting provides at least a 2 1 safety margin 6 Restore RATE to previous value Pacing Setup The Medtronic Model 5388 Temporary Pacemaker can be set toa single chamber mode AOO VOO AAI VVI or a dual chamber mode DDD DDI DVI DOO To quickly set the device to the desired pacing mode adjust OUTPUT upper dials SENSITIVITY Menu 1 and or A Atrial TRACKING Menu 1 The Pacing Setup Table see page 94 provides a quick reference for selecting a pacing mode Refer to Basic Operation see page 70 and Pacing Parameter Adjustments see page 79 for step by step instructions on how to adjust output and sensitivity 5388 Technical manual User guide 89 Pacing Setup Atrial Tracking To change from DDD to DDI mode set A TRACKING to OFF from Menu 1 Conversely to change from DDI to DDD mode set A TRACKING to ON from Menu 1 DDI A Sensitivity V Sensitivity A V Interval Figure 5 26 Atrial Tracking To Turn Atrial Tracking Off or On 1 Press the MENU key until Menu 1 is displayed 2 Press the SELECT key until A TRACKING is highlighted 3 DDI mode Turn the MENU PARAMETER dial count
20. SENSITIVITY can be turned off allowing the pacemaker to pace asynchronously in the ventricle by turning the MENU PARAMETER dial counterclockwise until the term ASYNC appears The Setup Indicators at the top of the upper screen reflect the change by the absence of the V under SENSE and the V SENSE LED will no longer flash The NBG code at the top of the lower screen also reflects the change in pacing mode i e chamber s paced and sensed Note Modes that are punctuated by should be avoided or adjusted to a clinically useful mode V SENSITIVITY is automatically set to ASYNC when EMERGENCY is pressed or DOO mode is selected from Menu M Note V SENSITIVITY is inaccessible when V OUTPUT is turned to OFF A V Interval A V INTERVAL may be adjusted from 20 to 300 ms in increments of 10 ms see A V Interval on page 43 A Atrial TRACKING This feature is only accessible or applicable when the device is set to sense and pace in both chambers When ON A Atrial TRACKING causes the device to pace the ventricle in synchrony with intrinsic atrial depolarizations When A TRACKING is ON DDD mode each sensed event on the atrial lead not only inhibits the scheduled atrial pacing pulse but also triggers an A V INTERVAL A Warning If a patient is prone to atrial arrhythmias atrial tracking could lead to the development of ventricular arrhythmias see Contraindications on page 12 A Sensitivit
21. The pacemaker detects the heart s own beat and does not deliver a pacing stimulus Figure 5 17 Sensing The ECG below shows one example of undersensing The pacemaker does not detect intrinsic activity and thus paces on or between beats Figure 5 18 Atrial Undersensing Sensing Threshold The sensing threshold is the least sensitive setting at which the pacemaker can detect a heartbeat Monitor the patients ECG and blood pressure as you follow the procedure to find the atrial and ventricular sensing thresholds Safety Margin Lead maturation and drug therapy can affect the threshold To ensure sensing and accommodate a changing threshold it is important to provide at least a 2 1 safety margin Set A SENSITIVITY V SENSITIVITY to a value that is at least one half to one third the sensing threshold value For example an appropriate setting for a patient with a 5 0 mV sensing threshold is 2 5 mV or less User guide 85 Thresholds To Find Atrial or Ventricular Sensing Thresholds Caution Pacing dependent patients will have limited or no intrinsic rate rhythm This procedure should be used only on patients with adequate intrinsic rhythm Figure 5 19 Decrease Rate and Output 1 Turn on the temporary pacemaker without connecting it to the patient lead system Caution Do not connect the temporary pacemaker to the patient lead system before step 4 Set RATE at least 10 min below patient s intrinsic
22. amp gt Medtronic 5388 Dual Chamber Temporary Pacemaker Technical Manual or on the order of a physician Caution Federal Law USA restricts this device to sale by 0123 MODEL 5388 Technical Manual Dual Chamber Temporary Pacemaker Symbols Explanation of symbols Consult instructions for use Type CF applied part e 5 Conformit Europ enne European Conformity This symbol means that the device fully complies with European Directive 93 42 EEC SA 3 N Do not dispose of this product in the unsorted municipal waste stream Dispose of this product according to local regulations See http recycling medtronic com for instructions on proper disposal of this product For US audiences only Fla USA Package contents 4 Temporary pacemaker Product documentation Accessories ot Storage temperature limitation Explanation of symbols Humitidy limitation Battery 6LR61 Reorder number EF Authorized representative in the European Community Manufacturer Date of manufacture Serial number S JHE ZE ga a 5388 Technical manual Contents Overview 9 General Description 10 Intended Use 12 Contraindications 12 Warnings precautions and adverse effects 15 Warnings 16 Precautions 18 Environmental Precautions 22 Adverse Effects 23 Controls indicators and other features 25 Controls 26 Light Emitting Diodes 32 Upper Screen 33 Lower Screen 37 Ph
23. atrial pacing RAP 44 to 45 90 to 92 A OUTPUT 45 91 caution 90 92 rate nominal 104 rate range increments 102 to resume upper screen pacing 91 RATE 35 5388 Technical manual Index dial 31 during RA 45 high rate indicators 35 74 inappropriate variance 18 limit 104 loss of control 18 nominal value 35 104 range increments 74 102 timing violations 53 54 versus A V INTERVAL PVARP 54 versus UPPER RATE 55 Rate to interval conversion chart 96 Rate dependent parameters 81 to 83 manual settings 41 menu 2 41 to 44 mode transition 53 reset using AUTO 83 specifications 103 timing violations 53 Receptacles caution 48 heartwires 47 safety cable 22 seal 64 Refractory periods 51 definitions 112 timing symbols 111 Refractory sense 51 reversion response 52 symbol 111 Registration card 11 Repair 100 Retrograde conduction 21 Reversion operation 51 random failure 18 window 111 Ring bails 48 61 S Safety checks 99 features 11 margin sensing threshold 84 margin stimulation threshold 87 pacing 52 103 SAV sensed A V interval 43 112 5388 Technical manual nominal value 104 range 102 vs UPPER RATE PVARP 54 Seal connector pin receptacle 64 SELECT key 31 Menu 3 rapid atrial pacing 44 Menu M Dial a mode 46 Self test 50 SENSE LEDs 32 during self test 50 SENSE setup indicators 34 69 Sensed A V interval see SAV Sensed event symbol 110 Sensing 84 atrial contraindication 13 Sensing threshold 84
24. begins after successful completion of the self test Pacing begins approximately one second after sensing if not inhibited by a sensed event Should the device fail the self test one of the PACE or SENSE LEDS remains on and no output pulses are issued Failure codes may be displayed on the lower screen Remove the battery Return the device and battery for service see the addresses on the back cover of the manual Note Each time the MENU key is pressed the device checks the SELECT key If the SELECT key is found to be stuck the menus will not advance Shut the device down by pressing OFF twice and return the device for service Controls indicators and other features 51 Functional Features Blanking and Refractory Periods Blanking Periods Blanking is the interval following a paced or sensed event during which the device sense amplifier is disabled Blanking following paced events lasts longer than blanking following sensed events see the specifications on Blanking on page 103 Refractory Periods The refractory period is the interval during which a sensed event does not affect pacing timing However an event sensed inside refractory but outside blanking i e a refractory sense restarts blanking and refractory periods see the Pacemaker Diagnostic Diagrams During refractory a sensed event in the atrium causes the A SENSE LED to flash However a refractory sensed event in the ventricle does not cause t
25. event sensed during a refractory or blanking period Premature Ventricular Contraction A ventricular sensed event following another ventricular sensed event without any intervening atrial paced or atrial sensed inside or outside refractory event A V interval A downward sloped line shows A V timing initiated by an atrial output pulse or a sensed atrial event V A interval An upward sloped line shows the V A interval initiated by a ventricular output pulse or a sensed ventricular event This period which is not directly programmable has a value equal to the programmed base RATE interval minus the programmed PAV or SAV interval Blanking A solid rectangle shows a blanking period or absolute refractory period during which the pacemaker is totally insensitive to signals Refractory An open rectangle shows the refractory period A refractory sensed event does not affect the A V or V A interval but restarts some blanking and refractory periods Reversion window Period between the end of blanking and the end of refractory Reversion occurs when the device senses repeatedly in successive reversion windows then paces asynchronously Blanking and Refractory Periods Blanking Periods PAAB Period The Post Atrial Atrial Blanking period prevents the atrial sense amplifier from sensing the atrial pace pulse PAVB Period The Post Atrial Ventricular Blanking period prevents the ventricular sense amplifier from
26. for an alkaline battery or approximately 16 days continuous operation for a lithium battery when RATE is set at 70 min 1 and all other parameters are at nominal values see Nominal Values on page 104 Battery Drawer Release Button Press the button at the lower end of the device to open the battery drawer Connector Block Controls indicators and other features Physical Features Reversible Battery Polarity The polarity is marked inside the battery drawer however the device will also function properly if the battery is installed with the polarity reversed Continued Operation After Battery Removal If the battery is removed the device will continue to operate for 15 seconds typical see Operation After Battery Removal on page 105 under the following conditions RATE of 70 min 1 or less A OUTPUT and V OUTPUT of 10 mA or less backlight off and lower screen blank Note If the battery is removed while the backlight is on or the lower screen is active the device may shut down immediately depending upon the battery level Located at the top end of the device the connector block has sockets which accept patient and surgical cables Medtronic Patient Cable Models 5433A and 5433V and Medtronic Surgical Cable Models 5832 and 5832S Chamber designations are marked A for atrium and V for Ventricle The sockets are also color coded blue for atrium and white for ventricle The connector block also has opening
27. is used 5388 Technical manual 59 60 Chapter 4 Cables Cables Medtronic Models 5433A and 5433V Patient Cables 5388 Technical manual The Patient Cable Models 5433A and 5433V are designed to connect atrial and ventricular pacing lead systems to the Medtronic Model 5388 Temporary Pacemaker for temporary external pacing The Patient Cable Models 5433A and 5433V have recessed non exposed pins They are reusable supplied non sterile and should be sterilized prior to use using either steam reliable up to 25 autoclave cycles or ethylene oxide see Sterilization on page 99 The lead connector assembly at one end of each cable accepts endocardial or myocardial pacing lead connector pins 0 38 mm to 2 41 mm 0 015 inch to 0 095 inch in diameter The terminal connector at the other end of each cable is designed to mate with the output terminal on the Model 5388 pacemaker Do not expose the cables to storage temperatures above 66 C 150 F or below 40 C 40 F The two cables are identical except for color coding and markings The Model 5433A for atrial use has a blue connector block and blue band around the terminal pin block One side of the connector block carries a symbol denoting Atrial Use see Figure 4 2 1 The Model 5433V for ventricular use has a white connector block and white band One side of the connector block carries a symbol denoting Ventricular Use see Figure 4 2 2 1 Atrial Use
28. locked If upper dials are turned while the parameters are locked this indicator remains on and a m and a flashing appear in the upper screen between RATE and A OUTPUT The message to the left appears in the lower screen The lower screen message and the two icons in the center of the upper screen disappear after approximately 15 seconds if nothing is done to unlock the upper screen parameters All three indicators disappear when the parameters are unlocked see Lock Feature on page 49 DDI Indicator This indicator appears below the Pacemaker Setup Indicators when the device is pacing and sensing in both chambers but A Atrial TRACKING is turned OFF see A Atrial TRACKING on page 40 Parameters A V A V UU 30 RATE 120 200 BG Controls indicators and other features 35 Upper Screen The RATE A OUTPUT and V OUTPUT settings are displayed both numerically and graphically The line next to each dial shows the range available for that parameter Line segments appear showing where within the range the parameter is set The setting s numerical value appears just below the segmented line graph RATE The base pacing rate ranges from 30 to 200 min and is incremented as in Table 3 4 Table 3 4 Rate Increments Range Increment 30 to 50 min 5 min 50 to 100 min 2 min 1 100 to 200 min 5 min Turn the top dial clockwise to increase RATE and counter clockwise to decr
29. normal use However electronic devices are susceptible to many environmental stresses Precautions should be taken to avoid damage to the unit including but not limited to the precautions listed in this chapter Do not drop the unit or handle it in a way that might physically damage the device The device may appear to work appropriately immediately after being dropped or mishandled but operational damage may have occurred Do not place the Model 5388 in any area where a patient may interact with it Tampering with programmed parameters may have direct and serious patient health effects The temporary pacemaker should be placed in an area that minimizes tampering with the device by unauthorized personnel patients visitors etc Medtronic recommends the use of a protective cover such as the Medtronic Model 5441 clear plastic cover to minimize tampering Avoid spilling fluid on the unit The Model 5388 was carefully designed to minimize leakage but fluid incursion may still occur Medtronic recommends the use of a protective cover such as the Medtronic Model 5409 plastic pouch to minimize fluid incursion Avoid contaminating the safety cable receptacle and connector pin receptacles with blood or other body fluids Always use safe electrostatic discharge ESD procedures this device could be adversely affected by ESD Do not open the device The seam joining the unit is designed to minimize fluid incursion and may not be effe
30. pacing in the presence of continuous noise reversion behavior If the ventricular event occurs within the ventricular blanking period it is not sensed and no action is taken 5388 Technical manual 118 Appendix A Dual Chamber Modes Dual Chamber Modes The Model 5388 will pace in four dual chamber modes DOO DVI DDD and DDI Note Modes that are punctuated by on the Menu screens should be avoided or adjusted to a clinically useful mode DOO Mode When pacing in the A V sequential asynchronous mode DOO the pacemaker will pace the atrium and the ventricle asynchronously at the programmed base RATE and with the programmed A V INTERVAL Both channels are continuously blanked a PVC OE S ai DOO Base Rate gt When the V A interval times out the pacemaker will Start the A V INTERVAL and Deliver a pacing stimulus in the atrium When the A V INTERVAL times out the pacemaker will Start the V A interval and Deliver a pacing stimulus in the ventricle 5388 Technical manual Pacemaker diagnostic diagrams 119 Dual Chamber Modes DVI Mode In the ventricular demand A V sequential DVI mode there is no atrial sensing function If a ventricular event is sensed outside of a refractory period during the V A interval the pacemaker restarts the V A interval If a ventricular event is sensed during the programmed A V INTERVAL the pacemaker inhibits the ventricular stimulus and starts th
31. rate This adjustment ensures non pacing Atrial Set A OUTPUT to 0 1 mA Ventricular Set VOUTPUT to 0 1 mA This adjustment prevents the risk of competitive pacing Connect the temporary pacemaker to the patient lead system Press the MENU key until Menu 1 is displayed Atrial A SENSITIVITY is highlighted Ventricular Press the SELECT key to highlight V SENSITIVITY 5388 Technical manual 86 Chapter 5 Thresholds DDD VN Figure 5 20 Decrease Sensitivity 7 Decrease SENSITIVITY Slowly turn the MENU PARAMETER dial counterclockwise increase mV value until the sense indicator stops flashing The pace indicator flashes continuously but capture is not likely because the output value is at minimum DDD i Figure 5 21 Increase Sensitivity 8 10 Capture Definitions Increase SENSITIVITY Slowly turn the MENU PARAMETER dial clockwise decrease mV value until the sense indicator starts flashing The pace indicator stops flashing This value is the sensing threshold Set SENSITIVITY to half or less the threshold value This setting provides at least a 2 1 safety margin Restore RATE A OUTPUT or V OUTPUT to previous values When a pacing pulse captures the heart it causes the heart to beat that is contract and pump blood The ECG shows a P wave or QRS complex after the pulse as in the example shown here anal Figure 5 22 Capture 5388 Technica
32. sensing an atrial pulse crosstalk PVAB Period The Post Ventricular Atrial Blanking period prevents the atrial sense amplifier from sensing a ventricular pulse crosstalk 5388 Technical manual 111 112 Appendix A Definitions 5388 Technical manual PVVB Period The Post Ventricular Ventricular Blanking period prevents the ventricular sense amplifier from sensing a ventricular pace pulse A PACE r ARS 5 PAAB V PACE Figure A 1 Typical Blanking and Refractory Periods Refractory Periods PVARP The Post Ventricular Atrial Refractory Period prevents atrial sensing of crosstalk far field R wave retrograde conducted R wave which may trigger PMT pacemaker mediated tachycardia PVARP also provides a reversion window PVVR Period The Post Ventricular Ventricular Refractory period provides a reversion window PAAR Period The Post Atrial Atrial Refractory period is started only when an atrial event is sensed inside PVARP The two A V intervals are PAV Interval Pace A V interval A V INTERVAL is the A V interval after an atrial pace It is programmable SAV Interval Sense A V interval is the A V interval after an atrial sense This parameter is not programmable and is set to PAV minus 30 ms Pacemaker diagnostic diagrams 113 Single Chamber Modes Single Chamber Modes The Model 5388 will pace in four single chamber modes AOO VOO AAI and VVI AOO and VOO Modes The a
33. the dial all the way counterclockwise to reach ASYNC no sensing Atrial sensitivity range 0 4 mV 10 mV and ASYNC Ventricular sensitivity range 0 8 mV 20 mV and ASYNC Notes Setting A SENSITIVITY to ASYNC turns atrial sensing off and starts asynchronous pacing in the atrium Setting V SENSITIVITY to ASYNC turns ventricular sensing off and starts asynchronous pacing in the ventricle The highest number in mV for A SENSITIVITY or V SENSITIVITY is the least sensitive setting the lowest number in mV is the most sensitive setting A SENSITIVITY and V SENSITIVITY are not selectable grayed out if the corresponding A OUTPUT or V OUTPUT is OFF Rate Dependent Parameters UPPER RATE PVARP and A V INTERVAL are automatically set whenever RATE is adjusted or can be manually adjusted from Menu 2 Adjusting RATE does not change the UPPER RATE PVARP or A V INTERVAL if these values were manually adjusted from Menu 2 To Adjust Upper Rate 1 Press the MENU key until Menu 2 is displayed 2 Press the SELECT key until UPPER RATE is highlighted 3 Turn the MENU PARAMETER dial clockwise to increase the upper rate counterclockwise to decrease the upper rate 5388 Technical manual 81 82 Chapter 5 Pacing Parameter Adjustments DDD MANUAL es 2 PVARP A V Interval 170 ms SELECT SETTING MANUAL ae Figure 5 13 Upper Rate To Adjust PVARP 1 Press the MENU key until Menu 2 is display
34. the mV value increases The change will take effect within the next two pacing cycles A SENSITIVITY can be turned off allowing the pacemaker to pace asynchronously in the atrium by turning the MENU PARAMETER dial counterclockwise until the term ASYNC appears The Setup Indicators at the top of the upper screen reflect the change by the absense of the A under SENSE and the A SENSE LED will no longer flash The NBG code at the top of the lower screen also reflects the change in mode i e chamber s paced and sensed Note Modes that are punctuated by should be avoided or adjusted to a clinically useful mode A SENSITIVITY is automatically set to ASYNC when EMERGENCY is pressed RAP is delivered or DVI or DOO mode is selected from Menu M Note A SENSITIVITY is inaccessible when A OUTPUT is turned to OFF V Ventricular SENSITIVITY Unless manually adjusted ventricular sensitivity V SENSITIVITY is set to the nominal value of 2 0 mV When selected the sensitivity may be adjusted between 0 8 and 20 mV by turning the MENU PARAMETER dial 5388 Technical manual 40 Chapter 3 Lower Screen A Sensitivity ASYNC A V Interval 170ms A Tracking 5388 Technical manual Turn the dial clockwise to increase V SENSITIVITY the mV value decreases and counterclockwise to decrease V SENSITIVITY the mV value increases The change will take effect within the next two pacing cycles V
35. the pacemaker will Start the PVARP and PVAB after sense period Start the PVVR and PVVB after sense periods Restart the UPPER RATE interval Start the V A interval and Cancel the scheduled ventricular pace 5388 Technical manual Pacemaker diagnostic diagrams 131 Dual Chamber Modes DDD e Start Stop VSP VSP Timer Timer AV Interval 170 ms PVARP 300 ms VA Interval 580 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 545 ms Blanking After Sense 125 ms If the detected ventricular event occurs outside of the ventricular refractory period and the ventricular safety pace timer has timed out and the A V INTERVAL timer has not timed out the pacemaker will Start the PVARP and PVAB after sense period Start the PVVR and PVVB after sense period Start the UPPER RATE interval Start the V A interval and Cancel the scheduled ventricular pace 5388 Technical manual 132 Appendix A Dual Chamber Modes 5388 Technical manual DDD Ox Sense Due Programmed To Crosstalk e Upper Rate gt Start lt Safety VSP Pace Timer AV Interval 170 ms PVARP 300 ms VA Interval 580 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 545 ms Blanking After Sense 125 ms If the A V INTERVAL is programmed to more than 110 ms anda ventricular event is
36. the same lead system should not exceed 15 mm 0 6 inches Also the atrial and ventricular lead systems should be positioned so that the electrodes of one system are a minimum of 4 cm 1 5 inches from the electrodes of the other system and are at right angles to each other Unipolar Lead Systems Atrial Sensing Unipolar lead systems are not recommended because they are more susceptible to electromagnetic interference which may result in inappropriate pacing Unipolar lead systems should not be used in the dual chambered pacing modes because the current path of one lead system may interfere with the current path of the other The atrial sensing threshold should be evaluated to ensure maximum electrogram amplitude and that an adequate atrial sensing threshold is obtained prior to programming to a mode that requires atrial sensing DDD DDI or AAI 5388 Technical manual 19 20 Chapter 2 Precautions Place the wires on the right atrial free wall oriented along the direction of the myocardial fibers approximately 1 cm apart It is important to achieve a sensing threshold of at least 1 0 mV The atrial sensitivity should be set to a minimum of one half the measured threshold This ensures a minimum safety margin of 2x the sensing threshold Failure to follow this procedure can lead to delivery of asynchronous pulses Sensitivity Settings Since the sensitivity setting determines the smallest signal that can be sensed by the
37. value 104 range increments 103 Index 145 timing violations vs RATE 55 vs SAV PVARP 54 wenckebach response 52 Upper screen 33 to 37 A OUTPUT 36 locked parameters 49 RATE 35 status line 33 to 35 V OUTPUT 36 Use intended 12 V V ventricular OUTPUT 75 dial 32 during RAP 45 high output indicator 37 75 nominal value 37 104 range increments 36 V ventricular SENSITIVITY 39 nominal value 39 104 range increments 102 vs V OUTPUT 40 V A interval timing symbol 111 timing violations 54 Ventricular pacing asynchronous 77 blanking specifications 103 demand 76 refractory 51 reversion response 52 safety pacing 52 Viewing intrinsic rhythm PAUSE 73 VOO mode definition 113 diagnostic diagram 114 pacing setup table 94 VSP ventricular safety pace definition 110 specification 103 VVI mode definition 113 diagnostic diagrams 116 to 117 menu M 46 89 pacing setup table 94 5388 Technical manual 146 Index Ww WARNING messages 41 to 42 Warnings 16 to 17 Wenckebach response 52 Wire attachment ring bails 48 61 5388 Technical manual Medtronic Manufacturer Medtronic Inc 710 Medtronic Parkway Minneapolis MN 55432 5604 USA www medtronic com Tel 1 763 514 4000 Fax 1 763 514 4879 Medtronic E C Authorized Representative Distributed by Medtronic B V Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel 31 45 566 8000 Fax 31 45 566 8668 Europe Africa Middle East Headquart
38. when EMERGENCY key is pressed ASYNC ASYNC To Initiate Emergency Pacing Press the EMERGENCY key device may be on or off ER Medtronic 5388 Dual Chamber Temporary Pacemaker Figure 5 4 Emergency To Terminate Emergency Pacing Press the ON key to resume dual chamber demand synchronous pacing RATE A OUTPUT and V OUTPUT will remain at the values displayed at the time that ON is pressed A SENSITIVITY and V SENSITIVITY will return to the nominal values Note Regardless of which mode the device was operating in before Emergency pacing pressing the ON key during Emergency DOO mode pacing sets the device to DDD mode pacing If necessary adjust the parameters to set the device to a different mode The LOCK UNLOCK key locks and unlocks the three upper dials When the upper dials are locked the padlock icon appears and the rate atrial output and ventricular output cannot be adjusted Also the screen backlight is turned off User guide 73 Basic Operation BU g Figure 5 5 Lock Unlock Press the LOCK UNLOCK key to unlock the upper dials before adjusting rate or output Press the LOCK UNLOCK key to lock the upper dials after adjusting rate output and other pacing parameters Notes To prevent unintentional parameter changes the upper dials automatically lock 60 seconds after the last parameter adjustment The ON OFF MENU EMERGENCY and PAUSE keys
39. when the Menu screens are active In Menus 1 and 2 Use the SELECT key to scroll through the parameters continuously from top to bottom and back to the top In Menu 3 Rapid Atrial Pacing Press and hold the SELECT key to deliver a Rapid Atrial Pacing burst see page 44 In Menu M DIAL A MODE Use the SELECT key to activate a new mode see page 46 The top dial is used to set the base rate at which pacing pulses are delivered in reciprocal minutes min see RATE on page 35 5388 Technical manual 31 32 Chapter 3 Light Emitting Diodes Atrial Output Dial The Atrial Output dial is the second dial from the top It is used to set the current amplitude in milliamps mA of the atrial pacing pulse see A Atrial OUTPUT on page 36 Ventricular Output Dial The Ventricular Output dial is the third dial from the top It is used to set the current amplitude in mA of the ventricular pacing pulse see V Ventricular OUTPUT on page 36 Menu Parameter Dial The Menu Parameter Dial is the fourth dial from the top It is used to adjust the parameters displayed on the Menu Screens see Lower Screen on page 37 Light Emitting Diodes 5388 Technical manual All light emitting diodes LEDs are illuminated during the Power on Self test QAO OVO PACE ne PACE SENSE al 11 PACE LEDs There are two green LEDs at the top of the device marked PACE The green LED next to the A fla
40. while Menu 3 RAP is active see Menu 3 Rapid Atrial Pacing on page 44 Indicators Low Battery Indicator This indicator comes on and flashes when the battery reaches replacement time 5388 Technical manual 34 Chapter 3 Upper Screen PACE SENSE A V A V To UNLOCK RATE A OUTPUT and V OUTPUT Press A V A V DDI 5388 Technical manual When the Low Battery indicator begins to flash during device operation the device will operate satisfactorily for a minimum of 24 hours at or below a RATE of 70 min 1 nominal OUTPUTs and with the lower screen inactive Nominal Values on page 104 The backlight will not illuminate once the low battery indicator appears To extinguish the Low Battery indicator replace the low battery see Battery Installation on page 58 with a recommended new 9 Volt battery Pacemaker Setup Indicators The PACE and SENSE labels painted on the light gray bar above the upper screen and the A and V indicators that appear on the screen below the labels communicate to the user which chambers A for atrium V for ventricle the device is currently set to pace and or sense These indicators can be used to determine the current pacing mode see Model 5388 Pacing Setup Table on page 94 Note The Setup Indicators do not indicate actual device interaction with the heart Lock Indicators A m appears when the upper screen parameters are
41. 40 89 A V INTERVAL 40 V ventricular SENSITIVITY 39 Menu 2 41 to 44 A V INTERVAL 43 82 PVARP 42 82 SETTING 44 83 UPPER RATE 42 81 Menu 3 RAP 44 to 45 90 to 92 see also Rapid atrial pacing MENU key 31 timing violations 53 Menu M Dial a mode 46 89 Menu parameter dial 32 Menus 79 fig 80 status line 38 won t advance 50 5388 Technical manual Messages 2 1 block point 54 asynchronous pacing 30 OFF 71 PAUSE 31 UPPER RATE violation 54 upper screen is locked 49 Mode selection 88 to 90 DDI 89 menu M DDD DVI DOO VVI 46 89 timing violations 53 transition rules 46 52 Modes 102 definition diagrams AAI 113 115 to 116 AOO 113 114 DDD 124 125 to 137 DDI 137 138 DOO 118 DVI 119 119 to 124 VOO 113 114 VVI 113 116 to 117 nominal 104 N NBG code 2 39 40 lower screen 38 parameter settings chart 94 tables 95 Noise reversion operation 51 Nominal values 104 emergency pacing 72 power on 71 RAP rate 44 O OFF key function 29 71 if upper screen is locked 49 29 ON key 28 function 28 71 if upper screen is locked 49 28 to pace synchronously demand 29 Operation after battery removal 105 OUTPUT 36 high output indicator 37 high adverse effect 24 inappropriate variance 18 loss of control 18 nominal values 104 ranges and increments 102 symbol 110 vs SENSITIVITY 39 40 P PACE LEDs 32 69 during self test 50 PACE setup indicators 34 69 Paced A V interval see A V INTERVAL PAV
42. 45 ms Blanking After Sense 125 ms If no ventricular event is sensed and the A V INTERVAL times out and the UPPER RATE interval has timed out the pacemaker will Start the PVAB after pace period and PVARP Start the PVVB after pace and PVVR periods Start the UPPER RATE interval Start the V A interval and Deliver a pacing stimulus in the ventricle Note UPPER RATE is started by a ventricular pace a ventricular sense or a ventricular refractory sense UPPER RATE is effective only after an atrial sense not an atrial refractory sense Pacemaker diagnostic diagrams 127 Dual Chamber Modes Ltt DDD Start Stop VSP gt vsP Timer Timer SAV Interval 170 ms 30 ms 140 ms PVARP 300 ms VA Interval 580 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 545 ms Blanking After Sense 125 ms If the detected atrial event occurs outside of the PVARP the pacemaker will Start the PAAB period which is set to the same value as the SAV interval and Start the SAV interval Note There is no PAVB period initiated upon an atrial sensed event since a sensed event as compared to a paced event is assumed to be small in amplitude and to not result in crosstalk An atrial sensed event also does not start the ventricular safety pace timer 5388 Technical manual 128 Appendix A Dual Chamber Modes DDD Retrograde Con
43. ER RATE is increased see Timing Violations on page 53 f further increase or decrease of the RATE would cause a timing violation with the A V INTERVAL or PVARP a warning message appears on the lower screen and RATE is not allowed to be adjusted until A V INTERVAL and or PVARP are adjusted see Timing Violations on page 53 5388 Technical manual 42 Chapter 3 Lower Screen 5388 Technical manual During manual adjustments if a rate dependent parameter is adjusted to a point where further adjustment would cause a timing violation see Timing Violations on page 53 a warning message will overwrite the Menu for 10 seconds During those 10 seconds either Adjust the RATE or Press the MENU key to activate Menu 2 and adjust the rate dependent parameter After 10 seconds the message will disappear and the device will continue operating at the currently selected parameter values Upper Rate This parameter is designed to set the maximum ventricular pacing rate allowed while tracking the atrium At sensed atrial rates above the UPPER RATE a Wenckebach type response results see page 52 This parameter is adjustable only in dual chamber modes with atrial tracking Unless manually adjusted this parameter is limited to the range of 110 to 230 min and is determined by the RATE setting using the following formula UPPER RATE RATE 30 min When selected on Menu 2 however the UPPER RATE can be ad
44. a secure connection Caution Bipolar lead systems are recommended over unipolar systems because they are less susceptible to electromagnetic interference see Bipolar Lead Systems and Unipolar Lead Systems on page 19 For unipolar systems One lead system single chamber Insert the cardiac lead connector pin into the negative receptacle of the cable Insert the connector pin of the indifferent electrode or ground into the positive receptacle of the cable Two lead systems dual chamber Insert the connector pin of each cardiac lead into the negative receptacle of the appropriate cable Insert the connector pin of the indifferent electrode into the positive receptacle of one patient cable Then connect the indifferent electrode to the positive receptacle of the other patient cable using a jumper cable Note Failure to use a jumper cable will result in no pacing or sensing in the chamber not jumpered to the indifferent electrode Figure 4 5 Connecting the pacing lead system to the Model 5433A or 5433V Patient Cable receptacles Refer to the applicable patient cable technical manual for more information 5388 Technical manual 64 Chapter 4 Connector Setup Connecting the Pacing Lead System Directly to the Model 5388 Pacemaker A A Warning Do not connect heartwires or leads directly to the Model 5388 except in emergency situations Caution There is no locking mec
45. arameter or A V INTERVAL on Menu 1 has been manually adjusted The word MANUAL appears to the right of SETTING and at the top of the lower screen with an asterisk An asterisk appears next to the value of each setting which has been manually adjusted and SETTING becomes accessible To change A V INTERVAL UPPER RATE and PVARP back to automatic rate dependent settings select SETTING and turn the MENU PARAMETER dial clockwise until AUTO replaces MANUAL The user can use the MENU PARAMETER dial to alternate between AUTO and MANUAL parameter settings as long as SETTING remains selected turn the dial counterclockwise to reinstate MANUAL values Previous MANUAL settings are lost if the user sets the parameters to AUTO and then adjusts an upper or lower screen parameter Note The rate dependent parameter values are immediately updated on the screen and go into effect at the next appropriate event when switching SETTING from AUTO to MANUAL or MANUAL to AUTO Menu 3 Rapid Atrial Pacing This Menu enables the Rapid Atrial Pacing RAP feature but the device continues to operate at the RATE A OUTPUT V OUTPUT and mode on the upper screen until the SELECT key is pressed When Menu 3 is accessed the RAP screen displays either the most recent RAP rate used or the nominal RAP rate of 320 min if RAP has not been used since the device has been powered ON Controls indicators and other features Lo
46. ary Pacemaker has been carefully engineered manufactured and quality tested to provide long trouble free service Should service or repair be necessary contact your local Medtronic representative at the appropriate address or telephone number listed on the back cover A serial number identifying each individual pacemaker is printed on the back surface of the device This serial number should be referenced in any correspondence regarding this device Specifications 7 Device Specifications 102 Device Accessories 105 102 Chapter 7 Device Specifications Device Specifications The following specifications apply at 20 C 68 F 2 C 4 F and with a 500 ohm 1 load Modes AOO AAI VOO VVI DOO DDD DDI DVIa Base Rate 30 200 min1 5 30 50 min in 5 min increments 50 100 min 1 in 2 min 1 increments 100 200 min in 5 min increments Rapid Atrial Pacing 80 800 min 1 5 80 180 min 1 in 20 min 1 increments Rate 180 250 min in 5 min increments 250 360 min 1 in 10 min 1 increments 360 800 min 1 in 20 min 1 increments Output Amplitude Atrial 0 1 20 mA 0 1 mA or 10 0 1 0 4 mA in 0 1 mA increments 0 4 1 0 mA in 0 2 mA increments 200 1000 Ohms 1 0 5 0 mA in 0 5 mA increments 5 0 20 mA in 1 0 mA increments Ventricular 0 1 25 mA 0 1 mA or 10 0 1 0 4 mA in 0 1 mA increments 0 4 1 0 mA in 0 2 mA increments 200 1000 Ohms 1 0 5 0 mA in 0 5
47. ase RATE interval and Deliver a pacing stimulus to the atrium voo PVC l lt q Programmed gp Base Rate When the base RATE interval times out the pacemaker will Restart the base RATE interval and Deliver a pacing stimulus to the ventricle 5388 Technical manual Pacemaker diagnostic diagrams 115 Single Chamber Modes AAI Programmed Base Rate Programmed Base Rate Restarted o AAI Blanking After Sense 125 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Atrial Refractory 250 ms If the base RATE interval times out the pacemaker will Restart the base RATE interval Start the atrial refractory and blanking after pace periods and Deliver a pacing stimulus in the atrium AAI q Programmed p i Base Rate Noise Programmed ke Base Rate gt Restarted o G GGG x A AAI V Blanking After Sense 125ms Base Rate Interval 750 ms Blanking After Pace 175 ms Atrial Refractory 250 ms 5388 Technical manual 116 Appendix A Single Chamber Modes If a detected atrial event occurs outside of the atrial refractory period the pacemaker will Restart the base RATE interval and Start the atrial refractory and blanking after sense periods If a detected atrial event occurs within the atrial refractory period the pacemaker will Not restart the base RATE interval Restart the atrial refractory and blanking afte
48. assed press the key or the MENU key 5388 Technical manual 45 46 Chapter 3 Physical Features Menu M Dial A Mode DIAL A MODE DDD DDD DV DOO VVI Press SELECT to ACTIVATE new Mode This Menu allows the user to select DDD DVI DOO or VVI pacing mode When the mode is underlined the message to the left appears and an arrow points to the SELECT key Turn the MENU PARAMETER dial to underline the desired mode Press the SELECT key The new mode is activated within the next two cycles The PACE and SENSE LEDs the Setup Indicators at the top of the upper screen and the NBG code at the top of the Menu screens reflect this change The new mode will retain the current setting of all applicable parameters of the previous mode if no timing violations occur If timing violations occur the rate dependent parameters will be set to automatic values see Timing Violations on page 53 Parameters that did not apply in the previous mode will be set to nominal values in the new mode see Pacing Mode Transitions on page 52 Physical Features Battery 5388 Technical manual Battery Drawer The battery drawer located on the lower right side of the device accepts a standard 9 volt alkaline or lithium battery see Battery Type on page 105 Battery Life Battery life is typically 9 days minimally 7 days continuous operation
49. asynchronous mode to a synchronous mode UPPER RATE is implemented immediately after switching to DDD mode Parameters that did not apply in the previous mode will be set to nominal or rate dependent values in the new mode Timing Violations Mode Changes If the relationship between two or more parameters reaches a point where improper pacing could occur further change in the conflicting direction is prevented A summary of the timing violations not allowed by the 5388 follows During a mode change if one or more of the rate dependent parameters was manually set in the previous mode to a value that will cause improper pacing to occur in the new mode then the device changes the parameter to its automatic rate dependent setting Parameter Adjustments During adjustments of the rate dependent parameters if the user tries to set the parameters to values that violate timing rules a warning message will overwrite the Menu and stay on for 10 seconds see the following paragraphs for the specific messages During those 10 seconds either Adjust the RATE or Press the MENU key to activate Menu 2 and adjust the rate dependent parameter or set the device to automatic settings using SETTING see SETTING on page 44 After 10 seconds if no adjustments are made the message will disappear the lower screen will remain blank and the device will continue operating at the selected values 5388 Technical manual
50. ature functions when the device is operating in a mode that senses and paces in the ventricle and paces in the atrium DVI DDI and DDD If a ventricular sensed event is detected outside the 20 ms blanking window but within 110 ms after an atrial paced event a ventricular safety pacing VSP pulse is delivered 110 ms after the atrial pace if the A V INTERVAL is greater than 110 ms The ventricular pacing pulse is delivered at the A V INTERVAL if the A V INTERVAL is less than 110 ms see Pacemaker Diagnostic Diagrams The V PACE LED and the V SENSE LED flash within 15 ms of each other Wenckebach Response In DDD mode when the intrinsic atrial rate increases beyond the UPPER RATE the device continues to lengthen the SAV interval until a P wave falls within the PVARP and thus is not sensed Because the P wave is not sensed the SAV interval is not started and a ventricular pace is not issued Pacing Mode Transitions The Model 5388 switches modes in accordance with the following guidelines When switching from an atrial only mode to a mode involving an A V Interval which could be as short as 20 ms the first ventricular pacing pulse will be inhibited to avoid pacing into a T wave 5388 Technical manual Controls indicators and other features 53 Timing Violations A complete cycle of the current mode is allowed to expire before implementing a new mode The device senses before pacing when switching from an
51. aution 20 High rate indicator 35 High rate pacing therapy contraindicated in ventricle 13 Index 141 no ventricular back up 17 precaution 17 19 Humidity 23 l Indications 12 Indicators 27 69 to 70 DDI 34 false signals 18 fig 27 high output 37 75 high rates 35 lock 34 49 73 low battery 33 pace and sense LEDs 32 pacemaker setup 34 Indifferent electrode 63 Intended use 12 Interference reversion response 51 Intrinsic rhythm effect on pacing therapy 68 view using PAUSE 30 73 J Jumper cable 63 K Keys 26 to 31 during lock 49 L Lead systems adverse effects 24 bipolar 10 19 63 connecting directly to device 64 fig 65 connecting to patient cables 62 fig 63 inappropriate connections 24 precautions 19 reposition 24 unipolar 19 63 warnings 17 LEDs light emitting diodes during self test 50 green pace 32 orange sense 32 5388 Technical manual 142 Index Line powered equipment 16 Lock indicators 34 70 Lock feature 49 72 during RAP 45 EMERGENCY ASYNC key 30 lock unlock key 26 MENU key 31 OFF key 29 ON key 28 PAUSE key 30 Locked up self test failure 50 Low battery indicator 33 69 at power on 28 Lower screen 37 to 46 controls 38 79 menu 1 38 to 41 menu 2 41 to 44 menu 3 RAP 44 to 45 menuM 46 messages 30 31 54 71 M Magnetic resonance imaging MRI 17 MANUAL AUTO 44 Mapping atrial 19 Medical telemetry equipment 17 Menu 1 38 to 41 A atrial SENSITIVITY 39 A TRACKING
52. cause capture 1 Plug the Model 5433A and Model 5433V patient cables into appropriate sockets at the top end of device see Figure 5 9 Plug a pair of Model 5832 or Model 5832S surgical cables into appropriate sockets at the top end of device see Figure 5 9 One socket is marked A atrium the other V ventricle Note To disconnect cable from the device press connector release button on cable and pull gently from socket Figure 5 9 Cable to Device Connections 2 Connect leads heartwires to the appropriate cable Match positive and negative leads to positive and negative sockets or clips for the atrium and ventricle not shown Figure 5 10 Emergency Connections 5388 Technical manual User guide 79 Pacing Parameter Adjustments In an emergency and in the absence of patient or surgical cables temporary pacing leads or heartwires plug directly into the four smaller sockets two for the atrium two for the ventricle at the top end of device see Figure 5 10 A Caution These are not the primary connector setup methods because there is no locking mechanism for the connection Refer to the applicable patient cable technical manual for more information Pacing Parameter Adjustments Menus allow you to manually adjust pacing parameters The parameters displayed on menus are based on the currently programmed pacing mode rate and output Parameters not selectable are dimmed
53. caution 18 type 58 105 Battery replacement 92 continued operation during 47 105 fig 92 reversible polarity 47 5388 Technical manual 140 Index Bipolar lead system 10 connecting directly to device 64 connecting to patient cable 63 precautions 19 Blanking 103 definitions 51 111 timing symbol 111 timing symbols 111 Cc Cable to device connections 78 Cable to lead system connections 63 Cables description patient 60 precautions 19 sockets for 47 surgical 10 Capture definition 86 Cardioversion 16 Cautery 16 Cellular phones 17 Chart mode vs parameter settings 94 Checks safety and technical 99 Cleaning patient cables 98 temporary pacemaker 98 see also Sterilization Communication transmitters 17 Conduction retrograde 21 Connector block temporary pacemaker 47 Connector pin receptacles 47 caution 64 seal fig 64 Connector setup 61 to 65 lead system to patient cables 62 leads directly to device 64 overview 77 to 79 patient cable to device 61 precaution 17 warning 64 Contents package 11 Contraindications 12 Controls 26 to 32 fig 27 lower screen 38 upper screen 26 31 5388 Technical manual Conversion chart rate and interval 96 Cover disposable 59 D DDD mode 28 definition 124 diagnostic diagrams 125 to 137 menu M Dial a mode 46 89 pacing setup table 94 DDI mode 89 definition 137 diagnostic diagram 138 indicator 34 69 pacing setup table 94 pacing setup tableAOO mode pacing setup table 94
54. ctive if improperly opened and resealed Furthermore removing the label on the back of the unit may compromise the ESD barrier Opening this unit will void the warranty Do not sterilize the Model 5388 by gamma irradiation or steam autoclave See Cleaning and Sterilization on page 98 for more information Rapid temperature changes may affect proper operation Always allow the temperature of the device to stabilize in the environment in which the device will be used before attachment and operation see page 104 for recommended storage and operation temperatures Warnings precautions and adverse effects 23 Adverse Effects Prolonged storage or operation of the device in high humidity may affect proper operation Allow the device to completely dry after exposure to humidity Other environmental factors may impact proper performance of the unit in the hospital setting Use of appropriate environmental health and safety practices will help prevent environmental damage to the unit Adverse Effects Temporary Pacemakers Potential adverse effects related to the use of temporary external pacemakers such as the Model 5388 include but are not limited to Asystole following abrupt cessation of pacing Inhibition or reversion in the presence of strong electromagnetic interference and Initiation of a tachyarrhythmia or acceleration of an existing tachyarrhythmia Atrial High Rate Burst Pacing Atrial high rate bur
55. duction y PF SAV Interval 170 ms 30 ms 140 ms VA Interval 580 ms Base Rate Interval 750 ms Upper Rate Interval 545 ms PVARP 300 ms Ventricular Refractory 250 ms Blanking After Pace 175 ms Blanking After Sense 125 ms If the atrial event occurs inside the PVARP a PAC a far field ventricular event a retrograde conducted ventricular event the pacemaker will Restart PAAR and PAAB after sense periods and Not start SAV interval Note This action prevents pacemaker mediated tachycardia PMT DDD PAC ae k fi o A DDD Vv Programmed gt a Programmed Upper Rate Upper Rate SAV Interval 170 ms 30 ms 140 ms VA Interval 580 ms Base Rate Interval 750 ms Upper Rate Interval 545 ms End of Upper Rate Interval 5388 Technical manual PVARP 300 ms Ventricular Refractory 250 ms Blanking After Pace 175 ms Blanking After Sense 125 ms Pacemaker diagnostic diagrams 129 Dual Chamber Modes If no ventricular event is sensed and the SAV interval times out from a preceding atrial sensed event and the UPPER RATE interval has not timed out the pacemaker will Extend PAAB and Schedule a pacing stimulus in the ventricle when the UPPER RATE interval times out Then if no ventricular event is sensed and the UPPER RATE interval times out the pacemaker will Start the PVARP and PVAB after pace period Start the PVVR and PVVB
56. e A V Interval after an atrial sensed event i e SAV is not programmable The SAV is automatically set to a value 30 ms less than the A V INTERVAL Unless manually adjusted A V INTERVAL is set to a value determined by the RATE setting It can never be shorter than 50 ms or longer than 250 ms as determined by the following formula A V INTERVAL ms 300 1 67 x RATE min The final value is rounded off to the nearest higher multiple of 10 within the automatic range i e 50 60 70 230 240 250 For example at a RATE of 70 min 1 the A V INTERVAL would be rounded to 190 ms When selected on Menu 1 or 2 however the A V INTERVAL can be manually set to values from 20 to 300 ms in 10 ms increments that do not cause a timing violation see Timing Violations on page 53 5388 Technical manual 44 Chapter 3 Lower Screen DDD MANUAL Upper Rate 110 min PVARP 300 ms A V Interval 200ms Press SELECT to DELIVER RAPID ATRIAL PACING 5388 Technical manual Note If A V INTERVAL is set shorter than 50 ms ventricular events may not be sensed during that interval due to ventricular blanking after an atrial event SETTING This feature sets the A V INTERVAL UPPER RATE and PVARP to automatic rate dependent settings see Auto on page 103 SETTING is inaccessible grayed out when the device is using automatic settings When a Menu 2 p
57. e V A interval The exception to this is safety pacing which is described later This mode is normally used when A V synchrony is desired but the atrium is prone to arrhythmias Notes PVARP and UPPER RATE do not apply in this mode When pacing in the DVI mode the pacemaker will pace the atrium and the ventricle at the programmed base RATE and with the programmed A V INTERVAL in the absence of detected ventricular electrical activity The atrial sense amplifier is continuously blanked DVI T Start End x VSP lt a VSP Timer Timer AV Interval 170 ms Ventricular Refractory 250 ms VA Interval 580 ms Blanking After Pace 175 ms Base Rate Interval 750 ms Blanking After Sense 125 ms If the V A interval times out the pacemaker will Start the ventricular safety pace timer VSP Start the A V INTERVAL Start the PAVB period and 5388 Technical manual 120 Appendix A Dual Chamber Modes Deliver a pacing stimulus in the atrium If no ventricular event is sensed and the A V INTERVAL times out the pacemaker will Start the V A interval Start the PVVR and PVVB after pace periods and Deliver a pacing stimulus in the ventricle DVI lt a A DVI v o a VA Interval gt Restarted AV Interval 170 ms Ventricular Refractory 250 ms VA Interval 580 ms Blanking After Pace 175 ms Base Rate Interval 750 ms Blanking After Sense 125 ms If the detected ventricular
58. e leads are connected to the atrium not the ventricle before enabling RAP 5388 Technical manual User guide 91 RAP Rapid Atrial Pacing SELECT 440 801 Press SELECT to DELIVER RAPID ATRIAL PACING Figure 5 28 RAP Rapid Atrial Pacing To Deliver Rap 1 Verify that the leads are in contact with the atrium and are connected to the atrial channel of the device through a patient or surgical cable 2 Press the MENU key until Menu 3 is displayed Screen displays RAP rate initial rate of 320 mim or rate last set Pacing continues at currently displayed settings 3 Adjust RAP rate as needed Turn the MENU PARAMETER dial clockwise to increase rate counterclockwise to decrease rate Range 80 min 800 min 4 Press and hold SELECT to deliver RAP burst AOO pacing begins at displayed RAP rate and current A OUTPUT The A PACE LED flashes during delivery of RAP pulses Note There is no ventricular support during RAP Note If AOUTPUT is set to OFF when you press the SELECT key RAP is delivered at 10 mA A OUTPUT returns to the OFF setting as soon as you release the SELECT key even if you adjust A OUTPUT during RAP delivery To Adjust Rate Atrial Output During RAP Delivery 1 Continue to press and hold the SELECT key 2 Turn the MENU PARAMETER dial to adjust RAP rate 3 Turn the A OUTPUT dial to adjust atrial output To Resume Pacing at Upper Screen Settings
59. ease RATE The nominal RATE setting at which the device powers up is 80 min For rates above 120 min 1 the line segments become taller and wider to warn the user that RATE is set above the typical range Note The rate dependent parameters UPPER RATE PVARP and A V INTERVAL are automatically adjusted each time RATE is adjusted unless they are manually set see Menu 2 on page 41 5388 Technical manual 36 Chapter 3 Upper Screen 5388 Technical manual A Atrial OUTPUT The atrial output ranges from 0 1 to 20 mA and is incremented as in Table 3 5 Table 3 5 Atrial Output Increments Range Increment 0 1 to 0 4 mA 0 1 mA 0 4 to 1 0 mA 0 2 mA 1 0to5mA 0 5 mA 5 to 20 mA 1 0 mA Turn the dial clockwise to increase A OUTPUT Turn the dial counterclockwise to decrease or turn A OUTPUT OFF The space above OFF fills in when A OUTPUT is turned OFF When A OUTPUT is set to OFF both the atrial output and the atrial sensitivity are turned off i e there is no atrial pacing or sensing If A OUTPUT is turned back on within approximately seven seconds atrial sensitivity is set to the previously selected value If A OUTPUT is OFF for longer than approximately seven seconds atrial sensitivity is set to the nominal value of 0 5 millivolts mV when A OUTPUT is turned back on Note A SENSITIVITY can be adjusted from Menu 1 on the lower screen see A Atrial SENSITIVITY on page 39 At power up A OUTPUT
60. ed 2 Press the SELECT key until PVARP is highlighted 3 Turn the MENU PARAMETER dial clockwise to lengthen the PVARP counterclockwise to shorten the PVARP DDD MANUAL SELECT Figure 5 14 PVARP To Adjust A V Interval 1 Press the MENU key until Menu 1 or 2 is displayed 2 Press the SELECT key until A V INTERVAL is highlighted 3 Turn the MENU PARAMETER dial clockwise to lengthen the A V INTERVAL counterclockwise to shorten the A V INTERVAL 5388 Technical manual User guide 83 Thresholds MANUAL Upper Rate SELECT Figure 5 15 A V Interval To Reset Rate Dependent Values To Automatic Settings 1 Press the MENU key until Menu 2 is displayed 2 Press the SELECT key until SETTING is highlighted 3 Turn the MENU PARAMETER dial clockwise to display AUTO DDD Upper Rate PVARP A V Interval SELECT Figure 5 16 Resetting to Automatic Values Thresholds Threshold values are needed to determine the appropriate settings for output and sensitivity Procedures for finding atrial and ventricular sensing and stimulation thresholds are presented in this section Note To reduce the risk of competitive pacing find the sensing thresholds first if the patient s intrinsic rhythm is adequate 5388 Technical manual 84 Chapter 5 Thresholds Sensing Definitions 5388 Technical manual The ECG below shows intrinsic beats mixed with paced beats
61. een 60 seconds after the last device adjustment with the exception of Menu 3 When in Menu 3 Rapid Atrial Pacing the device waits five minutes before locking When the upper screen is locked press this key to unlock the upper screen allowing the upper screen parameters to be adjusted again The backlight turns on unless the low battery indicator is flashing see Low Battery Indicator on page 33 OD N DOT PS ONO ae i ak k i O on a 14 15 16 17 18 19 20 21 22 Pace Sense LEDs Lock Unlock Key Lock Indicators Rate Dial Atrial Output Dial Ventricular Output Dial Menu Parameter Dial Parameter Selection Key Menu Selection Key Pause Key Power On Key Power Off Key Emergency Asynchronous Pacing Key Lower Screen Ventricular Output Graphics Atrial Output Graphics Upper Screen Rate Graphics Setup Indicators DDI Indicator Low Battery Indicator Setup Labels Controls indicators and other features Controls SR Medtronic 5388 Dual Chamber Temporary Pacemaker Figure 3 1 Controls and Indicators of the Model 5388 5388 Technical manual 27 28 Chapter 3 Controls ON Key 5388 Technical manual Press the ON key once to power the device up The device first senses then begins sensing and pacing in both chambers DDD mode The upper screen and the backlight illuminate and a self test is initiated see Self test on page 50
62. emaker delivers a pacing stimulus to the ventricle at the end of the programmed A V INTERVAL An exception to this is safety pacing which is illustrated in the diagrams The pacing rate can be limited by the programmed UPPER RATE so that the pacemaker does not pace the ventricle too fast in the presence of atrial arrhythmias When pacing in the DDD mode the pacemaker will pace the atrium and the ventricle at the programmed base RATE and with the programmed A V INTERVAL in the absence of detected atrial or ventricular intrinsic events DDD PVARP Programmed Upper Rate Start Stop VSP lt a VSP Timer Timer AV Interval 170 ms PVARP 300 ms VA Interval 580 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 545 ms Blanking After Sense 125 ms If the V A interval times out the pacemaker will Start the ventricular safety pace timer Start the PAAB period which is set to the same value as the A V INTERVAL Start the PAVB period Start the A V INTERVAL and Deliver a pacing stimulus in the atrium 5388 Technical manual 126 Appendix A Dual Chamber Modes 5388 Technical manual DDD Programmed Upper Rate Start Stop VSP a VSP Timer Timer AV Interval 170 ms PVARP 300 ms VA Interval 580 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 5
63. er however Medtronic recommends the use of a Medtronic Pacing System Analyzer Contraindications 5388 Technical manual There are no known contraindications to the use of temporary pacing as a means to control the heart rate The patient s age and medical condition however may dictate the type of temporary pacemaker and lead system used by the physician Overview 13 Contraindications Atrial Sensing Pacing modes which allow sensing in the atrium to trigger a ventricular response are contraindicated in the presence of rapid atrial arrhythmias such as atrial fibrillation or atrial flutter Atrial Pacing Atrial pacing is ineffective in the presence of atrial fibrillation or flutter Single chamber atrial pacing is contraindicated in the presence of AV conduction disorders Asynchronous Pacing Asynchronous pacing is contraindicated in the presence of intrinsic cardiac rhythms Atrial High Rate Burst Pacing Therapy Atrial high rate burst pacing therapy is intended for use in the atrium only High rate burst pacing in the ventricle may result in life threatening arrhythmias 5388 Technical manual Warnings precautions and Warnings 16 Precautions 18 Environmental Precautions 22 Adverse Effects 23 adverse effects 2 16 Chapter 2 Warnings Warnings Equipment Modification Do not modify this equipment Modifications could impact device effectiveness and adversely affect patient safety Defibrilla
64. erclockwise to display OFF DDI pacing and sensing begin The DDI indicator appears DDD mode Turn the MENU PARAMETER dial clockwise to display ON DDD pacing and sensing begin Note A TRACKING can be set to OFF only from DDD mode and set to ON only from DDI mode Dial A Mode Menu M allows you to select DDD DOO DVI or VVI pacing modes 5388 Technical manual 90 Chapter 5 RAP Rapid Atrial Pacing Press SELECT amp to ACTIVATE new Mode Ss Figure 5 27 Dial A Mode To Dial a Mode 1 Press the MENU key until Menu M is displayed 2 Turn the MENU PARAMETER dial to underline desired pacing mode 3 Press the SELECT key to activate the selected pacing mode Pacing in the selected mode begins as follows Manually set values for UPPER RATE PVARP and A V INTERVAL are retained when they apply to the newly selected mode Otherwise the settings are returned to their automatic rate dependent values Example lf you change from DVI to DDD mode the setting for A V INTERVAL is retained or carried forward UPPER RATE and PVARP are set to their automatic rate dependent values Nominal or previously programmed settings for OUTPUT and SENSITIVITY Example f you change from AAI to DDD mode the value for A OUTPUT is retained V OUTPUT is set to the nominal value m Previously programmed RATE RAP Rapid Atrial Pacing A Caution RAP is for atrial use only Be sure th
65. ered equipment used on or in the vicinity of the patient see Warnings on page 16 Caution Monitor the patient s ECG and blood pressure and keep defibrillation equipment on standby immediately available for emergency use during pacing lead insertion and pacemaker connection 58 Chapter 4 Battery Installation Battery Installation 5388 Technical manual To install or replace the battery press the battery drawer release button until the battery drawer opens see Figure 4 1 Remove the old battery and replace it with a new 9 Volt type 6LR61 or type 6F22E or NEDA 1604A Eveready 522 or equivalent alkaline battery or a NEDA 1604LC Ultralife U9VL or equivalent lithium battery Make sure the drawer clicks shut Note Use of other than the recommended batteries may result in one of the following conditions 1 less than 24 hours of operation after the low battery indicator comes on 2 degraded pacemaker performance and or 3 overall reduced battery life Caution Use of batteries with different physical dimensions from that of the recommended batteries or use of batteries with contamination on the battery terminals may result in erratic or no pacing output Note Medtronic does not recommend replacing the battery while the pacemaker is turned on Note The battery should be removed when the device is not in use Figure 4 1 Press battery drawer release button Preparation for use Disposable Pouch
66. erilization Note While either of the following sterilization methods is acceptable repeated steam sterilization typically causes more rapid degradation Steam Sterilization Remove the cable from the original package and place the cable in a suitable autoclavable packaging material The packaged cable should be autoclaved at 121 C 250 F at 103 kPa 15 PSIG for 30 minutes or 132 C 270 F at 186 kPa 27 PSIG for 7 minutes Ethylene Oxide Sterilization Remove the cable from the original package and wrap the cable in packaging permeable to ethylene oxide Follow standard method for ethylene oxide sterilization Use an acceptable method such as biological indicators for determining sterilizer effectiveness Safety and Technical Checks Visual Inspection Safety and technical checks should be carried out on the Model 5388 at least once every 12 months and after any malfunction or accident Medtronic recommends that the checks be carried out by qualified engineers and technicians trained in the service of Medtronic products Below is a brief outline of necessary checks For service or training contact your Medtronic sales or service representative Technical Manual m Inscriptions information and warning signs properly and completely fixed Mechanical damage to the device Inspection of battery compartment and battery connection for corrosion and other contamination Functional Inspection Faultle
67. ers Medtronic International Trading Sarl Route du Molliau 31 Case Postale 84 CH 1131 Tolochenaz Switzerland www medtronic co uk Tel 41 21 802 7000 Fax 41 21 802 7900 Technical manuals www medtronic com manuals Medtronic Inc 2009 198092001J 198092001
68. esentation or warranty is made that failure or cessation of function of cables will not occur 5388 Technical manual Pacemaker diagnostic diagrams A About the Chapter 110 Definitions 110 Single Chamber Modes 113 Dual Chamber Modes 118 5388 Technical manual 110 Appendix A About the Chapter About the Chapter Definitions VSP 5388 Technical manual About the Chapter A 110 Definitions A 110 Single Chamber Modes A 113 AOO A 114 VOO A 114 AAI A 115 VVI A 116 Dual Chamber Modes A 118 DOO Mode A 118 DVI Mode A 119 DDD Mode A 124 DDI Mode A 137 Throughout this manual certain terms and symbols are used that are defined here for clarity The software program operating in the Model 5388 provides the pacemaker with the capabilities to respond to sensed signals in unique ways and to produce appropriate output signals Some of the most frequently used terms to describe the software program activity of the Model 5388 are Ventricular Safety Pace A stimulus to the ventricle to prevent inappropriate inhibition see Ventricular Safety Pacing on page 52 This small diamond is used to signify the end of the UPPER RATE interval A star indicates that the pacemaker has emitted an output pulse to that chamber A circle indicates the pacemaker has sensed an event in that chamber ose BP ions x Pacemaker diagnostic diagrams Definitions A circle with a slash indicates an
69. event occurs outside of the ventricular refractory period and in the V A interval the pacemaker will Restart the V A interval and Start the PVVR and PVVB after sense periods 5388 Technical manual Pacemaker diagnostic diagrams 121 Dual Chamber Modes PVC A DVI v o AV Interval 170 ms Ventricular Refractory 250 ms VA Interval 580 ms Blanking After Pace 175 ms Base Rate Interval 750 v Blanking After Sense 125 ms If the ventricular event is sensed inside the ventricular refractory period and in the V A interval the pacemaker will Not restart the V A interval Start the PVVR and PVVB after sense periods DVI o Start Stop VSP VSP Ti Timer E 110 ms AV Interval 170 ms Ventricular Refractory 250 ms VA Interval 580 ms Blanking After Pace 175 ms Base Rate Interval 750 ms Blanking After Sense 125 ms If the ventricular event is sensed outside the ventricular safety pace window and in the A V INTERVAL the pacemaker will 5388 Technical manual 122 Appendix A Dual Chamber Modes Start the V A interval and Start the PVVR and PVVB after sense periods A DVI v T T T Ox Sense Due To Crosstalk Start Safety VSP gt lt Pace Timer 110 ms AV Interval 170 ms Ventricular Refractory 250 ms VA Interval 580 ms Blanking After Pace 175 ms Base Rate Interval 750 ms Blanking After Sense 125 ms If the A V INTERVAL is p
70. fter pace period Start the UPPER RATE interval Start the V A interval and Deliver a pacing stimulus to the ventricle Note The response is similar if the ventricular sensed event is a refractory sense inside the ventricular safety pace window 5388 Technical manual 134 Appendix A Dual Chamber Modes DDD PVARP Programmed value Restart PVARP gt 400 ms 1 _ 1 Cc ft Restart gt Start VA Interval 0 Upper gt Rate Upper This sensed event Rate is treated as a PVC Restarted AV Interval 170 ms PVARP 300 ms VA Interval 580 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 545 ms Blanking After Sense 125 ms If the detected ventricular event occurs outside of the ventricular refractory period and the V A interval has not timed out and the event is recognized as a PVC the pacemaker will Start the PVARP at a value of 400 ms or to the programmed value if set longer than 400 ms because the event is recognized as a PVC Start the PVAB after sense period Start the PVVR and PVVB after sense periods Restart the UPPER RATE interval and Restart the V A interval Note PVARP is extended only during the cycle in which the PVC is recognized Otherwise it goes back to the programmed value 5388 Technical manual Pacemaker diagnostic diagrams 135 Dual Chamber Modes
71. g and sensing so patient s intrinsic rhythm can be viewed EMERGENCY key starts dual chamber asynchronous DOO pacing at maximum output What is Dual Chamber Pacing 5388 Technical manual A pacemaker is able to sense the heart s electrical activity and determine if it is necessary to stimulate the heart to contract or peat A dual chamber pacemaker has the ability to sense and pace in both chambers of the heart the atrium and the ventricle The Medtronic Model 5388 Temporary Pacemaker is a dual chamber temporary pacemaker When first turned on it senses the heart s intrinsic activity If it senses normal contractions in the atrium or ventricle pacing is inhibited If it senses no intrinsic activity in a chamber pacing occurs in that chamber User guide 69 Indicators Indicators Pace Sense LEDs QAO OVO ENSE PACE SENSE Low Battery Indicator Padlock Icon DDI Indicator etup Indicators Figure 5 1 Indicators Pace Sense LEDs One set of pace sense LEDs is for the atrium the other for the ventricle The green pace LED flashes each time the device delivers a pacing stimulus The orange sense LED flashes each time the device senses the patient s heartbeat Setup Indicators The setup indicators identify in which chamber s the device is setup to pace and in which chamber s the device is setup to sense a __ __ Vv Or A v Low Battery Indicator When the battery voltage is
72. g leads in a bipolar configuration using patient cables Medtronic Models 5433A and 5433V or surgical cables Medtronic Model 5832 or 5832S Figure 1 1 The Medtronic Model 5388 Dual Chamber Temporary Pacemaker and the Model 5433A or 5433V Patient Cable The device operates using a 9 volt alkaline or lithium battery installed in the battery drawer at the lower right side of the device Note The Model 5388 is a constant current device When it emits a pulse the current output is maintained at a constant value This value is set by the output control and does not vary 1 For atrial use only Overview 11 General Description Safety Features The Medtronic Model 5388 is designed to be reliable easy to operate and comfortable to hold Safety features of the Model 5388 include Cables with no exposed electrical connections Self test function Low Battery indicator Lock feature to prevent accidental change of parameters Safe two step operation to turn the device off Runaway rate protection Protection from defibrillation shock Continuous operation during battery replacement see page 105 Reversible battery polarity Electrostatic protection Minimized susceptibility to electromagnetic and magnetic interference and Rubber seals to cover the connector pin receptacles Package Contents See the enclosed card for a detailed list of package contents Check the package prior to use
73. han 110 ms Atrial At atrial pace DDD DDI AAI At atrial sense DDD DDI AAI At atrial refractory DDD DDI AAI sense At ventricular pace At ventricular sense Ventricular At atrial pacef A V Interval 125 ms 50 ms 0 ms A V Interval 75 ms 50 ms 0 ms 75 ms 50 ms 0 ms 125 ms 50 ms 0 ms 75 ms 50 ms 0 ms 20 ms 5 ms 10 ms 5388 Technical manual 104 Chapter 7 Device Specifications At ventricular pace At ventricular sense Rate Limit Nominal Values Mode Rate Output Amplitude Atrial Ventricular Pulse Width fixed Atrial Ventricular Sensitivity Atrial Ventricular AV Interval Sensed Paced PVARP Upper Rate Rapid Atrial Pacing Rate Dimensions Height Width Depth without dials Weight with battery Temperature Operating Storage without battery 125 ms 50 ms 0 ms 75 ms 50 ms 0 ms A crystal is used to set the pacing rate If the crystal rate deviates from the appropriate value the rate runaway protection circuit resets the device once If the crystal rate remains incorrect the rate runaway protection circuit turns the device off DDD 80 min 10 mA 10 mA 1 0 ms 1 5 ms 0 5 mV 2 0 mV 140 ms 170 ms 300 ms 110 mint 320 min 1 21 1 cm 8 3 in 15 8 1 cm 3 2 in 15 3 6 cm 1 4 in 15 510 g 18 oz maximum 17 C to 33 C 64 F to 92 F 9 40 C to 70 C 40 F to 158 F DOO for Emergency 20 mA for Emergency
74. hanism within the connector pin receptacles to hold connector pins securely in place consequently use the Model 5433A or 5438V patient cable whenever possible see Connecting the Pacing Lead System to the Model 5433A or 5433V Patient Cable on page 62 Caution The connector pins must be at least 12 67 mm 0 5 inches in length Caution It is recommended that exposed pins and wires be covered to prevent contact with each other or with electrically conductive or wet surfaces Remove each connector pin receptacle seal by gripping the rubber handle and pulling it away from the device Figure 4 6 Removing the connector pin receptacle seals 2 5388 Technical manual Push the connector pins into the holes on the connector block as shown see Figure 4 7 A Caution DO NOT insert the pins into the receptacle for the patient cable For bipolar systems Insert each pin into the proper receptacle marked and of the appropriate chamber marked A or V Bipolar lead systems may exhibit different threshold values depending on the polarity of the lead connections Preparation for use 65 Connector Setup Figure 4 7 Connecting connector pins directly to the Model 5388 Z Caution Bipolar lead systems are recommended over unipolar systems because they are less susceptible to electromagnetic interference see Bipolar Lead Systems and Unipolar Lead Systems on page 19 3 To remove t
75. he V SENSE LED to flash Atrial Refractory The two types of atrial refractory periods in the Model 5388 are Atrial Refractory Period which is initiated by an atrial sense or pace and Post Ventricular Atrial Refractory Period PVARP which is initiated by a ventricular sense or pace Ventricular Refractory The Model 5388 uses one type of ventricular refractory period Ventricular Refractory Period which is initiated by a ventricular pace or sense Reversion Operation This safety feature is designed to prevent inappropriate pacing therapy during continuous interference such as noise or arrhythmias When sensed events are continuously detected by the pacemaker the device reverts to predetermined modes until the interference stops 5388 Technical manual 52 Chapter 3 Functional Features This response occurs when refractory sensed events are continuously detected In single chamber pacing continuous refractory sensing will cause AAI to revert to AOO and VVI to revert to VOO In dual chamber pacing continuous refractory sensing in the atrium causes the device to inhibit atrial pacing pulses Continuous refractory sensing in the ventricle causes the device to pace asynchronously in the ventricle Ventricular Safety Pacing This feature is intended to prevent improper inhibition of ventricular pacing pulses if a non ventricular event e g cross talk noise is sensed by the ventricular lead This fe
76. he pins simply pull them out A Caution It is important to keep hands and gloves free of blood and body fluids while connecting or disconnecting the temporary pacing leads to the Model 5388 pacemaker to avoid contaminating difficult to clean areas 5388 Technical manual Overview 68 Indicators 69 Basic Operation 70 Connector Setup 77 Pacing Parameter Adjustments 79 Thresholds 83 Pacing Setup 88 RAP Rapid Atrial Pacing 90 Battery Replacement 92 Tables 94 User guide 5 68 Chapter 5 Overview Overview Features Single chamber pacing AOO VOO AAI VVI Dual chamber pacing DDD DDI DVI DOO Easy to view rate and output settings Easy to view setup indicators show in which chamber s the device is set to pace and or sense Pace and sense indicators show pacemaker interaction with the heart Low battery indicator indicates when to replace the battery Three dial operation provides therapy for most patient needs Rate dependent parameters rate adjustment automatically sets Upper Rate PVARP and A V Interval LOCK UNLOCK key safeguards against unintentional parameter changes Lower screen messages aid in device operation Menu screens for adjusting additional parameters including sensitivity rate dependent parameters for RAP Rapid Atrial Pacing and for directly selecting four modes DDD DVI DOO and VVI PAUSE key suspends pacin
77. i e grayed out on the menu screen The MENU key activates the lower screen and allows you to page through the four menus listed here see Figure 5 11 Menu 1 Menu 2 Menu 3 Menu M A Sensitivity V Sensitivity A V Interval A Tracking Upper Rate PVARP A V Interval SETTING AUTO MANUAL Rapid Atrial Pacing RAP Dial a Mode The SELECT key allows you to scroll through and select parameters displayed on each menu The MENU PARAMETER dial allows you to adjust the value of the selected parameter 5388 Technical manual 80 Chapter 5 Pacing Parameter Adjustments Sensitivity 5388 Technical manual DDD A Sensitivity V Sensitivity 20 10 A V Interval A Tracking PVARP A V Interval Menu 1 Pacing Parameters Press SELECT to DELIVER RAPID ATRIAL PACING Menu 2 Rate Based Pacing Parameters Menu 3 Rapid Atrial Pacing Figure 5 11 Lower Screen Menus Press SELECT new Mode Menu M Dial A Mode DDD Figure 5 12 Sensitivity User guide Pacing Parameter Adjustments To Adjust Atrial Ventricular Sensitivity 1 Press the MENU key until Menu 1 is displayed 2 Press the SELECT key until A SENSITIVITY or V SENSITIVITY is highlighted 3 Turn the MENU PARAMETER dial clockwise to increase sensitivity decrease numerical value counterclockwise to decrease sensitivity increase numerical value Turn
78. ice operation see page 33 Check the battery status at least twice daily Replace alkaline batteries at least once every week when the temporary pacemaker is in continuous use or when the low battery indicator is displayed When replacing the battery make sure the battery drawer is fully closed and latches in place with an audible click Inspect the contacts on the battery for visible signs of contamination prior to use Use of batteries with contamination on the contacts may result in erratic or no output Failure to ensure that the battery drawer is fully latched may result in a loss of power Continued device operation is NOT an indication that the battery drawer is properly latched Warnings precautions and adverse effects Precautions Pacing Leads and Cables Improper connection displacement or fracture of leads or cables may result in pacemaker system failure Inspect leads and cables for damage prior to each use Pacing System Adjustments Monitor the patient s ECG and blood pressure and keep defibrillation equipment on standby immediately available for emergency use during evaluation of stimulation and sensing thresholds pacemaker and pacing lead connections and adjustments and atrial high rate burst pacing therapy Bipolar Lead Systems Bipolar lead systems are recommended because they are less susceptible to electromagnetic interference Separation between the positive electrode and negative electrode of
79. ing RAP 45 91 nominal value 104 A atrial SENSITIVITY 39 nominal value 104 range increments 102 vs A OUTPUT 39 A TRACKING atrial tracking 41 89 DDI indicator 34 AAI mode definition 113 diagnostic diagrams 115 to 116 pacing setup table 94 Adverse effects 23 to 24 Amplitude inappropriate variance 18 AOO mode definition 113 diagnostic diagram 114 during RAP 45 pacing setup table 94 ASYNC 339 40 Asynchronous pacing 29 30 76 to 77 adjusting A V INTERVAL 30 caution 76 contraindication 13 diagnostic diagrams 114 118 EMERGENCY ASYNC key 29 76 to resume demand pacing 30 transition rules 53 Atrial arrhythmias 13 mapping 19 Atrial pacing asynchronous 77 blanking specifications 103 contraindicated 13 demand synchronous 75 mode transition 52 output dial 32 refractory ARF 51 reversion response 52 Atrial sensing contraindication 13 Attachment ring bails 48 61 fig 48 AUTO MANUAL 38 44 resetting rate dependent parameters 83 A V INTERVAL PAV 43 82 112 nominal value 104 ranges automatic and manual 43 102 safety pacing 52 timing symbol 111 timing violations vs RATE PVARP 54 A V Intervals paced A V interval see A V INTERVAL PAV sensed A V interval see SAV sensed A V interval B Backlight during lock 26 49 during low battery 26 Bails attachment 48 Base rate see RATE 102 Basic operation 70 to 77 off 70 to 71 on 70 to 71 Battery drawer 46 drawer release button 46 indicator 33 life 46 105 pre
80. is 10 mA nominal A SENSITIVITY is 0 5 mV nominal and pulse width is fixed at 1 0 ms V Ventricular OUTPUT The ventricular output ranges from 0 1 to 25 mA and is incremented as in Table 3 6 Table 3 6 Ventricular Output Increments Range Increment 0 1 to 0 4 mA 0 1 mA 0 4 to 1 0 mA 0 2 mA 1 0 to 5 mA 0 5 mA 5 to 25 mA 1 0 mA HIGH OUTPUT o mul OFF 01 F 10 20 25 V OUTPUT p 5 mA Lower Screen Functions Controls indicators and other features 37 Lower Screen Turn the dial clockwise to increase V OUTPUT Turn the dial counterclockwise to decrease or turn V OUTPUT to OFF The space above OFF fills in when V OUTPUT is turned OFF If V OUTPUT is set above 20 mA the line segments becomes taller and wider and an icon with the message HIGH OUTPUT appears above the taller segments When V OUTPUT is set to OFF both the ventricular output and the ventricular sensitivity are turned off i e there is no ventricular pacing or sensing If V OUTPUT is turned back on within approximately 7 seconds ventricular sensitivity is set to the previously selected value If V OUTPUT is OFF for longer than approximately 7 seconds ventricular sensitivity is set to the nominal value of 2 0 millivolts mV when V OUTPUT is turned back on Notes V SENSITIVITY can be adjusted using Menu 1 on the lower screen see V Ventricular SENSITIVITY on page 39 V OUTPUT is set to OFF when
81. isplayed in the lower screen Press the ON key twice if the asynchronous pacing message is not displayed in the lower screen After the first press of the ON key the asynchronous pacing message appears The device begins pacing synchronously at the following values Table 3 2 ON key synchronous values RATE current setting A OUTPUT and V OUTPUT current settings A SENSITIVITY 0 5 mV nominal V SENSITIVITY 2 0 mV nominal a f the corresponding OUTPUT is not OFF To turn the device off press the OFF key twice within 5 seconds After the first press a message appears in the lower screen telling the user to press OFF a second time to turn the device off The backlight turns off the screens blank and three LEDs illuminate then turn off when OFF is pressed the second time Note If the OFF key is pressed once when the upper screen parameters are locked The backlight illuminates and the upper screen unlocks allowing the parameters to be adjusted The lower screen displays the message telling the user to press OFF a second time Ignoring this message allows the device to continue pacing at the currently selected values EMERGENCY ASYNC Key pero ASYNC A single press of this key selects high output dual chamber asynchronous pacing DOO at any time including when the device is off Avoid accidentally activating the Emergency key Note Asynchronous pacing can also be reached by adjusting
82. justed to values from 80 to 230 min incremented as follows Table 3 7 Upper Rate increments Rate Increment 80 to 130 min 2 min 130 to 230 min 1 5 min 1 PVARP Post Ventricular Atrial Refractory Period This parameter sets the length of time following a ventricular event during which atrial sensing does not affect pacemaker timing PVARP is designed to prevent the device from responding to atrial sensing of ventricular activities such as far field R waves PVCs and retrograde conduction Unless manually adjusted this parameter is determined by the base pacing rate as shown in Table 3 7 Controls indicators and other features Lower Screen Table 3 8 Default PVARP settings Rate PVARP lt 100 min 1 300 ms 105 to 150 min 250 ms 155 to 180 min 1 225 ms gt 180 mins 200 ms The PVARP can be manually adjusted to any value from 150 ms to 500 ms in 10 ms increments that does not cause a timing violation see Timing Violations on page 53 Note If PVARP is set to 150 ms atrial events may not be sensed due to the tolerance allowed for blanking after a paced event see Blanking on page 103 A V Interval Displayed on both Menu 1 and Menu 2 the A V Interval after an atrial pace i e PAV or A V INTERVAL is the amount of time in ms milliseconds that the pacemaker waits between the delivery of an atrial pacing pulse and delivery of the corresponding ventricular pacing pulse Note Th
83. l manual User guide 87 Thresholds When capture is lost the ECG shows no heart response after the pulse as in the example shown here Figure 5 23 Loss of Ventricular Capture Stimulation Threshold The stimulation threshold is the minimum output mA needed to consistently capture the heart Monitor the patient s ECG and blood pressure as you follow the procedure to find the atrial and ventricular stimulation thresholds Safety Margin Lead maturation and drug therapy can affect the threshold To achieve consistent capture and accommodate a changing threshold it is important to provide at least a 2 1 safety margin Set A OUTPUT V OUTPUT to a value at least 2 to 3 times greater than the stimulation threshold value For example the appropriate output setting for a patient with a 1 0 mA threshold is 2 0 mA or greater To Find Atrial or Ventricular Stimulation Thresholds Atrial or Ventricular Figure 5 24 Increase Rate Decrease Output 1 Patient is connected to temporary pacemaker and is being monitored on ECG 2 Set RATE at least 10 min above patient s intrinsic rate 5388 Technical manual 88 Chapter 5 Pacing Setup This adjustment ensures pacing The pace indicator flashes 3 Decrease OUTPUT Slowly turn the OUTPUT dial counterclockwise until ECG shows loss of capture Pace and sense indicators flash intermittently Atrial or Ventricular Figure 5 25 Increase Output 4 Increase
84. levels of interference the Model 5388 may inhibit completely or revert to asynchronous operation pacing at the rate set by the RATE dial Warnings precautions and adverse effects 17 Warnings It is recommended that the device be set to an asynchronous mode at a rate higher than the patient s intrinsic rate when operated in the presence of strong electromagnetic interference EMI Sources of excessively strong EMI which may temporarily affect the operation of the Model 5388 include Electrosurgical equipment Diathermy equipment Some medical telemetry equipment when operated within one meter about three feet of the pacemaker Communication transmitters such as cellular phones walkie talkies and transmitters in emergency transport vehicles and Magnetic Resonance Imaging MRI equipment Atrial High Rate Burst Pacing Therapy Use of high rates in the atrium could result in high rate conduction to the ventricle Defibrillation equipment should be on standby immediately available during atrial high rate burst pacing therapy There is no ventricular back up pacing during delivery of atrial high rate burst pacing therapy Connecting the Lead System The patient cable should be connected to the temporary pacemaker before the lead s is connected to the patient cable s To prevent pacing into the vulnerable period of the T wave turn the temporary pacemaker ON and turn A and V OUTPUT down to the minimum am
85. loth moistened with water or 70 isopropyl alcohol Note Do not expose the unit to ethers acetone or chlorinated solvents as these may damage the case or labels Z Caution The Model 5388 must not be immersed in water or cleaning agents Severe damage to the device may occur Sterilization The Model 5388 can be exposed to ethylene oxide gas for disinfection Due to the variability among sterilizers precise sterilization instructions must come from the sterilizer manufacturer However the process should not exceed temperatures of 52 C 125 F nor pressures of 103 kPa 15 PSIG Use an acceptable method such as biological indicators for determining sterilizer effectiveness Z Caution Do not sterilize the Model 5388 by gamma irradiation and do not steam sterilize autoclave the device Model 5433A and 5433V Patient Cables 5388 Technical manual The Model 5433A and 5433V Patient Cables are supplied non sterile and must be sterilized by steam or ethylene oxide prior to use Cleaning Prior to sterilization the Model 5433A or 5433V Patient Cable should be cleaned thoroughly with a mild detergent or 70 isopropyl alcohol to remove all visible blood and body fluids The cables may be immersed for cleaning The cables must be thoroughly dried after cleaning Inspection and testing by a qualified technician should be done after cleaning to verify proper cable function Device maintenance Safety and Technical Checks St
86. low the low battery indicator appears and the backlights do not turn on When the low battery indicator appears during device operation the battery should be replaced as soon as possible The device operates adequately for approximately 24 hours after the low battery indicator first appears DDI Indicator This indicator appears while the device is pacing in the DDI mode When the device is in DDD mode dual chamber pacing and sensing manually turning off A Atrial TRACKING changes the mode to DDI 5388 Technical manual 70 Chapter 5 Basic Operation Lock Indicator The padlock icon appears when the three upper dials are locked indicating that RATE and OUTPUT cannot be adjusted If you turn the RATE A OUTPUT or V OUTPUT dial the upper screen displays another padlock symbol along with a flashing key symbol The lower screen displays a message that tells you how to unlock the upper dials for RATE and OUTPUT Basic Operation On Off T o o amp Medtronic 5388 Dual Chamber Temporary Pacemaker Figure 5 2 On Off When you press the ON key the pacemaker performs a power on self test that lasts about four seconds Ifthe battery voltage is low the battery indicator appears and the backlights do not turn on Ifthe device fails the self test the device remains on but does not pace Ifthe device passes the self test the upper and lower screens initialize the backlights turn on and dual chambe
87. mA increments 5 0 25 mA in 1 0 mA increments Pulse Width fixed Atrial 1 0 ms 10 Ventricular 1 5 ms 10 Sensitivity Atrial ASYNC 0 4 0 8 mV in 0 1 mV increments 0 4 10 mV 0 3 mV or 25 0 8 2 0 mV in 0 2 mV increments 2 0 3 0 mV in 0 5 mV increments 3 0 10 mV in 1 0 mV increments Ventricular ASYNC 0 8 1 0 mV in 0 2 mV increments 0 8 20 mV 0 3 mV or 25 1 0 3 0 mV in 0 5 mV increments 3 0 10 mV in 1 0 mV increments 10 20 mV in 2 0 mV increments A V Interval 5388 Technical manual Specifications 103 Device Specifications Safety Pace Auto 50 250 ms 5 ms or 5 PAV 15 ms or 15 SAV Manual 20 300 ms 5 ms or 5 Refractory Period Atrial At atrial event 250 ms 10 At ventricular event Auto PVARP all values are 10 Manual Ventricular 250 ms 10 Upper Rate Auto base rate 30 min 1 10 Manual 80 230 min 10 Paced A V PAV 300 1 67 x RATE in min Sensed A V SAV PAV 30 in 10 ms increments Rate range PVARP lt 100 min 300 ms 105 150 min 1 250 ms 155 180 min 1 225 ms gt 180 min 1 200 ms 150 500 ms 10 in 10 ms increments minimum of 110 min 80 130 min in 2 0 min 1 increments 130 230 min in 5 0 min increments Occurs 110 ms after atrial pace if A V interval is set to more than 110 ms or at programmed A V interval if A V interval is set to less Blanking t
88. meters RATE A OUTPUT and V OUTPUT Note The ON OFF EMERGENCY ASYNC PAUSE and MENU keys do not lock When the upper screen is locked turning the upper screen dials does not change the upper screen parameter values The upper screen parameters will lock 60 seconds after the last parameter adjustment has been made or When the key is pressed When the upper screen is locked the backlight turns off and a padlock amp appears in the upper right corner of the upper screen If the upper dials are turned while the parameters are locked the remains on the backlight illuminates and a anda flashing appear in the center of the upper screen The lower screen displays the message to the left To unlock the upper parameters press the key If no action is taken to unlock the upper screen and no other dial movements occur the icons in the center of the upper screen disappear the lower screen blanks and the backlight turns off When the upper screen unlocks all lock indicators on the upper screen disappear the backlight illuminates and the RATE A OUTPUT and V OUTPUT values can be changed again by turning the upper dials Notes When the upper screen unlocks the backlight will not illuminate if the low battery indicator is on Ifthe ON OFF EMERGENCY ASYNC PAUSE or MENU key is pressed while the upper screen is locked the upper screen parameters will unlock However changes i
89. n device operation and parameters may occur depending upon which key was pressed see page 28 through page 31 5388 Technical manual 49 50 Chapter 3 Functional Features Self test 5388 Technical manual When the Model 5388 is turned on the device takes approximately four seconds to complete the power on self test and initialize the screens The self test includes a check of the SELECT OFF PAUSE MENU and LOCK keys and critical internal circuits The PACE and SENSE LEDS light one at a time during the Power on Self test During the self test information in the display buffer from the previous use of the device will appear on the upper display This information is cleared during screen initialization and nominal values are restored Note Pressing a key while the self test is in process can cause the Model 5388 to fail the self test and display error code 0004 The device may interpret the pressed key as being stuck and therefore malfunctioning If a key is pressed during the self test remove and re insert the battery to clear the error code If the self test fails again remove the battery and return the device to Medtronic for service see the addresses on the back cover of the manual During screen initialization the low battery indicator may appear This does not indicate that the battery is low unless the backlight does not turn on and the indicator remains visible during device operation Sensing
90. o disconnect the patient cable from the device press the connector release button on the patient cable plug see Figure 4 4 Figure 4 4 Disconnecting the Model 5433A or Model 5433V Patient Cable from the Model 5388 Temporary Pacemaker 2 Gently pull the plug from the receptacle A Caution It is important to keep hands and gloves free of blood and body fluids while connecting or disconnecting the Model 5433A or 5433V patient cable and or pacing leads to the Model 5388 pacemaker to avoid contaminating difficult to clean areas Refer to the applicable patient cable technical manual for more information Connecting the Pacing Lead System to the Model 5433A or 5433V Patient Cable Note Carefully inspect the leads for visible signs of wear or damage 1 Loosen the patient cable connector knobs by twisting each knob counterclockwise until resistance is felt 2 Insert the lead connector pins into the patient cable receptacles as shown see Figure 4 5 It is important to connect each lead system to the appropriate patient cable atrial or ventricular 5388 Technical manual Preparation for use 63 Connector Setup For bipolar systems Insert each connector pin into the appropriate receptacle marked and Bipolar lead systems may exhibit different threshold values depending on the polarity of the lead connections Finger tighten each terminal knob clockwise until snug Gently pull on each lead conductor to verify
91. ot be lit The atrial sense indicator will light each time there is an atrial event sensed inside or outside the refractory period The pacemaker is essentially in VVI mode Note A cancelled atrial pace will not start a ventricular safety pace window The device behaves in DDI mode as in DDD mode in all aspects except the following the pacing in the ventricle does not track atrial sensed events This mode is used when physiological pacing is desired but the patient is prone to atrial arrhythmia 5388 Technical manual 138 Appendix A Dual Chamber Modes Note In DDI mode UPPER RATE is not applicable DDI Cancelled A Pace o Start Stop VSP gt vsP Timer Timer AV Interval 170 ms Ventricular Refractory 250 ms VA Interval 580 ms Blanking After Pace 175 ms Base Rate Interval 750 ms Blanking After Sense 125 ms If the non refractory atrial event is detected in the V A interval the pacemaker will Start the PAAB after sense period which starts with the atrial sensed event and continues until the delivery of the ventricular pace and a Not start the SAV interval At the end of V A interval the pacemaker will Cancel the scheduled atrial pacing stimulus and Start the A V INTERVAL 5388 Technical manual Index Symbols 1 39 40 Numerics 2 1 safety margin sensing threshold 84 stimulation threshold 87 3 letter code NBG definition 95 A A atrial OUTPUT 36 dur
92. output is derated an additional 5 the specification for sensitivity is derated an additional 7 and the specification for rate is not derated h Typical is the average minimum value at 24 hours after the low battery indicator first appears i Medtronic does not recommend replacing the battery while the pacemaker is connected to a patient Device Accessories Listed below are accessories for use with the Model 5388 Temporary Pacemaker Contact your local Medtronic representative to obtain them Model 5441 Disposable Cover Model 5409 Disposable Pouch Model 5433 A V Cable 5388 Technical manual Warranty information 8 Special Notices 108 108 Chapter 8 Special Notices Special Notices Special Notice for the Medtronic Model 5388 Temporary Pacemaker Use of prior Medtronic Temporary Pacemakers has met with some success in the treatment of certain heart disorders including heart block and heart arrhythmias However Medtronic makes no warranty that the Model 5388 Temporary Pacemaker will efficiently restore adequate cardiac function for all patients For information regarding common causes of pacing difficulty consult other portions of the manual Special Notice for the Medtronic Model 5433A or Model 5433V Patient Cable Cables may be easily damaged by improper handling or use due to their unavoidably fragile character which is dictated by the unusual requirements of their application Consequently no repr
93. pacemaker set the sensitivity dial to one half the mV value of the patient s sensitivity threshold see Sensing Threshold on page 84 This setting will provide a 2x safety margin to ensure proper sensing Amore sensitive setting may be chosen to provide a greater safety margin However be aware that setting the sensitivity value too low too sensitive could result in inappropriate sensing of far field signals e g sensing of R or T waves on the atrial channel or P waves on the ventricular channel leading to inappropriate inhibition of pacing pulses High Output and Maximum Sensitivity Although the pacemaker contains a safety pacing feature that prevents inappropriate inhibition of ventricular pacing due to far field sensing the simultaneous use of high output and maximum sensitivity i e the lowest mV value should be avoided Electrostatic Discharge ESD 5388 Technical manual The pacing lead s provides a low impedance pathway to the heart Therefore it is recommended that attending health care professionals discharge any static electricity by touching a large metal or conductive grounded surface prior to touching the patient the cable the leads or the pacemaker Also neutralize any static electricity from the patient by touching the patient away from i e distal to the leads Warnings precautions and adverse effects 21 Precautions Retrograde Conduction If retrograde P waves are being sensed outside
94. plitude before connecting the temporary pacemaker to the patient s lead system Determine sensing thresholds see Sensing Threshold on page 84 before turning A and V OUTPUT up to threshold levels Handling Implanted Leads When handling implanted leads temporary or permanent the terminal pins or exposed metal must not be touched nor be allowed to contact electrically conductive or wet surfaces 5388 Technical manual 18 Chapter 2 Precautions Precautions Random Failures Batteries 5388 Technical manual The physician should be aware that operational failure of the Model 5388 temporary pacemaker can occur as the result of battery depletion mishandling or random component failure Possible operational failures of the Model 5388 can include No output or erratic output No sensing or erratic sensing False indicator light signals Inappropriate variance of rate output pulse width or output amplitude Reversion to asynchronous pacing and Loss of control of rate output sensitivity or power If loss of control of rate output sensitivity or power occurs and it is not due to a low battery disconnect the device from the patient and return it to Medtronic for service Use of batteries with different physical dimensions from that of the recommended batteries may result in erratic or no pacing output Replace the battery for each new patient and when the low battery indicator appears during dev
95. r access Menu 1 and adjust A SENSITIVITY and or V SENSITIVITY see page 39 This key interrupts pacing and sensing to allow the user to view the patient s intrinsic rhythm A Caution Use the PAUSE key with care since the patient is without pacing support for a maximum of 10 seconds at a time when PAUSE is pressed and held PACEMAKER PAUSE Caution Pacing and Sensing are suspended MENU Key SELECT Key SELECT Rate Dial Controls indicators and other features Controls When the PAUSE key is pressed and held the device stops pacing and sensing for a maximum of 10 seconds The message to the left appears in the lower screen reminding the user that pacemaker operation is suspended To suspend device operation for up to another 10 seconds release then press and hold the PAUSE key again Repeat this as many times as required When the PAUSE key is released the device first senses then resumes pacing at the programmed parameters The device also senses before pacing if PAUSE times out at 10 seconds If the PAUSE key is pressed when the upper screen is locked pacing and sensing are suspended as described above and the upper screen parameters unlock The MENU key is used to activate and page through the Menus on the lower screen from Menu 1 to Menu M If pressed when the upper screen is locked the Menu screen becomes active and the upper screen parameters unlock The SELECT key is only active
96. r pacing and sensing begin at these nominal values 5388 Technical manual User guide 71 Basic Operation Table 5 1 Nominal Values at Power On RATE 80 min A V INTERVAL 170 ms A OUTPUT 10 mA A SENSITIVITY 0 5mV V OUTPUT 10 mA V SENSITIVITY 2 0 mV UPPER RATE 110 min Note During the self test information in the display buffer from the previous use of the device will appear on the upper display This information is cleared during screen initialization and nominal values are restored To Turn Device On Press the ON key Note Pressing the EMERGENCY key also turns the device on To Turn Device Off Press the OFF key twice within five seconds Note After you press OFF the first time the following message appears on the lower screen as a reminder to press the OFF key a second time within five seconds To SHUT DOWN Press again Figure 5 3 Device Shut Down Message Emergency Pacing When you press the EMERGENCY key the pacemaker initiates high output dual chamber asynchronous pacing whether the pacemaker is on or off Pacing occurs at these parameter values 5388 Technical manual 72 Chapter 5 Basic Operation Lock Unlock 5388 Technical manual Table 5 2 Emergency Pacing Values RATE Current setting A V INTERVAL or 80 min if device is off when EMERGENCY key is pressed A OUTPUT 20mA A SENSITIVITY V OUTPUT 25 mA V SENSITIVITY Current setting or 170 ms if device is off
97. r sense periods Note This action forces asynchronous atrial pacing in the presence of continuous noise reversion behavior If the atrial event occurs within the atrial blanking period it is not sensed and no action is taken vvi Programmed Base Rate Programmed Base Rate gt Restarted o Base Rate Interval 750 ms Ventricular Refractory 250 ms Blanking After Pace 175 ms Blankina After Sense 125 ms If the base RATE interval times out the pacemaker will Restart the base RATE interval Start the ventricular refractory and blanking after pace periods and Deliver a pacing stimulus in the ventricle 5388 Technical manual Pacemaker diagnostic diagrams 117 Single Chamber Modes AAN e PRS Noise Base Rate Programmed kk Base Rate Restarted VVI o 4S GGG D Base Rate Interval 750 ms Ventricular Refractory 250 ms Blanking After Pace 175 ms Blanking After Sense 125 ms If a detected ventricular event occurs outside of the ventricular refractory period the pacemaker will Restart the base RATE interval and Start the ventricular refractory and blanking after sense periods If a detected ventricular event occurs within the ventricular refractory period the pacemaker will Not restart the base RATE interval but Restart the ventricular refractory and blanking after sense periods Note This action forces asynchronous ventricular
98. riod outside of blanking and the V A interval has not timed out and the event is recognized as a PVC the pacemaker will Restart the PVARP at a value of 400 ms or to the programmed PVARP if set longer than 400 ms because the event is recognized as a PVC Restart the PVAB after sense period m Restart the PVVR and PVVB after sense periods Restart the UPPER RATE interval but Not restart the V A interval Note PVARP is extended only during the cycle in which the PVC is recognized Otherwise it goes back to the programmed value 5388 Technical manual DDI Mode Pacemaker diagnostic diagrams 137 Dual Chamber Modes DDD Cancelled A pace Start Stop Upper Rate lt Upper Rate Interval Interval AV Interval 170 ms PVARP 300 ms VA Interval 580 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 545 ms Blanking After Sense 125 ms If atrial events are sensed in successive atrial refractory periods atrial tachycardia with a cycle time of about 100 to 250 ms the pacemaker will Cancel the scheduled atrial pacing stimulus at the end of the V A interval to prevent pacing into an atrial tachycardia and potentially converting it into atrial fibrillation and Pace in the ventricle in the demand mode at the programmed base RATE Note Since the atrial pacing stimulus is inhibited the atrial pace indicator will n
99. rogrammed to more than 110 ms then when a ventricular sensed event occurs inside the ventricular safety pace window the pacemaker will Start PVVR and PVVB after sense and Schedule a safety pacing stimulus in the ventricle 110 ms after the atrial event After the 110 ms period the pacemaker will Start the V A interval m Restart PVVR and PVVB after pace and Deliver a pacing stimulus in the ventricle Note The response is similar if the ventricular sensed event is a refractory sense inside the ventricular safety pace window 5388 Technical manual Pacemaker diagnostic diagrams 123 Dual Chamber Modes DVI A DVI V T T Ox Sense Due To Crosstalk AV 80 Interval ms AV a 80 Interval ms Start Stop VSP lt a VSP Timer Timer 110 ms VA Interval VA Interval 670 ms 670 ms AV Interval 80 ms Ventricular Refractory 250 ms VA Interval 670 ms Blanking After Pace 175 ms Base Rate Interval 750 ms Blanking After Sense 125 ms If the A V INTERVAL is programmed to less than 110 ms then when a ventricular sensed event occurs inside the ventricular safety pace window the pacemaker will Start the PVVR and PVVB after sense periods At the end of A V INTERVAL the pacemaker will Deliver a pacing stimulus in the ventricle Start the V A interval and Restart PVVR and PVVB after pace Note The response is similar if the ventricular sensed event is a refractory sense inside
100. s for the direct connection of heartwires or leads from 0 38 mm to 2 28 mm 0 015 inch to 0 09 inch in diameter and from 12 67 mm to 22 8 mm 0 5 inch to 0 9 inch in length These connector pin receptacles are covered with removable rubber seals to minimize contamination Chamber designations are marked A for atrium and V for ventricle The receptacles are also color coded blue for atrium and white for ventricle Figure 3 2 The Model 5388 Connector Block 5388 Technical manual 47 48 Chapter 3 Physical Features Caution The connector pin receptacles are to be used in emergency situations only They have no locking mechanism so the retention force within the receptacles varies with pin diameter and length Attachment Ring and Bails The attachment ring and bails are located on the back of the device The ring is used to attach the device to an IV pole The bails should only be used to temporarily secure the device to the patient or bed rail when the patient is in transit When not in use the ring and the bails fold flat against the back of the device 1 Ring 2 Bails Figure 3 3 Ring and Bails on the Back Side of the Model 5388 5388 Technical manual Controls indicators and other features Functional Features Functional Features Lock Feature To UNLOCK RATE A OUTPUT and V OUTPUT Press This safety feature is intended to prevent inadvertent adjustment of the upper screen para
101. s shown on the diagram inside the battery drawer Note Inspect battery terminals for contamination Use of replacement batteries with contaminated terminals can result in device shutdown Note The device works with the battery polarity reversed Close battery drawer Make sure it clicks Note Failure to fully close the battery drawer can result in the battery drawer opening and the pacemaker shutting down Press the ON key to start power on self test The pace sense and battery indicators flash briefly If the device passes the power on self test dual chamber demand pacing and sensing begin 5388 Technical manual 94 Chapter 5 Tables jenuew jed UYd9 y Ul SOUNyee JOUIO PUL S1O EOIPUT S O4 UOD 0 JEJ9Y PePUELULUODEJ JOU 1e INQ sepow siqisseooe ae COO pue dya uolNeD e HO uO VN VN VN VN VN VN Buryoeil y 18S E uO uO uO ONASV uO VN ONASV VN AyAnisues A uO uO ONASV ONASV VN uO VN ONASV AWAIISUaS y AUAIISUES 18S Z uO uO uO uO uO HO uO HO indjno A uO uO uO uO HO uO HO uO indino V yNdynO 38S suoljonsjsu mv lA laty ll a yl la layli layla a lvy vil Ta E wyl 3SNIS_39Va SsNas ova ass ova sswas govd sswas govd Ssnas sova SNIS Ovd 3SNaS Ova ssoyeoipu dnyas Iaa aaa IAQ ooa IAA IVV OOA eOOV aiqel dnjas Buloed 88EG IPPON E G e1qeL s jqe L 5388 Technical manual User guide 95 Tables uoN O lend aqd Huloed syqiyuj
102. sensed before the VSP timer times out the pacemaker will Start the PVVB after sense period Continue the PVAB after sense period and Schedule a safety pacing stimulus in the ventricle 110 ms after the atrial event Then when the ventricular safety pace period times out 110 ms later the pacemaker will Start the PVARP and PVAB after pace period Start the PVVR and PVVB after pace periods Start the UPPER RATE interval Start the V A interval and Deliver a pacing stimulus in the ventricle Note The response is similar if the ventricular sensed event is a refractory sense inside the ventricular safety pace window Pacemaker diagnostic diagrams 133 Dual Chamber Modes DDD Z Sense Due 2 To Crosstalk AV q 80 Interval ms AV Interval 80 ms PVARP 300 ms VA Interval 670 ms Ventricular Refractory 250 ms Base Rate Interval 750 ms Blanking After Pace 175 ms Upper Rate Interval 545 ms Blanking After Sense 125 ms When the A V INTERVAL is programmed to less than 110 ms and when a detected ventricular event occurs and the A V INTERVAL has not timed out the pacemaker will Start the PVVB after sense period Continue the PVAB after sense period and Schedule a pacing stimulus in the ventricle at the end of A V INTERVAL Then when the A V INTERVAL does time out the pacemaker will Start the PVVR and PVVB after pace period Start the PVARP and PVAB a
103. shes each time the device delivers a pacing pulse on the atrial channel The green LED next to the V flashes each time the device delivers a pacing pulse on the ventricular channel Note These LEDs indicate delivery of a pacing pulse but do not necessarily indicate that the pacing pulse has initiated cardiac stimulation SENSE LEDs There are two orange LEDs at the top of the device marked SENSE Controls indicators and other features 33 Upper Screen The orange LED next to the A illuminates when events are sensed on the atrial channel The A SENSE LED flashes when the device detects events inside and outside the atrial refractory period The orange LED next to the V illuminates when events are sensed on the ventricular channel The V SENSE LED flashes only when the device detects an event outside the refractory period Upper Screen The upper screen displays Indicators Low Battery Indicator Pacemaker Setup Indicators Lock Indicators DDI Indicator Parameters for basic pacing RATE A Atrial OUTPUT V Ventricular OUTPUT When the device is off the upper screen is blank except for the number lines which are painted on the glass When the device is on the numerical and graphical values for the parameters appear and the screen is illuminated by a backlight The backlight remains on while parameters are adjusted but is turned off 60 seconds after the last adjustment even
104. sitivity on page 80 3 Turn the A OUTPUT and V OUTPUT dials to adjust output to appropriate values Resulting Setup Indicators A v A V To Set To Demand Pacing In The Atrium 1 Verify the Setup Indicators are A v A Vv These indicate the device is setup to pace and sense in both chambers 5388 Technical manual 76 Chapter 5 Basic Operation 2 Turn the V OUTPUT dial counterclockwise until OFF is highlighted Pacing and sensing occur only in the atrium Resulting Setup Indicators A A To Set To Demand Pacing In The Ventricle 1 Verify the Setup Indicators are A V A V These indicate the device is setup to pace and sense in both chambers 2 Turn the A OUTPUT dial counterclockwise until OFF is highlighted Pacing and sensing occur only in the ventricle Resulting Setup Indicators vV V Note When A OUTPUT or V OUTPUT is turned back on sensitivity returns to the nominal value Asynchronous Pacing 5388 Technical manual Patients best suited for asynchronous non sensing modes have m An intrinsic rate consistently below the pacing rate No intrinsic activity A Caution Because it may compete with the intrinsic activity of the heart asynchronous pacing may result in tachyarrhythmia Use caution when setting the device to asynchronous modes Pressing the EMERGENCY key immediately initiates dual chamber asynchronous pacing To quickly set the device to single chamber asynchronous pacing pre
105. ss self test at power up Front panel dials keys and displays Inspection of all connections and cables Examination of warnings 5388 Technical manual 99 100 Chapter 6 Service Practical Measurements Service 5388 Technical manual Rate Test Rapid Atrial Pacing Output Sensitivity Off Current Drain 150 microamp maximum On Current Drain with backlight and lower screen off 2 95 milliamp max when measured away from pacing peaks Leakage and Patient Auxiliary Current Measurements per IEC 601 2 31 paragraph 19 Caution Do not open the device as this will void the warranty Medtronic does not recommend field repair of the device For service or repair contact your local Medtronic representative at the appropriate address or telephone number listed on the back cover Medtronic employs highly trained representatives and engineers located throughout the world to serve you and upon request to provide training to qualified hospital personnel in the use of Medtronic products Medtronic also maintains a professional staff to provide technical consultation to product users For medical consultation Medtronic can often refer product users to outside medical consultants with appropriate expertise For more information contact your local Medtronic representative or call or write Medtronic at the appropriate address or telephone number listed on the back cover The Medtronic Model 5388 Tempor
106. ss the EMERGENCY key and turn either A OUTPUT or V OUTPUT to OFF To Set To Dual Chamber Asynchronous Pacing 1 Press the EMERGENCY key The ASYNCHRONOUS PACING message appears 2 Adjust A OUTPUT and V OUTPUT to provide adequate safety margins to assure capture Pacing occurs in the atrium and ventricle No sensing occurs Resulting Setup Indicators a v User guide 77 Connector Setup To Set To Asynchronous Pacing In The Atrium 1 3 Press the EMERGENCY key The ASYNCHRONOUS PACING message appears Turn the V OUTPUT dial counterclockwise until OFF is highlighted Pacing occurs only in the atrium No sensing occurs Adjust A OUTPUT to provide an adequate safety margin Resulting Setup Indicators A To Set To Asynchronous Pacing In The Ventricle 1 3 Press the EMERGENCY key The ASYNCHRONOUS PACING message appears Turn the A OUTPUT dial counterclockwise until OFF is highlighted Pacing occurs only in the ventricle No sensing occurs Adjust V OUTPUT to provide an adequate safety margin Resulting Setup Indicators __v Connector Setup Model 5832 Model 5433A 5433V Figure 5 8 Cables Notes Connect the cable to the temporary pacemaker before connecting the lead system to the cable 5388 Technical manual 78 Chapter 5 Connector Setup m Do not connect the Model 5388 to the lead system if the Model 5388 is turned on and is operating at an output amplitude that could
107. st pacing may result in the onset of tachycardia acceleration of an existing tachycardia or fibrillation Application of temporary atrial high rate burst pacing should be performed in a carefully monitored and controlled patient environment Monitor the patient s ECG and blood pressure and keep defibrillation equipment on standby immediately available for emergency use Dual Chamber Modes In the DVI DDI and DDD modes the ventricular sense amplifier may sense the atrial pacing pulse Reducing the atrial amplitude the ventricular sensitivity and or repositioning the electrodes may be necessary to avoid this situation 5388 Technical manual 24 Chapter 2 Adverse Effects Safety Margins Lead Systems 5388 Technical manual Determine an adequate safety margin for sensing and pacing in both the ventricle and atrium see Chapter 5 Failure to do so may result in inappropriate pacing Potential adverse effects related to the use of pacing lead systems used in conjunction with the Model 5388 temporary pacemaker include but are not limited to Inappropriate lead connections Inadvertent disconnection of the lead system Lead fracture or displacement causing intermittent or complete loss of capture and or sensing and Perforation and tamponade Other potential adverse effects related to the use of any implanted lead system include but are not limited to Myocardial irritability resulting in fibrillation
108. synchronous modes AOO and VOO emit a pacing pulse into one chamber either the atrium AOO or the ventricle VOO at the end of the base rate interval regardless of any intrinsic activity When pacing in the AOO mode the pacemaker will pace the atrium asynchronously at the programmed base RATE The atrial and ventricular channels are continuously blanked When pacing in the VOO mode the pacemaker will pace the ventricle asynchronously at the programmed base RATE The atrial and ventricular channels are continuously blanked AAI and VVI Modes In the inhibited or demand modes AAI and VVI when an intrinsic beat is sensed outside of a refractory period and before timeout of the base rate interval the pacemaker inhibits the output pulse If no intrinsic beat is sensed before the timeout of the base rate a pacing stimulus is delivered When pacing in the AAI mode the pacemaker will pace the atrium at the programmed base RATE in the absence of detected atrial activity The ventricular channel is continuously blanked When pacing in the VVI mode the pacemaker will pace the ventricle at the programmed base RATE in the absence of detected ventricular activity The atrial channel is continuously blanked 5388 Technical manual 114 Appendix A Single Chamber Modes AOO Intrinsic Atrial Activity Programmed p Base Rate A A00 V When the base RATE interval times out the pacemaker will Restart the b
109. the rate dependent automatic Post Ventricular Atrial Refractory Period PVARP setting manually increase the PVARP until the retrograde waves fall inside the PVARP Failure to follow this procedure may lead to a pacemaker mediated tachycardia PMT Termination of Pacing Abrupt termination of pacing stimuli may result in intervals of asystole before an intrinsic rhythm is reestablished Prior to terminating pacing set the pacemaker to a demand mode then gradually reduce the pacing rate below the patient s intrinsic rate PAUSE Key Use the PAUSE key with care since the patient is without pacing support for a maximum of 10 seconds at a time when PAUSE is pressed and held A V Interval Programming long A V intervals may result in pacing the ventricle during the vulnerable period of ventricular repolarization thus precipitating ventricular arrhythmias in unstable patients EMERGENCY Key Use the EMERGENCY key only when high output asynchronous pacing DOO is needed When the EMERGENCY key is pressed the emergency pacing mode is entered and remains in effect until the emergency pacing mode is deactivated Press the ON key to deactivate emergency pacing mode For more information see EMERGENCY ASYNC Key on page 29 5388 Technical manual 22 Chapter 2 Environmental Precautions Environmental Precautions 5388 Technical manual The Model 5388 has been carefully designed and tested to ensure reliability during
110. the SELECT key is pressed for RAP delivery see Menu 3 Rapid Atrial Pacing on page 44 V OUTPUT returns to its previous value when SELECT is released At power up V OUTPUT is 10 mA nominal V SENSITIVITY is 2 0 mV nominal and pulse width is fixed at 1 5 ms The Lower Screen has two functions To display warnings and instructions and To provide access to the four Menus MENU 1 Allows adjustment of A Atrial and V Ventricular SENSITIVITY the A V INTERVAL and A Atrial TRACKING MENU 2 Allows adjustment to the rate dependent parameters UPPER RATE PVARP A V INTERVAL and to a feature called SETTING MENU 3 Allows access to Rapid Atrial Pacing RAP 5388 Technical manual 38 Chapter 3 Lower Screen Controls Status Line Menu 1 5388 Technical manual MENU M DIAL A MODE allows direct selection of DDD DVI DOO or VVI mode The controls for the Menus and their parameters are MENU PARAMETER dial SELECT key and MENU key While the Menus in the lower screen are in use the upper screen remains unlocked and the upper screen parameters may be adjusted at any time using the corresponding dial Press c to exit the Menus The NASPE and British Pacing and Electrophysiology Group NBG code is displayed at the top of every Menu and is updated when parameter adjustments cause a mode change see page 95 and Pacemaker diagnostic diagrams on page 109 for information
111. the ventricular safety pace window 5388 Technical manual 124 Appendix A Dual Chamber Modes DVI l Noise A DVI Vv x o BOGE SS ES Safety Pace AV Interval 170 ms Ventricular Refractory 250 ms VA Interval 580 ms Ventricular Blanking After Pace 175 ms Base Rate Interval 750 ms Ventricular Blanking After Sense 125 ms If the detected events occur within successive ventricular refractory periods the pacemaker will m Restart the PVVR and PVVB after sense periods and Not restart the V A interval m Asynchronously pace in both chambers The rate is equal to the V A interval plus 110 ms if the A V INTERVAL is set longer than the ventricular safety window 110 ms The rate will be shorter than the programmed base RATE The rate is equal to the programmed base RATE if the A V INTERVAL is set shorter than 110 ms The pacemaker is essentially in DOO mode DDD Mode This mode provides a P wave synchronous rate response with A V sequential pacing Intrinsic activity in the atrium and ventricle inhibits output stimuli and restarts certain timers Without atrial events within certain periods the pacemaker delivers a pacing stimulus to the atrium at the end of the V A interval which is equal to the programmed base RATE minus the programmed A V INTERVAL 5388 Technical manual Pacemaker diagnostic diagrams Dual Chamber Modes Without ventricular activity during certain periods the pac
112. tion Cardioversion Defibrillation discharges up to 360 watt seconds have not affected the Model 5388 in laboratory tests However for maximum safety it is recommended that paddles be placed at least 15 cm 6 inches away from the Model 5388 or the lead system Whenever possible for the safety of the patient disconnect the pacemaker from the lead system before defibrillating or cardioverting A relatively low resistance pathway exists between the positive and negative electrodes of the implanted lead system During defibrillation a large current could flow across this pathway causing myocardial damage Line powered Equipment An implanted lead or lead with extension cable constitutes a direct low resistance current pathway to the myocardium Due to the danger of tachyarrhythmias resulting from alternating current leakage extreme caution must be taken to properly ground all line powered equipment used on or in the vicinity of the patient Electrosurgical Units Cautery Electrosurgical units can cause tachyarrhythmias by inducing current on the leads and thus should never be used within 15 cm 6 inches of the pacemaker lead system Electromagnetic Interference EMl 5388 Technical manual Pacemakers operating in the demand mode respond to intracardiac potentials with magnitudes of a few millivolts This level of sensitivity makes the pacemaker inherently sensitive to some external fields In the presence of excessive
113. tput counterclockwise to decrease atrial output or set to OFF Atrial output range 0 1 mA to 20 mA Demand Pacing User guide 75 Basic Operation To Adjust Ventricular Output Turn the V OUTPUT dial clockwise to increase ventricular output counterclockwise to decrease ventricular output or set to OFF Ventricular output range 0 1 mA to 25 mA Note When V OUTPUT is set higher than 20 mA the bar size on the segmented line graph gets taller and thicker and the HIGH OUTPUT icon appears During demand synchronous pacing output is inhibited when the pacemaker senses intrinsic activity This minimizes competition between the paced rhythm and the intrinsic activity of the heart Note Be sure to determine sensitivity thresholds see page 83 or asychronous pacing may occur When the device is off pressing the ON key immediately initiates dual chamber demand pacing To quickly change from dual chamber to single chamber demand pacing set either A OUTPUT or V OUTPUT to OFF To Set To Dual Chamber Demand Pacing 1 Check the Setup Indicators If they are A V A V skip to step 3 as the device is already setup to pace and sense in both chambers 2 Turn A OUTPUT and V OUTPUT on If sensing is off in both chambers press ON twice to resume dual chamber demand pacing Pacing and sensing occurs in both chambers A SENSITIVITY is 0 5 mV and V SENSITIVITY is 2 0 mV If sensing is off in only one chamber refer to Sen
114. wer Screen The RAP rate is displayed numerically and graphically and can be adjusted between or during RAP delivery by turning the MENU PARAMETER dial When SELECT is pressed and held the device waits a maximum of two pacing cycles then begins pacing asynchronously in the atrium AOO at the selected RAP rate When SELECT is released the device stops delivering RAP and resumes operation at the non RAP settings within three seconds The device senses before pacing when resuming operation in a demand mode A OUTPUT may be adjusted during RAP delivery VOUTPUT is OFF and not accessible during RAP delivery V OUTPUT returns to its previous value when SELECT is released Notes f the device should continue to deliver RAP after the SELECT key is released press OFF or EMERGENCY to stop RAP Return the device for service f A OUTPUT is OFF prior to RAP delivery A OUTPUT is set to 10 mA when SELECT is pressed In this case AOUTPUT may be adjusted during RAP delivery but returns to OFF when SELECT is released The backlight turns off 60 seconds after the last adjustment or RAP delivery but the upper screen parameters do not lock and Menu 3 does not blank Each time an upper dial or the SELECT key is used the backlight turns on again The upper screen parameters do not lock and the lower screen does not blank until five minutes after the last adjustment or RAP delivery To exit Menu 3 RAP before five minutes have p
115. y V Sensitivity A V Interval 0 5mv 2 0mv 170ms Menu 2 Controls indicators and other features 41 Lower Screen When A TRACKING is OFF DDI mode an atrial sense does not trigger an A V INTERVAL The ventricle is paced at the selected RATE To turn A TRACKING OFF use SELECT to highlight the parameter then turn the MENU PARAMETER dial counterclockwise until OFF replaces ON Turn the MENU PARAMETER dial clockwise to turn A TRACKING ON Note A TRACKING can be manually turned OFF only from DDD mode A TRACKING can be manually turned ON only from DDI mode However A TRACKING is automatically set to ON when the mode changes from DDI to any other mode regardless of its applicability in the new mode This Menu allows manual adjustment of these dual chamber rate dependent parameters UPPER RATE PVARP post ventricular atrial refractory period A V INTERVAL appears on Menu 1 also and SETTING which is a toggle between automatic and manual settings for the rate dependent parameters When not manually adjusted these parameters are automatically set to a factor of the base pacing rate see Nominal Values on page 104 When manually set the rate dependent parameters do not change with adjustments to the RATE If further increase of the RATE would cause a timing violation with the UPPER RATE a warning message appears on the lower screen and RATE is not allowed to be increased until UPP
116. ysical Features 46 Functional Features 49 Timing Violations 53 Preparation for use 57 Battery Installation 58 Disposable Pouch 59 Disposable Cover 59 Cables 60 Connector Setup 61 User guide 67 Overview 68 Indicators 69 Basic Operation 70 Connector Setup 77 Pacing Parameter Adjustments 79 Thresholds 83 Pacing Setup 88 5388 Technical manual 8 Contents 5388 Technical manual RAP Rapid Atrial Pacing 90 Battery Replacement 92 Tables 94 Device maintenance 97 Cleaning and Sterilization 98 Safety and Technical Checks 99 Service 100 Specifications 101 Device Specifications 102 Device Accessories 105 Warranty information 107 Special Notices 108 Pacemaker diagnostic diagrams 109 About the Chapter 110 Definitions 110 Single Chamber Modes 113 Dual Chamber Modes 118 Index 139 Overview 1 General Description 10 Intended Use 12 Contraindications 12 10 Chapter 1 General Description 5388 Technical manual General Description The Medtronic Model 5388 is a battery powered temporary dual chamber pacemaker designed primarily for temporary antibradycardia pacing therapy The device provides eight selectable modes of pacing therapy DDD DVI DDI DOO VOO VVI AOO and AAI High rate burst pacing therapy up to 800 min reciprocal minutes for atrial tachyarrhythmias is available in the asynchronous mode The device is typically connected to temporary transvenous epicardial or myocardial pacin

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