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R Series® ALS Operator`s Guide

1. DEFIB 120J SEL 00 01 Code Sync Options Param Marker Alarms On Off If you have configured Shocks 1 2 and 3 to escalating energy levels see the R Series Configuration Guide for instructions the R Series automatically sets the energy to the preconfigured Energy Level Shock 1 2 3 setting at power up and after each of the first two shocks The ENERGY INCREMENTED message will be displayed after Shocks 1 and 2 are delivered Manually changing the energy level outside the preprogrammed sequence and delivering a shock disables this function 3 8 www zoll com 9650 0912 05 Rev C Emergency Defibrillation Procedure with Hands Free Therapy Electrodes 2 Charge Defibrillator Press the CHARGE button on the front panel To increase or decrease the selected energy after you have pressed the CHARGE button use the defibrillator ENERGY SELECT buttons Caution Changing the selected energy while the unit is charging or charged causes the defibrillator to disarm itself Press the CHARGE button again to charge the unit After charging to the selected energy the SHOCK button on the front panel lights A distinctive charge ready tone sounds and the DEFIB XXXJ READY is displayed The defibrillator is now ready to discharge 3 Deliver Shock WARNING Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge Do not touch the bed patient or any equipment connected to the pat
2. As can be seen from the table the Biphasic experience is superior over the entire course of shocks delivered The one degree of freedom chi square statistic for the Mantel Haenszel test is 30 39 p lt 0 0001 Similarly the log rank test also a one degree of freedom chi square statistic is 30 38 p lt 0 0001 The residual number of patients not successfully treated after four shocks is 5 7 for biphasic compared to 20 8 for monophasic There was a significant difference between the first shock efficacy of biphasic shocks at 70J of 68 and that of monophasic shocks at 100J of 21 p 0 0001 95 confidence interval of the difference of 34 1 to 60 7 Successful cardioversion with rectilinear biphasic shocks was achieved with 48 less delivered current than with monophasic shocks 11 1 vs 2144 A p 0 0001 One half of the patients who failed cardioversion after four consecutive escalating monophasic shocks were subsequently successfully cardioverted using a biphasic shock at 170J No patient was successfully cardioverted using a 360J monophasic shock after the patient had failed cardioversion with biphasic shocks Conclusion The data demonstrate the superior efficacy of low energy rectilinear biphasic shocks compared to high energy monophasic shocks for transthoracic cardioversion of atrial fibrillation There were no unsafe outcomes or adverse events due to the use of Rectilinear Biphasic Waveform Synchronized Cardioversion of Atr
3. Informational message only the unit emits a two beep audio tone and displays a message for a timed period Suspending and Silencing Alarms 9 10 When a high priority alarm occurs the unit emits a continuous alarm tone highlights the value of the alarming parameter on the display and flashes the bell icon associated with that parameter You can either suspend the alarm tone for 90 seconds or you can silence the alarm tone Suspending Alarm Tones To suspend an alarm tone for 90 seconds press and release the ALARM SUSPEND x button in less than 1 second The alarms tone stops the unit displays an X across the alarm s flashing bell icon and the value for the alarming parameter remains highlighted If you press the ALARM SUSPEND button again alarm processing is reactivated After 90 seconds if the physiological parameter remains at a value that triggers the alarm the unit sounds the alarm tone again If the alarm condition clears the physiological parameter returns to a value within range after you suspend the alarm tone the unit resets the alarm and displays the bell icon no flashing no X The alarm parameter displays normally no highlighting If a second different alarm occurs after you suspend an alarm tone you can suspend the alarm tone for that second parameter by pressing and releasing the ALARM SUSPEND button again The unit behaves the same as described above for the first alarm Suspending a second ala
4. Advisory Defibrillation Procedure When used with OneStep Pediatric electrodes the default energy selections for pediatric patients are e Shock 1 50 joules e Shock 2 70 joules e Shock 3 85 joules WARNING Use only OneStep Pediatric electrodes to defibrillate patients under 8 years of age in Advisory mode Use of adult electrodes or pediatric electrodes other than OneStep Pediatric electrodes can result in the delivery of excessive energy doses After the third shock all subsequent shocks are delivered at the same energy as the third shock in both Adult and Pediatric modes If medical protocols allow you may select a different energy level using the energy select up and down arrow buttons on the front panel The new energy setting displays on the monitor DEFIB 120J SEL 00 01 Code Sync Options Marker Alarms On Off If you have configured SHOCK 1 2 and 3 to escalating energy levels and then you manually change the energy level outside preconfigured SHOCK 1 2 3 sequence and deliver a shock it disables the automatic energy escalation See the Energy Level Shock 1 2 3 section of the R Series Configuration Guide for more details 2 Press ANALYZE Button WARNING Keep patient motionless during ECG analysis Do not touch the patient during analysis Cease all movement via stretcher or vehicle before analyzing the ECG 9650 0912 05 Rev C ZOLL R Series Operator s Guide 4 3 CHAPTER 4 ADVISORY DEFIBRILLAT
5. CHAPTER 2 PRODUCT OVERVIEW Attach the OneStep cable from the R Series unit to the connector at the base of the apex paddle 1 Align OneStep cable as shown 2 Insert OneStep cable into APEX paddle OneStep cable connected to APEX paddle Figure 2 8 OneStep Cable Connected to APEX Paddle If you need to detach the OneStep cable from the APEX paddles push the RELEASE button see Figure 2 9 in the direction of the arrow and unplug the OneStep cable Refer to Chapter 3 Manual Defibrillation before using paddles for defibrillation The paddles include controls for selecting defibrillation energy charging delivering a shock and turning the stripchart recorder on and off SHOCK RECORDER Buttons GuaRGE Button Button 3 ys ENERGY ET IF D Charge Ready Mo a pe SELECT indicator fo 3 Y Buttons d a E in Z z E f N f N PEASE A NIB 7 Vi A Connector e and RELEASE button for OneStep cable 7NI d Kam J Sternum Paddle Apex Paddle Figure 2 9 External Paddles 2 10 www zoll com 9650 0912 05 Rev C Working with Menus Pediatric size electrodes are built into the paddle assembly beneath the standard electrode plates The user must manually adjust energy settings to pediatric levels consistent with their institution s protocols PEDI button To expose the pediatric plate press the PEDI button at the top of the p
6. Catalogue number EIER Consult instructions for use RX onLy Prescription only 9650 0912 05 Rev C ZOLL R Series Operator s Guide 1 5 CHAPTER 1 GENERAL INFORMATION Symbol Description E 200J Maximum energy MAX Test at 30 J e e Test port GN Conventions This guide uses the following conventions Within text the names and labels for physical buttons and softkeys appear in boldface type for example Dress the SHOCK button or the Code Marker softkey This guide uses uppercase italics for audible prompts and for text messages displayed on the screen for example CHECK PATIENT WARNING Caution Warning statements alert you to conditions or actions that can result in personal injury or death Caution statements alert you to conditions or actions that can result in damage to the unit Defibrillator Function The R Series product contains a direct current DC defibrillator capable of delivering up to 200 joules It may be used in synchronized mode to perform synchronized cardioversion using the patient s R wave as a timing reference The unit uses paddles or disposable pregelled electrodes for defibrillation Intended Use Manual Operation Use of the R Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by e Unconsciousness e Absence of b
7. Figure A 10 Rectilinear Biphasic Waveform at 20 Joules 10 e 25 Ohm 2 50 Ohm 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm ms Figure A 11 Rectilinear Biphasic Waveform at 15 Joules 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 19 APPENDIX A SPECIFICATIONS 25 Ohm 8 50 Ohm T5 Ohm 100 Ohm 125 Ohm 9 150 Ohm 175 Ohm 200 Ohm Figure A 12 Rectilinear Biphasic Waveform at 10 Joules 25 Ohm 1 50 Ohm 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm Figure A 13 Rectilinear Biphasic Waveform at 9 Joules A 20 www zoll com 9650 0912 05 Rev C R Series Rectilinear Biphasic Waveform Characteristics 25 Ohm 8 50 Ohm 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm ms Figure A 14 Rectilinear Biphasic Waveform at 8 Joules 25 Ohm 8 50 Ohm 75 Ohm 100 Ohm 125 Ohm 150 Ohm 42 175 Ohm 200 Ohm ms Figure A 15 Rectilinear Biphasic Waveform at 7 Joules 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 21 APPENDIX A SPECIFICATIONS 25 Ohm 8 50 Ohm T5 Ohm 100 Ohm 125 Ohm 150
8. SUMMARY REPORT PARTIAL LISTING REPORT START TIME 29 MAY 09 11 23 17 LAST EVENT TIME 29 MAY 09 11 23 45 TOTAL SHOCKS 1 PACER TOTAL TIME 00 00 00 SYSTEM SERIAL NUM 99800008 DEVICE ID 89808008 800 4 2 lt a Figure 10 1 Summary Report 10 2 www zoll com 9650 0912 05 Rev C Summary Report Defibrillation Event Format The summary report function records 6 seconds of pre shock and 9 seconds of post shock patient ECG data Also recorded are joules selected joules delivered Sync if active includes Sync markers ECG lead ECG size patient current defib impedance actual time and date The date time printed on the top of the strip corresponds to the ECG data occurring 6 seconds before the event 4 E d 2i PRE SHOCK 11 23 39 29 MAY 09 NAME BIPHASIC DEFIBRILLATION 29 MAY 09 11 23 45 ECG LEAD PADS Spo 95 ECG SIZE 1 5 EtCO2 Comp 02 amp N20 JOULES SELECTED 5 RR JOULES DELIVERED 5 4 H PATIENT CURRENT 3 5 Amps DEFIB IMPEDANCE 55 1 Ohms SUMMARY COMPLETE ZOLLR 00000000 04 57 01A5 L5 B 87 5 2E H2 SOLL Medi D a der P N 8000 0300 a poratior Reorder P N 8000 0300 L d Figure 10 2 Defibrillation Event Format Pre Shock 3 a Ir q POST SHOCK ZOLL Medical Corporatior Reorder P N 8000 0300 3 gq ZOLL Medical Corporation Reorder P N 8000 0300 e ZOLL Medical Corporatior Figure 10 3 Defibrillation Event Format Post Shock 9650 0912 05 Rev C ZOLL R Series Operator s Guide 10 3
9. 8000 0261 01 Reusable Adult Airway Adapter 8000 0262 01 Reusable Neonatal Pediatric Airway Adapter 8000 0263 01 SPU Pediatric Adult Airway Adapter with Mouthpiece 8000 0265 01 CAPNO mask Large Adult 8000 0761 CAPNO mask Standard Adult 8000 0760 CAPNO mask Pediatric 8000 0762 NIBP Cuffs and Hoses REF Thigh reusable 38 to 50 cm 14 96 to 19 69 in 8000 1654 Large Adult reusable 31 to 40 cm 12 20 to 15 75 in 8000 1653 Adult reusable 23 to 33 cm 9 06 to 12 99 in 8000 1651 Small Adult reusable 17 to 25 cm 6 69 to 9 84 in 8000 1650 Child reusable 12 to 19 cm 4 72 to 7 48 in 8000 1655 Neonate 5 disposable 8 0 cm to 15 0 cm 3 1 to 5 9 in 8000 0644 Neonate 4 disposable 7 0 to 13 0 cm 2 8 to 5 1 in 8000 0643 Neonate 3 disposable 6 0 to 11 0 cm 2 4 to 4 3 in 8000 0642 Neonate 2 disposable 4 0 to 8 0 cm 1 6 to 3 1 in 8000 0641 Neonate 1 disposable 3 0 to 6 0 cm 1 2 to 2 4 in 8000 0640 Air hose with pneumatic fittings 3 m 9 8 ft 8000 0662 Air hose with pneumatic fittings 1 5 m 4 9 ft 8000 0655 Miscellaneous REF Recorder Paper 80mm Fan Fold 8000 0301 20 pkgs 8000 0302 10 pkgs R Series Data COMM Card 8005 000101 01 9650 0912 05 Rev C ZOLL R Series Operator s Guide B 3 APPENDIX B R SERIES ACCESSORIES This page intentionally left blank B 4 www zoll com 9650 0912 05 Re
10. A colored stripe on the paper means that the paper supply is low A CHECK RECORDER message appears on the display when the stripchart recorder is activated without paper The stripchart recorder automatically shuts off when there is no paper After loading new paper press the RECORDER button to start the strip chart recorder Diagnostic Bandwidth When using an ECG cable for monitoring you can switch the unit to diagnostic bandwidth 0 05 150 Hz by pressing and holding the RECORDER button depressed Diagnostic bandwidth is maintained and printing continues as long as the RECORDER button is held down The unit reverts to standard monitoring bandwidth when you release the RECORDER button Alarms Setting Alarm Limits Unless configured otherwise heart rate alarms are preset at 30 bpm bradycardia and 150 bpm tachycardia Refer to the R Series Configuration Guide for details on setting power up alarm limits 9 8 www zoll com 9650 0912 05 Rev C Alarms To set alarm parameters 1 Press the Alarms softkey to view the Alarm Set screen and softkeys ALARM SET Parameter State i e Each setting includes the alarm state ECG HR ENABLE 50 ENABLE DISABLE or AUTO and E the low and high limit of the RESP RATE acceptable range of values NIBP SYS NIBP DIA NIBP MEAN Next Prev Next Change Param Param Field Value Return 2 Press the Next Param or Prev Param softkey This scrolls the highlighted area among the
11. and the CPR Dashboard is configured Off the R Series will display the words RATE and or DEPTH to assist the rescuer in determining whether chest compression rate or depth should be increased When an appropriate rate or depth has been achieved 80 cpm and 1 5 or 2 inches respectively one or both of these words will disappear from the display This feature is unavailable while using Pediatric CPR electrodes CPR Idle Time Display This display indicates the elapsed time in minutes and seconds since the last detected chest compression When compressions are being delivered this time display will be blanked Ten seconds following the cessation of compressions the display will illuminate and show the elapsed time since the last detected compression If no compressions have been delivered for more than 20 minutes dashes will be displayed in this time field CPR Rate and Depth Display If the CPR Dashboard is configured On and the CPR Idle Time is not displayed the Rate and Depth values will be displayed in the Real CPR Help field The values will be highlighted and displayed in red if they are below the appropriate values adult CPR electrodes only 6 2 www zoll com 9650 0912 05 Rev C Real CPR Help Field Compression Release Bar Adult only If the CPR Dashboard is configured On the Compression Release Bar shows the release of the chest compression by the rescuer When the release of the chest is properly administered fully r
12. buttons One pair is located on the front panel of the unit the other pair is located on the sternum paddle o SHOCK 2 ANALYZE CHARGE EE or Al ENERGY SELECT ei Note Neonatal and pediatric defibrillator energy levels should be selected based on site specific protocols 3 2 www zoll com 9650 0912 05 Rev C Emergency Defibrillation Procedure with Paddles The selected energy level is shown as DEFIB XXXJ SEL on the display DEFIB 120J SEL 00 01 Code Sync Options Param Marker Alarms On Off If you have configured Shocks 1 2 and 3 to escalating energy levels see the R Series Configuration Guide for instructions the R Series automatically sets the energy to the preconfigured Energy Level Shock 1 2 3 setting at power up and after each of the first two shocks The ENERGY INCREMENTED message will be displayed after Shocks 1 and 2 are delivered Manually changing the energy level outside the preprogrammed sequence and delivering a shock disables the automatic escalation function Prepare Paddles Release the paddles apply a liberal amount of electrolyte gel to the electrode surface of each paddle and rub the electrode surfaces together to evenly distribute the applied gel You can substitute electrode gel patches for the gel Apply Paddles to Chest Apply the paddles firmly to the anterior wall of the chest Place the sternum paddle to the right of the patient s sternum patient s ri
13. cable allows you to monitor the following ECG leads e LILIII e aVR aVL aVF e VI Changing from 3 Lead Monitoring To change from 3 lead to 5 lead monitoring simply disconnect the 3 Lead ECG patient cable or OneStep Pacing cable ECG connector and connect the 5 lead ECG cable Refer to the beginning of this section for appropriate preparations i e placing electrodes attaching electrodes setting the controls etc If any ECG lead becomes disconnected during monitoring an ECG LEAD OFF message appears on the display www zoll com 9650 0912 05 Rev C 5 Lead Monitoring Changing from 5 Lead ECG Monitoring To change from 5 lead monitoring to 3 lead monitoring you must power off the unit for at least 10 seconds remove the 5 lead cable connect the 3 lead cable then power on the unit again If you fail to shut the unit off for at least 10 seconds the unit displays the ECG LEAD OFF message after you disconnect the 5 lead wire cable even if leads from a 3 lead ECG cable are properly attached to the patient Simultaneous 3 Lead Printing The R Series unit can display and print three simultaneous ECG leads when using a 5 lead cable and an ECG lead is selected as the signal source not PADS or PADDLES Note This feature does not work with a 3 lead cable To display and print 3 simultaneous leads 1 Press the Options softkey then press the Traces softkey 2 Press 3 Leads Leads belong to two groups limb leads L II a
14. 12 0 12 0 23 0 1 0 38 0 38 0 38 0 73 1 1 2 1 2 1 2 2 3 10 3 8 3 8 3 8 7 3 100 12 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distances for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelinood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The life support functions on the R Series are defined to be any function associated with ECG monitoring pacing defibrillation and shock analysis Specifically these functions include but are not limited to the ECG wave
15. 1500 1750 Accuracy 1J 1J 1J 1J 1J 1J 1J 1J 15 2J 1J 2J 2J 2J 2J 2J 2J 15 3J 2J 3J 3J 3J 3J 3J 3J 15 4J 3J 4J 4J 5J 5J 5J 4J 15 5J 3J 5J 6J 6J 6J 6J 6J 15 6J 4J 6J 7J 7J 7J 7J 7J 15 7J 5J 7J 8J 8J 8J 8J 8J 15 8J 5J 8J 9J 9J 10J 9J 9J 15 9J 6J 9J 10J 11J 11 J 11J 10 J 15 10J 7J 10J 12J 12J 12J 12J 12J 15 15J 10J 16J 17J 18J 18J 18J 17J 15 20J 14J 21J 23J 24J 24J 24 J 23J 15 30 J 21J 32J 35J 36 J 37J 36 J 35J 15 50J 35J 54J 59J 61J 62J 61J 59J 15 70J 49J 76J 83 J 85J 87J 86 J 83 J 15 75J 53 J 81 J 89 J 91 J 93 J 92 J 89 J 15 85J 60 J 92 J 101 J 104 J 106 J 104 J 101 J 15 100 J 71J 109 J 119 J 122 J 125 J 123 J 119 J 15 120 J 85 J 131 J 143 J 147 J 150 J 147 J 143 J 15 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 13 APPENDIX A SPECIFICATIONS Table A 2 Delivered Energy at Every Defibrillator Setting into a Range of Loads Load Selected Energy 250 500 750 1000 1250 1500 1750 Accuracy 150 J 107 J 164 J 180 J 183 J 188 J 184 J 179 J 15 200 J 142 J 230 J 249 J 253 J 269 J 261 J 260 J 15 A 14 For all energy levels accuracy is equal to either 15 or 3 joules whichever is greater The R Series Rectilinear Biphasic waveform employs the same first and second phase timing similar first and second phase currents voltages and essentially the same mechanisms for controlling defibrillation waveshape as the ZOLL M
16. 170 joules efficacy of the rectilinear biphasic waveform with that of a monophasic waveform three consecutive 200 300 and 360 joules A significance level of p 0 05 or less was considered statistically significant using Fischer s Exact test Also differences between the two waveforms were considered statistically significant when the customary 9596 or AHA recommended 90 confidence interval between the two waveforms was greater than 0 Results The study population of 184 patients had a mean age of 63 14 years Of these 143 patients were male 98 patients were in the biphasic group ventricular fibrillation flutter n 80 ventricular tachycardia n 18 and 86 patients were in the monophasic group ventricular fibrillation flutter n 76 ventricular tachycardia n 10 There were no adverse events or injuries related to the study The first shock first induction efficacy of biphasic shocks at 120 J was 99 versus 93 for monophasic shocks at 200 J p 0 0517 95 confidence interval of the difference of 2 7 to 16 5 and 90 confidence interval of the difference of 1 01 to 15 3 Monophasic Biphasic First shock efficacy 93 99 p value 0 0517 95 confidence interval 2 796 to 16 5 9096 confidence interval 1 0196 to 15 396 1 Kerber RE et al Automated External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Perf
17. ECG Monitoring J g ECG leads are a defibrillation protected Type CF patient connection The R Series products can be used for either short or long term ECG monitoring R Series products have built in circuitry to prevent damage to their ECG monitoring circuits during defibrillation Monitoring electrodes however can become polarized during defibrillator discharge causing the ECG trace to briefly disappear from the screen High quality silver silver chloride Ag AgCl electrodes minimize this effect Circuitry in the unit returns the ECG trace to the display within a few seconds You can monitor a patient s ECG using an ECG patient cable hands free therapy electrodes or through standard defibrillation paddles During ECG monitoring the R Series displays the following information Five seconds of ECG waveforms Heart Rate Heartbeat indicator ECG source lead I II III aVR aVL aVF or V with ECG cable PADS or PADDLES ECG size 0 5 1 1 5 2 0 or 3 cm mV Alarm indicator Whenever more than one waveform is displayed the selected ECG lead appears as the uppermost trace unless the unit is configured for Filtered ECG 9650 0912 05 Rev C ZOLL R Series Operator s Guide 9 1 CHAPTER9 ECG MONITORING Caution ECG electrodes embedded in OneStep Pacing and Complete resuscitation pads produce non standard ECG monitoring lead vectors designated P1 P2 and P3 While ECG signals acquired from these leads are appropriate for
18. Mode Selector to MONITOR 2 Press the Options softkey 3 Press More 4 Press Set Clock The month field will be highlighted Enter and Return Figure 12 4 Set Time Screen 5 Press the Inc Value or Dec Value softkeys to select the appropriate month 6 Press the Next Field softkey to set the selected month and move the highlight to the next field day 7 Repeat steps 5 and 6 to set the correct day year hours and minutes values Note The last field does not automatically scroll wrap to the beginning You must press the Prev Field softkey to enter the values for the previous field If you need to make corrections press the Prev Field softkey to move the highlight to the field previously entered 8 Press the Enter and Return softkey to set all values and return to normal monitoring mode Cleaning the R Series Unit 12 8 R Series products and accessories are chemically resistant to most common cleaning solutions and noncaustic detergents The following cleaning solutions are approved e 90 isopropyl alcohol except on adapters patient cable and Wi Fi Data COMM Card e Soap and water e Chlorine bleach solution of 30 milliliters per liter of water except on Sync In Marker Out connector battery compartment pins and Wi Fi cards ZOLL recommends cleaning the device paddles and cables with a soft damp cloth using the approved cleaning agents The external printer parts should be cleaned with a damp soft cloth o
19. Ohm 175 Ohm 200 Ohm Figure A 16 Rectilinear Biphasic Waveform at 6 Joules 25 Ohm 50 Ohm T5 Ohm 100 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm Figure A 17 Rectilinear Biphasic Waveform at 5 Joules A 22 www zoll com 9650 0912 05 Rev C R Series Rectilinear Biphasic Waveform Characteristics 25 Ohm 8 50 Ohm 75 Ohm 100 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm ms Figure A 18 Rectilinear Biphasic Waveform at 4 Joules e 25 Ohm 8 50 Ohm 75 Ohm 100 Ohm k 125 Ohm e 150 Ohm 12 175 Ohm 200 Ohm ms Figure A 19 Rectilinear Biphasic Waveform at 3 Joules 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 23 APPENDIX A SPECIFICATIONS 25 Ohm 8 50 Ohm 75 Ohm 100 Ohm 125 Ohm 9 150 Ohm 175 Ohm 200 Ohm Figure A 20 Rectilinear Biphasic Waveform at 2 Joules 25 Ohm 50 Ohm 75 Ohm 100 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm Figure A 21 Rectilinear Biphasic Waveform at 1 Joule A 24 www zoll com 9650 0912 05 Rev C Clinical Trial Results for the Biphasic Waveform Clinical Trial Results for the Biphasic Waveform The efficacy of the ZOLL Rectilin
20. Rechargeable lithium ion battery pack AC Power Requirements 100 120 Vrms 50 60 Hz 220 240 Vrms 50 Hz AC Power Consumption 275 VA maximum Device classification Class and internally powered per EN 60601 1 Design standards Meets or exceeds applicable requirements of UL 60601 AAMI DF80 IEC 60601 2 4 EN 60601 2 25 and EN 60601 2 27 Patient safety All patient connections are electrically isolated Environmental Operating temperature OC to 40 C 32 F to 104F Storage and shipping 20 C to 60 C 4 F to 140 F temperature Humidity 5 to 95 relative humidity noncondensing Vibration IEC 68 2 6 and IEC 68 2 34 Shock IEC 68 2 27 50 g 6mS half sine Operating pressure 594 to 1060 millibars 1253 to 14046 ft Particle and water ingress IEC 529 IP 22 Electromagnetic compatibility EMC CISPR 11 Class B radiated and conducted emissions Electromagnetic immunity AAMI DF80 EN 61000 4 3 to 10 V m Electrostatic discharge AAMI DF80 EN 61000 4 2 Conducted susceptibility EN 61000 4 4 61000 4 5 61000 4 6 Display Screen type High resolution liquid crystal display LCD Screen size 6 5 inches 16 5 cm diagonally Display format Nonfade moving bar display Sweep speed 25 mm s Viewing time 5 seconds 4 seconds with certain monitoring parameter options www zoll com 9650 0912 05 Rev
21. Stripchart Printer Paper 80 mm thermal grid width 90 mm paper width Speed 25 mm s Delay 6 seconds Annotations Time date defibrillation energy heart rate pacer output QRS synchronization marker ECG size ECG lead alarm defibrillator test result analyze ECG diagnostic bandwidth Messages ANALYSIS HALTED NOISY ECG SHOCK ADVISED NO SHOCK ADV 9650 0912 05 Rev C ZOLL R Series Operator s Guide APPENDIX A SPECIFICATIONS Printing method High resolution thermal array print head Printout modes Manual or automatic user configurable Data card Type Compact flash card Sync in Marker out EC G out Sync In 0 5 V TTL Level pulse active high 5 to R Series Connector 15 msec in duration no closer than 200 Pinout ms apart Energy transfer begins within ECG 25 ms of the leading edge of the external GND OUT sync pulse Xe Marker Out 0 5 V TTL Level pulse active high 10 Sue 39 ms in duration the leading edge of the B d pulse occurs within 35 ms of the peak of kg DI the R wave Se E ES MARKER OUT ECG Out 1 0 V cm of deflection on stripchart AMP TYCO P N 1445718 1 recorder Mating Connector AMP TYCO 1445322 1 25 ms delay from patient ECG input Wi Fi Card ZOLL R Series Model 802 11 abgn Wireless LAN Compact Flash Card Data COMM Battery Pack Specifications Type Rechargeable lithium ion Weight 1 7 lb 0
22. a decision to shock has been made The R Series unit will not automatically disarm the defibrillator if the patient s rhythm reverts to a non shockable rhythm before the shock has been delivered PRESS SHOCK DEFIB 120J READY 00 01 Code Report Sync Options Param Marker Data Alarms On Off A continuous tone sounds for 50 seconds followed by an intermittent beeping for 10 seconds You must deliver the shock within this 60 second interval or the defibrillator will disarm itself Press and hold the illuminated SHOCK button on the front panel until energy is delivered to the patient An XXXJ DELIVERED message appears on the display for approximately 5 seconds Watch the patient or ECG response to verify that the shock has been delivered After the energy has been delivered to the patient the display returns to DEFIB XXX J SEL Perform CPR Begin chest compressions and rescue breathing per local protocol Repeat Analysis Press the ANALYZE button to restart an ECG analysis and determine if additional shocks are required Note Reanalysis of the ECG rhythm is inhibited for 3 seconds after each shock Continue Patient Care Continue patient care according to medical protocols 4 6 www zoll com 9650 0912 05 Rev C Advisory Function Messages Advisory Function Messages SELECT DEFIB MODE Displayed if the ANALYZE button is pressed but the unit is not in the DEFIB mode Turn the Mode Selector to DEFIB to enable the de
23. adjust the energy settings based on site specific protocols 1 Select DEFIB WARNING Turn the Mode Selector to DEFIB The unit automatically defaults to 120 joules or the preconfigured first shock energy selection RECORDER PADS are selected as the ECG source when the instrument is turned to MONITOR or DEFIB and paddles are not connected to the OneStep cable You may select any of the other ECG leads by pressing the front panel LEAD button Energy Select Look at the display and verify the selected energy is appropriate The default energy selections for adult patients are e Shock 1 120 joules e Shock 2 150 joules e Shock 3 200 joules When used with OneStep Pediatric electrodes the default energy selections are e Shock 1 50 joules e Shock 2 70 joules e Shock 3 85 joules When used with pedi padz defibrillator energies must be set manually based on site specific institutional protocols for pediatric defibrillation 9650 0912 05 Rev C ZOLL R Series Operator s Guide 3 7 CHAPTER 3 MANUAL DEFIBRILLATION After the third shock all subsequent shocks are delivered at the same energy as the third shock in both Adult and Pediatric modes If medical protocol allows you may select a different energy level using the ENERGY SELECT buttons on the front panel o SHOCK 2 LE CHARGE ENERGY SELECT 1 wj The selected energy level is shown as DEFIB XXXJ SEL on the display
24. affected by absorption and reflection from structures objects and people a The non life support functions on the R Series are defined to be any function not listed as a life support function in the EID for Life Support Functions table Note a Specifically this function is SpOs www zoll com 9650 0912 05 Rev C R Series Rectilinear Biphasic Waveform Characteristics R Series Rectilinear Biphasic Waveform Characteristics Table A 1 shows the characteristics of the R Series Rectilinear Biphasic waveform when discharged into 25 ohm 50 ohm 100 ohm 125 ohm 150 ohm and 175 ohm loads at the maximum energy setting of 200 joules Table A 1 R Series Rectilinear Biphasic Waveform Characteristics 200 J discharged into 250 50 1000 1250 1500 1750 First phase Maximum initial current 31 4A 30 4A 19 7A 19 4 A 16 7A 15 6A Average current 27 1 A 24 9 A 17 5A 16 2A 14 4A 13 2A Duration 6 ms 6 ms 6 ms 6 ms 6 ms 6 ms Interphase duration 200 us 200 us 200 us 200 us 200 us 200 us between first and second phases Second phase Initial current 29 2A 18 8A 15 1A 13 2A 12 1A 11A Average current 14 7A 13A 12 5A 11 3A 10 7A 9 9A Duration 4 ms 4 ms 4 ms 4 ms 4 ms 4 ms Table A 2 Delivered Energy at Every Defibrillator Setting into a Range of Loads Selected Eogd Energy 250 509 75 1000 1250
25. and DEFIB XXXJ SEL After approximately 5 seconds the XXXJ DELIVERED message disappears and the DEFIB XXXJ SEL message remains to indicate the selected energy level Note If the defibrillator is not discharged within 60 seconds after reaching the selected energy level the unit automatically disarms itself During the 10 seconds prior to disarming the charge ready tone beeps intermittently The charge ready tone then stops the charge indicator light goes off and the monitor message changes to DEFIB XXXJ SEL Press the CHARGE button to recharge the unit Autoclavable External Paddles ZOLL Autoclavable External Paddles are available for use with manually operated ZOLL defibrillators when sterile conditions must be maintained during defibrillation 9650 0912 05 Rev C ZOLL R Series Operator s Guide 3 5 CHAPTER 3 MANUAL DEFIBRILLATION Emergency Defibrillation Procedure with Hands Free Therapy Electrodes LI 4 ZOLL hands free therapy electrodes are a defibrillation protected Type BF patient connection J g ECG leads are a defibrillation protected Type CF patient connection Determine the Patient s Condition Following Local Medical Protocols Verify e Unconsciousness e Absence of breathing e Absence of pulse Begin CPR Following Medical Protocols Request additional assistance Prepare Patient Remove all clothing covering the patient s chest Dry chest if necessary If the patient has excessive chest hair clip o
26. card is properly installed in the unit TRANSFER FAILED The transfer failed because the Wi Fi configuration Invalid Wi Fi configuration was illegal N indicates one of following error codes Error Number N Contact Network Administrator N 1 Local Static IP settings Action 1 If running in Static IP mode make sure that the relevant static IP addresses are not 0 0 0 0 2 Make sure the subnet mask is in the correct format N 2 Server Static IP address Action With DNS set to No make sure that the IP addresses for the Full Disclosure Server and Defib History Server are not 0 0 0 0 N 3 Server Name Action With DNS set to Yes make sure that valid names exist for the Full Disclosure Server and the Defib History Server N 4 DNS IP address Action With DHCP set to No and DNS set to Yes make sure that the DNS IP Address is not 0 0 0 0 N 5 SSID Action Make sure that there is at least one valid SSID for each desired mode infrastructure and data management server 9650 0912 05 Rev C ZOLL R Series Operator s Guide 11 7 CHAPTER 11 FILE TRANSFER TRANSFER FAILED Network Error General Errror Number NNNN Contact Network Administrator The transfer failed because of a general network Wi Fi error NNNN may indicate one of the following error codes N 7004 N 7010 N 7011 N 7015 N 7016 Action Install another ZOLL Data COMM card N 7017 Action Make sure that the Defib
27. for use with R Series products To order any of these items contact your local ZOLL representative REF Electrodes Pads Paddles and Connectors OneStep resuscitation electrodes 8900 0211 01 OneStep pacing defibrillation electrodes with Monitor while Pace MwP 8900 0212 01 OneStep resuscitation electrodes with CPR 8900 0213 01 OneStep pacing defibrillation electrodes with CPR and Monitor while Pace CPR MwP 8900 0214 01 OneStep pediatric resuscitation electrodes 8900 0215 01 OneStep pediatric resuscitation electrodes with CPR 8900 000219 01 1 per box 8900 000220 01 8 per box Adult Multi Function Pacing Defibrillation stat padz 12 pair box 8900 4003 Pediatric Multi Function Pacing Defibrillation pedi padz 8900 0218 40 1 per box 9600 0215 40 8 per box External Paddle Assembly Apex Sternum with built in pediatric electrodes 8000 1010 01 External autoclavable paddles 8011 0503 Internal autoclavable handles no switch 8011 0505 Internal autoclavable handles with switch 8011 0501 01 9650 0912 05 Rev C 8011 0140 XX Molded autoclavable internal handles no switch ZOLL R Series Operator s Guide B 1 APPENDIX B R SERIES ACCESSORIES Molded autoclavable internal handles with switch 8011 0141 XX Cables REF OneStep Cable 100 240V 50 60Hz 8009 0749 OneStep Pacing Cable 100 240V 50Hz 8009 0
28. installed or a battery green charging fault has been detected Not lit The defibrillator is not connected to AC mains Note Upon power up it takes approximately 45 seconds for the LEDs on the battery to accurately display run time e External charging use the ZOLL SurePower Battery Charger to charge the battery pack and test the battery s capacity For details refer to the ZOLL SurePower defibrillator battery Operator s Manual Code Ready System The R Series defibrillator s Code Ready system tests the defibrillator whenever the unit is turned on periodically during operation whenever manual testing is initiated by the operator and automatically at pre configured intervals The code readiness indicator on the front panel shows the result of the most recent readiness check Also OneStep Pacing CPR or Complete electrodes provide an interface that communicates the electrode s expiration date and condition to the defibrillator The Defib Test Log stores the results for as many as 1000 defibrillator tests in internal memory Each log entry shows the time and date of the defibrillator test The Defib Test Log can be printed on the stripchart or transferred to a personal computer for printing and archiving Safety Considerations N All operators should review these safety considerations before using the R Series R Series products are high energy defibrillators capable of delivering 200 joules To completely deact
29. the selected energy to 20 joules The defibrillator will disarm itself 6 Press the ENERGY SELECT buttons to reset the energy to 30 joules Note For testing the unit discharges the defibrillator only if the energy is set to 30 joules 7 Press the CHARGE button When the charge ready tone sounds the message DEFIB 30J READY appears 12 4 www zoll com 9650 0912 05 Rev C 8 Manual Defibrillator Testing Press paddles firmly into their wells and using your thumbs simultaneously press and hold the SHOCK buttons one on each paddle until the shock is delivered The unit displays the message 30J TEST OK and prints a stripchart indicating 30J TEST OK and the delivered energy If the message 30J TEST FAILED appears contact appropriate technical personnel or the ZOLL Technical Service Department Defibrillator Testing with Hands Free Therapy Electrodes To test the manual defibrillation function using hands free therapy electrodes 1 Turn the unit off for at least 10 seconds 6 Turn the Mode Selector to DEFIB The unit emits a four beep tone indicating successful completion of the power on self test The ECG source is PADS and ECG size is X1 DEFIB 120J SEL and DEFIB PAD SHORT appear on the display The ECG trace appears as a solid line while the OneStep cable is connected to either the Test Port or OneStep electrodes Press the ENERGY SELECT buttons to set the energy to 30 joules Press the CHARGE button on t
30. to resolve the problem 2 Code Readiness indicator displays a red X while unit is powered on Turn the unit off and then on again Follow messages and prompts to resolve the problem Perform a Manual Defibrillator test as described in Manual Defibrillator Testing on page 12 3 If the unit continues to fail take it out of service and contact ZOLL Technical Service 9650 0912 05 Rev C ZOLL R Series Operator s Guide 13 1 CHAPTER 13 Monitor 13 2 TROUBLESHOOTING Symptom Recommended Action 3 Pad Expired Replace Pads Check the expiration date on OneStep electrodes and replace them if they are expired 4 Poor Pad Condition Replace Pads OneStep electrode condition sensor indicates that the electrode gel has dried or aged beyond its specifications The electrodes may no longer provide optimal therapy Replace therapy electrodes If emergency defibrillation is required and spare hands free therapy electrodes or paddles are not immediately available it may be advisable to use the pads in question rather than delay therapy Symptom Recommended Action 1 Unit does not turn on or unexpect edly shuts off e Check that battery pack is properly installed e Verify the unit is plugged into AC power e Replace battery pack with a fully charged battery pack 2 X FAULT XX message e A fault has been detected e Attempt to clear the X FAULT XX message by turnin
31. used and the unit is switched to PACER mode P3 is automatically selected as the ECG source When separate ECG electrodes and hands free therapy electrodes are used Lead II is automatically selected as the ECG source While ECG signals acquired from P1 P2 or P3 are appropriate for ECG rhythm assessment and determining electrical capture during pacing they should not be used for diagnostic purposes Conventional ECG electrodes and cable should be used for this purpose 2 Turn Selector Switch to PACER RECORDER Set the Pacer Output to 0 mA If the unit has just been turned on the PACER OUTPUT is automatically set to 0 mA 3 Set Pacer Rate Set the PACER RATE to a value 10 20 ppm higher than the patient s intrinsic heart rate If no intrinsic rate exists use 100 ppm 9650 0912 05 Rev C ZOLL R Series Operator s Guide 8 3 CHAPTER 8 NONINVASIVE TEMPORARY PACING OPTIONAL The pacer rate increments or decrements by a value of 2 ppm on the display when the knob is turned OUTPUT mA Observe the pacing stimulus marker on the display or stripchart 1J and verify that it is well positioned in diastole Pacing Stimuli 4 Set Pacer Output Increase PACER OUTOUT until stimulation is effective capture the output mA value is displayed The pacer output increments and decrements by a value of 2 mA on the display when the knob is turned E OUTPUT Q RATE mA ppm Note When the unit is switched out of PACER mo
32. 0 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption 9650 0912 05 Rev C a The life support functions on the R Series are defined to be any function associated with ECG monitoring pacing defibrillation and shock analysis Specifically these functions include but are not limited to the ECG waveform monitoring from leads or pads the pacing pulse output QRS detection defibrillation energy discharge and shock advisory functions b The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz c The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges d Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmi
33. 2 Make sure that the R Series configuration values pertaining to the server names Full Disclosure and Defib History are correct www zoll com 9650 0912 05 Rev C TRANSFER FAILED Full Disclosure Service Not Available Contact Network Administrator The option to accept full disclosure files is not enabled on the server Action Contact the Network Administrator for assistance TRANSFER FAILED Defib History Service Not Available Contact Network Administrator The option to accept Defib History files is not enabled on the server Action Contact the Network Administrator for assistance TRANSFER FAILED Server Rejection Contact Network Administrator The server rejected the unit s request Action Contact the Network Administrator for assistance TRANSFER FAILED Wi Fi Card Not Detected Verify Installation of Wi Fi Card The card installed in the CF slot is not an R Series Data COMM card Action Install a ZOLL approved Data COMM card TRANSFER FAILED Authentication Error The encryption passphrase key is incorrect Action Contact the Network Administrator for assistance 9650 0912 05 Rev C ZOLL R Series Operator s Guide 11 9 CHAPTER 11 FILE TRANSFER This page intentionally left blank 11 10 www zoll com 9650 0912 05 Rev C Chapter 12 Maintenance Defibrillator equipment must be maintained to be ready for immediate use The defibrillator should be tested dai
34. 2 05 Rev C Defibrillator Controls and Indicators Patient Cables and Connectors The back of the unit includes a set of connectors for patient cables Sync In NIBP EtCO SpOz OneStep Marker Out optional optional ECG optional Cable ECG Out Figure 2 3 Patient Cable Connectors Connector Description OneStep Cable For connecting paddles or ZOLL hands free therapy and pacing electrodes using either OneStep or OneStep Pacing cables ECG For connecting 3 or 5 lead ECG cable or OneStep Pacing cable s ECG cable Sync In Marker Out ECG Connector for x1000 e Anincoming defibrillator synchronization signal from an external patient monitor Output of R wave marker to an external patient monitor e ECG signal output for use with other equipment such as patient monitors and radio telemetry equipment 1 V cm of displayed ECG signal NIBP Optional For connecting blood pressure cuff cable EtCOs Optional For connecting CO monitor cable SpO gt Optional For connecting pulse oximeter cable OneStep Cables The R Series ships with either a OneStep or OneStep Pacing cable The OneStep Pacing cable has an additional connector that plugs into the rear panel ECG connector This cable is used with OneStep Pacing electrodes or OneStep Complete electrodes for external pacing and ECG monitoring Alternatively you can disconnect the OneStep Pacing cable fr
35. 2 05 Rev C Monitoring Electrodes Attachment 3 lead configuration 5 lead wire configuration 3 lead cable 5 lead cable i Note Lead sets and lead cables are different accessories and are not interchangeable For 5 lead monitoring use a 5 lead cable Monitoring Electrodes Attachment Attach snap on leads to electrodes and check for good contact between the electrode and the lead termination If you are using a 3 lead set connect the end of the 3 lead set to a OneStep Pacing cable OneStep Pacing cable 3 lead set a connection complete Peel the protective backing from the ECG electrode Be careful to keep adhesive surface free of electrolyte gel Caution Only use electrodes that are well within the expiration date indicated on the package Apply the ECG electrodes firmly to the patient s skin pressing around the entire perimeter of the electrodes 9650 0912 05 Rev C ZOLL R Series Operator s Guide 9 3 CHAPTER9 ECG MONITORING Plug the patient cable connector into the black ECG input connector located on the rear panel of the instrument Note If you are using a 3 lead set that is connected to a OneStep Pacing cable plug the red connector into the red OneStep cable input connector on the device and plug the connector that is black inside into the black ECG input connector on the device OneStep Pacing cable 3 lead or 5 lead cable connected to a 3 lead set Cauti
36. 3 CHAPTER 7 SEE THRU CPR OPTIONAL The following figure shows a patient in VF which during compressions is slightly more difficult to discern When viewing this ECG it is possible to view the underlying rhythm as the filter is able to reject all of the CPR artifact CoarseVF Raw ECG Nj Raw ECG Filtered ECG P 4 Filtered ECG CPR CPR 0 00 Coarse VF Raw ECG N Raw ECG Filtered ECG CPR 0 12 e CoarseVF Raw ECG aw ECG Filtered ECG amp CPR 0 24 12 5 mm sec 5 mm mV 7 4 www zoll com 9650 0912 05 Rev C Raw ECG Filtered ECG Raw ECG Filtered ECG Raw ECG Filtered ECG CPR 0 24 Using See Thru CPR The following figure shows a patient in PEA which could easily be mistaken for Fine VF because enough of the compression artifact leaks through to distort this signal When the CPR filter turns on the PEA is still not obvious because of the left over ripples from the CPR signal About 14 seconds into this chart the rhythm changes to asystole which could easily be mistaken for coarse VF When the CPR filter turns on the CPR compression ripples are still obvious making the rhythm look like Fine VF Raw ECG Filtered ECG Raw ECG Filtered ECG Raw ECG Filtered ECG 12 5 mm sec 5 mm mV 9650 0912 05 Rev C ZOLL R Series Operator s Guide 7 5 CHAPTER 7 SEE THRU CPR OPTIONAL The following figure shows a patient
37. 750 AAMI 3 Lead Wire ECG Patient Cable 8000 0025 02 6 8000 0025 12 IEC 3 Lead ECG Patient Cable 8000 0026 AAMI 5 Lead Wire ECG Patient Cable 8000 1005 01 IEC 5 Lead Wire ECG Patient Cable 8000 0091 Power Cord Extension Cable 12 8000 0730 AC power cord 0500 0028 Batteries and Chargers REF SurePower Charger 8050 0030 XX SurePower Battery 8019 0535 SpO Sensors and Cables REF LNCS Adtx 8000 0320 Single use sensor for patients gt 30 kg LNCS Pdtx 8000 0321 Single use sensor for Pediatrics and Slender Adults 10 50 kg LNCS Inf L 8000 0322 Single use sensor for Infants 3 20 kg LNCS Neo L 8000 0323 Single use sensor for Neonates lt 3 kg LNCS NeoPt L 8000 0324 Single use sensor for Neonates lt 1 kg Pre term LNCS DCI 8000 0294 Reusable sensor for Adults and Pediatrics gt 30 kg LNCS DCIP 8000 0295 Reusable sensor for Pediatrics 10 50 kg LNC 4 4 Reusable Patient Cable 8000 0298 LNC 10 10 Reusable Patient Cable 8000 0293 LNC Ext LNC Extension Cable DB 9 Termination 4ft 8000 0325 LNCS to LNOP Adapter Cable LNCS Sensor to LNOP 8000 0327 Patient Cable LNOP DC 12 LNOP Adult Reusable Direct Connect 12 8000 0296 Cable www zoll com 9650 0912 05 Rev C EtCO Sensors and Cables REF CAPNOSTAT 5 CO Sensor and Cable 8000 0312 01 SPU Pediatric Adult Airway Adapter 8000 0260 01 SPU Neonatal Pediatric Airway Adapter
38. 77 kg Nominal voltage 10 6 V Recharge time 4 hours or less within R Series Operating time pulses per minute For a new fully charged battery at 20 C e 100 defibrillator discharges at maximum energy 200 joules or e 4 hours of continuous ECG monitoring or e 3 5 hours of continuous ECG monitoring and pacing at 60 mA 80 Low battery indicator battery age and condition The message LOW BATTERY is displayed on the screen when there is approximately 15 minutes of ECG monitoring time left on the battery Two beep low battery tone sounds once a minute until just before shutdown when the unit beeps twice every 2 seconds The time from display of the message LOW BATTERY or REPLACE BATTERY until the defibrillator shuts down varies depending on the Battery Shelf Life 3 months before retest and recharge www zoll com 9650 0912 05 Rev C IEC 60601 1 2 Specifications IEC 60601 1 2 Specifications This section provides specification tables for the R Series as per IEC 60601 1 2 Electromagnetic Emissions Declaration Guidance and manufacturer s declaration electromagnetic emissions for the R Series The R Series is intended for use in the electromagnetic environment specified below The customer or user of the R Series should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF Emissions Group 1 The R Seri
39. ACT The therapy electrodes are not properly attached to the patient or the cable connections have become loose Check that the therapy electrodes are making good contact with the patient s skin and that all cables are securely connected This voice prompt will not sound if the therapy electrodes were not previously connected to the patient 9650 0912 05 Rev C ZOLL R Series Operator s Guide 4 7 CHAPTER 4 ADVISORY DEFIBRILLATION This page intentionally left blank 4 8 www zoll com 9650 0912 05 Rev C Chapter 5 oyhchronized Cardioversion e 4 Paddles are a defibrillation protected Type BF patient connection 4 el ECG leads are a defibrillation protected Type CF patient connection WARNING Only skilled personnel trained in Advanced Cardiac Life Support and familiar with equipment operation should perform synchronized cardioversion The precise cardiac arrhythmia must be determined before attempting defibrillation or cardioversion Before attempting synchronized cardioversion ensure that ECG signal quality is sufficient to minimize the risk of synchronizing on artifact Certain arrhythmias such as ventricular tachycardia atrial fibrillation and atrial flutter require synchronizing the defibrillator discharge with the ECG R wave to avoid the induction of ventricular fibrillation In this case a synchronizing Sync circuit within the defibrillator detects the patient s R waves When the SHOCK button or butto
40. C Defibrillator Specifications Messages ERASING REPORT INSERT CARD REPLACE BATTERY LOW BATTERY PERFORM CPR NOISY ECG RETRY ANALYSIS CHECK PATIENT ANALYSIS HALTED PRESS ANALYZE NO SHOCK ADV SHOCK ADVISED PRESS CHARGE SELECT PADS SELECT ECG LEADS SELECT DEFIB MODE VF ALARMS OFF REMOVE SYNC CHECK PADS ATTACH PADS POOR PAD CONTACT DEFIB PAD SHORT PADDLE FAULT ECG LEAD OFF USE PADDLE DISCHG CANNOT CHARGE RELEASE SHOCK PRESS SHOCK 30J TEST OK TEST FAILED PACER DISABLED DEFIB DISABLED SET PACE MA CHECK RECORDER ANAYLZING ECG FULLY RELEASE Electrodes Hands free therapy electrodes e OneStep electrodes e pro padz e Stat padz e Adult stat padz II Pediatric pedi padz Defibrillator Waveform Rectilinear Biphasic Energy selection Adult Selection through front panel buttons or paddle buttons ADULT 1 2 3 4 5 6 7 8 9 10 15 20 30 50 75 100 120 150 200 joules e PEDIATRIC 1 2 3 4 5 6 7 8 9 10 15 20 30 50 70 85 100 120 150 200 joules Charge Time e Less than 7 seconds with a new fully charged battery first 15 charges to 200 joules e For the fifteenth discharge at maximum energy the charge time is less than 10 seconds Depleted batteries result in a longer defibrillator charge time e Less than 15 seconds when operating without a battery using AC power alone at 90 of the rated mains voltage Less than 25 secon
41. C recommendations of 2 inches 5 cm minimum for adult patients Defibrillator Complications Inappropriate defibrillation or cardioversion of a patient for example with no malignant arrhythmia may precipitate ventricular fibrillation asystole or other dangerous arrhythmias Defibrillation without proper application of electrodes or paddle electrolyte gel might be ineffective and cause burns particularly when repeated shocks are necessary Erythema or hyperemia of the skin under the paddles or electrodes often occurs this effect is usually enhanced along the perimeter of the paddles or electrodes This reddening should diminish substantially within 72 hours Defibrillator Output Energy R Series defibrillators can deliver as much as 200 joules into a 50 ohm impedance The energy delivered through the chest wall however is determined by the patient s transthoracic impedance An adequate amount of electrolyte gel must be applied to the paddles and a force of 10 to 12 kilograms 22 to 26 4 pounds must be applied to each paddle in order to minimize this impedance If hands free therapy electrodes are used make sure that they are properly applied Refer to the instructions on the electrode package 9650 0912 05 Rev C ZOLL R Series Operator s Guide 1 7 CHAPTER 1 GENERAL INFORMATION External Pacemaker Optional Some R Series products include an optional transcutaneous pacemaker consisting of a pulse generator and ECG sensing circu
42. CG rhythm and morphology When depressed this button causes pacing stimuli to be delivered at 4 of the indicated ppm setting Pace Fault If the unit is attempting to deliver pacing therapy and one of the following conditions occur the messages CHECK PADS and POOR PAD CONTACT are alternately displayed on the screen and an audible alarm sounds e The OneStep cable is not connected to the device e The cable is defective e Therapy pads are not connected to the OneStep cable e The therapy pads are not making good skin contact The alarm will continue to sound until proper connections between the patient and pacer are achieved and the leftmost softkey Clear Pace Alarm is pressed CHECK PADS PACE 50 mA 70 PPM Async Pacing On Off www zoll com 9650 0912 05 Rev C Special Pacing Applications Special Pacing Applications Noninvasive Temporary Pacing can be performed in the Cardiac Catheterization Lab either for emergency pacing or standby pacing For pacing in X ray and fluoroscopic applications ZOLL pro padz radiolucent hands free therapy electrodes may be used Noninvasive Temporary Pacing can be performed in the Operating Room using ZOLL pro padz sterile hands free therapy electrodes Caution Under certain conditions it might not be possible to properly monitor or pace while electrosurgical apparatus is operating Observe the device carefully for evidence of proper operation Standby Pacing For c
43. CHAPTER 10 EVENT RECORDS AND REPORTS Pacer Mode Selected Format The summary report function records 6 seconds of pre pace patient ECG data Also recorded are the ECG lead ECG size patient s heart rate pace rate pace current time and date The date time printed on the top of the strip corresponds to the ECG data occurring 6 seconds before the event 11 39 19 29 MAY 09 NAME PRE PACE ECG 29 MAY 09 11 39 25 ECG LEAD II Sp02 95 ECG SIZE 2 0 HEART RATE 72 LO al PACE RATE ppm 70 PACE CURRENT mA 42 SUMMARY COMPLETE ZOLLR 00000000 04 57 0145 8 5 21 Hz Figure 10 4 Pacer Mode Selected Format After establishing a paced rhythm turning the recorder on briefly records the paced rhythm for later reports If Async pace is active the annotation ASYNC PACE is also recorded and printed The date time printed on the top of the strip corresponds to the ECG data occurring 6 seconds before the event a 11 41 35 29 MAY 09 NAME RECORDED ECG 29 MAY 09 11 41 41 ECG LEAD I Sp02 95 ECG SIZE 1 5 HEART RATE 70 i pto rrj 4 H J Ber M i H Ir VW i i PACE RATE ppm 70 PACE CURRENT mA 90 SUMMARY COMPLETE LOLLR 0000000004 57 01A5 8 5 21 Hz 4 ner z Figure 10 5 Pacer Mode Selected Format Asynchronous Pacing 10 4 www zoll com 9650 0912 05 Rev C Summary Report Heart Rate Alarm Activated Format The summary report function records 6 seconds of pre alarm patient ECG Also rec
44. Code Ready defibrillator It extends testing beyond shock delivery and checks more than 40 measures of readiness including the presence of the correct cables and electrodes the type of electrode and other important electronic functions The R Series also verifies the condition and expiration date of OneStep electrodes This code readiness testing can occur automatically without disconnecting electrodes or paddles or requiring additional equipment to test shock delivery The system also provides a printed or electronic log to alert hospital personnel of any defibrillator functions or accessories that are compromised in advance of a code Some R Series models include an optional transcutaneous pacemaker consisting of a pulse generator and ECG sensing circuitry The pacing option supports both demand and asynchronous noninvasive pacing for adult pediatric or neonatal patients OneStep Pacing electrodes and OneStep Complete electrodes allow demand pacing and ECG monitoring without separate ECG electrodes when the R Series is used with the OneStep Pacing cable Information regarding the unit s operation ECG and other physiological waveforms are displayed on a large 6 5 inch 16 5 cm diagonal display which provides high contrast and visibility under virtually all lighting conditions Operating and warning messages are displayed on the monitor and the unit can also be configured with voice prompts to alert the user to unit status The R Series perfo
45. Cu uuu p aque Eh 4 7 Warning crop cc 4 7 ii www zoll com 9650 0912 05 Rev C Chapter 5 Synchronized Cardioversion Synchronized Cardioversion Procedure EEN 5 2 Determine the Patient s Condition and Provide Care Following Local Medical igi eeoe ACTUM 5 2 Prepare P AUC aee m 5 2 EE e EN 5 3 Steen Ee ege T ee 5 4 CUBEI e t EE 5 5 Remote Synchronized Cardioversion PDrocedure ne 5 5 Determine the Patient s Condition and Provide Care Following Local Medical Steen 5 6 PI6Pare Palen ipe 5 6 EEE D A e e EE 5 6 Soria PM D H n 5 7 EE PER NER FELT 5 7 Chapter 6 Real CPR Help Real CPR Help Piel WE 6 2 CPR Index Optional EE 6 2 UE See gi ER EE 6 2 CPR Rate and Depth RTE TEEN 6 2 Compression Release Bar Adult only AAA 6 2 CPR Metronome eene Eege ee ee 6 3 Fully Release prompt e EI te Lk oie da exa SEEK Deae DEE ed Sie 6 3 GPR Voice Denn TEE 6 3 Chest Compressions Waveform AAA 6 3 Displaying the CPR WAVOTOTTTI EE 6 4 Chapter See Thru CPR Optional Using Ee Rer Rem 7 2 EE ue as ears eon pa ae ee e AE een ee ae 7 2 Chapter 8 Noninvasive Temporary Pacing Optional Noninvasive Temporary Pacing cccceeeeeeeeeeeeeeeeeeeeeeseceeeeeeeeeeeessaaaaaaaeeeeeeeeseeneneaeees 8 2 Determine Patient Condition and Provide Care Following Local Medical Protocols 8 2 Prepare the Patient eR egene 8 2 1 Apply ECG Electrodes Hands F
46. EAL CPR HELP e CPR Idle Time Display e CPR Rate Metronome e Voice prompts Chest Compressions Waveform display e FULLY RELEASE display prompt if configured Real CPR Help Field Whenever OneStep CPR or OneStep Complete electrodes are connected to the R Series defibrillator the unit illuminates the Real CPR Help field in the upper center portion of the display This field includes the indicators described in the next sections CPR Index Optional Adult Only This diamond shaped figure provides a quick overall indicator of how well the rescuer s combined rate and depth of chest compressions match the AHA ERC recommendations for adult CPR Before chest compressions begin and after each shock the CPR Index is displayed as a hollow outline This index starts to fill from the center out as compressions begin and becomes fully filled when consistent chest compression depth exceeding 1 5 or 2 inches depending on the configuration and rate exceeding 90 compressions per minute cpm are simultaneously achieved Should the chest compression rate or depth begin to fall below the AHA ERC recommended levels the Index will only partially fill to indicate the need for more vigorous efforts Following the cessation of compressions the Index s fill level gradually decreases until a hollow outline is displayed after a short period of time When complete filling of the CPR Index has not been achieved due to diminished compression rate or depth
47. ECG rhythm assessment and determining electrical capture during pacing they should not be used for ECG morphological evaluations Attach conventional ECG electrodes for diagnostic purposes Preparations Proper application and placement of electrodes is essential for high quality ECG monitoring Good contact between the electrode and skin minimizes motion artifact and signal interference Remove all clothing covering the patient s chest Dry chest if necessary If the patient has excessive chest hair clip or shave it to ensure proper adhesion of the electrodes Electrode Placement Depending upon local usage the ECG leads are marked either RA LA LL RL and V or R L F N and C The following table shows the markings and color codes for the different lead sets IEC Color AHA Color Placement of Electrodes Coding Coding R Red Electrode RA White Place near patient s right mid clavicular line directly below Electrode clavicle L Yellow LA Black Place near patient s left mid clavicular line directly below Electrode Electrode clavicle F Green LL Red Place between 6th and 7th intercostal space on patient s left Electrode Electrode mid clavicular line N Black RL Green Place between 6th and 7th intercostal space on patient s right Electrode Electrode mid clavicular line C White V Brown Single movable chest electrode Electrode Electrode Not used for 3 lead monitoring www zoll com 9650 091
48. G heart rate alarm capabilities are enhanced with the defibrillation advisory feature called Smart Alarms When alarms are operating this feature triggers an audible alarm and displays the message CHECK PATIENT whenever the unit detects ventricular fibrillation or wide complex ventricular tachycardias This message appears on the display and the stripchart recorder print out If alarms are operating in PACER mode the unit displays VF ALARMS OFF indicating that the Smart Alarms feature has been disabled The Smart Alarms feature is always disabled when augmented leads a VR aVL aVF V leads or PADDLES are selected for ECG monitoring The messages VF ALARMS OFF and SELECT LIMB LEADS are alternately displayed when alarms are activated and augmented leads or V leads are selected These messages are displayed only the first time you select the augmented or V leads They are not redisplayed as you cycle through the lead selection 9650 0912 05 Rev C ZOLL R Series Operator s Guide 9 11 CHAPTER9 ECG MONITORING This page intentionally left blank 9 12 www zoll com 9650 0912 05 Rev C Chapter 10 Event Records and Heports The R Series defibrillator records important event information during operation You can retrieve this information in various forms e Summary Report Summary report allows you to store and later retrieve important ECG and event information You can print summary report information in various formats For more inform
49. ION WARNING 4 4 Press the ANALYZE button to begin the analysis of the patient s ECG rhythm and to determine if a shockable rhythm is present ANALYZING ECG 00 01 Options Param An ANALYZING ECG message is displayed for 6 to 12 seconds while the patient s ECG is analyzed Once the analysis is completed the unit indicates whether or not a shock is advised The analysis normally consists of three consecutive 3 second ECG rhythm analyses If at least two of the three analyses determine that the patient has a shockable rhythm the unit automatically charges to the preconfigured energy level and prompts the operator to shock the patient If two or more of the three 3 second ECG analyses do not detect a shockable rhythm the unit alerts the operator that no shock is advised ECG rhythm analysis does not warn of patient asystole which is not a shockable rhythm NO SHOCK ADV E DEFIB 120J SEL 00 01 Sync Options Param On Off When a nonshockable rhythm is detected the unit displays a NO SHOCK ADV message Follow the local protocols to continue CPR or other life support and re analyze the ECG at appropriate intervals Note When a nonshockable rhythm is detected the R Series does not prevent the user from manually defibrillating the patient When a shockable rhythm is detected ventricular fibrillation or wide complex tachycardia with heart rate gt 150 one of the following occur e Units with the automa
50. N ke The R Series is now in Wi Fi Transfer Mode and a status text message box appears in the middle of the screen and describes the status of the files being sent When the files are transferred the messages TRANSFER COMPLETE Device Check Was Sent and Activity Log Was Sent are displayed Note If you are out of the range of an access point the data will not be transferred and the message Wi Fi Network Not Found is displayed To exit Wi Fi DataTransfer Mode press the Return softkey and then the Exit Transfer softkey or switch the Mode Selector to OFF www zoll com 9650 0912 05 Rev C Transferring Device Check and Activity Log Files Through Wi Fi Optional Related Wi Fi Messages Informational Message Description INITIALIZING NETWORK A transfer has been initiated CONNECTING TO THE NETWORK The association with the host network is being established CONNECTING TO SERVER The unit is connecting to a remote system TRANSFER IN PROGRESS The data transfer is in progress TRANSFER COMPLETE The data transfer is complete and lists the file type XX Was Sent that was sent XX file type Full Disclosure Activity Log or Device check Error Message Description Action TRANSFER FAILED The transfer failed because no Wi Fi card is installed Wi Fi Card Not Detected in the CF slot or the card was ejected from the slot Verify Installation of Wi Fi Card during transmission Action Make sure that the correct Wi Fi
51. NC PACE to indicate that asynchronous pacing has been activated The annotation ASYNC PACE is also printed on the stripchart when activated by the 9650 0912 05 Rev C ZOLL R Series Operator s Guide 8 7 CHAPTER 8 NONINVASIVE TEMPORARY PACING OPTIONAL RECORDER button and printed on the corresponding summary report To return to demand pacing press the Async Pacing On Off softkey again The display returns to PACE ASYNC PACE 00 01 50 mA 70 PPM Async Code Pacing Options Param Marker Alarms On Off Pace stimuli are also delivered asynchronously whenever there is an ECG LEAD OFF condition Due to the lead off condition no ECG waveforms will be displayed when pacing by this method Use other means to determine capture such as checking the patient s pulse When asynchronously pacing with an ECG LEAD OFF condition the rate and mA should be set at the known capture level or high enough 100mA to presume capture Pediatric Pacing Noninvasive pacing of pediatric patients is performed in an identical manner to adult pacing Smaller size pediatric therapy electrodes OneStep pediatric electrodes are available for patients weighing less than 33 Ibs 15 kg Continuous pacing of neonates can cause skin burns If it is necessary to pace for more than 30 minutes periodic inspection of the underlying skin is strongly advised Carefully follow all instructions on electrode packaging www zoll com 9650 0912 05 Rev C Chapter 9
52. ORMATION Cautions If the unit is to be stored longer than 90 days remove the battery pack Do not sterilize the defibrillator or its accessories unless the accessories are labelled as sterilizable Do not immerse any part of the defibrillator in water Do not use ketones such as acetone or MEK on the defibrillator Avoid using abrasives including paper towels on the display window Grounding reliability can be achieved only when the equipment is connected to a receptacle marked HOSPITAL ONLY HOSPITAL GRADE or equivalent If the grounding integrity of the line cord or AC receptacle is questionable operate the defibrillator using battery power only To protect the unit from damage during defibrillation for accurate ECG information and to protect against noise and other interference use only internal current limiting ECG cables specified or supplied by ZOLL For continued safety and EMI performance use only the line cord supplied by ZOLL Dispose of battery packs in accordance with national regional and local regulations Battery packs should be shipped to a reclamation facility for recovery of metal and plastic compounds as the proper method of waste management Restarting the Defibrillator Certain events require the R Series products to be restarted after they shut off or become inoperative for example when the battery runs down and the unit shuts off In such a case always try to restore defibrillator o
53. P1 P2 and P3 are non standard ECG leads derived from electrodes within particular OneStep electrodes While ECG signals acquired from these leads are appropriate for rhythm assessment and determining electrical capture during pacing they should not be used for ECG morphological evaluation Attach conventional ECG electrodes for diagnostic purposes e ECG size 0 5 1 1 5 2 3 cm mV other operational prompts messages and diagnostic codes Monitoring or diagnostic ECG bandwidth is selectable Recorder Function The strip recorder is provided to document events The strip recorder normally operates in the delay mode 6 seconds to ensure the capture of ECG information immediately preceding critical events The recorder may be activated manually by pressing the RECORDER button It is activated automatically whenever a defibrillation SHOCK is delivered a heart rate alarm occurs or the rhythm analysis function is activated The strip recorder may also be configured not to print during these events 9650 0912 05 Rev C ZOLL R Series Operator s Guide 1 11 CHAPTER 1 GENERAL INFORMATION Paddles and Electrodes The R Series will defibrillate cardiovert and monitor ECG using either defibrillation paddles or hands free therapy electrodes The pacer version of the R Series will pace using ZOLL hands free therapy electrodes ENERGY SELECT CHARGE and SHOCK controls are located on the paddles and front panel When using hands free the
54. PTER 12 MAINTENANCE The messages CHECK PADS and POOR PAD CONTACT appear alternately The pace alarm sounds and the Clear Pace Alarm softkey flashes Reconnect the OneStep cable and press the Clear Pace Alarm softkey The messages CHECK PADS and POOR PAD CONTACT disappear and the alarm tone stops Recorder Check 1 Check the printer for an adequate supply of paper then press the RECORDER button Press and hold the SIZE button for at least 2 seconds A calibration pulse of 1 mV appears on the display while the button is held The amplitude of the calibration pulse is independent of the SIZE setting Inspect the recorder waveform for uniformity and darkness 4 Inspect for uniformity of annotated characters and completeness of words Check the printer speed by verifying that the calibration pulse is e 2 5 mm 0 5 mm wide e 10mm 1 0 mm high Code Readiness Log 12 6 Each automatic and manual defibrillation test result is stored in internal non volatile memory the Code Log A total of 1000 Code Readiness test records can be stored in internal memory When the Code Readiness Log is full the oldest records are erased on a first in first out FIFO basis The Code Readiness Log can be transferred to an external computing device see Transferring Files to an External Device on page 11 1 If configured the R Series prints a Code Readiness Test Report following the completion of each automatic defibrillator test T
55. Pacer Kc ciere e c AATE KRES EEEa 12 5 Recorder ET 12 6 Code Readiness Eog 2 ure utu ee RUE MR x EE bu HR EU EAR 12 6 Setting Time and Me EE 12 8 Cleaning the R Series Unit EE 12 8 loading Edge Eege EE 12 9 Cleaning the Print ead out vio mette Re ettet eode n puto d d eege 12 10 Operator s Checklist for R Series Product AAA 12 11 Chapter 13 Troubleshooting KEE reo seen MM EEN 13 1 MORMON iiec zeceo ete dede De E EEES 13 2 See I RENE UR 13 3 m is ER T ERES 13 4 Detibrllatorzs mde Ge hh NEE 13 5 IAG CMAN M MR LP 13 7 Appendix A Specifications DetibrillatorSpeeltl6ATIOnS EE A 2 Battery Pack Specifications 2 n as ae bee EE o A 6 IEC 60601 1 2 SOSCIICATONS E A 7 Electromagnetic Emissions Declaration ccccccccssseeecccceeeeeeeeeeeesceeeeeeeeenseeeaeeeees A 7 Electromagnetic Immunity Declaration EID eese A 8 EID for Life Support Functions ertet rrt e epe Lo Eee Ex reb en A 9 Recommended Separation Distances from RF Equipment for the R Series Life Support Functioris rsrsr renina a ud eene be Fe eb Du tae Nen rebar en buds A 10 EID for Non Life Support Functions dente m gestr eese tede debet a Ride A 11 Recommended Separation Distances from RF Equipment for the R Series Non Life Support Functions ge as aera Sh heer as Seen A 12 R Series Rectilinear Biphasic Waveform Characteristics esesssssesesss A 13 9650 0912 05 Rev C ZOLL R Series Op
56. Real CPR Help e J Real CPR Help is defibrillation proof Type BF equipment WARNING The Real CPR Help function is fully functional only when using adult CPR electrodes Do not use Adult CPR electrodes with patients under 8 years of age WARNING Useonly Pediatric CPR electrodes with patients under 8 years of age The use of Pediatric CPR electrodes enables the R Series unit to display Idle Time and Compression Rate and Depth measurements Pediatric CPR electrodes do not enable Real CPR voice prompts or any visual indication of ineffective CPR When used with OneStep CPR electrodes or OneStep Complete electrodes the R Series unit can provide rescuers with feedback about the quality of CPR they are delivering to their patients The way in which feedback is provided varies with respect to the operational mode and user configuration but is derived from compression rate and depth measurements When applied according to package instructions ZOLL OneStep CPR and OneStep Complete electrodes provide a chest compression sensor that is located between the rescuer s hands and the patient s lower sternum This sensor monitors the rate and depth of chest compressions and sends this information to the R Series unit for processing and display The R Series defibrillator uses this information to provide feedback to the rescuer in one or more of the following forms e CPR Index 9650 0912 05 Rev C ZOLL R Series Operator s Guide 6 1 CHAPTER 6 R
57. Remote Sync function the procedure and displayed information are different Make sure to follow the instructions for Remote Synchronized Cardioversion on page 5 5 Synchronized Cardioversion Procedure Determine the Patient s Condition and Provide Care Following Local Medical Protocols Prepare Patient 5 2 Remove all clothing covering the patient s chest Dry chest if necessary If the patient has excessive chest hair clip or shave it to ensure proper adhesion of the electrodes Attach ECG electrodes as described in Monitoring Electrodes Attachment on page 9 3 A standard ECG cable and ECG electrodes are recommended for use during cardioversion Hands free therapy electrodes may be used as an ECG source Signal quality will be equal to that of standard leads except immediately following a discharge when there may be more noise due to muscle tremors especially if an electrode is not in complete contact with the skin Attach hands free therapy electrodes according to instructions on the electrode packaging and as described in Therapy Electrode Application on page 3 6 Ensure that the therapy electrodes are making good contact with the patient s skin and are not covering any part of any other electrodes Connect the hands free therapy electrodes to the OneStep cable if not preconnected www zoll com 9650 0912 05 Rev C Synchronized Cardioversion Procedure If therapy electrodes are not making good contact with the patien
58. Replacing a Battery EE 2 13 Adjusting Display Brightness decade orden dput ra utc an epu sig spe teer en Ex e eR RUE 2 13 Using Code ET E 2 14 Chapter 3 Manual Defibrillation Emergency Defibrillation Procedure with Paddles AAA 3 1 Determine the Patient s Condition Following Local Medical Protocols 3 1 Begin CPR Following Local Medical Protocols sesssee 3 2 T Select DEFIB eem Rc 3 2 2 Charge Defibrillator eene eebe 3 4 Ree 3 5 Autoclavable External Paddles E 3 5 Emergency Defibrillation Procedure with Hands Free Therapy Electrodes 3 6 Determine the Patient s Condition Following Local Medical Protocols 3 6 Begin CPR Following Medical Protocols 3 6 PLO Dare Patigi ec S 3 6 e DE EE 3 7 2 harge Defibrillator giereg 3 9 3 Deliver Shock gic cts est cae ny ee Ee 3 9 Autoclavable ele 3 10 Chapter 4 Advisory Defibrillation Advisory Defibrillation ProCeQure cccccseeececeeeeeeeeseeeeneeeeeeeeeesseeeeeeeeeeeeseseeseeeeseneenneaes 4 2 Determine the Patient s Condition Following Local Medical Protocols 4 2 Begin CPR Following Local Medical Protocols cccccceceeeeeeeeeeeeeeeeeeeeeeneeeteeneeees 4 2 Prepare Patient eei oven e aca eio d exa e A D ER hanes 4 2 1 sSelect KI TEE 4 2 2 Press ANALYZE Button WEE 4 3 KA SHOCK EE 4 5 Advisory Function Messages etit rentre tte pantipduaesdneeseacandins
59. Rhythms Size Performance Observed Lower y 9 second Goals Performance Confidence records Limit Shockable Sensitivity 49 patients Coarse VF 42 gt 90 100 0 93 1 Rapid VT 79 gt 75 100 0 96 3 Nonshockable Specificity 155 patients NSR 208 gt 99 100 0 98 6 AF SB SVT4 348 gt 95 99 4 98 2 heart block idioventricular PVCs Asystole 29 gt 95 100 90 2 Intermediate 16 patients Fine VF 0 Report only Other VT 44 Report only 84 1 72 2 a 161 of the 348 abnormal rhythm records were SVT 72 patients The SVT heart rates ranged from 152 to 302 beats per minute Arrhythmia performance is reported according to the article Kerber RE Becker LB Bourland JD Cummins RO Hallstrom AP Michos MB Nichol G Ornato JP Thies WH White RD Zuckerman BD Automated External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety Circ J Am Heart Assoc 1997 95 1677 1682 References Young KD Lewis RJ What is confidence Part 2 Detailed definition and determination of confidence intervals Ann Emerg Med September 1997 30 311 318 Beyer WH Percentage Points F Distribution Table CRC Standard Mathematical Tables 28 ed Boca Raton Fla CRC Press 1981 573 www zoll com 9650 0912 05 Rev C Appendix B R Series Accessories The following accessories are compatible
60. Series defibrillator The M Series and R Series defibrillation waveforms are considered substantially equivalent Figures A 1 through A 21 show the Rectilinear Biphasic waveforms that are produced when the R Series defibrillator is discharged into loads of 25 50 75 100 125 150 and 175 ohms at each energy setting The vertical axis shows the current in amperes A the horizontal axis shows the duration of time in milliseconds ms e 25 Ohm 8 50 Ohm 75 Ohm lt 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm 40 Figure A 1 Rectilinear Biphasic Waveform at 200 Joules ms www zoll com 9650 0912 05 Rev C R Series Rectilinear Biphasic Waveform Characteristics 30 25 Ohm 50 Ohm 75 Ohm 100 Ohm 12 125 Ohm e 150 Ohm 175 Ohm 200 Ohm 20 4 30 ms Figure A 2 Rectilinear Biphasic Waveform at 150 Joules 30 25 Ohm 8 50 Ohm 75 Ohm 100 Ohm x 125 Ohm e 150 Ohm 175 Ohm 200 Ohm 30 ms Figure A 3 Rectilinear Biphasic Waveform at 120 Joules 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 15 APPENDIX A SPECIFICATIONS 25 Ohm 50 Ohm 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm Fi
61. Series unit into a power source or install a fully charged battery pack When the warning REPLACE BATTERY appears immediately replace the battery pack with a fully charged pack or plug the R Series unit into a power source as unit shut down due to a low battery condition is imminent If mistreated a battery pack might explode Do not disassemble a battery pack or dispose of it in fire Operator Safety anesthetics or other flammable agents such as gasoline Using the unit in such environments Do not use R series products in the presence of oxygen rich atmospheres flammable might cause an explosion 9650 0912 05 Rev C ZOLL R Series Operator s Guide 1 15 CHAPTER 1 GENERAL INFORMATION Do not use the unit near or within standing water Electrical safety might be compromised when the defibrillator is wet Never discharge the unit with the defibrillation electrodes or paddles shorted together or in open air Do not discharge the defibrillator except as indicated in the instructions Discharge the defibrillator only when defibrillation electrodes or paddles are properly applied to the patient To avoid risk of electrical shock do not touch the gelled area of the hands free therapy electrodes during pacing or defibrillation To avoid risk of electrical shock do not allow electrolyte gel to accumulate on hands or paddle handles To avoid risk of electrical shock do not allow patient connectors to contact other conductive pa
62. Step Complete electrodes When these electrodes exceed their expiration date the Code Readiness indicator will change to a red X Note ZOLL electrodes contain no hazardous materials and may be disposed of in general trash unless contaminated with pathogens Use appropriate precautions when disposing of contaminated electrodes When the poc is less than 8 years old or weighs less than 55 Ib 25 kg use ZOLL pedi padz IT pediatric defibrillation electrodes Do not delay therapy to determine the patient s exact age or weight Batteries R Series products use an easily replaced rechargeable lithium ion battery pack the ZOLL SurePower battery pack A new fully charged battery pack typically delivers more than 5 hours of ECG monitoring Use of other functions such as the defibrillator printer or pacemaker reduces this time When a LOW BATTERY message appears on the display and the unit emits two beeps in conjunction with the displayed message the battery must be replaced and recharged www zoll com 9650 0912 05 Rev C Code Heady System You can charge the battery by either of the following methods e Internal charging plug the R Series into an AC power supply to automatically begin charging the installed battery pack The front panel battery indicator operates as follows When the indicator is It means Steady yellow Battery is charging Steady green Battery is charged Alternating yellow and No battery is
63. There are multiple models of the R Series defibrillator that can contain a variety of functions Your model may not contain all of the functions that are documented in this manual Those features that are not contained in all models are specified as optional The R Series is a versatile manual advisory external defibrillator When operating in the manual configuration the device operates as a conventional defibrillator where the device s charging and discharging are fully controlled by the operator In advisory mode some of the features of the device are automated and a sophisticated algorithm is used to identify shockable ECG rhythms VF and wide complex VT 2150 bpm that should be treated by defibrillator shock delivery Depending on local protocols the unit may be configured to automatically analyze the ECG charge the defibrillator 1f appropriate and prompt the operator to PRESS SHOCK between periods of CPR The R Series unit assists caregivers during cardiopulmonary resuscitation CPR by evaluating the rate and depth of chest compressions and providing feedback to the rescuer 9650 0912 05 Rev C ZOLL R Series Operator s Guide 1 1 CHAPTER 1 GENERAL INFORMATION Real CPR Help requires the use of OneStep CPR electrodes or OneStep Complete electrodes When using these pads the displayed ECG waveforms can be adaptively filtered using the See Thru CPR feature to reduce the artifact caused by chest compressions The R Series is a
64. Upload Server is running is operational and can be reached on the network TRANSFER FAILED Action Make sure that no illegal characters are used Network Error Unknown 7002 for the SSID names TRANSFER FAILED The R Series could not associate with a Wi Fi Wi Fi Network Not Found Contact Network Administrator network Action 1 Make sure that the configuration values for the SSID names are correct 2 Make sure that the R Series unit is within range of the wireless server 3 Contact the Network Administrator for assistance TRANSFER FAILED Could Not Connect To Server Contact Network Administrator The R Series could not communicate with the DefibUpload Server Action 1 Make sure that the DefibUpload Server is running is operational and can be reached on the network 2 If WEP is enabled make sure that the WEP keys on the R Series and Access Point match value and slot location 3 Make sure that the server port is correct TRANSFER FAILED Network Error DHCP Contact Network Administrator The DHCP request has failed Action 1 If WEP is enabled make sure that the WEP keys on the R Series and Access Point match value and slot location 2 Make sure that the DHCP server is operational TRANSFER FAILED Network Error DNS Contact Network Administrator The DNS request has failed Action 1 Make sure that the DNS server is running operational and properly configured
65. ZOLL R Seriese Ais Operator s Guide K 7B w gt d 2 LEAD ANALYZE CHARGE NERGY REGI 9650 0912 05 Rev C The issue date for the R Series Operator s Guide ALS REF 9650 0912 05 Rev C is June 2012 If more than 3 years have elapsed since the issue date contact ZOLL Medical Corporation to determine if additional product information updates are available Copyright 2012 ZOLL Medical Corporation All rights reserved R Series M Series pedi padz pro padz stat padz CodeNet Real CPR Help RescueNet See Thru CPR Code Ready SurePower OneStep Smart Alarms CPR Index Defib Mentor Rectilinear Biphasic and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and or other countries Masimo is a registered trademark of Masimo Corporation in the United States and or other countries All other trademarks are property of their respective owners ZOLL Medical Corporation 269 Mill Road Chelmsford MA USA 01824 4105 ZOLL International Holding B V Newtonweg 18 6662 PV ELST The Netherlands Ce 0123 Table of Contents Chapter 1 General Information PrOGUCl Destripti M M E m 1 1 HowTo IJse This E a EE 1 2 Operator s Guide Updates e t RR Re ERE A EXER TER o BERE REED KR E UR REA 1 3 Bere dem EE 1 3 Symbols Used on the Equipment AAA 1 3 Sending e 1 6 Defibrillator CON DEET 1 6 Intended Use Manual Operat
66. able and alarm status indicators for CO monitoring optional refer to the insert End Tidal Carbon Dioxide EtCO part number 9650 0915 01 Messages and prompts Labels above the softkeys appropriate to the context CPR Index and Release Bar CPR Rate and Depth Figure 2 2 shows the layout of parameter values waveforms system data and softkey labels 9650 0912 05 Rev C ZOLL R Series Operator s Guide 2 5 CHAPTER 2 PRODUCT OVERVIEW SpO values and alarm indicator optional NIBP values and alarm indicator optional CO values and alarm indicator optional Elapsed time Softkey labels Rate and Depth Indicators ndn size CPR CPR selected lead Idle Index alarm indicator Time optional heartbeat indicator Heart rate beats per minute KEE Messages 80 Trace 1 100 XN Trace 2 Trace 3 11 24 Mode Messages Sync Data Alarms On Off Code Report Options Param Marker Figure 2 2 R Series Display Screen shown with optional SpO NIBP and CO monitoring Color coding To differentiate information for various parameters the unit displays each type of information in a specific user configurable color Messages During operation a fault or error message is displayed when a fault is detected If this occurs turn the unit off and then on and recheck operation If the fault persists contact your authorized ZOLL agent as described on page 1 21 www zoll com 9650 091
67. access point Wi Fi data transfer will be slowed down If the access point is too overloaded data transmission failures can occur The use of accessories transducers and cables other than those specified in this manual and related R Series option manual inserts may result in increased emissions or decreased immunity of the R Series Do not use or place the unit in service if the Code Readiness indicator at the upper right of the front panel displays a red X Carefully route patient cables to avoid tripping over them or inadvertently pulling the unit onto the patient Always inspect the unit for damage if it has been dropped www zoll com 9650 0912 05 Rev C Warnings ECG Analysis Defibrillating Pacing and CPR Prior to attempting synchronized cardioversion ensure the ECG signal quality is good and that sync markers are displayed above each QRS complex Do not use the unit in advisory mode during patient movement A patient must be motionless during ECG rhythm analysis Do not touch the patient during analysis If transporting the patient cease all movement before beginning ECG analysis ECG rhythm analysis does not warn of patient asystole which is not a shockable rhythm The ECG rhythm analysis function might not reliably identify ventricular fibrillation in the presence of an implanted pacemaker Inspection of the electrocardiogram and clinical evidence of cardiopulmonary arrest should be the basis for any treatment of p
68. acer option contain a V VI demand pacemaker a safe and effective design for Noninvasive Temporary Pacemakers Proper demand pacing requires a reliable high quality surface ECG signal For best results Apply both standard ECG monitoring electrodes and hands free pacing therapy electrodes such as OneStep electrodes or stat padz to the patient or Use OneStep Pacing electrodes or OneStep Complete electrodes These hands free therapy pads include both ECG monitoring and pacing defibrillation electrodes in a single pad assembly They provide reliable ECG monitoring without the need to use separate ECG leads With these electrodes you must also use the OneStep Pacing cable Determine Patient Condition and Provide Care Following Local Medical Protocols Prepare the Patient Remove all clothing covering the patient s chest Dry chest if necessary If the patient has excessive chest hair clip it to ensure proper adhesion of the electrodes 1 Apply ECG Electrodes Hands Free Therapy Electrodes The R Series supports two electrode configurations for pacing OneStep Pacing Configuration Simultaneous ECG monitoring and pacing can be performed with a single set of therapy electrodes when using OneStep Pacing electrodes or OneStep Complete electrodes along with a OneStep Pacing cable The OneStep Pacing cable must be connected to both the MFC and ECG connectors of the R Series unit Attach OneStep electrodes according to instructions on th
69. addle then slide the Adult plate upward Before replacing the Adult plate be sure to clean the pediatric plate and surrounding area thoroughly Slide the Adult plate onto the paddle until it locks into place Figure 2 10 Pediatric Plate Note The R Series defibrillator also supports ZOLL autoclavable internal handles for use during open chest defibrillation procedures Working with Menus For some functions the screen shows a menu of options with related softkeys for navigating through the menus and making selections and entries ALARM SET Parameter State ENABLE Spo2_ DISABLE SS 100 Etco2 STE 25 5s REsPRATE ENABLE 5 12 NIBPSYS ENABLE o 15 NIBPDIA ENABLE 50 mo NIBP MEAN ENABLE 60 130 EE ees EEN gt E ee Next Prev Next Change Param Param Field Value Return Figure 2 11 Example Display Screen On the display highlighting indicates the currently selected item that is the item or value you are working with 9650 0912 05 Rev C ZOLL R Series Operator s Guide 2 11 CHAPTER 2 PRODUCT OVERVIEW The following table summarizes some of the more common softkeys Softkey Action Next Item Moves the highlighting down to the next item in a vertical list Next Field Prev Item Moves the highlighting up to the previous item in a vertical list Next Digit Moves the highlighting to the right in a series of lett
70. al examples of effective pacing LA AN can ding n qs q CH n n i u 1 Large T wave H Hy Hid H iH y O EH ila W i f i Negative R wave Pacer Markers Widened positive QRS Inverted T wave absence of P waves which looks like an f l d ectopic beat TWO l D f ji EH rct ARE MA EE di NI i Ni ji wv M il M u 4 H Pacer Markers Changing ECG leads and size can sometimes be helpful in determining capture Note The shape and size of the paced ECG waveforms can vary depending on the ECG lead configuration chosen variation from patient to patient can be expected 9650 0912 05 Rev C ZOLL R Series Operator s Guide 8 5 CHAPTER 8 NONINVASIVE TEMPORARY PACING OPTIONAL 6 Determine Optimum Threshold The ideal pacer current is the lowest value that maintains capture usually about 10 above threshold Typical threshold currents range from 40 to 80 mA Location of the hands free therapy or OneStep therapy electrodes affects the current required to obtain ventricular capture Typically the lowest threshold is obtained when the position of the electrodes provides the most direct current pathway through the heart while avoiding large chest muscles Lower stimulation currents produce less skeletal muscle contraction and are better tolerated 4 1 Mode OUTPUT mA Pressing and holding the 4 1 button temporarily withholds pacing stimuli thereby allowing you to observe the patient s underlying E
71. alcohol swabs razors and antiperspirant Ensure that two sets of ZOLL therapy pads are available in sealed packages Check the expiration date on all ZOLL therapy pad packages Batteries Check that a fully charged battery pack is installed in the unit Check that a fully charged spare battery pack accompanies the unit Code Readiness status Look at the Y x Code Readiness indicator on the R Series defibrillator If the Code Readiness indicator displays a red X the unit is not ready for therapeutic use Should the automatic Code Readiness test fail the R Series unit sets its Code Readiness indicator to a red X If the failed unit is connected to AC power it will also display a Code Readiness status report highlighting the defibrillator functions or accessories that are compromised If the failed unit is not connected to AC power only the red X will display Connect the unit to AC power Turn the unit to MONITOR mode then press the Test Log softkey to determine the problem Readiness test reports can be displayed and printed as described in Code Readiness Log on page 12 6 Take corrective actions for example replace electrodes or remove the unit from service and consult Troubleshooting on page 13 1 While a red X indicates the unit is not ready for therapeutic use the device will not prevent a user from attempting to deliver therapy An example of a condition in which therapy delivery may still be pos
72. and or organization if known and different from originator s organization company name address contact name and contact phone number 4 Date when the change took effect Please address the information to ZOLL Medical Corporation Attn Tracking Coordinator 269 Mill Road Chelmsford MA 01824 4105 Fax 978 421 0025 Telephone 978 421 9655 Notification of Adverse Events As a health care provider you may have responsibilities under the Safe Medical Devices Act SMDA for reporting to ZOLL Medical Corporation and possibly to the FDA the occurrence of certain events These events described in 21 CFR Part 803 include device related death and serious injury or illness In addition as part of our Quality Assurance Program ZOLL Medical Corporation requests to be notified of device failures or malfunctions This information is required to ensure that ZOLL Medical Corporation provides only the highest quality products 9650 0912 05 Rev C ZOLL R Series Operator s Guide 1 19 CHAPTER 1 GENERAL INFORMATION Software License Service Note Read this Operator s Guide and License agreement carefully before operating any of the R Series products Software incorporated into the system is protected by copyright laws and international copyright treaties as well as other intellectual property laws and treaties This software is licensed not sold By taking delivery of and using this system the Purchaser signifies agreemen
73. are Fs E D ry Dy D Keep dry cy amp This end up Temperature limitation Conformit Europ enne Complies with medical device directive 93 42 EEC oN fan 9650 0912 05 Rev C ZOLL R Series Operator s Guide 1 3 CHAPTER 1 1 4 GENERAL INFORMATION Symbol Description A Type B patient connection Type BF patient connection Type CF patient connection Defibrillator proof type BF patient connection Defibrillator proof type CF patient connection Fusible link Equipotentiality Alternating current AC Direct current DC Contains lithium Recycle or dispose of properly Keep away from open flame and high heat Do not open disassemble or intentionally damage Do not crush Do not discard in trash Recycle or dispose of properly www zoll com 9650 0912 05 Rev C Symbols Used on the Equipment Symbol Description Return to a collection site intended for waste electrical and electronic equipment WEEE Do not dispose of in unsorted trash Date of manufacture 1B ES x N Use by Latex free Do not reuse Do not fold been Not sterile ZA s V Bm Nonionizing electromagnetic radiation from Wi Fi during data transfer Manufacturer Authorized representative in the European Community Serial Number
74. are the patient s skin prior to electrode attachment e Check for proper adhesion of electrodes to patient e Reduce or eliminate ECG artifact due to electrode or patient cable movement Route cables so that they don t pull on electrodes or swing excessively e Ensure patient is motionless e Check for possible excessive radio frequency interference 7 Poor ECG signal amplitude calibration pulse normal e Select another lead e Apply new electrodes using different placement 8 Inconsistent QRS beep or heart rate e Select another lead e Alter ECG electrode placement 9 Sync marker is absent or inconsistent with QRS waveform on display and recorder e Ensure device is in Sync mode e Ensure that device in NOT in Remote Sync mode e Change ECG lead selection e Alter ECG electrode placement e Paper too narrow It should be 90 mm wide 10 No ECG trace or dashed line on display e Device is in Remote Sync mode Press the Sync On Off softkey to exit Remote Sync mode Recorder Symptom Recommended Action 1 CHECK RECORDER message e Recorder out of paper e Remove paper check paper type check recorder for paper jam and reload paper e Recorder door is open e Paper is loaded upside down 2 Recorder makes stuttering sound when activated Check recorder for paper jam 3 Light or poor quality printing Ensure correct paper is in use e Ensure paper is ins
75. as sce onceneeseskenstaautanesyananeandetemensenars 10 8 Full Disclosure Recording eae retro perte caddie Sege 10 8 Incident LOGS EE 10 8 Printing an Incident E90 ao priu epo ined cunda e node pina aa ome ates 10 8 Erasing Summary Report and Full Disclosure see 10 9 Manual Erasure uui reet o et REESEN 10 9 Automatic Eras re Asoro onnie apiu Eege 10 9 Formatting the RTE 10 9 Related Mee eebe 10 9 Chapter 11 File Transfer Transferring Files to an External D VICC ccccceeseeeseeeceeeeeeeeeeeeeeeeeeeeeeeeeeneeeeeeeeeennnnees 11 1 Wi Fi Optional EE 11 2 Installing or Removing a Compact Flash Card 11 2 iv www zoll com 9650 0912 05 Rev C Transferring a Full Disclosure File to a Compact Flash Card 11 3 Transferring Device Check and Activity Log Files to a Compact Flash Card 11 3 Transferring Files Through the USB Port Cpottonal 11 4 Transferring Full Disclosure Files Through Wi Fi Optional 11 5 Transferring Device Check and Activity Log Files Through Wi Fi Optional 11 6 SEENEN iare iia iio cd 11 7 Chapter 12 Maintenance Routine e ee EE 12 2 Daily Visual Inspection EE 12 2 Gode Readiness TEst ec eo QU OH a Naaa ia a dus A Der qae 12 3 Manual Defibrillator Jet CER 12 3 Defibrillator Testing with Paddles eeeeeeeeeeeeeenenne 12 4 Defibrillator Testing with Hands Free Therapy Electrodes 12 5
76. atients with an implanted pacemaker Implanted pacemakers might cause the heart rate meter to count the pacemaker rate during incidents of cardiac arrest or other arrhythmias Dedicated pacemaker detection circuitry may not detect all implanted pacemaker spikes Check the patient s pulse do not rely solely on heart rate meters Patient history and physical examination are important factors in determining the presence of an implanted pacemaker Pacemaker patients should be carefully observed Do not place electrodes directly over an implanted pacemaker The R Series unit detects ECG electrical signals only It does not detect a pulse effective circulatory perfusion Always verify pulse and heart rate by physical assessment of the patient Never assume that the display of a nonzero heart rate means that the patient has a pulse To avoid possible damage to the R Series unit turn off pacing before defibrillating the patient with a second defibrillator Do not use the unit s ECG out signal as a synchronization pulse for another defibrillator or cardioverter Place the patient on a firm surface before performing CPR Battery Do not operate the unit without a battery Keep a fully charged spare battery pack with the defibrillator at all times Test battery packs regularly A battery that does not pass the ZOLL charger s capacity test might cause the R Series unit to shut down unexpectedly When the warning LOW BATTERY appears plug the R
77. ation about Summary Report and how to print a report refer to the Summary Report section below e Full Disclosure Recording Full Disclosure waveforms along with event information are stored and may be reviewed using ZOLL CodeNet Central software For information about Full Disclosure Recording refer to Full Disclosure Recording on page 10 8 Incident Log The Incident log is an abbreviated list of all major events recorded in Summary Report For more information about the Incident log and how to print it refer to Printing an Incident Log on page 10 8 Summary Report The R Series defibrillator automatically records defibrillation and cardioversion events PACER mode information heart rate alarms and segments of ECG when the recorder is activated Associated event information including device control settings time and date are also recorded The following events trigger Summary Report to automatically record information e Power is turned on e Stripchart recorder is turned on Defibrillator shock is administered Code markers entered e ECG rhythm analysis is initiated e VF alarm is triggered 9650 0912 05 Rev C ZOLL R Series Operator s Guide 10 1 CHAPTER 10 EVENT RECORDS AND REPORTS Parameter alarm is triggered e Mode Selector is turned to PACER Note Diagnostic bandwidth recordings are not included in Summary Report The unit stores and prints summary information in chronological order The memo
78. atistically via two procedures the Mantel Haenszel statistic and the log rank test significance level of p 0 05 or less was considered statistically significant The data are completely analogous to the comparison of two survival curves using a life table approach where shock number plays the role of time The secondary goal was to compare the first shock success of rectilinear biphasic and monophasic waveforms A significance level of p 0 05 or less was considered statistically significant using Fisher Exact tests Also differences between the two waveforms were considered statistically significant when the 95 confidence interval between the two waveforms was greater than 0 Results The study population of 165 patients had a mean age of 66 12 years with 116 male patients www zoll com 9650 0912 05 Rev C Clinical Trial Results for the Biphasic Waveform The total efficacy of consecutive rectilinear biphasic shocks was significantly greater than that of monophasic shocks The following table displays the Kaplan Meier product limit survival curves for each of the two waveforms As all patients begin in the failure mode the estimated life table probabilities refer to the chance of still being in failure after the k shock k 1 2 3 4 Table A 3 Kaplan Meier Estimate for the Probability of Shock Failure Shock Biphasic Monophasic 0 1 000 1 000 1 0 318 0 792 2 0 147 0 558 3 0 091 0 324 4 0 057 0 208
79. brillation protected Type BF patient connection J g ECG leads are a defibrillation protected Type CF patient connection Emergency Defibrillation Procedure with Paddles WARNING To avoid risk of electrical shock do not allow electrolyte gel to accumulate on hands or paddle handles When defibrillating with paddles use your thumbs to operate the SHOCK buttons in order to avoid inadvertent operator shock No portion of the hands should be near the paddle plates Determine the Patient s Condition Following Local Medical Protocols Verify e Unconsciousness e Absence of breathing e Absence of pulse 9650 0912 05 Rev C ZOLL R Series Operator s Guide 3 1 CHAPTER 3 MANUAL DEFIBRILLATION Begin CPR Following Local Medical Protocols Request additional assistance 1 Select DEFIB Turn the Mode Selector to DEFIB The unit automatically defaults to 120 joules or the preconfigured first shock energy selection RECORDER Note Defibrillator PADDLES are selected as the ECG source when the instrument is turned to MONITOR or DEFIB with paddles connected to the OneStep cable Energy Select Look at the Display and verify the energy is appropriate Unless internal handles are connected to the OneStep cable the default energy selections for adult patients are e Shock 1 120 joules e Shock 2 150 joules e Shock 3 200 joules If medical protocol allows you may select a different energy level using the up and down arrow
80. cal commercial or hospital IEC 61000 4 4 1 kV for input output Not applicable environment lines Surge 1 kV differential mode 1 kV differential Mains power quality should be that of IEC 61000 4 5 2 kV common mode mode a typical commercial or hospital 2 kV common mode environment Voltage dips lt 5 U1 gt 95 dip in U7 lt 5 U gt 95 dip in Mains power quality should be that of shortinterruptions for 0 5 cycle Uy for 0 5 cycle a typical commercial or hospital and voltage 40 Ux 60 dip in Uy environment If the user of the variations on power supply input lines IEC 61000 4 11 for 5 cycles 70 U4 30 dip in UT for 25 cycles lt 5 U1 gt 95 dip in U7 for 5 seconds 40 Ur 60 dip in Uy for 5 cycles 70 U7 30 dip in Ux for 25 cycles 596 Uz gt 95 dip in Ux for 5 seconds R Series requires continued operation during power mains interruptions it is recommended that the R Series be powered by an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of typical location in a typical commercial or hospital environment NOTE Ur is the AC mains voltage prior to the application of the test level www zoll com 9650 0912 05 Rev C EID for Life Support Functions IEC 60601 1 2 Specifications Guidance and manufacturer s decla
81. cause the unit to leave Remote Sync mode View the ECG trace on the remote device s display Verify that Sync markers appear with each R wave The Sync markers will appear as described in the remote device s user manual www zoll com 9650 0912 05 Rev C WARNING Remote Synchronized Cardioversion Procedure Verify the ECG waveform is stable and that a Sync marker appears only with R waves If Sync markers are not present on the remote device display or do not appear to be nearly simultaneous with each R wave do not proceed with synchronized cardioversion 2 Charge Defibrillator Press the CHARGE button on the front panel or if using paddles on the apex paddle handle o SHOCK 2 ANALYZE CHARGE 6 or ENERGY SELECT 1v To abort charging and increase or decrease the selected energy after the CHARGE button has been pressed use the ENERGY SELECT buttons on either the defibrillator front panel or the sternum paddle Press the CHARGE button again to charge the unit After charging the unit to the selected energy either the front panel SHOCK button or the apex paddle charge indicator illuminates A distinctive audible tone sounds and the energy ready REMOTE SYNC XXXJ READY message is displayed The defibrillator is now ready to deliver therapy 3 Deliver SHOCK WARNING Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge Verify that no one is in contact wi
82. ck e Unplug device from AC mains and plug device back into AC mains e Verify AC mains is working properly 3 Neither the Battery nor AC Power indicator is illuminated when the device is plugged into AC mains e Unplug device from AC mains and plug device back into AC mains e Verify AC mains is working properly 9650 0912 05 Rev C ZOLL R Series Operator s Guide 13 7 CHAPTER 13 TROUBLESHOOTING This page intentionally left blank 13 8 www zoll com 9650 0912 05 Rev C Appendix A opecifications This section describes the specifications for the R Series Defibrillator as well as the ECG rhythm analysis algorithm e Defibrillator Specifications on page A 2 e Battery Pack Specifications on page A 6 e TEC 60601 1 2 Specifications on page A 7 e R Series Rectilinear Biphasic Waveform Characteristics on page A 13 e Clinical Trial Results for the Biphasic Waveform on page A 25 e ECG Rhythm Analysis Algorithm Accuracy on page A 29 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 1 APPENDIX A SPECIFICATIONS Defibrillator Specifications General Size height width length 8 2 in 10 5 in 12 5 in with handle or 10 0 in without handle 20 8 cm 26 7 cm 31 7 cm with handle or 25 4 cm without handle Weight 13 6 Ib 6 17 kg with OneStep cable and battery pack 15 2 Ib 6 89 kg with paddles Power for R Series ALS BLS and Plus models Battery
83. d ECG analyses do not detect a shockable rhythm the unit alerts the operator that no shock is advised 10 6 www zoll com 9650 0912 05 Rev C Summary Report Note If the first two segments are shockable only two asterisks appear on the stripchart and the third segment is not analyzed a 11 48 21 29 MAY 09 NO SHOCK ADVISED NAME DEFIB ADVISORY 29 Mar 09 11 48 27 Spo2 95 ECG LEAD PADS Z S LE PP 1i 1 h H H NOISE EVENTS b i rt H al xil j Mo Shock ADU Kaa PL Ss LL NS Aa th SUMMARY COMPLETE ZOLLR 00000000 84 57 81A5 8 67 21 Hz 41 Figure 10 9 Analyze Format In addition the ECG rhythm analysis report can include the following annotations Annotation Description POOR PAD CONTACT The hands free therapy electrodes are improperly connected ANALYSIS HALTED A fault condition occurred or the operator pressed the ANALYZE button again NOISY ECG Excessive noise was detected SHOCK ADVISED A shockable rhythm was detected NO SHOCK ADV No shockable rhythm was detected Printing the Entire Summary Report To print all summary report data 1 Press the Report Data softkey then press Print Chart 2 Press the Print All softkey The unit prints all stored code events and code markers in chronological order beginning with the oldest entry If the stripchart recorder is on or the defibrillator is charged summary report printing is disabled To stop printi
84. de into DEFIB or MONITOR mode and then switched back to PACER mode within 10 minutes the pacer settings remain unchanged If the unit is turned off for more than 10 seconds the pacer s power up default settings are restored www zoll com 9650 0912 05 Rev C Noninvasive Temporary Pacing 5 Determine Capture It is important to recognize when pacing stimulation has produced a ventricular response capture Determination of capture must be assessed both electrically and mechanically in order to ensure appropriate circulatory support of the patient Electrical capture is determined by the presence of a widened QRS complex the loss of any underlying intrinsic rhythm and the appearance of an extended and sometimes enlarged T wave Ventricular response is normally characterized by suppression of the intrinsic QRS complex WARNING Determination of electrical capture should only be performed by viewing the ECG trace on the R Series display with its ECG connection directly attached to the patient Use of other ECG monitoring devices might provide misleading information due to the presence of pacer artifacts Mechanical capture is assessed by palpation of the peripheral pulse To avoid mistaking muscular response to pacing stimuli for arterial pulsations use ONLY the following locations for palpating pulse during pacing e femoral artery e right brachial or radial artery Effective pacing The following ECG traces illustrate typic
85. de placement is critical to obtaining optimal results Operators must be thoroughly familiar with proper device operation The use of external pacing defibrillation electrodes or adapter devices from sources other than ZOLL is not recommended ZOLL makes no representations or warranties regarding the performance or effectiveness of its products when used with pacing defibrillation electrodes or adapter devices from other sources Defibrillator failures attributable to the use of pacing defibrillation electrodes or adapters not manufactured by ZOLL might void ZOLU s warranty Do not disassemble the unit A shock hazard exists Refer all problems to authorized service personnel Follow all recommended maintenance instructions If a problem occurs obtain service immediately Do not use the defibrillator until it has been inspected by appropriate personnel The R Series unit might not perform to specifications when stored at the upper or lower extreme limits of storage temperature and then immediately put into use Avoid using the R Series adjacent to or stacked on other equipment If unavoidable verify that the R Series operates normally in this configuration before clinical use The R Series should be installed and put into service according to the EMC information in Appendix A of this manual Assess the Wi Fi performance for the possibility of RFI in your environment of use If multiple devices are transmitting simultaneously to the same
86. description of that control s function appears on the screen To exit Mentor mode press the Exit Mentor softkey or turn the Mode Selector to OFF DEFIB or PACER Note After 60 seconds of non use in the Mentor mode the R Series returns to MONITOR mode www zoll com 9650 0912 05 Rev C Common Tasks Common Tasks Follow the instructions in the subsequent sections for e Replacing a Battery Pack on page 2 13 e Adjusting Display Brightness on page 2 13 Using Code Markers on page 2 14 Replacing a Battery Pack To remove a battery pack press the tab on the end of the battery pack inward and lift the battery pack out of the compartment Figure 2 12 Removing a Battery Pack To install a battery pack 1 Place the end of the battery pack opposite the tab into the end of the compartment closest to the front of the unit 2 Lower the tabbed end of the battery pack into the compartment and press down on the tabbed end until it locks into place Figure 2 13 Installing a Battery Pack Adjusting Display Brightness To adjust brightness 1 Press the Options softkey 9650 0912 05 Rev C ZOLL R Series Operator s Guide 2 13 CHAPTER 2 PRODUCT OVERVIEW 2 Press the High Bright or Low Bright softkey to select high and low brightness Note Brightne
87. different available vital signs If you want to change the state of the highlighted vital sign a Press the Change Value softkey b Press the Inc gt or Dec lt softkey to change the state value c Press the Enter softkey The State field can be set to three possible values Enable Disable or Auto Disable permanently turns off alarm processing for the selected physiological parameter e Enable causes alarm processing to operate whenever alarms are activated via the front panel ALARM key Selecting AUTO sets the lower and upper alarm limits to 80 and 120 of the patient s currently measured heart rate if valid measurements are present for the vital sign when the Enter softkey is pressed Refer to appropriate Operator s Guide parameter insert s for percentages associated with other parameters 3 Press the Next Field softkey to move to the Low or High field for the highlighted vital sign repeat steps 2a through 2c to change the Low or High value Note To recalculate the Low and High limits for any parameter when these limits have previously been set using the AUTO State follow the procedure above to select AUTO again and then press the Enter softkey The unit automatically resets the Low and High limits based upon the currently measured value of the selected physiological parameter 4 Press the Return softkey to set all values and return to normal operating mode Heart Rate Alarm Limits The heart rate is displayed
88. ds from the initial power on with a new fully charged battery pack depleted by up to fifteen 200 Joule discharges or when operating without a battery using AC power alone at 9096 of the rated mains voltage Less than 30 seconds from initiation of rhythm analysis advisory mode with a new fully charged battery pack depleted by up to fifteen 200 Joule discharges or when operating without a battery using AC power alone at 90 of the rated mains voltage Patient Impedance Range 15 300 ohms Energy display Screen shows selected and delivered energy Synchronized mode Synchronizes defibrillator discharge to the patient s R wave SYNC is indicated on the display with R wave markers above the ECG waveform on the screen and stripchart When ECG is monitored by the device meets the DF 80 2003 requirement of 60ms maximum time delay between the peak of the R wave and the delivery of energy Charge controls CHARGE button on front panel and apex paddle Paddles Standard apex sternum paddles Adult plate slides off to expose smaller plate for pediatric patients 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 3 APPENDIX A SPECIFICATIONS A 4 Automatic Defibrillator Test Verifies defibrillator charging and discharging without removing paddles from storage wells or with OneStep cable connected to the Test Port or OneStep electrodes Defibrillation advisory Evaluates el
89. e 0 5 1 1 5 2 and 3 centimeters per millivolt cm mV ALARM SUSPEND Button Activates deactivates or audibly suspends all alarm functions A bell symbol 3 appears on the display when alarms are enabled When alarms are either audibly or permanently disabled an X appears across the bell amp symbol RECORDER Button Starts or stops the stripchart recorder You can switch the unit to diagnostic ECG bandwidth 0 05 150Hz by pressing and holding the RECORDER button Diagnostic bandwidth is maintained as long as the RECORDER button is held down When the RECORDER button is released the unit reverts to standard monitoring bandwidth PACER OUTPUT mA optional When pacing is selected this control sets the amount of current delivered The selected current setting is indicated on the display PACER RATE ppm optional When pacing is selected this control sets the rate pulses per minute at which the pacemaker will operate The selected pace rate setting is indicated on the display www zoll com 9650 0912 05 Rev C Defibrillator Controls and Indicators Table 2 2 R Series Controls and Indicators continued Control or Indicator Description 4 1 Button This button is used to determine a patient s underlying ECG rhythm optional While depressed this button causes pacing stimuli to be delivered at 1 4 of the indicated ppm setting When the button is released normal pacing res
90. e electrode packaging Then connect the electrodes to the OneStep Pacing cable Separate ECG Electrodes and Hands free Therapy Electrodes Configuration Apply ECG electrodes attach lead wires and connect the ECG cable to the R Series rear panel see page 9 3 for instructions on attaching ECG electrodes to the patient Attach hands free therapy electrodes according to instructions on the electrode packaging Connect these therapy electrodes to the OneStep cable Therapy Electrode Application WARNING Poor adherence and or air under the therapy electrodes can lead to the possibility of arcing and skin burns 1 Apply one edge of the pad securely to the patient www zoll com 9650 0912 05 Rev C Noninvasive Temporary Pacing 2 Roll the pad smoothly from the applied edge to the other being careful not to trap any air pockets between the gel and skin 3 Ensure that hands free therapy electrodes are making good contact with the patient s skin and are not covering any part of any other ECG electrodes 4 If using OneStep Pacing electrodes or OneStep Complete electrodes select ECG lead P1 P2 or P3 otherwise select an appropriate ECG lead Adjust ECG size for a clean well defined ECG signal 5 Verify proper R wave detection The heart shaped symbol flashes with each R wave when proper detection is taking place Adjust ECG size for a clean well defined ECG signal Note When the OneStep Pacing electrode configuration is
91. e of the device To copy the Code Readiness Log to a CF card 1 Turn the mode selector to MONITOR 9650 0912 05 Rev C ZOLL R Series Operator s Guide 11 3 CHAPTER 11 FiLE TRANSFER Press the Report Data softkey Press the Transfer Mode softkey Press the More softkey Press the Defib History to Card softkey The message TRANSFERRING DATA is displayed All data is transferred to the installed CF data card nk Wh Note Do not remove the CF card while files are transferring Corruption may result on the data card When all files are transferred the message DATA TRANSFERRED is displayed You can now remove the CF card from the R Series unit To exit the Data Transfer mode press the Return softkey and then the Exit Transfer softkey Transferring Files Through the USB Port Optional 11 4 Before you begin connect a USB cable from the Windows external device with USB host capability for example a Window PC to the R Series defibrillator USB device port USB Host Port USB Device Port Future Use Figure 11 3 USB Ports To transfer data through the USB port Turn the Mode Selector to MONITOR 2 Press the Report Data softkey 3 Press the Transfer Mode softkey 4 Press the More softkey 5 Press the Enable USB softkey The R Series is now in USB Transfer Mode 6 Initiate data transfer using ZOLL CodeNet Central To exit USB Transfer mode press the Disable USB softkey or switch the Mode Selecto
92. e sure the cover is flush with the top of the device 9650 0912 05 Rev C ZOLL R Series Operator s Guide 12 9 CHAPTER 12 MAINTENANCE TI6Z eange 4 J0MOg8Ing Figure 12 6 Inserting the Paper and Closing Printer Door After the paper is loaded press the RECORDER button to resume printing Note To ensure you have loaded the paper properly check to make sure the arrows printed on the red grid side of the paper point upward Cleaning the Print Head To clean the recorder print head perform the following steps 1 Press the release button and allow the printer door to open see Figure 12 5 then remove any paper 2 Locate the printhead along the front floor of the printer compartment just below the release button 3 Gently wipe the printhead with a cotton swab moistened with isopropyl alcohol and dry any residual alcohol with another dry cotton swab Figure 12 7 Cleaning the Print Head 4 Place the paper back into the unit and close the cover see Figure 12 6 12 10 www zoll com 9650 0912 05 Rev C Operator s Checklist for R Series Product Recommended checks and procedures to be performed Date daily or weekly depending on Automatic Test Location configuration Unit Serial Number 1 Condition Remarks Unit clean no spills clear of objects on top case intact 2 Hands free Therapy elect
93. ear Biphasic waveform has been clinically verified during a study of defibrillation of Ventricular Fibrillation VF and Ventricular Tachycardia VT A feasibility study was performed initially for defibrillation of VF VT n 20 on two separate groups of patients to ensure waveform safety and energy selection Subsequently a separate multicenter randomized clinical trial was performed to verify the waveform s efficacy A description of this study is provided below The study was performed using ZOLL defibrillation systems consisting of ZOLL defibrillators the ZOLL Rectilinear Biphasic waveform and ZOLL defibrillation electrodes Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation VF and Ventricular Tachycardia VT Overview The defibrillation efficacy of the ZOLL Rectilinear Biphasic waveform was compared to a monophasic damped sine waveform in a prospective randomized multicenter study of patients undergoing ventricular defibrillation for VF VT during electrophysiological studies ICD implants and test A total of 194 patients were enrolled in the study Ten patients who did not satisfy all protocol criteria were excluded from the analysis leaving a study population of 184 Objectives The primary goal of this study was to compare the first shock efficacy of the 120 J rectilinear biphasic waveform with a 200 J monophasic waveform The secondary goal was to compare all shock three consecutive 120 150 and
94. ectrode connection and patient ECG to determine if defibrillation is required Shockable rhythms e Ventricular fibrillation VF with amplitude gt 100 uV e Wide complex ventricular tachycardia VT with rates greater than 150 beats per minute adult or 200 beats per minute pediatric Refer to ECG Rhythm Analysis Algorithm Accuracy on page A 29 for sensitivity and specificity performance CPR Monitoring Compression depth 0 75 to 3 inches 0 25 inches 1 9 to 7 6 cm 0 6 cm Compression rate 50 to 150 compressions per minute ECG Monitoring Patient connection 3 lead cable 5 lead cable paddles or hands free therapy electrodes Input protection Fully defibrillator proof Special circuitry prevents distortion of ECG during pacer pulse Implanted pacemaker spike display Dedicated circuitry detects most implanted pacemaker spikes and provides standard display marker of spike on ECG trace Implanted Pulses Detected 2 mV to 700mV amplitude 0 1ms to 2ms width with a recharge constant of 0 to 100ms Note The pacemaker pulse rejection capability for the R Series with pacemaker pulses alone includes pulses between 2mV and 700mV amplitude with widths between 0 1ms and 2ms and overshoot from 0 to 100ms The pacemaker pulse rejection capability for the R Series with pacemaker pulses and a normally paced QRS and T wave includes pulses between 2mV and 700mV amplitude wi
95. eleased the bar will fill all the way to the top This feature is unavailable while using Pediatric CPR electrodes CPR Dashboard CPR Index Depth and Rate Indicators Compression Release Bar CPR Metronome The R Series unit includes a CPR metronome feature that can be used to encourage rescuers to perform chest compressions at the AHA ERC recommended rate of 100 compressions per minute This feature can be configured On or Off When activated the metronome beeps at the AHA ERC recommended rate to provide a compression rhythm for rescuers to follow The metronome is silent when no chest compressions are being detected by CPR equipped hands free therapy electrodes In Manual and Advisory modes the metronome only beeps when chest compressions are detected and their rate falls below the AHA ERC recommended levels When compressions are being performed at 80 compressions per minute or higher the metronome is silent Should the detected compression rate fall below this level the metronome will begin beeping until recommended compression rates are consistently achieved over several compression cycles The metronome stops beeping approximately 2 seconds after the last chest compression is detected Fully Release prompt The R Series unit can be configured to display the text prompt FULLY RELEASE which reminds rescuers to lift fully release their hands from the patient s chest during compressions to allow full recoil By default
96. erator s Guide V TABLE OF CONTENTS Clinical Trial Results for the Biphasic Waveform sssse A 25 Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation VF and Ventricular Tachycardia NI A 25 Randomized Multi Center Clinical trial for Cardioversion of Atrial Fibrillation AF A 26 Synchronized Cardioversion of Atrial Fibrillation seeseeeeeeeeee A 27 ECG Rhythm Analysis Algorithm Accuracy sss A 29 Appendix B R Series Accessories Appendix C Wi Fi Radio Module Information vi www zoll com 9650 0912 05 Rev C Chapter 1 General Information Product Description The ZOLL R Series products combine a defibrillator ECG display advanced monitoring capabilities and Noninvasive Transcutaneous Pacing NTP with communication data printing and recording capabilities in a single lightweight portable instrument The unit has been designed for all resuscitation situations and its small compact lightweight design makes it ideal for accompanying patients during transport The product is powered by AC mains and an easily replaced battery pack that is quickly recharged in the device when it is connected to AC mains In addition the unit s battery may be recharged and tested using a ZOLL SurePower Battery Charger The product is designed for use in the hospital All of its ruggedized features add to its durability in hospital applications
97. ers or digits Prev Digit Moves the highlighting to the left in a series of letters or digits Inc Increases the highlighted value or digit Inc Digit For example changes 2 to 3 or B to C Dec Decreases the highlighted value or digit Dec Digit For example changes 2 to 1 or B to A Newer Moves the highlighting to the adjacent item with the more recent date or time Older Moves the highlighting to the adjacent item with the older date or time Enter Accepts the settings with the values currently shown Return Displays the previous menu Next Param Moves the highlighting to the next parameter Prev Param Moves the highlighting to the previous parameter Change Value Changes the value of the selected parameter Defib Mentor Mode Optional Defib Mentor mode is a nonclinical tutorial mode available when the Mode Selector is turned to MONITOR When in this mode the device displays a brief description of each front panel control s function when that control is activated 2 12 Note Do not run the Defib Mentor mode with a patient connected to the R Series unit To access Defib Mentor mode 1 Turn the Mode Selector to MONITOR 2 Press the Options softkey 3 Press MORE Additional options appear 4 Press Mentor 5 Press Confirm Mentor Mode The unit is now in Defib Mentor Mode a non clinical operating mode 6 Activate a front panel control except the Mode Selector or the Exit Mentor softkey A brief
98. ertain patients at risk of developing symptomatic bradycardia it may be advisable to use the unit in standby mode When used in standby mode the unit automatically provides pacing stimuli whenever the patient s heart rate drops below the pacer rate setting Patient s ECG must be monitored using one of the two electrode configurations described on page 8 2 To use the device in standby mode Establish effective pacing see instructions on previous pages Note the mA output at capture and run an ECG stripchart to document ECG morphology during capture 2 Set the mA output 10 higher than the minimum mA output necessary to effect consistent ventricular capture 3 Turn the pacing rate ppm below the patient s heart rate This suppresses pacing unless the patient s own rate drops below the pacer rate setting The pacing rate should be set at a level sufficient to ensure adequate cardiac output 4 Check the threshold periodically Asynchronous Pacing If ECG electrodes are not available or there is some circumstance that prevents or interferes with the surface ECG the R Series delivers pacemaker pulses asynchronously Asynchronous pacing should be performed only in an emergency when no alternative is available To pace asynchronously Turn the Mode Selector to PACER Press the Async Pacing On Off softkey Note Ifthe pacer output is set to 8 mA or higher pacing stimuli begin immediately at the set rate The display shows ASY
99. es FORMATTING DISK and DO NOT POWER OFF will be displayed while the disk is formatting This procedure may take several minutes to complete Related Messages Message Description CHECK RECORDER The paper supply in the stripchart printer is exhausted 9650 0912 05 Rev C ZOLL R Series Operator s Guide 10 9 CHAPTER 10 10 10 EVENT RECORDS AND REPORTS Message Description DISK FORMAT REQ The internal flash memory disk file system has been corrupted Follow the procedure in the previous section Formatting the Disk DO NOT POWER OFF Do not remove power both battery and AC while the unit is erasing reports or formatting the disk ERASING REPORT The unit is erasing the selected report data FORMATTING DISK The internal flash memory disk is being formatted www zoll com 9650 0912 05 Rev C Chapter 11 File Transfer This chapter describes procedures for transferring files from the R Series defibrillator to an external system such as a personal computer or handheld device It also explains how to remove install and erase a Compact Flash card Transferring Files to an External Device You can transfer the following files from the R Series defibrillator to an external device e Device check activity log and full disclosure waveforms e Defibrillator test information The unit includes the following data transfer features e 802 11 Wi Fi optional e USB device connector opti
100. es uses RF energy for its internal function only CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class B The R Series is suitable for use in all establishments including CISPR 11 domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic Emissions Class A IEC 61000 3 2 Voltage Complies Fluctuations Flicker Emissions IEC 61000 3 3 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 7 APPENDIX A SPECIFICATIONS Electromagnetic Immunity Declaration EID Guidance and manufacturer s declaration electromagnetic immunity for the R Series The R Series is intended for use in the electromagnetic environment specified below The customer or user of the R Series should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3096 Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typi
101. etal muscle contraction might be troublesome in very sick patients and might limit continuous use to a few hours Erythema or hyperemia of the skin under the hands free therapy electrodes often occurs this effect is usually enhanced along the perimeter of the electrode This reddening should lessen substantially within 72 hours There have been reports of burns under the anterior electrode when pacing adult patients with severely restricted blood flow to the skin Prolonged pacing should be avoided in these cases and periodic inspection of the underlying skin is advised There are reports of transient inhibition of spontaneous respiration in unconscious patients with previously available units when the anterior electrode was placed too low on the abdomen This device must not be connected to internal pacemaker electrodes 9650 0912 05 Rev C ZOLL R Series Operator s Guide 1 9 CHAPTER 1 GENERAL INFORMATION Pediatric Pacing Pacing can be performed on pediatric patients weighing 33 Ib 15 kg or less using ZOLL pediatric hands free therapy electrodes Prolonged pacing in excess of 30 minutes particularly in neonates can cause burns Periodic inspection of the underlying skin is recommended Intended Use SpO Monitoring The R Series pulse oximeter with the Masimo SET technology and the LNCS series of oximeter sensors is indicated for the continuous noninvasive monitoring of arterial oxygen saturation SpO gt and pulse ra
102. every 8 large divisions Set PACER OUTPUT to 0 mA no CHECK PADS message Set PACER OUTPUT to 16 mA CHECK PADS message and alarm Reconnect OneStep cable to test connector or OneStep electrodes Press Clear Pace Alarm softkey CHECK PADS message disappears and Pace alarm stops E Recorder Press RECORDER button Recorder runs Press again Recorder stops Inspect Recorder printing Please check the appropriate box after each use of this checklist No action required Signature Minor problem s corrected Disposable supplies replaced Major problem s identified UNIT OUT OF SERVICE CHAPTER 12 MAINTENANCE This page intentionally left blank 12 12 www zoll com 9650 0912 05 Rev C Chapter 13 Troubleshooting The troubleshooting information provided in this chapter is intended for use by nontechnical medical personnel during device operation This chapter answers many of the common problems or questions that may arise during operation If trouble persists after consulting this guide contact the appropriate technical personnel or ZOLL Technical Service Department Refer to the R Series Service Manual for more detailed troubleshooting information Code Ready Symptom Recommended Action 1 Code Readiness indicator displays a red X while unit is turned off Turn the unit on Print Code Readiness log as described on page 12 6 Follow messages and prompts
103. fibrillator and advisory capability SELECT PADS Displayed if the ANALYZE button is pressed while the device is operating in any ECG lead other than PADS Press the LEAD button until PADS is selected REMOVE SYNC Displayed if the ANALYZE button is pressed while the device is in Sync mode Turn off Sync mode by pressing the Sync On Off softkey Press the ANALYZE button again to initiate ECG rhythm analysis Warning Messages Warning messages prompt the operator to check the patient the unit the electrodes and or connections NOISY ECG RETRY ANALYSIS A NOISY ECG message alternating with a RETRY ANALYSIS message is displayed for 5 seconds when the unit detects a noisy ECG signal during ECG analysis Check and adjust electrode placement and cable connections to help eliminate the noise source Keep patient motionless during ECG analysis Press the ANALYZE button again to begin ECG analysis CHECK PATIENT The unit has detected a shockable rhythm during continuous background ECG analysis i e Smart Alarms The prompt is given only when the heart rate alarms are enabled and the unit detects a shockable rhythm The screen message persists as long as a shockable rhythm is being detected Press the ANALYZE button to begin ECG analysis Note This CHECK PATIENT analysis function operates continuously when heart rate alarms are enabled and does not require pressing the ANALYZE button for operation CHECK PADS POOR PAD CONT
104. form monitoring from leads or pads the pacing pulse output QRS detection defibrillation energy discharge and shock advisory functions A 10 www zoll com 9650 0912 05 Rev C EID for Non Life Support Functions IEC 60601 1 2 Specifications Guidance and manufacturer s declaration electromagnetic immunity for non life supporting equipment and systems The non life support functions of the R Series are intended for use in the electromagnetic environment specified below The customer or user of the R Series should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the R Series including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 12NP d 1 2 VP 80 MHz to 800 MHz d 2 3 NP 800 MHz to 2 6 GHz where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and dis the recommended separation distance in meters Field strengths from fixed RF transmitters as determined by electromagnetic site survey P should be less than t
105. g the Mode Selector to OFF for more than 10 seconds then back to the desired operating mode Note Some settings e g alarm settings lead selection ECG size may need to be restored 3 SET CLOCK message e Set time and date information e Verify that the internal lithium battery has been replaced within the last 5 years Contact ZOLL Technical Service Department for assistance 4 ECG LEAD OFF message e Check that ECG cable or OneStep Pacing cable is connected to patient and instrument Check that ECG electrodes or OneStep Pacing or Complete electrodes are making good contact and are not dried out e If changing from 5 lead ECG patient cable to 3 lead ECG patient cable remove the 5 lead cable then turn unit OFF for at least 10 seconds e Replace ECG cable or OneStep cable 5 POOR LEAD CONTACT message e Check that ECG cable or OneStep Pacing cable is connected to patient and instrument Check that ECG electrodes or OneStep Pacing or Complete electrodes are making good contact and are not dried out e f changing from 5 lead ECG patient cable to 3 lead ECG patient cable remove the 5 lead cable then turn unit OFF for at least 10 seconds e Replace ECG cable or OneStep cable www zoll com 9650 0912 05 Rev C Hecorder Symptom Recommended Action 6 Noisy ECG artifact wandering baseline e Consider 1 21Hz filter bandwidth see R Series Configuration Manual e Prep
106. g the patient and that the patient is motionless 13 6 www zoll com 9650 0912 05 Rev C AC Charger Symptom Recommended Action 11 No 30J TEST OK message is displayed when performing a manual defibrillator self test e Check to make sure unit is set to 30 joules e f testing with OneStep electrodes make sure that the OneStep cable patient connector is firmly inserted into the electrode connector Ensure the OneStep electrode package is sealed e If testing with the Test Port make sure the OneStep cable is firmly inserted into the Test Port e If testing with paddles make sure to press the paddles firmly into the paddle wells while discharging 12 DEFIB MAINT REQ message e Contact ZOLL Technical Service Department AC Charger Symptom Recommended Action 1 The Battery indicator is alternately illuminating green and yellow e Verify battery is installed e Turn unit ON to identify the fault condition Replace battery pack with a fully charged battery pack e lf problem persists replace battery pack unplug device from AC mains for more than 10 seconds and plug device back into AC mains 2 LOW BATTERY message appears on monitor when unit is plugged into AC mains e Verify that the AC Power Indicator is illuminated e If not check AC power cord connection at the wall outlet and at the rear of the device Replace battery pack with a fully charged battery pa
107. ght just below the clavicle Place the apex paddle on the chest wall just below and to the left of the patient s left nipple along the anterior axillary line Sternum Apex Rub the paddles against the skin to maximize the paddle to patient contact 9650 0912 05 Rev C ZOLL R Series Operator s Guide 3 3 CHAPTER 3 MANUAL DEFIBRILLATION WARNING Do not permit gel to accumulate between the paddle electrodes on the chest wall gel bridge This could cause burns and reduce the amount of energy delivered to the heart If using defibrillator gel pads make sure that the size of the pad is large enough to cover the entire paddle electrode area The paddles may be used for ECG monitoring in emergency situations when time does not allow connection of standard ECG monitoring electrodes If an ECG cable and ECG electrodes are in use press the LEAD button to select the desired ECG lead 2 Charge Defibrillator Caution Press the CHARGE button on the apex handle or on the front panel o SHOCK 2 ANALYZE CHARGE d Or a ENERGY SELECT 1 V7 If both SHOCK buttons on the paddles are depressed when the CHARGE button is activated the unit does not charge and a RELEASE SHOCK BUTTON message appears on the display To increase or decrease the selected energy after you have pressed the CHARGE button use the defibrillator ENERGY SELECT buttons on either the sternum paddle or the defibrillator fro
108. gure A 4 Rectilinear Biphasic Waveform at 100 Joules 25 Ohm m8 50 Ohm 75 Ohm 100 Ohm 9 125 Ohm 150 Ohm 1 175 Ohm 200 Ohm Figure A 5 Rectilinear Biphasic Waveform at 85 Joules A 16 www zoll com 9650 0912 05 Rev C R Series Rectilinear Biphasic Waveform Characteristics 25 20 25 Ohm 8 50 Ohm 75 Ohm 100 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm 20 ms Figure A 6 Rectilinear Biphasic Waveform at 75 Joules e 25 Ohm 2 50 Ohm 75 Ohm 100 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm 20 ms Figure A 7 Rectilinear Biphasic Waveform at 70 Joules 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 17 APPENDIX A SPECIFICATIONS 25 Ohm 8 50 Ohm T5 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm 25 Ohm 50 Ohm 75 Ohm 100 Ohm b 125 Ohm e 150 Ohm 1 175 Ohm 200 Ohm Figure A 9 Rectilinear Biphasic Waveform at 30 Joules A 18 www zoll com 9650 0912 05 Rev C R Series Rectilinear Biphasic Waveform Characteristics 25 Ohm 8 50 Ohm 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm ms
109. he compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol e A NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The non life support functions on the R Series are defined to be any function not listed as a life support function in the EID for Life Support Functions table Note a Specifically this function is SpOs b Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the R Series is used exceeds the applicable RF compliance level above the R Series should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the R Series C Over the frequency ranges 150 kHz to 80 MHz field strength should be less than 3 V m 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 11 APPENDIX A SPECIFICATIONS Recommended Separa
110. he front panel When the charge ready tone sounds press the ENERGY SELECT buttons to set the energy to 20 joules The defibrillator will disarm itself Press the ENERGY SELECT buttons to reset the energy to 30 joules Note For testing the unit discharges the defibrillator only if the energy is set to 30 joules 7 8 Press the CHARGE button on the front panel When the Ready tone sounds press the SHOCK button on the front panel until the shock is delivered The unit displays the message 30J TEST OK and prints a stripchart indicating 30J TEST OK and the delivered energy If the message 30J TEST FAILED appears contact appropriate technical personnel or the ZOLL Technical Service Department Pacer Testing 1 Turn the Mode Selector to PACER Turn the PACER RATE control to 150 ppm then press the RECORDER button On the stripchart verify that pacing stimulus markers J occur approximately every centimeter 10 small divisions or 2 large divisions Press and hold the 4 1 button The frequency of the pacing stimulus markers decreases occurring approximately every 4 centimeters 40 small divisions or 8 large divisions Turn the PACER OUTPUT control to 0 mA There should be no CHECK PADS or POOR PAD CONTACT messages Disconnect the OneStep cable from the test port or OneStep electrodes and slowly turn the PACER OUTPUT control to 16 mA or more 9650 0912 05 Rev C ZOLL R Series Operator s Guide 12 5 CHA
111. he product was manufactured The month appears in the form of a single alphanumeric character A for January B for February C for March and so on through L for December The product serial number is a unique set of alphanumeric characters that ZOLL assigns to each individual unit Chapter 2 Product Overview Defibrillator Controls and Indicators Front 13 14 12 9650 0912 05 Rev C ZOLL R Series Operator s Guide CHAPTER 2 PRODUCT OVERVIEW Table 2 1 R Series Unit Features Item Description 1 Front panel Includes the display screen and primary controls 2 Handle Integrated carrying handle 3 External paddle well Holds paddles when not in use Allows defib self test when paddles are stowed in their respective wells 4 Beeper Emits R wave detection beeps defib charge Ready tones and alarm tones 5 USB host connector Reserved for future use do not connect to any equipment Optional 6 USB device connector For connecting the R Series defibrillator to a USB device For details refer to Event Records and Reports on page 10 1 7 Data card slot Holds a compact flash card for copying data stored in the device s internal memory Accepts a CF memory card or a WiFi card 8 Defibrillator test port When not using OneStep electrodes or paddles connect the
112. her information for each monitored parameter messages time and softkey labels Battery indicator Indicates battery status Battery is charging Battery is charged No battery is installed or there is a battery charging fault Steady yellow Steady green Alternating yellow and green Indicator for AC power Illuminated when the unit is plugged into an alternating current AC power source Code Readiness indicator Shows the status of the unit based on its most recent Readiness check e A green v indicates the unit is ready for therapeutic use e Ared X indicates the units Readiness is compromised an that it may not be ready for therapeutic use 9650 0912 05 Rev C ZOLL R Series Operator s Guide 2 3 CHAPTER 2 PRODUCT OVERVIEW Table 2 2 R Series Controls and Indicators continued Control or Indicator Description Mode Selector Selects the mode of operation available options depend on model e OFF Unit is powered off e MONITOR Physiological monitoring ECG and other options e DEFIB Manual or advisory defibrillation e PACER Noninvasive external pacing ENERGY SELECT Buttons Two sets of up down arrow buttons control the selection of defibrillator energy one set located on the front panel and the other located on the sternum paddle CHARGE Button Charges the defibrillator to the selected energy In addition to the CHARGE bu
113. ial Fibrillation Cardioversion of atrial fibrillation AF and overall clinical effectiveness is enhanced by proper pad placement Clinical studies refer to above of the M Series Biphasic Defibrillator Waveform demonstrated that high conversion rates are achieved when defibrillation pads are placed as shown in the diagram below 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 27 APPENDIX A SPECIFICATIONS Recommended Anterior Posterior Placement Back Posterior Place the front apex pad on the third intercostal space mid clavicular line on the right anterior chest The back posterior pad should be placed in the standard posterior position on the patient s left as shown A 28 www zoll com 9650 0912 05 Rev C ECG Hhythm Analysis Algorithm Accuracy ECG Rhythm Analysis Algorithm Accuracy Sensitivity and specificity are expressions of ECG rhythm analysis algorithm performance when compared to ECG interpretation by a clinician or expert Sensitivity refers to the algorithm s ability to correctly identify shockable rhythms as a percentage of the total number of shockable rhythms Specificity refers to the algorithm s ability to correctly identify nonshockable rhythms as a percentage of the total number of nonshockable rhythms The data in Table A 4 and Table A 5 summarize the accuracy of the ECG rhythm analysis algorithm as tested against ZOLL s ECG rhythm database Rhythm sources included data records from ZOLL de
114. ient during defibrillation A severe shock can result Do not allow exposed portions of the patient s body to come into contact with metal objects such as a bed frame as unwanted pathways for defibrillation current may result Press and hold the SHOCK button until energy is delivered to the patient o SHOCK 2 ANALYZE CHARGE ENERGY SELECT 1 vV 9650 0912 05 Rev C ZOLL R Series Operator s Guide 3 9 CHAPTER 3 MANUAL DEFIBRILLATION Note If the defibrillator is not discharged within 60 seconds after reaching the selected energy level the unit automatically disarms itself During the 10 seconds prior to disarming the charge ready tone beeps intermittently The charge ready tone then stops the SHOCK button light goes off and the monitor message changes to DEFIB XXXJ SEL Press the CHARGE button to recharge the unit Once the energy is delivered the display simultaneously shows XXXJ DELIVERED and DEFIB XXXJ SEL After approximately 5 seconds the XXXJ DELIVERED message disappears and the DEFIB XXXJ SEL message remains to indicate the selected energy level Autoclavable Electrodes 3 10 ZOLL Autoclavable Internal Handles are designed for use with a manually operated ZOLL defibrillator to defibrillate the heart during open chest procedures Two types of Autoclavable Internal Handles are available e Molded Autoclavable Internal handles with integrated electrode spoons e Autoclavable Internal Handles wi
115. ies EtCO option can be used on adult patients 21 years of age and older and on pediatric patients as described in the following table Pediatric Subpopulation Approximate Age Range Newborn neonate Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12 21 years of age 1 10 www zoll com 9650 0912 05 Rev C Intended Use NIBP Intended Use NIBP The ZOLL R Series NIBP option is indicated for the non invasive measurement of arterial blood pressure for resting patients in critical care and in hospital transport The R Series NIBP option is designed to measure blood pressure for adult patients 21 years of age and older and for pediatric patients as described in the following table Pediatric Subpopulation Approximate Age Range Newborn neonate Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12 21 years of age ECG Monitoring The patient s ECG is monitored by connecting the patient to the unit via a 3 or 5 lead patient cable hands free therapy electrodes or through paddles Five seconds of ECG is presented on the display along with the following information e averaged heart rate derived by measuring R to R intervals e lead selection I II III aVR aVL aVF V with ECG cable PADDLES or PADS P1 P2 P3 when using OneStep Pacing cable with OneStep Complete electrodes
116. in the original containers if available or equivalent packaging Be sure the assigned service request number appears on each package For customers Return the unit to In the U S A ZOLL Medical Corporation 269 Mill Road Chelmsford MA 01824 4105 Attention Technical Service Department SH number Telephone 1 800 348 9011 In Canada ZOLL Medical Canada Inc 1750 Sismet Road Unit 1 Mississauga ON LAW 1R6 Attention Technical Service Department SH number Telephone 1 866 442 1011 In other locations The nearest authorized ZOLL Medical Corporation representative To locate an authorized service center contact the International Sales Department at ZOLL Medical Corporation 269 Mill Road Chelmsford MA 01824 4105 Telephone 1 978 421 9655 The ZOLL Serial Number Each ZOLL product displays a serial number that contains information about that product From left to right ZOLL serial numbers are structured as follows e Atwo character product code e A three character date of manufacture code e A product serial number of six or more alphanumeric characters The product code for the R Series defibrillator is AF 9650 0912 05 Rev C ZOLL R Series Operator s Guide 1 21 The first two characters of the date of manufacture code give the last two digits of the year for example 06 appears for products manufactured in 2006 The last character of the date of manufacture code gives the month in which t
117. in the upper right hand corner of the screen Unless configured otherwise heart rate alarms are preset at 30 bpm bradycardia and 150 bpm tachycardia The low heart rate alarm limit range is 20 bpm to 100 bpm 9650 0912 05 Rev C ZOLL R Series Operator s Guide 9 9 CHAPTER9 ECG MONITORING When the unit is monitoring a patient s heart rate via ECG the range for the high heart rate alarm limit is 60 to 280 bpm with a default setting of 150 bpm When the unit is monitoring a patient s pulse rate via pulse oximetry SpO however the unit automatically lowers the upper limit for the high heart rate alarm to 235 bpm The unit restores the original high heart rate alarm limit when ECG monitoring resumes Vital Sign Alarms Each vital sign has associated high and low alarm limits You can set alarm limits for patient heart rate and other optional monitoring parameters such as pulse oximetry SpO non invasive blood pressure NIBP or end tidal carbon dioxide monitoring EtCO if available The R Series unit has three levels of alarms e High Priority Reflects physiological parameters that are out of bounds When these alerts occur the unit emits a continuous audio tone highlights the alarming parameter and flashes the associated alarm bell e Medium Priority Reflects equipment related user correctable faults such as LEAD OFF The unit emits a two beep audio tone and displays a message for a timed period Low Priority
118. ion ENEE 1 6 Intended Use ECG Monitoring tior rasch p Er proa P REP eoque testo ku ME 1 7 Intended Use Real CPR Help ENEE 1 7 Defibrillator Complications RES PE 1 7 Defibrillator Output Ee 1 7 External Pacemaker Option l eorr rre ud Ed EA 1 8 Intended Use Pacemaker acea ie Pe rogato era ecu Ph ae Fla nteags 1 8 Pacemaker Complications tee mr anteu sr top ee Rr eub Oti den Ue EORR due ERR vx 1 9 Pediatic Pacing varene E T I LU UP 1 10 Intended Use SpO Monitoring AEN 1 10 Intended Use EtCOs Monitoring etm rere e ee tae xk Re Ee PR Ra SUPR RR 1 10 Intended Use EE 1 11 ZAERO EE 1 11 Recorder FUNCHON Pe 1 11 Paddles and Be 1 12 iiic M MN E 1 12 ode Heady SY STON is E 1 13 e Meel E Le 1 13 VE lee EE 1 14 Operator EE 1 15 x inisri dM m 1 16 Caution EE 1 18 Restarting the Defibrillator gn M ENEE eege 1 18 FDA Tracking Nee CEET 1 19 Notification of Adverse E E 1 19 Software License EE 1 20 SONIC ee ee 1 20 The ZOLL Serial NUIiDGE ec ico eot ot er rested egeo trt o mde e e Ere E Rad 1 21 9650 0912 05 Rev C ZOLL R Series Operator s Guide i TABLE OF CONTENTS Chapter 2 Product Overview Defibrillator Controls and Indicators uk 2 1 The Wegen EE 2 3 RI Ee HD 2 5 Patient Cables and Connectors EE 2 7 External Paddles EE 2 9 Working E TEE 2 11 Defib Mentor Mode Optional tee pete tra ee Sn Er EE ep ertet Mundie Een 2 12 Gommon TASKS sst gereent 2 13
119. ire remote monitor and defibrillator system prior to clinical use Synchronization delay for the system as a whole must not exceed 60 msec 9650 0912 05 Rev C ZOLL R Series Operator s Guide 5 5 CHAPTER 5 SYNCHRONIZED CARDIOVERSION Determine the Patient s Condition and Provide Care Following Local Medical Protocols Prepare Patient Prepare the patient as described in Prepare Patient on page 5 2 Follow the instructions provided with the external monitoring device to prepare the patient for ECG monitoring and synchronization with a separate defibrillator 1 Select DEFIB 5 6 Turn the Mode Selector to DEFIB Select the desired energy using the up and down arrow keys on the front panel or sternum paddle if using paddles 3 sHock 2 ANALYZE CHARGE ENERGY SELECT iv Press Sync On Off softkey then press the Remote Sync Softkey The selected energy level is displayed on the monitor The words REMOTE SYNC are displayed in place of the ECG trace and a REMOTE SYNC XXXJ SEL message appears on the display The ECG heartbeat indicator will flash with each synchronization pulse received from the remote monitoring device Unless otherwise configured the unit automatically exits Sync mode after each shock and if the Mode Selector is moved to MONITOR PACER or OFF Press the Syne On Off Remote Sync softkey sequence again to reactivate Remote Sync mode Changing the selected energy levels does not
120. itry Noninvasive transcutaneous pacing NTP is an established and proven technique This therapy is easily and rapidly applied in both emergency and nonemergency situations when temporary cardiac stimulation is indicated The output current of the pacemaker is continuously variable from 0 to 140 mA The rate is continuously variable from 30 to 180 pulses per minute ppm by increments of 2 The pacing output pulse is delivered to the heart via ZOLL hands free defibrillation pacing electrodes placed on the patient s back and the precordium The characteristics of the output pulse together with the design and placement of the electrodes minimize cutaneous nerve stimulation cardiac stimulation threshold currents and reduce discomfort due to skeletal muscle contraction The unique design of the R Series products allow clear viewing and interpretation of the electrocardiogram on the display without offset or distortion during external pacing Proper operation of the device together with correct electrode placement is critical to obtaining optimal results Every operator must be thoroughly familiar with these operating instructions Intended Use Pacemaker This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation The purposes of pacing include e Resuscitation from standstill or bradycardia of any etiology Noninvasive pacing has been used for re
121. ivate the unit turn the Mode Selector to OFF To manually disarm a charged or charging defibrillator do one of the following e Turn the Mode Selector to OFF MONITOR or PACER e Change the selected defibrillator energy For safety the R Series unit automatically disarms if left charged for more than either 60 or 120 seconds user configurable if the SHOCK button is not pressed 9650 0912 05 Rev C ZOLL R Series Operator s Guide 1 13 CHAPTER 1 GENERAL INFORMATION Warnings General Federal U S A law restricts this defibrillator to use by or on the order of a physician Only appropriately trained skilled personnel who are familiar with equipment operation should perform emergency defibrillation The prescribing physician should determine what training such as Advanced Cardiac Life Support ACLS or Basic Life Support BLS certification is appropriate Only skilled personnel trained in Advanced Cardiac Life Support ACLS and who are familiar with equipment operation should perform synchronized cardioversion The precise cardiac arrhythmia must be determined before attempting defibrillation These operating instructions describe the functions and proper operation of the R Series products They are not a substitute for a formal patient care training course Operators should obtain formal training from an appropriate authority before using this defibrillator for patient care Proper operation of the unit and correct electro
122. ly The R Series defibrillator gives you two readiness testing options e Automatic e Manual Note Both automatic and manual test results are automatically recorded to internal memory Maintenance Frequency Visual Inspection Once per day inspect Code Readiness indicator Code Readiness Test Once per day unless configured Off in which case perform manual Automatic defibrillator testing daily Manual Defibrillator Once per week daily if Code Readiness Test is configured Off Testing When the R Series device ships from ZOLL the Code Readiness indicator may show a red X A manual readiness test should be performed in addition to other site specific tests such as HiPot and Leakage prior to putting the device into service Follow the procedure on page 12 3 and verify that the Code Readiness indicator displays a green v 9650 0912 05 Rev C ZOLL R Series Operator s Guide 12 1 CHAPTER 12 MAINTENANCE Routine Procedures Daily Visual Inspection 12 2 Equipment Ensure that the unit is clean with no fluid spills and free of visible damage Inspect all cables cords and connectors for good condition no cuts fraying or bent pins Check that the paddle surfaces are clean and free of electrolyte gel and other contaminants Supplies and accessories Verify the presence proper condition and quantity of all disposable supplies such as ECG monitoring electrodes electrode gel stripchart paper
123. n www zoll com 9650 0912 05 Rev C Operator s Guide Updates Operator s Guide Updates An issue or revision date for this manual is shown on the front cover If more than three years have elapsed since this date contact ZOLL Medical Corporation to determine if additional product information updates are available All users should carefully review each manual update to understand its significance and then file it in its appropriate section within this manual for subsequent reference Product documentation is available through the ZOLL website at www zoll com From the Products menu choose Product Manuals Unpacking Carefully inspect each container for damage If the shipping container or cushion material is damaged keep it until the contents have been checked for completeness and the instrument has been checked for mechanical and electrical integrity If the contents are incomplete if there is mechanical damage or if the defibrillator does not pass its electrical self test U S A customers should call ZOLL Medical Corporation 1 800 348 9011 Customers outside of the U S A should contact the nearest ZOLL authorized representative If the shipping container is damaged also notify the carrier Symbols Used on the Equipment Any or all of the following symbols may be used in this manual or on this equipment Symbol Description Dangerous voltage Attention consult accompanying documents Fragile handle with c
124. n s until energy is delivered to the patient 7 No apparent energy delivery to patient Under certain circumstances some patients will not show a physical reaction when energy is delivered Perform defibrillator self test Check for CHECK PADS and POOR PAD CONTACT messages alternating on the monitor If hands free therapy electrodes are used ensure proper placement and contact Review the discharge stripchart for Joules current delivered 8 CHECK PADS or ATTACH PADS message Verify proper OneStep cable hands free therapy electrode connection by disconnecting and reconnecting the OneStep cable and hands free therapy electrodes Ensure proper contact of hands free therapy electrodes and that the patient does not have excessive hair beneath the electrodes OneStep cable is defective If message persists disconnect OneStep cable from therapy pads and plug cable into test connector CHECK PADS or ATTACH PADS should change to DEFIB PAD SHORT Manual mode only Try using paddles to defibrillate 9 SELECT PADS message ECG Analysis will operate only when hands free therapy electrodes are attached to the patient Disconnect paddle and connect hands free therapy electrodes for use in Advisory defibrillation Activate manual mode to use Paddles 10 NOISY ECG RETRY ANALYSIS message Check for proper application and adhesion of hands free therapy electrodes Check to make sure that nobody is touchin
125. nd IIT and augmented leads aVR aVL and aVF The selected lead is always displayed and printed in the Trace 1 uppermost position The other two leads are displayed in the Trace 2 and 3 positions For example if aVL is the selected Trace 1 lead the Trace 2 and 3 positions display aVR and aVF respectively 3 ECG leads will also be printed when an ECG lead is selected if the Print 3 Leads When Leads are Sel configuration option is set to YES Refer to the R Series Configuration Guide for instructions See Thru CPR Filter Optional When OneStep CPR electrodes or OneStep Complete electrodes are in use the R Series unit allows simultaneous display and printing of the selected ECG lead and the same ECG lead with CPR filtering applied The CPR filter uses signals from the electrode s CPR sensor to help reduce artifact in the ECG signal caused by mechanical compressions of the chest thereby providing a clearer view of the ECG during periods of CPR For more detailed information on this feature see Chapter 7 See Thru CPR Optional To apply the See Thru CPR Filter to the selected ECG lead and display it 1 Press the Options softkey then press the Traces softkey 2 Press the Trace 2 or Trace 3 softkey 3 Press Filt ECG If Display Filtered ECG in Tracel is configured the unit displays the filtered ECG in Tracel You can then switch between filtered and unfiltered ECG using the Enable Disable Filt ECG softkey With the unfilte
126. ng a report press the RECORDER button or turn off the unit You can print an unlimited number of copies of the report by repeating this procedure Note Summary report printing is interrupted when a ECG analysis is in progress or the defibrillator is charging or charged Also if a summary report is printing and you press the Report softkey to print another type of report such as the log report the device stops printing the summary report and begins printing the selected report If the recorder is out of paper when the Report Data softkey and a corresponding print softkey are pressed a CHECK RECORDER message appears on the display Load paper and press the Report Data softkey again to select the report to print 9650 0912 05 Rev C ZOLL R Series Operator s Guide 10 7 CHAPTER 10 EVENT RECORDS AND REPORTS Printing a Partial Summary Report To print a partial summary report 1 Press the Report Data softkey then press Print Chart 2 Press the Print Range softkey 3 Use the First Event Prev Event Next Event and Last Event softkeys to locate the event from which printing will start all subsequent events are also printed 4 Press the Print softkey The unit prints all records from the selected item to the most recent Note The overview information such as the number of shocks delivered covers all stored summary data not just the selected range Full Disclosure Recording Along with event information captured in Summar
127. nly Do not immerse any part of the defibrillator or its accessories in water Do not use ketones such as acetone or MEK on the defibrillator Do not sterilize the defibrillator Avoid using abrasives including paper towels on the display window www zoll com 9650 0912 05 Rev C Manual Defibrillator Testing Take special care to clean the defibrillation paddles after each use The buildup of gel can interfere with ECG monitoring through the paddles can adversely effect energy delivery and may reduce operator safety Keep the paddle handles clean as well Loading Stripchart Paper The unit displays the message CHECK RECORDER when the printer is activated without paper or if the supply runs out during printing Use ZOLL stripchart paper Part number 8000 0300 To load paper into the stripchart printer 1 Press the release button and allow the printer door to open then remove any paper o 8 E TIOZ mea Figure 12 5 Opening the Printer Door 2 Refer to the illustration inside of the paper compartment for proper paper orientation and place a new pad of stripchart paper in the tray Note Paper feeds from the top of the stack with gridlines facing down 3 Pull enough paper off the pad so that paper extends out of the unit when the printer cover is closed 4 Close the printer cover by pressing down lightly on the edge of the cover next to the release button B
128. not be connected to internal pacemaker electrodes Pacemaker Complications WARNING Ventricular fibrillation does not respond to pacing and requires immediate defibrillation Therefore the patient s dysrhythmia must be determined immediately so that you can employ appropriate therapy If the patient is in ventricular fibrillation and defibrillation is successful but cardiac standstill asystole ensues you should use the pacemaker Ventricular or supraventricular tachycardias can be interrupted with pacing but in an emergency or during circulatory collapse synchronized cardioversion is faster and more certain Pulseless electrical activity PEA can occur following prolonged cardiac arrest or in other disease states with myocardial depression Pacing might then produce ECG responses without effective mechanical contractions making other effective treatment necessary Pacing can evoke undesirable repetitive responses tachycardia or fibrillation in the presence of generalized hypoxia myocardial ischemia cardiac drug toxicity electrolyte imbalance or other cardiac diseases Pacing by any method tends to inhibit intrinsic rhythmicity Abrupt cessation of pacing particularly at rapid rates can cause ventricular standstill and should be avoided Noninvasive temporary pacing can cause discomfort of varying intensity which occasionally can be severe and preclude its continued use in conscious patients Similarly unavoidable skel
129. ns if using paddles is pressed and held the unit discharges with the next detected R wave thus avoiding the vulnerable T wave segment of the cardiac cycle When in the Sync mode the unit displays markers above the ECG trace to indicate the points in the cardiac cycle R waves where discharge can occur 9650 0912 05 Rev C ZOLL R Series Operator s Guide 5 1 CHAPTER 5 SYNCHRONIZED CARDIOVERSION vo V i vM 8 Marker indicates each detected R wave during synchronization Verify that markers are clearly visible on the monitor and their location is appropriate and consistent from beat to beat If necessary use the LEAD and SIZE buttons to establish settings that yield the most consistent Sync marker pattern The synchronized cardioversion procedure for ZOLL hands free therapy electrodes is identical to that for paddles with the exception of the SHOCK button location The R Series defibrillator supports two types of synchronized cardioversion e Synchronized Cardioversion The R Series monitors the patient s ECG and synchronizes shock delivery with this ECG source For instructions refer to Synchronized Cardioversion Procedure below e Remote Synchronized Cardioversion An external device such as a patient monitor monitors the patient s ECG and provides a synchronization pulse to the R Series Sync In Marker Out connector The R Series synchronizes shock delivery with these external pulses Note When using the
130. nstall a compact flash card 1 Insert the card with its label side up into the front slot on the lower left side of the unit You can install a compact flash card while the unit is operating or while it is turned off 2 Slide the card into the slot until it is firmly seated Figure 11 1 Inserting Compact Flash Card www zoll com 9650 0912 05 Rev C Transferring a Full Disclosure File to a Compact Flash Card To remove a compact flash card Press the release button and pull the card out of the slot Figure 11 2 Removing a Compact Flash Card Transferring a Full Disclosure File to a Compact Flash Card Make sure that a compact flash card is installed in the slot on the left side of the device To transfer data to a compact flash card 1 Turn the Mode Selector to MONITOR 2 Press the Report Data softkey 3 Press the Transfer Mode softkey 4 Press the Report to Card softkey The message TRANSFERRING DATA is displayed All data is transferred to the installed CF data card Note Do not remove the CF card while files are transferring Corruption may result on the data card When all files are transferred the message DATA TRANSFERRED is displayed You can now remove the CF card from the R Series unit To exit Data Transfer mode press the Exit Transfer softkey Transferring Device Check and Activity Log Files to a Compact Flash Card Make sure that a compact flash card is installed in the slot on the left sid
131. nt panel Changing the selected energy while the unit is charging or charged causes the defibrillator to disarm itself Press the CHARGE button again to charge the unit to the newly selected energy level After charging to the selected energy the charge indicator on the apex paddle lights A distinctive charge ready tone sounds and the message DEFIB XXXJ READY is displayed The defibrillator is now ready to discharge www zoll com 9650 0912 05 Rev C Autoclavable External Paddles 3 Deliver Shock WARNING Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge Do not touch the bed patient or any equipment connected to the patient during defibrillation A severe shock can result Do not allow exposed portions of the patient s body to come into contact with metal objects such as a bed frame as unwanted pathways for defibrillation current may result Apply a force of 10 12 kilograms 22 26 4 pounds to each paddle in order to minimize patient impedance and achieve optimal results Using your thumbs simultaneously press and hold both SHOCK buttons one on each paddle until energy is delivered to the patient Caution Use only thumbs to depress the SHOCK buttons Failure to do so could result in the inadvertent depression of the ENERGY SELECT buttons causing the defibrillator to disarm itself Once the energy is delivered the display simultaneously shows XXXJ DELIVERED
132. o print the Code Readiness Log 1 In MONITOR mode press the Report Data softkey then the Test Log softkey A menu appears with the print options 2 To print a specific test use the Prev Test and Next Test softkeys to select the test then press Print Test or press Print Test Log to print the log of all of the tests www zoll com 9650 0912 05 Rev C Manual Defibrillator Testing Code Readiness Test Log Date 10 NOV 06 00 01 03 Battery OK Type Automatic 30J Self Test OK Defib OK OneStep Cable OK Pace OK ECG OK AC Power Connected Print Print Test Log Test Return Figure 12 1 Code Readiness Test Log Print Display a 4 Code Readiness Test Log COMMENTS i 09 NOV 06 11 23 21 Manual PASS 10 Nov 06 00 01 03 Automatic PASS LOG COMPLETE First Test Time 09 Nov 06 11 23 21 Last Test Time 10 Nov 06 00 01 03 SYSTEM SERIAL NUM 60000158 DEVICE ID 00000000 000 Figure 12 2 Code Readiness Test Log wu Code Readiness Test Report COMMENTS Date 10 Nov 06 00 01 03 Ind Type Automatic Defib OK i Pace OK Readiness Test PASS 10 NOV 06 00 01 03 ECG OK AC Power Connected Battery Dk 30 Self Test OK Si OneStep Cable OK SYSTEM SERIAL NUM 00000158 DEVICE ID 090000000 000 j o wn 4 Figure 12 3 Code Readiness Test Report 9650 0912 05 Rev C ZOLL R Series Operator s Guide 12 7 CHAPTER 12 MAINTENANCE Setting Time and Date To set the unit s time and date 1 Set the
133. ode and a status text message box appears in the middle of the screen and describes the status of the file being sent When the full disclosure file is transferred the messages TRANSFER COMPLETE and Full Disclosure Was Sent are displayed TRANSFER COMPLETE Full Disclosure Was Sent DATA TRANSFER MODE Erase Report Return 7 To erase the report press the Erase Report softkey To keep the report and return to the Transfer Mode screen press the Return softkey 9650 0912 05 Rev C ZOLL R Series Operator s Guide 11 5 CHAPTER 11 FILE TRANSFER Note If you are out of the range of an access point the data will not be transferred and the message Wi Fi Network Not Found is displayed Press the Return softkey to return to the previous menu and try again TRANSFER FAILED Full Disclosure Not Sent DATA TRANSFER MODE To exit Wi Fi DataTransfer Mode press the Return softkey and then the Exit Transfer softkey or switch the Mode Selector to OFF Transferring Device Check and Activity Log Files Through Wi Fi Optional Before you begin ensure the Wi Fi card is properly seated with the name R Series DATA COMM facing up in the compact flash slot Make sure that the Wi Fi guard has been attached To transfer data through Wi Fi Turn the Mode Selector to MONITOR Press the Report Data softkey Press the Transfer Mode softkey Press the More softkey Press the Defib History to Wi Fi softkey Un BW
134. of the following e Connect unopened OneStep electrodes to the OneStep cable Unopened OneStep electrodes act as a test port The test port capability no longer functions once the electrode package is opened and electrodes are deployed e Connect the OneStep cable to paddles and seat the paddles in the paddle wells Verify adult paddles are installed and pushed all the way into the paddle wells or e Connect the OneStep cable to the test port Follow the instructions in either the next section Procedure for Testing with Paddles or in Defibrillator Testing with Hands Free Therapy Electrodes on page 12 5 Defibrillator Testing with Paddles WARNING When performing this check use your thumbs to operate the SHOCK buttons in order to avoid inadvertent shock No portion of the hand should be near the paddle electrode plates To test the manual defibrillation function using paddles Turn the unit off for at least 10 seconds 2 Turn the Mode Selector to DEFIB The unit emits a four beep tone indicating successful completion of the power on self test The ECG source is PADDLES and ECG size is X1 DEFIB 120J SEL appears on the display The ECG trace appears as a solid line while the paddles are seated in the paddle wells 3 Press the ENERGY SELECT buttons to set the energy to 30 joules 4 Press the CHARGE button on the apex handle 5 When the charge ready tone sounds press the ENERGY SELECT buttons to change
135. om the ECG connector and use a 3 or 5 lead ECG cable 9650 0912 05 Rev C ZOLL R Series Operator s Guide 2 7 CHAPTER 2 PRODUCT OVERVIEW OneStep Cable OneStep Pacing Cable Figure 2 4 OneStep Cables OneStep Cable Manager Optional As an option the OneStep Cable Manager is available to store and organize cables OneStep Cable Manager Figure 2 5 The R Series with the Optional OneStep Cable Manager Side View 2 8 www zoll com 9650 0912 05 Rev C Defibrillator Controls and Indicators Power Cord The AC power cord is used to operate the R Series unit when battery power is not being used An additional extension cord is available for use when the cable organizer accessory is attached to the unit The extension cord plugs into the main AC power cord as shown below External Paddles 4 Paddles are defibrillation proof Type BF equipment The external paddles on the R Series device are used for defibrillation and synchronized cardioversion Caution You cannot use paddles for ECG analysis or pacing Defibrillation paddles can be used for ECG monitoring when it is not practical to apply ECG electrodes Press the LEAD button to select PADDLES as the ECG source The paddles are stowed in wells on either side of the unit To release the paddles grasp the handles and then press down on the latch button above each paddle Figure 2 6 Releasing the Paddles 9650 0912 05 Rev C ZOLL R Series Operator s Guide 2 9
136. omplete electrodes are attached To prepare for Code Readiness tests do the following 1 Connect the R Series to AC mains 2 Do one of the following e Connect unopened OneStep electrodes to the OneStep cable Unopened OneStep electrodes act as a test port The test port capability no longer functions once the electrode package is opened and electrodes are deployed e Connect the OneStep cable to paddles and seat the paddles in the paddle wells Verify adult paddles are installed and pushed all the way into the paddle wells or e Connect the OneStep cable to the test port After the successful completion of the readiness check the Code Readiness indicator displays a green check indicating that the unit is ready for therapeutic use If configured the R Series will print a test record following automatic test completion The unit performs an automatic device check if configured to do so once per day at the configured time For information refer to the R Series Configuration Guide Manual Defibrillator Testing The following test performs e Power on sequence check e SHOCK button and delivered energy check e Pacer check e Recorder check 9650 0912 05 Rev C ZOLL R Series Operator s Guide 12 3 CHAPTER 12 MAINTENANCE If a LOW BATTERY message appears during testing the battery is close to depletion and should be replaced or recharged Before you begin 1 Connect the R Series to AC mains 2 Do one
137. on To avoid electrosurgery burns at monitoring sites ensure proper connection of the electrosurgery return circuit so that the return paths cannot be made through monitoring electrodes or probes During electrosurgery observe the following guidelines to minimize ESU interference and provide maximum user and patient safety e Keep all patient monitoring cables away from earth ground ESU knives and ESU return wires Use electrosurgical grounding pads with the largest practical contact area Always assure proper application of the electrosurgical return electrode to the patient www zoll com 9650 0912 05 Rev C Monitoring the Patient s ECG Monitoring the Patient s ECG Set the Controls Set the Mode Selector to MONITOR then press the LEAD button until the desired lead configuration is selected The selected lead is indicated at upper right of the display LEAD SIZE ALARM SUSPEND RECORDER m S MONITOR If the unit displays the ECG LEAD OFF POOR LEAD CONTACT or CHECK PADS message inspect the ECG electrodes or therapy electrodes lead wires and cables for proper connections If heart rate alarms are enabled with paddles selected the unit displays the messages SELECT LIMB LEADS and VF ALARMS OFF If you see these messages select limb or precordial leads If you want to change the size of the displayed ECG waveform press the SIZE button until the desired waveform size is displayed Options a
138. onal e Compact flash card slot To retrieve and review event files you need one of the following software packages installed on the receiving equipment e ZOLL CodeNet Central software e ZOLL RescueNet Code Review software To retrieve and review maintenance files you need ZOLL Maintenance software installed on the receiving equipment R Series defibrillators use the Microsoft Windows file structure for stored records Files can be transferred to a properly equipped Windows based personal computer or handheld device With CodeNet Central software the personal computer allows the user to access the files for review 9650 0912 05 Rev C ZOLL R Series Operator s Guide 11 1 CHAPTER 11 FILE TRANSFER Wi Fi Optional The R Series has an optional Wireless Ethernet function that transfers data files using the IEEE 802 11 protocol Wi Fi This includes a ZOLL R Series Data COMM Card and a protective guard that must be installed on the unit See R Series Data COMM Instructions for Use and Wi Fi Guard Installation Part number 9652 000395 for instructions on how to install the Wi Fi Guard Do not clean the Wi Fi Data COMM Card with isopropyl alcohol All file transfer operations are terminated when the defibrillator is switched to either Defib mode or Pacing mode or powered off Installing or Removing a Compact Flash Card 11 2 Before you begin check the card and its connector to ensure that they are clean and undamaged To i
139. ond between the See Thru CPR waveform and the Trace 1 ECG waveform If configured to display the CPR Dashboard the R Series unit can also be configured to display the filtered ECG in Tracel When the unit is configured to display the filtered ECG in Tracel the softkey Disable Filt ECG appears which you can press to disable display of the filtered ECG in Tracel and replace it with the unfiltered ECG When the unit displays the unfiltered ECG in Tracel the softkey Enable Filt ECG appears which can redisplay the filtered ECG in Tracel Examples The following examples show the effects of See Thru CPR filtering on ECG signals contaminated with CPR artifacts Each example includes e ECG signal with CPR artifact e ECG signal after the See Thru CPR filter has removed CPR artifact e Indication of the period during which See Thru CPR is active e CPR signal to show when CPR activity occurred 7 2 www zoll com 9650 0912 05 Rev C Using See Thru CPR The following figure shows a patient in Fine VF It is difficult for a rescuer to discern this rhythm during CPR compressions When the CPR filter turns on the Fine VF rhythm becomes more obvious Raw ECG Filtered ECG CPR 0 00 Raw ECG x Filtered ECG CPR 0 12 l Raw ECG s Filtered ECG CPR 024 9650 0912 05 Rev C FineVF Raw ECG FineVF Raw ECG Raw ECG 12 5 mm sec 5 mm mV ZOLL R Series Operator s Guide 7
140. orded are the ECG lead ECG size patient s heart rate actual event time and date The date time printed on the top of the strip corresponds to the ECG data occurring 6 seconds before the event If the pacer is on during this event the pacing rate and pacing current are also recorded a 4 11 03 14 29 way 89 NAME HEART RATE ALARM 29 MAY 09 11 03 20 ECG LEAD PADS Sp02 951 ECG SIZE 1 5 EtCO2 Comp 02 amp N20 f HEART RATE 185 nt RR 0 M NIBP mnHg 119 82 94 M a 1 MEAS TIME 11 02 i Mc NE 8 67 21 Hz Figure 10 6 Heart Rate Alarm Activated Format VF Alarm Activated Format The summary report function records 18 seconds of patient ECG data associated with each VF alarm Also recorded are the ECG lead ECG size actual event time the number of noise events and the message CHECK PATIENT The date time printed on the top of the strip corresponds to the ECG data occurring 6 seconds before the event at 4 11 03 20 29 MAY 09 CHECK PATIENT NAME DEFIB ADVISORY 29 MAY 09 11 03 26 Spo2 95 ECG LEAD PADS Etco2 20 AAA ibid NONE SUMMARY COMPLETE Z0LLR 00000000 04 57 01A5 0 67 21 Hz Figure 10 7 VF Alarm Activated Format 9650 0912 05 Rev C ZOLL R Series Operator s Guide 10 5 CHAPTER 10 EVENT RECORDS AND REPORTS Recorder On Format The summary report function records 6 seconds of patient ECG prior to turning on the recorder Also recorded are the ECG lead ECG size
141. ormance Incorporating New Waveforms and Enhancing Safety Circ J Am Heart Assoc 1997 95 1677 1682 the task force suggests that to demonstrate superiority of an alternative waveform over standard waveforms the upper boundary of the 90 confidence interval of the difference between standard and alternative waveforms must be lt 0 ie alternative is greater than standard 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 25 APPENDIX A SPECIFICATIONS Successful defibrillation with rectilinear biphasic shocks was achieved with 5846 less delivered current than with monophasic shocks 14 1 amperes versus 3347 amperes p 0 0001 The difference in efficacy between the rectilinear biphasic and the monophasic shocks was greater in patients with high transthoracic impedance greater than 90 ohms The first shock first induction efficacy of biphasic shocks was 100 versus 63 for monophasic shocks for patients with high impedance p 0 02 95 confidence interval of the difference of 0 0217 to 0 759 and 90 confidence interval of the difference of 0 037 to 0 706 Monophasic Biphasic First shock efficacy 63 100 high impedance patients p value 0 02 95 confidence interval 0 02196 to 0 759 90 confidence interval 0 037 to 0 706 A single patient required a second biphasic shock at 150 joules to achieve 100 efficacy versus six patients for whom monophasic shocks of up to 360 joules we
142. ously Check ECG cable for damage e Patient R to R interval varying Pace rate close to patient s heart rate e Verify rate is set appropriately 5 Heart rate display reads 0 with e Check patient s pulse proper pacing capture displayed e Select different ECG Lead configuration on ECG trace 6 Bedside Central Station Telemetry None the patient monitor ECG inputs are overloaded by ECG display becomes erratic when pacing pacer signals ECG can only be monitored by the R Series or pacing device while pacing www zoll com 9650 0912 05 Rev C Defibrillator Defibrillator Symptom Recommended Action 1 Excessive artifact detected when using paddles as ECG source Ensure PADDLES is selected Firmly press paddles against patient skin Use gel on paddles Clean paddle surface Check and clean between adult and pediatric shoe Check cable for damage Use ECG electrodes 2 Defibrillator will not charge energy level does not increment on display Ensure that SHOCK button s on paddles or front panel are not stuck on Replace the battery pack Charge time to 200 J exceeds 10 seconds Typical in a low battery condition up to 20 seconds Plug device into AC power Install fully charged battery pack Energy does not discharge when the SHOCK button s is pressed 60 seconds have elapsed in manual mode since initial charge ready Energy was internally discharged Device i
143. patient end of a OneStep cable to this port to allow device checks 9 Speaker Issues voice prompts 10 Paper Compartment Holds the paper for the stripchart printer 11 RELEASE button Allows access to the paper compartment 12 Battery compartment Holds a rechargeable lithium ion battery pack 13 Grounding post Electrical ground for biomedical test equipment 14 AC mains connector For connecting the device to an AC power source 15 Patient connectors For details refer to Patient Cables and Connectors on page 2 7 www zoll com 9650 0912 05 Rev C The Front Panel Defibrillator Controls and Indicators The front panel of the R Series device includes the display screen softkeys battery indicator AC power indicator Code Readiness indicator SHOCK button and control panel The control panel configuration varies slightly depending on the model See Figure 2 1 Display screen NIBP Button optional Figure 2 1 Battery AC power Code indicator indicator Readiness x Been CT Hi 3 suock 2 LEAD ANALYZE CHARGE SIZE PN ALARM ENERGY SUSPEND SELECT iv RECORDER Mode Selector OUTPUT o RATE mA ppm Six softkeys R Series Front Panel Table 2 2 describes the controls and indicators that appear on the front panel Table 2 2 R Series Controls and Indicators Control or Indicator Description Display screen Shows therapeutic settings physiological waveforms and ot
144. patient s heart rate actual event time and date The date time printed on the top of the strip corresponds to the ECG data occurring 6 seconds before the event If the pacer is on during this event the pacing rate and current are also recorded If Async pace is active the annotation ASYNC PACE is recorded LM 11 05 58 29 MAY 09 NAME RECORDED ECG 29 MAY 09 11 06 04 ECG LEAD PADS Sp02 95 ECG SIZE 1 5 Etco2 i Comp 02 amp N20 li D HEART RATE 72 RR e E D f NIBP mmHg 119 82 94 m et ahh a U MEAS TIME 11 02 SUMMARY COMPLETE i ADLER 86000066 04 57 8145 0 67 21 Hz Figure 10 8 Recorder On Format Analyze Format The summary report function records six seconds of pre analysis ECG 12 seconds of ECG recorded during the analysis and the annotation SHOCK ADVISED or NO SHOCK ADVISED The date time printed on the top of the strip corresponds to the ECG data occurring 6 seconds before the analysis was started The analysis normally consists of three consecutive 3 second ECG rhythm analyses Each segment is represented at the top of the strip with either an asterisk for shockable or a dash for non shockable The unit automatically charges to the preconfigured energy level upon detection of the first shockable segment If at least two of the three analyses determine that the patient has a shockable rhythm the unit will prompt the operator to shock the patient If two or more of the three 3 secon
145. patients can result in the delivery of excessive energy doses 9650 0912 05 Rev C ZOLL R Series Operator s Guide 4 1 CHAPTER 4 ADVISORY DEFIBRILLATION Advisory Defibrillation Procedure Determine the Patient s Condition Following Local Medical Protocols Verify e Unconsciousness Absence of breathing e Absence of pulse Begin CPR Following Local Medical Protocols Request additional assistance Prepare Patient Remove all clothing covering the patient s chest Dry chest if necessary If the patient has excessive chest hair clip or shave it to ensure proper adhesion of the electrodes Attach hands free therapy electrodes according to instructions on the electrode packaging and as described in Therapy Electrode Application on page 3 6 Ensure that the electrodes are making good contact with the patient s skin and are not covering any part of the ECG electrodes If therapy electrodes are not making good contact with the patient s skin the unit issues the messages CHECK PADS and POOR PAD CONTACT and does not allow delivery of energy If a short circuit exists between the electrodes the unit issues the message DEFIB PAD SHORT 1 Select DEFIB Turn the Mode Selector to DEFIB The unit displays DEFIB 120J SEL on the monitor RECORDER Energy Select The default energy selections for adult patients are e Shock 1 120 joules e Shock 2 150 joules e Shock 3 200 joules 4 2 www zoll com 9650 0912 05 Rev C
146. peration as follows 1 Turn the Mode Selector to OFF 2 If necessary replace a depleted battery with a fully charged pack or connect the defibrillator to AC mains 3 Turn the Mode Selector to the desired operating mode to restart the unit This sequence is necessary to restart the defibrillator and can also be used to clear some fault messages when immediate use of the defibrillator is required If restarted after a shutdown period of 10 seconds or more the unit restores all settings such as ECG lead ECG size and alarm state and limits to their power up default values After restoring device operation you might need to reinstate previously selected non default settings www zoll com 9650 0912 05 Rev C FDA Tracking Requirements FDA Tracking Requirements U S Federal Law 21 CFR 821 requires the tracking of defibrillators Under this law owners of this defibrillator must notify ZOLL Medical Corporation if this product is e received e lost stolen or destroyed e donated resold or otherwise distributed to a different organization If any such event occurs contact ZOLL Medical Corporation in writing with the following information 1 Originator s organization Company name address contact name and contact phone number 2 Model number and serial number of the defibrillator 3 Disposition of the defibrillator for example received lost stolen destroyed distributed to another organization new location
147. ps and the defibrillator remains in Sync mode Once the energy is delivered the display simultaneously shows XXXJ DELIVERED and DEFIB XXXJ SEL After approximately 5 seconds the XXXJ DELIVERED message disappears and the DEFIB XXXJ SEL message remains to indicate the selected energy level If additional countershocks are necessary readjust the energy level as necessary press the Sync On Off softkey followed by the Sync softkey if your unit supports Remote Sync and repeat Note that SYNC XXXJ SEL must be displayed prior to pressing the CHARGE button If the ANALYZE button is pressed while the unit is in Sync mode the unit displays the REMOVE SYNC message and does not allow ECG rhythm analysis until the unit is taken out of Sync mode Remote Synchronized Cardioversion Procedure The R Series may be configured to receive defibrillation synchronization pulses from a remote ECG monitoring device See the R Series Configuration Manual Be sure that the remote device is connected to the Sync In Marker Out connector on the R Series unit The remote device must have a Sync out connector and a cable must be provided to connect the two devices Ensure the remote device conforms with the Sync In Marker Out specifications described in Appendix A Defibrillator Specifications WARNING A lethal arrhythmia may be induced through improper synchronization Qualified personnel within the hospital should verify synchronization delay for the ent
148. ptions softkey then press Traces 2 Press either the Trace 2 or Trace 3 softkey 3 Press CPR 9650 0912 05 Rev C ZOLL R Series Operator s Guide 6 5 CHAPTER 6 REAL CPR HELP 6 6 www zoll com 9650 0912 05 Rev C Chapter 7 oee Thru CPR Optional WARNING The See Thru CPR filter works only when the R Series defibrillator is monitoring CPR The See Thru CPR filter stops if The unit is in pace mode Patient impedance is invalid OneStep CPR electrodes or OneStep Complete electrodes are no longer detected The See Thru CPR filter will not remove all CPR artifact Always stop CPR to verify the patient s ECG rhythm before making treatment decisions The See Thru CPR filter does not operate during ECG rhythm analysis Always stop chest compressions during ECG rhythm analysis to avoid incorrect results caused by the presence of CPR artifact Diagnostic bandwidth is never applied to the See Thru CPR waveform See Thru CPR enables the rescuer to see a close approximation of the patient s underlying ECG rhythm while performing CPR See Thru CPR is available if the R Series is monitoring CPR Chest compressions introduce CPR artifact into the ECG signal See Thru CPR uses a filter that relies on the correlation between CPR compressions as detected by the ZOLL Onestep CPR or OneStep Complete electrodes and the CPR artifact to remove much but not all of the artifact from the ECG signal Under some conditions re
149. r shave it to ensure proper adhesion of the electrodes Attach hands free therapy electrodes according to instructions on the electrode packaging Ensure that the therapy electrodes are making good contact with the patient s skin and are not covering any part of the ECG electrodes Connect the hands free therapy electrodes to the OneStep cable if not preconnected If defibrillation electrodes are not making good contact with the patient s skin the unit issues the messages CHECK PADS and POOR PAD CONTACT and does not allow delivery of energy If a short circuit exists between the electrodes the unit issues the message DEFIB PAD SHORT Therapy Electrode Application WARNING Poor adherence and or air under the therapy electrodes can lead to the possibility of arcing and skin burns 1 Apply one edge of the pad securely to the patient 2 Roll the pad smoothly from the applied edge to the other being careful not to trap any air pockets between the gel and skin 3 6 www zoll com 9650 0912 05 Rev C Emergency Defibrillation Procedure with Hands Free Therapy Electrodes Note If it is not possible to place the BACK electrode on the patient s back place the electrodes in the standard apex sternum positions Effective defibrillation results but pacing will usually be less effective WARNING Application of adult electrodes to a pediatric patient will result in the automatic selection of adult energy levels If needed manually
150. r to DEFIB PACER or OFF www zoll com 9650 0912 05 Rev C Transferring Full Disclosure Files Through Wi Fi Optional Transferring Full Disclosure Files Through Wi Fi Optional Before you begin ensure the Wi Fi card is properly seated with the name R Series DATA COMM facing up in the compact flash slot Make sure that the Wi Fi guard has been attached To transfer data through Wi Fi Turn the Mode Selector to MONITOR Press the Report Data softkey Press the Transfer Mode softkey Press the Report to Wi Fi softkey The Enter Report ID screen will appear and you will be prompted to enter a unique report ID Use the arrow keys to select the desired characters then press the Enter Char softkey Pressing the key will change the table to a different set of characters including upper case letters To cancel and return to the previous screen use the arrow keys and select Cancel Un BW N Enter Report ID Pat230 NE poaconooncice falafel ofall s efolo mlx bet EBBBOBBHEBBBHUUOESS BHONDHEDUHHNEIES DATA TRANSFER MODE Ent Send S d 4 Bd Char SESCH Note Enable Report ID must be enabled in System Configuration mode for the report screen to appear See the R Series Configuration Guide If Enable Report ID is set to No then the screen will not be displayed and the report will be sent immediately 6 To send the report press the Send Report softkey The R Series is now in Wi Fi Transfer M
151. rapy electrodes you must use the controls on the front panel of the unit To switch between paddles and hands free therapy electrodes remove the OneStep cable from the apex paddle and connect the hands free therapy electrodes to the cable The Advisory function cannot be activated unless hands free therapy electrodes are attached to the OneStep cable and used as the ECG monitoring lead The R Series can monitor the patient s ECG while pacing without the need for a separate ECG cable and ECG electrodes This also allows demand pacing when separate ECG electrodes are either not connected or unavailable OneStep pacing capability requires the OneStep Pacing cable along with OneStep Pacing electrodes or OneStep Complete electrodes Note The ZOLL OneStep Pacing electrodes or OneStep Complete electrodes MFE Pads Pediatric MFE Pads stat padz and ECG electrodes are disposable single use items You should always check the expiration date on the electrode packaging Do not use expired electrodes which might result in false patient impedance readings and affect the level of delivered energy or cause burns This symbol on the electrode package is accompanied by the expiration date For stat padz Il this symbol does not appear the expiration date appears on the lower right corner of the label below the lot number The R Series defibrillator reads and reports the expiration date for OneStep Pacing electrodes OneStep CPR electrodes and One
152. ration electromagnetic2 immunity for life supporting equipment and systems The life support functions of the R Series are intended for use in the electromagnetic environment specified below The customer or user of the R Series should ensure that it is used in such an environment Immunity IEC 60601 test Compliance test level level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the R Series including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz d 1 17 NP outside ISM bands 10 Vrms 10 Vrms 150 kHz to 80 MHz d 1 2 VP in ISM bands Radiated RF 10 V m 10 V m IEC 61000 4 3 80 MHz to 2 5 GHz d 1 2 NP 80 MHz to 800 MHz d 2 3 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and d is the recommended separation distance in meters Field strengths from fixed RF transmitters as determined by electromagnetic site survey d should be less than the compliance level in each frequency Lange P Interference may occur in the vicinity of equipment marked with the following symbol Ko A and reflection from structures objects and people NOTE 1 At 80 MHz and 80
153. re 0 5 1 1 5 2 and 3 times the normal size 1 cm mv If you want to shut off the heart rate beeper press the Options then the QRS VOL OFF softkeys To turn it back on press the QRS VOL ON softkey WARNING Implanted pacemakers may cause the heart rate meter to count pacemaker pulses during incidents of cardiac arrest or other arrhythmias Pacemaker patients should be carefully observed Check the patient s pulse do not rely solely on heart rate meters Dedicated pacemaker detection circuitry may not detect all implanted pacemaker spikes patient history and physical exam are important in determining the presence of an implanted pacemaker Implanted Pacemakers The R Series device can be configured to detect pacemaker signals from a patient with an implanted pacemaker and indicate their presence on the display When pacer pulses are detected the device displays a 5mm vertical solid line on the ECG trace 9650 0912 05 Rev C ZOLL R Series Operator s Guide 9 5 CHAPTER 9 ECG MONITORING i Pace Marker MONITOR Code Report Test Options Param Marker Data Alarms Log To disable detection of pacemaker spikes 1 Press the Param softkey 2 Press ECG 3 Press Disable Pacer Detect To re enable detection of pacemaker spikes 1 Press the Param softkey 2 Press ECG 3 Press Enable Pacer Detect 5 Lead Monitoring You can perform 5 lead ECG monitoring with the appropriate ECG patient cable The 5 lead
154. re required for 100 total defibrillation efficacy Conclusion The data demonstrate the equivalent efficacy of low energy rectilinear biphasic shocks compared to standard high energy monophasic shocks for transthoracic defibrillation for all patients at the 95 confidence level The data also demonstrate the superior efficacy of low energy rectilinear biphasic shocks compared to standard high energy monophasic shocks in patients with high transthoracic impedance at the 90 confidence level There were no unsafe outcomes or adverse events due to the use of rectilinear biphasic waveform Randomized Multi Center Clinical trial for Cardioversion of Atrial Fibrillation AF A 26 Overview The defibrillation efficacy of ZOLL s Rectilinear Biphasic Waveform was compared to a monophasic damped sine waveform in a prospective randomized multi center study of patients undergoing cardioversion of their atrial fibrillation A total of 173 patients entered the study Seven 7 patients who did not satisfy all protocol criteria were excluded from the analysis ZOLL disposable gel electrodes with surface areas of 78 cm anterior and 113 cm posterior were used exclusively for the study Objective The primary goal of the study was to compare the total efficacy of four consecutive rectilinear biphasic shocks 70J 120J 150J 170J with four consecutive monophasic shocks 100J 200J 300J 360J The significance of the multiple shocks efficacy was tested st
155. reathing e Absence of pulse This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats www zoll com 9650 0912 05 Rev C Defibrillator Function In manual mode the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias A qualified physician must decide when synchronized cardioversion is appropriate The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia greater than 150 beats per minute in patients meeting the three conditions indicating lack of circulation listed above Intended Use ECG Monitoring The unit is intended for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology In ECG monitoring mode the unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator basic life and or advanced life support or other physician authorized emergency medical training Intended Use Real CPR Help The Real CPR Help function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA ERC recommended rate of 100 compressions per minute Voice and visual prompts encourage a compression depth in accordance with AHA and or ER
156. red ECG displayed in Tracel the user of the R Series unit can also enable the display of the filtered ECG in Trace2 or Trace3 Adding Traces to Be Displayed The screen can display up to three traces simultaneously The trace for the selected ECG lead always appears in the Trace 1 uppermost position 9650 0912 05 Rev C ZOLL R Series Operator s Guide 9 7 CHAPTER9 ECG MONITORING If optional physiological monitoring parameters are installed in the unit the operator can select applicable traces to appear in the second or third position To select the display for the second or third trace 1 Press the Options softkey then press Traces 2 Press Trace 2 or Trace 3 to select the position 3 Press the softkey for the parameter or other waveform to display in the selected position or Off to clear that position Note Trace 3 is not available while the unit is in Pacer mode Printing the ECG on a Stripchart The stripchart recorder documents the ECG trace with a 6 second delay at all times To start the stripchart recorder press the RECORDER button The stripchart recorder runs continuously until you press the button again Each time the strip chart recorder is started the time date ECG lead size and heart rate are printed on the top part of the paper If the unit is pacing the output current is also printed Note Check the paper supply at the beginning of each shift and after each use to ensure adequate recording capability
157. ree Therapy Electrodes AA 8 2 2 Turn Selector Switch to LEE 8 3 S Set EE 8 3 4 Set Pacer Output eege ee ege 8 4 5 Determine Capt re geegent geed 8 5 6 Determine Optimum Threshold rero taxed treten dta Etpa 8 6 9650 0912 05 Rev C ZOLL R Series Operator s Guide iii TABLE OF CONTENTS Special Pacing Applications EE 8 7 Standby Pacing inanir dot Ete Ode es EDS RES ANDA pue 8 7 ASYMEMTONOUS eru e BEE 8 7 POCIAWIC PACING s 8 8 Chapter 9 ECG Monitoring Preparations eR at oe ot Cac cates mE 9 2 Eletirode PIA COMO EE 9 2 Monitoring Electrodes en an EE 9 3 Monitoring the Patients EGG rect ener acer ia thas aane es ue dr EE 9 5 oerte Controls deem o be pompae iced e detegere 9 5 Implanted Pacemakers Je e ire eege ee tasks 9 5 S Lead Monitoring eet c 9 6 Simultaneous 3 Lead Printing BEE 9 7 See Thru CPR Filter Optional tre tren nile erbe ete dd 9 7 Adding Traces to Be Displayed i rto eH peto ER eee etta 9 7 Printing the ECG on ER die E E 9 8 Diagriostuc Baridwidth WEE 9 8 PRBS eMe DM M TE MUI EE 9 8 Setting Alarm la 9 8 wl qu H nl 9 9 Vital Sign Ed EE 9 10 Suspending and Silencing Alarms eeseeessssseseeeeee eene 9 10 Smart Alarms m 9 11 Chapter 10 Event Records and Reports last le AE DORN EE 10 1 Summary Report Formats 1 c rein ker nee seeds 10 2 Printing the Entire Summary Report ANNE 10 7 Printing a Partial Summary Report secciecve csscccessiece
158. rm does not alter the timing or processing of the previously suspended alarm www zoll com 9650 0912 05 Rev C Alarms Silencing Alarm Tones To silence the alarm tone press and hold down the ALARM SUSPEND button for M between 1 and 3 seconds The alarm tone stops the unit displays the alarm s bell icon 4 ininverse video with an X across it and the value of the alarm parameter remains highlighted If you press the ALARM SUSPEND button again alarm processing is reactivated The alarm tone will not sound again as long as the physiological parameter s value remains out of range If the alarm condition clears the physiological parameter returns to a value within range after you silence the alarm tone the unit resets the alarm and displays the bell icon no inverse video no X The alarm parameter value displays normally no highlighting After the unit resets an alarm should the physiological parameter again go out of range it will trigger the alarm Activating and Deactivating Alarm Processing To deactivate all alarms on the R Series unit press and hold down the ALARM x SUSPEND button for 3 seconds or longer The bell icons for all alarms will have an X through them to indicate that the alarms are deactivated Alarm parameter values display normally no highlighting To reactivate the alarms press and release the ALARM SUSPEND button in less than 1 second Smart Alarms In DEFIB or MONITOR mode EC
159. rms code readiness testing when the unit is OFF but connected to AC power when the defibrillator is initially turned on and periodically during operation An annotating strip chart recorder is included to provide immediate documentation as well as summary report functions about patient care and treatment A sophisticated data collection system including summary report printer and multiple communication ports is available for this unit The stored data can be reviewed and archived on a properly equipped personal computer using ZOLL CodeNet Central software or ZOLL RescueNet Code Review software R Series data files may be transferred to a PC using USB or Compact Flash cards or Wi Fi R Series products are intended for use in Manual mode by personnel certified by appropriate federal state or local government authority to provide advanced life support care How to Use This Manual The R Series Operator s Guide provides information operators need for the safe and effective use and care of the R Series products It is important that all persons using this device read and understand all the information contained within Please read thoroughly the safety considerations and warnings section Procedures for daily checkout and unit care are located in Maintenance on page 12 1 This manual is supplemented by manual inserts for options available on the R Series These inserts contain additional warnings precautions and safety related informatio
160. rodes 1 set preconnected 1 spare 3 Paddles Paddles clean not pitted Release from housing easily Inspect cables for cracks broken wires connector A ECG electrode cable connector B Defibrillator paddle cables C OneStep cable connector D Other patient cables Batteries A Fully charged battery in unit B Fully charged spare battery available Disposable supplies A Defib gel or gel patches B Hands free therapy electrodes in sealed packages 2 sets C ECG electrodes D Recorder paper E Alcohol wipes F Razors Operational checks A Power On Sequence Turn unit to MONITOR 4 beep tone heard MONITOR message on display ECG size X 1 PADDLES or PADS as lead selected B Paddles Paddles in holder Set defib energy level to 30 joules press paddles firmly into the side wells and simultaneously press and hold both defib discharge buttons 30J TEST OK message on Recorder C Defibrillator OneStep cable connected to test connector or OneStep electrodes Set defib energy level to 30 joules press SHOCK button 30J TEST OK message on Recorder D Pacer Operation Optional OneStep cable not connected to Test Connector or OneStep electrodes Turn to PACER set pacer rate to 150 ppm press RECORDER button Pacer pulses occur ever 2 large divisions 10 small divisions Press 4 1 button pulses occur
161. rts including earth For defibrillation using paddles use only high conductivity electrolyte gel specified for such use by the manufacturer When using paddles for defibrillation use your thumbs to operate the SHOCK buttons Doing so avoids inadvertent shock to the operator and unintentional depression of an ENERGY SELECT button which causes the defibrillator to disarm Keep your hands and fingers away from the paddle plates The use of accessory equipment that does not comply with the equivalent safety requirements of the R Series defibrillator could reduce the level of safety of the combined system When choosing accessory equipment consider the following e Use of the accessory in the patient vicinity e Evidence that the safety certification of the accessory has been performed in accordance with the appropriate IEC EN 60601 1 and or IEC EN 60601 1 1 harmonized national standards Always check that the equipment functions properly and is in proper condition before use Disconnect all electro medical equipment that is not defibrillation protected from the patient prior to defibrillation Before discharging the defibrillator warn everyone to STAND CLEAR of the patient Do not touch the bed patient or any equipment connected to the patient during defibrillation A severe shock can result To avoid hazardous pathways for the defibrillation current do not allow exposed portions of the patient s body to touch any metal objects
162. ry allocated for summary data can hold up to 350 defibrillation or 350 recorder activated events All event data remains in memory and is accessible until data is manually erased or until the preconfigured time interval has elapsed The time interval is specified in the Set Report Restart Delay parameter see the R Series Configuration Manual for more information A new patient record is automatically created when the unit has been turned off for a configurable time period of 5 minutes to 36 hours When all memory for code summary is used the unit issues the message REPORT FULL To continue recording the code event after the memory has been filled or to prepare the unit for a new code the operator can erase the stored records Refer to Erasing Summary Report and Full Disclosure on page 10 9 Summary Report Formats This section describes the information included with each type of summary report record Each summary report begins with an overview of all events currently stored in memory including e Date and time e Report start time either when the unit was turned on or if data was manually erased when subsequent recording began e Time of the last recorded event e Total number of shocks delivered e Cumulative pacing time e Device ID e System serial number Space is provided for patient name and comments On the last event recorded the unit prints SUMMARY COMPLETF on the bottom left of the stripchart a a NAME COMMENTS
163. s device The R Series does not require periodic recalibration or adjustment Appropriately trained and qualified personnel should however perform periodic tests of the defibrillator to verify proper operation If a unit requires service contact the ZOLL Technical Service Department Forcustomers In he lis A For customers outside the U S A Telephone 1 800 348 9011 Call the nearest authorized ZOLL Medical Corporation 1 978 421 9655 representative Fax 1 978 421 0010 To locate an authorized service center contact the International Sales Department at ZOLL Medical Corporation 269 Mill Road Chelmsford MA 01824 4105 Telephone 1 978 421 9655 www zoll com 9650 0912 05 Rev C The ZOLL Serial Number When requesting service please provide the following information to the service representative e Unit serial number e Description of the problem e Department using the equipment and name of the person to contact e Purchase order to allow tracking of loan equipment e Purchase order for a unit with an expired warranty e Sample ECG or other stripcharts demonstrating the problem if available and applicable less any confidential patient information Returning a unit for service Before sending a unit to the ZOLL Technical Service Department for repair obtain a service request SR number from the service representative Remove the battery pack from the unit Pack the unit with its cables and battery
164. s in Sync mode or Remote Sync mode and no QRS complex is detected Energy internally discharged because energy selection was changed during charge or after the device was ready Unit was not completely charged when SHOCK button s were pressed Wait for DEFIB XXXJ READY message and ready tone Press and hold SHOCK button s until energy is delivered to the patient Pads or paddles not making good contact with patient 5 Unable to SHOCK when in Sync mode Ensure SYNC XXXJ SEL is displayed on monitor Make sure ECG signals are displayed Check for Sync markers arrow above R wave If not present change lead selection or electrode placement Press and hold SHOCK button s until energy is delivered to the patient Alter ECG electrode placement 9650 0912 05 Rev C ZOLL R Series Operator s Guide 13 5 CHAPTER 13 TROUBLESHOOTING Symptom Recommended Action 6 Unable to SHOCK when in Remote Sync mode Ensure REMOTE SYNC is displayed in place of the ECG waveform and that REMOTE SYNC XXXJ SEL is displayed Ensure that a remote device conforming with the Sync In Marker Out specifications in Appendix A is properly connected Ensure that Sync markers appear with each R wave on the remote device s display If Sync markers are not present on the remote device s display or do not appear to be nearly simultaneous with each R wave do not proceed with synchronized cardioversion Press and hold SHOCK butto
165. sclosure memory are filled data recording stops You must erase the records to continue recording Make sure to print out any important summary records currently in memory Transfer important full disclosure records to ZOLL CodeNet Central To manually erase stored data 1 Press the Report Data softkey 2 Press the Erase softkey then the Erase Report softkey To erase all reports stored in the unit press Erase All Automatic Erasure Automatic erasure of summary report and full disclosure data occurs if the R Series unit has been turned off for a user configurable period of 5 minutes to 36 hours Formatting the Disk The R Series uses an internal flash memory disk that stores the data in files similar in structure to those on a personal computer hard drive Like a personal computer there may be rare occasions when the internal disk requires formatting For example this may occur if all power battery and ac is removed while erasing a report Under such a circumstance the message DISK FORMAT REQ will be displayed Perform the following steps to format the flash memory disk All patient data will be erased during this procedure If possible print out any important summary records currently in memory and transfer important full disclosure records to ZOLL CodeNet Central 1 Press the Report Data softkey 2 Press the Erase softkey then the Format Disk softkey 3 When you are ready press the Confirm Format softkey The messag
166. sible is when expired electrodes are connected to the device www zoll com 9650 0912 05 Rev C Manual Defibrillator Testing Code Readiness Test The R Series defibrillator performs Code Readiness tests automatically to verify its integrity and readiness for emergency use These tests verify the following e Battery Verifies that the battery state of charge is sufficient for at least one hour of continuous monitoring and ten shocks at maximum energy e Therapy Electrodes Verifies that OneStep Pacing CPR or Complete electrodes are attached to the unit have not expired and that the electrode gel has not dried out Note The Code Readiness system automatically verifies the integrity of the specific electrodes listed above Other electrodes including members of the OneStep family should be verified manually for connection condition and expiration date e ECG circuitry Verifies that the ECG signal acquisition and processing electronics are functional e Defibrillator charge and discharge circuitry Verifies that the defibrillator electronics are functional and can charge and discharge at 30 joules through the patient cable and into paddles OneStep electrodes or the Test Port e Microprocessor hardware and software Verifies the proper function of the microprocessor electronics and the integrity of software e CPR circuitry and sensor Verifies that the Real CPR Help circuits are functional when OneStep CPR or C
167. sidual noise after filtering can obscure the ECG rhythm requiring the rescuer to stop CPR to assess the ECG For example in the case of asystole or low amplitude PEA the residual artifact seen after filtering may look like fine ventricular fibrillation 9650 0912 05 Rev C ZOLL R Series Operator s Guide 7 1 CHAPTER 7 SEE THRU CPR OPTIONAL Because the filtered ECG signal may contain residual chest compression and or filtering artifacts a rescuer should always follow the standard procedure of stopping CPR to assess the patient s ECG rhythm before determining treatment Using See Thru CPR To use See Thru CPR e The R Series unit must be monitoring CPR e OneStep CPR or OneStep Complete electrodes must be attached to the unit When chest compressions begin the R Series unit automatically starts filtering the CPR artifact after detecting the first 3 to 6 compressions The filtered ECG with the label FIL may be displayed on the second or third trace by selecting FILT ECG in the Trace2 or Trace3 menu See Thru CPR filtering continues as long as the OneStep CPR or OneStep Complete electrodes detect compressions and patient impedance is valid When no compressions are detected or one of the conditions noted above occurs See Thru CPR filtering stops and unfiltered ECG signals are displayed When compressions resume filtering automatically restarts after 3 to 6 chest compressions Note There is a delay of approximately 1 16 sec
168. ss level affects battery run time Selecting high bright will cause the battery charge to be depleted at a faster rate than when selecting low bright Using Code Markers 2 14 Pressing the CODE MARKER softkey causes the unit to display a preconfigured list of clinical actions Pressing the softkey associated with a particular action causes that action and 6 seconds of ECG to be recorded along with a date and time stamp in the Summary Report memory You can supplement an event summary by manually adding code markers which itemize drugs or treatments administered to the patient Up to six Code Markers can be displayed on the screen at one time CPR Intubate EPI LIDO Narcan MORE Figure 2 14 Code Markers The right most softkey is labeled MORE when there are more than six items on the code marker list Press the MORE softkey to see the next set of Code Markers displayed above the softkeys Separate code marker lists are maintained for DEFIB MONITOR and PACER modes thereby enabling the display of appropriate code markers for each particular protocol For information on configuring these code marker lists refer to the R Series Configuration Guide The code markers are removed from the display after 10 seconds If no Code Marker softkey has been pressed during that time a default event mark is stored in Summary Report memory www zoll com 9650 0912 05 Rev C Chapter 3 Manual Defibrillation e 4 Paddles are a defi
169. such as a bed frame When the R Series is performing a Code Readiness test as indicated on the display do not touch the connected paddles electrodes or OneStep cable connector Patient Safety This equipment should be connected to only one patient at a time Use only OneStep Pediatric electrodes to defibrillate patients under 8 years of age in Advisory modes Use of adult electrodes or pediatric electrodes other than OneStep Pediatric electrodes can result in the delivery of excessive energy doses Neonatal and pediatric defibrillation energy level settings should be based on site specific clinical protocols www zoll com 9650 0912 05 Rev C Warnings To ensure patient safety connect the R Series only to equipment with galvanically isolated circuits Use only high quality ECG electrodes ECG electrodes are for rhythm acquisition only you cannot use ECG electrodes for defibrillation or pacing Do not use therapy or ECG electrodes if the gel is dried separated torn or split from the foil patient burns may result from using such electrodes Poor adherence and or air pockets under therapy electrodes can cause arcing and skin burns Check the expiration date on the electrode packaging Do not use electrodes after their expiration date Excessive body hair or wet diaphoretic skin can inhibit electrode coupling to the skin Clip excess hair and dry any moisture from the area where an electrode is to be attached Therapy elec
170. suscitation from cardiac standstill reflex vagal standstill drug induced standstill due to procainamide quinidine digitalis b blockers verapamil etc and unexpected circulatory arrest due to anesthesia surgery angiography and other therapeutic or diagnostic procedures It has also been used for temporary acceleration of bradycardia in Stokes Adams disease and sick sinus syndrome It is safer more reliable and more rapidly applied in an emergency than endocardial or other temporary electrodes Asastandby when standstill or bradycardia might be expected Noninvasive pacing can be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction drug toxicity anesthesia or surgery It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy In standby pacing applications noninvasive pacing might provide an alternative to transvenous therapy that avoids the risks of displacement infection hemorrhage embolization perforation phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing 1 8 www zoll com 9650 0912 05 Rev C WARNING External Pacemaker Optional e Suppression of tachycardia Increased heart rates in response to external pacing often suppress ventricular ectopic activity and might prevent tachycardia This device must
171. t charging and increase or decrease the selected energy after the CHARGE button has been pressed use the ENERGY SELECT buttons on either the defibrillator front panel or the sternum paddle Press the CHARGE button again to charge the unit to the newly selected energy level After charging the unit to the selected energy either the front panel SHOCK button or the APEX paddle charge indicator illuminates A distinctive audible tone sounds and the SYNC XXXJ READY message is displayed The defibrillator is now ready to deliver therapy www zoll com 9650 0912 05 Rev C Remote Synchronized Cardioversion Procedure 3 Deliver SHOCK WARNING Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge Verify that no one is in contact with the patient monitoring cable or leads bed rails or any other potential current pathways Verify that the ECG waveform is stable and that Sync markers appear over each R wave Press and hold the illuminated SHOCK button on the front panel or simultaneously press and hold both paddle SHOCK buttons until energy is delivered to the patient The defibrillator will discharge with the next detected R wave Note Ifthe defibrillator is not discharged within 60 seconds after reaching the selected energy level the unit automatically disarms itself During the ten seconds prior to this internal disarm the charge ready tone beeps intermittently The charge ready tone then sto
172. t s skin the unit issues the messages CHECK PADS and POOR PAD CONTACT and does not allow delivery of energy If a short circuit exists between the electrodes the unit issues the message DEFIB PAD SHORT An ECG LEAD OFF condition prevents synchronized discharge if leads are selected as the ECG source This condition does not prevent the use of the defibrillator it simply prevents use in a synchronized manner If paddles are being used for synchronized cardioversion refer to Emergency Defibrillation Procedure with Paddles on page 3 1 for preparing paddles applying paddles charging the defibrillator and delivering a shock Note however that synchronized discharge with paddles as an ECG source is discouraged since the artifact induced by moving the paddles may resemble an R wave and trigger defibrillator discharge at the wrong time 1 Select DEFIB Turn the Mode Selector to DEFIB Select the desired energy using the up and down arrow keys on the front panel or sternum paddle if using paddles e 3 sHock 2 ANALYZE CHARGE A ENERGY SELECT Press the Sync On Off softkey Your system will be in Sync mode once you press the Sync On Off softkey if your R Series is not configured to support Remote Sync However if your R Series is configured to support Remote Sync pressing the Sync On Off softkey will cause two other softkeys to be displayed Remote Sync and Sync Press the Sync softkey to enter Sync mode The selected energ
173. t to and acceptance of the following terms and conditions 1 Grant of License In consideration of payment of the software license fee which is part of the price paid for this product ZOLL Medical Corporation grants the Purchaser a non exclusive license without right to sublicense to use the system software in object code form only 2 Ownership of Software Firmware Title to ownership of and all rights and interests in the system software and all copies thereof remain at all times vested in the manufacturer and Licensors to ZOLL Medical Corporation and they do not pass to purchaser 3 Assignment Purchaser agrees not to assign sublicense or otherwise transfer or share its rights under the license without the express written permission of ZOLL Medical Corporation 4 Use Restrictions As the Purchaser you may physically transfer the products from one location to another provided that the software firmware is not copied You may not disclose publish translate release or distribute copies of the software firmware to others You may not modify adapt translate reverse engineer decompile crosscompile disassemble or create derivative works based on the software firmware NO IMPLIED LICENSE Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would alone or in combination with this device fall within the scope of one or more of the patents relating to thi
174. talled grid side against recorder print head e Recorder print head requires cleaning 4 Summary Report will not print when Report Print Chart softkeys are activated e 15 seconds have not elapsed since one of the events that trigger Summary Report to record have occurred Wait 15 seconds then try again 9650 0912 05 Rev C ZOLL R Series Operator s Guide 13 3 CHAPTER 13 Pacer 13 4 TROUBLESHOOTING Symptom Recommended Action 1 CHECK PADS message Ensure therapy electrodes are connected to the OneStep cable Ensure electrode gel is not dry Replace therapy electrodes if necessary Ensure good electrode to patient contact Check integrity of OneStep cable by plugging into test connector CHECK PADS should disappear No stimulus marker LJ is present on the ECG trace Ensure unit is in PACER mode e Ensure PACER RATE ppm is set greater than patient heart rate 3 No ventricular capture beat e Check patient s pulse appears after stimulus marker on Increase output current ECG display Ensure therapy electrodes are making good contact with the patient e Select different ECG Lead configuration Review therapy electrode placement 4 Patient on Standby pacing gets Ensure proper ECG electrode or OneStep Pacing paced intermittently Complete electrode connection and placement If ECG lead wire comes off pacer will automatically pace asynchron
175. te during both no motion and patient motion conditions for adult patients and no motion conditions for pediatric and neonatal patients in a hospital or prehospital environment Intended Use EtCO Monitoring The ZOLL R Series EtCO option with Respironics Novametrix technology is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide EtCO and respiration rate in patients requiring ventilator support in hospital transport or anesthesia This option uses the CAPNOSTAT 5 Mainstream CO sensor attached to an airway adapter that connects to an endotracheal tube mask or disposable mouthpiece The R Series EtCO option is designed to monitor adult pediatric and neonatal patients The following substances can influence CO measurements made with the CAPNOSTAT 5 CO sensor elevated oxygen levels nitrous oxide halogenated agents The R Series EtCO option provides settings for high oxygen and or nitrous oxide compensation Halogenated anesthetic agents alter CO readings but the R Series unit will monitor CO within specifications when these agents are present at normal clinical levels The presence of Desflurane in the exhaled breath beyond normal values 5 may positively bias measured carbon dioxide values by up to an additional 3 mmHg The R Series EtCO option is intended for use only with the ZOLL Respironics Novametrix CAPNOSTAT 5 Mainstream CO Sensor and mainstream airway adapters The R Ser
176. th removable internal defibrillation electrodes When these internal handles are used the R Series defibrillator can operate only in Manual mode even if the unit supports Advisory mode When an internal handle set is connected to the R Series it automatically limits energy output to a maximum of 50 joules For step by step procedures for open chest defibrillation as well as important cleaning and sterilization information refer to the Autoclavable Internal Handle and Electrode Operator s Guide www zoll com 9650 0912 05 Rev C Chapter 4 Advisory Defibrillation e 4 ZOLL hands free therapy electrodes are a defibrillation protected Type BF patient connection When the Mode Selector is turned to DEFIB and hands free therapy electrodes are used the R Series can identify shockable rhythms using its built in ECG analysis capability You must read the advisory messages charge the defibrillator to the preconfigured or user selected energy level if automatic charge is disabled and deliver treatment to the patient when required by protocol and patient condition The advisory function can be activated only when e Hands free therapy electrodes are connected and selected as the ECG source e Hands free therapy electrodes are properly connected to the patient e The Mode Selector is turned to DEFIB WARNING Use only pediatric electrodes to defibrillate patients under 8 years of age in Advisory mode Use of adult electrodes with pediatric
177. th the patient monitoring cable or leads bed rails or any other potential current pathways Press and hold the illuminated SHOCK button on the front panel or simultaneously press and hold both paddle SHOCK buttons until energy is delivered The defibrillator will discharge with the next remote synchronization pulse Note Ifthe defibrillator is not discharged within 60 seconds after reaching the selected energy level the unit automatically disarms itself During the ten seconds prior to this internal disarm the charge ready tone beeps intermittently The charge ready tone then stops and the defibrillator remains in Remote Sync mode 9650 0912 05 Rev C ZOLL R Series Operator s Guide 5 7 CHAPTER 5 SYNCHRONIZED CARDIOVERSION Once the energy is delivered the display simultaneously shows XXXJ DELIVERED and DEFIB XXXJ SEL After approximately 5 seconds the XXXJ DELIVERED message disappears and the DEFIB XXXJ SEL message remains to indicate the selected energy level If additional countershocks are necessary readjust the energy level as necessary press the Sync On Off and then the Remote Sync softkeys and repeat Note that REMOTE SYNC XXXJ SEL must be displayed prior to pressing the CHARGE button If the ANALYZE button is pressed while the unit is in Remote Sync mode the unit displays the REMOVE SYNC message and disallows ECG rhythm analysis until the unit is taken out of Sync mode 5 8 www zoll com 9650 0912 05 Rev C Chapter 6
178. th widths between 0 1ms and 2ms and overshoot from 0 to 100ms The pacemaker pulse rejection capability for the R Series with pacemaker pulses with an ineffectively paced QRS pattern includes pulses between 2mV and 700mV amplitude with widths between 0 1ms and 2ms and overshoot from 0 to 100ms The R Series is not capable of rejecting A V Sequential pacemaker pulses Bandwidth 0 5 Hz to 21 Hz standard 0 05 Hz to 150 Hz diagnostic 0 5 Hz to 40 Hz and 1 Hz to 21 Hz as configurable options Lead selection I II IIl aVR aVL aVF V PADS PADDLES INTL PADDLES P1 P2 P3 with OneStep Pacing electrodes ECG size 0 5 1 1 5 2 or 3 cm mV Current value shown on display Heart rate range 0 to 300 beats per minute www zoll com 9650 0912 05 Rev C Defibrillator Specifications Heart rate accuracy 5 Heart rate alarm Tall T wave Rejection Screen icon indicates activated deactivated status User selectable Tachycardia 60 to 280 beats per minute Bradycardia 20 to 100 beats per minute lt 0 8 mV Heart Rate Averaging The R Series averages the interval between the last 5 detected beats On startup the R Series averages the rate between detected beats once two beats are detected until a full 5 beats have been received The rate is updated every beat After this condition is met the meter is updated every beat with an average of the last 5 beats If a period of
179. the FULLY RELEASE text prompt is not enabled This feature is unavailable while using Pediatric CPR electrodes 9650 0912 05 Rev C ZOLL R Series Operator s Guide 6 3 CHAPTER 6 REAL CPR HELP CPR Voice Prompts Adult only The R Series unit can be configured to issue voice prompts related to the depth of chest compressions as feedback to rescuers performing CPR Two voice prompts are available for this purpose e Push Harder e Good Compressions When chest compressions are detected but their depth is consistently less than 1 5 or 2 inches 3 8 or 5 cm depending on the configuration the defibrillator will issue the prompt Push Harder every 15 seconds If the rescuer responds by increasing compression depth to more than 1 5 or 2 inches 3 8 or 5 cm depending on the configuration on a consistent basis the unit will issue a Good Compressions prompt See the R Series Configuration Guide for information on enabling disabling CPR voice prompts CPR Voice prompts are unavailable while using Pediatric CPR electrodes Chest Compressions Waveform The R Series can display the chest displacement waveform computed from the CPR sensor signals Displacement waveforms are displayed at the same sweep speed as ECG resulting in a 5 second CPR display www zoll com 9650 0912 05 Rev C Displaying the CPR Waveform Displaying the CPR Waveform To display the CPR displacement waveform in the Trace 2 or 3 position 1 Press the O
180. tic charge option enabled automatically charge to the preconfigured or user selected energy setting www zoll com 9650 0912 05 Rev C Advisory Defibrillation Procedure Units with the automatic charge option disabled will alternately display the messages SHOCK ADVISED and PRESS CHARGE Press the CHARGE button Regardless of the analysis result the user can control the defibrillator manually For example the user can defibrillate the patient even if the advisory function issues a NO SHOCK ADV message eju 0 0 FANDAN D DEFIB 120J SEL 00 01 Code Report Sync Options Param Marker Data Alarms On Off 3 Press SHOCK Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge WARNING Do not touch the bed patient or any equipment connected to the patient during defibrillation A severe shock can result Do not allow exposed portions of the patient s body to come in contact with metal objects such as a bed frame as unwanted pathways for defibrillation current may result 9650 0912 05 Rev C ZOLL R Series Operator s Guide CHAPTER 4 ADVISORY DEFIBRILLATION Once the unit is charged to the selected energy the SHOCK button illuminates and the PRESS SHOCK message is displayed Simultaneously the monitor displays the energy level to which the defibrillator is charged DEFIB XXXJ READY Note Rhythm analysis does not continue after the defibrillator is charged and ready once
181. time greater than 5 seconds elapses without a beat detected the heart rate meter reports a rate of 0 bpm which is repeated every 5 seconds Accuracy and Response Time to Irregular Rhythm Averaging over 5 R R intervals per AAMI EC 13 2002 e Ventricular bigeminy Figure 3a 80 5 bpm Slow alternating ventricular bigeminy Figure 3b 60 5 bpm Slow alternating ventricular bigeminy Figure 3c 120 5 bpm Bidirectional systoles Figure 3d 93 3 bpm Response Time to Change in Heart Rate Average response time 3 37 seconds Time to Alarm for Tachycardia Minimum time to alarm 3 66 seconds Maximum time to alarm 8 41 seconds Leads Off Sensing A dc current of 0 04 uA per lead wire is supplied to the patient Active Noise Suppression The sum of all leadwire currents is returned via the active noise suppression leadwire e 0 08 uA DC in 3 lead mode 0 16 uA DC in 5 lead mode Pacemaker option Type VVI demand asynchronous fixed rate when used without ECG leads or in asynchronous Async pacing mode Pulse type Rectilinear constant current Pulse duration 40 ms 2 ms Pulse amplitude output Variable 0 mA to 140 mA 5 or 5 mA whichever is greater Increments decrements by a value of 2 mA Pacing rate 30 to 180 pulses per minute ppm 1 5 Increments decrements by a value of 2 ppm Output protection Fully defibrillator protected and isolated Recorder and
182. tion Distances from RF Equipment for the R Series Non Life Support Functions A 12 Recommended separation distances between portable and mobile RF communications equipment and the R Series The non life support functions of the R Series are intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the R Series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the R Series as recommended below according to the maximum output power of the communications equipment Rated maximum output power of Separation distance according to frequency of transmitter equipment in meters in watts 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 NP d 12 dp d 2 3 4p 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is
183. trodes should be replaced periodically during continuous pacing Consult electrode directions for proper replacement instructions Prolonged pacing more than 30 minutes particularly in neonates or adults with severely restricted blood flow may cause burns Periodically inspect the skin under the electrodes Carefully route the patient cables to reduce the possibility of patient entanglement or strangulation To avoid electrosurgery burns at monitoring sites ensure proper connection of the electrosurgery return circuit so that a return path cannot be made through monitoring electrodes or probes During electrosurgery observe the following guidelines to minimize electrosurgery unit ESU interference and provide maximum operator and patient safety e Keep all patient monitoring cables away from earth ground ESU knives and ESU return wires e Use electrosurgical grounding pads with the largest practical contact area Always ensure proper application of the electrosurgical return electrode to the patient Check electrical leakage levels before use Leakage current may be excessive if more than one monitor or other piece of equipment is connected to the patient Do not use the ZOLL OneStep Pacing cable REF 1009 0913 02 or the ZOLL Multi Function Cable REF 1009 0913 03 in a 220 240 VAC 60Hz power environment Patient leakage current may be excessive 9650 0912 05 Rev C ZOLL R Series Operator s Guide 1 17 CHAPTER 1 GENERAL INF
184. tters an electromagnetic site survey should be considered If the measured field strength in the location in which the R Series is used exceeds the applicable RF compliance level above the R Series should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the R Series e Over the frequency ranges 150 kHz to 80 MHz field strength should be less than 10 V m ZOLL R Series Operator s Guide APPENDIX A SPECIFICATIONS Recommended Separation Distances from RF Equipment for the R Series Life Support Functions Recommended separation distances between portable and mobile RF communications equipment and the R Series The life support functions of the R Series are intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the R Series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the R Series as recommended below according to the maximum output power of the communications equipment Rated maximum output power of Separation distance according to frequency of transmitter equipment in meters in watts 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz outside ISM bands in ISM bands d 12 AP d 1 2 4P d 1 2 P d 2 3 dp 0 01 0 12 0
185. tton on the front panel there is one located on the apex paddle handle SHOCK Button The front panel SHOCK button is only active when using OneStep electrodes hands free therapy electrodes see R Series Accessories on page B 1 for a list external autoclavable paddles or internal defibrillation paddles without a discharge button The SHOCK button illuminates when the device is charged and ready To discharge the defibrillator when using paddles internal or external with discharge buttons press and hold the SHOCK buttons on the paddles ANALYZE Button Initiates ECG analysis to determine whether or not a shockable rhythm is present LEAD Button Selects the ECG source for display and printing Pressing this button sequentially selects ECG signals derived from each of the following lead configurations I II Ill aVR aVL aVF PADDLES or PADS P1 P2 and P3 when using OneStep Pacing electrodes or OneStep Complete electrodes with OneStep Pacing cable for display The PADS or PADDLES lead setting is automatically selected when the defibrillator powers up in DEFIB or MONITOR mode with either hands free therapy electrodes or paddles attached to the OneStep cable Lead II or P3 OneStep Pacing is automatically selected when the R Series is powered up in PACER mode Pads or Paddles monitoring is not available in PACER mode SIZE Button Selects the amplitude scale for the displayed ECG waveform Available sizes ar
186. umes NIBP Button Allows you to start single auto or STAT non invasive blood pressure optional measurements as described in the option insert Non Invasive Blood Pressure part number 9650 0914 01 Your unit has this button only if you ordered this configuration Softkeys Six unlabeled buttons located directly below the display control different functions depending on the operating mode of the unit Labels for the softkeys appear at the bottom of the display directly above each softkey to indicate its function Charge Indicator Light Located on the apex paddle this light turns on when the defibrillator is not shown charged and reagy Display Screen The front panel includes a color display which shows The elapsed time since the unit was turned on The ECG trace selected lead size heartbeat indicator and alarm status The selected energy charging status and delivered energy for defibrillation and synchronized cardioversion The output current and stimulus rate for pacing The measured SpO percent saturation signal strength plethsymographic trace if applicable and alarm status indicators for optional SpO monitoring Non invasive blood pressure NIBP readings diastolic systolic and mean plus alarm status indicators optional refer to the insert Non Invasive Blood Pressure NIBP part number 9650 0914 01 The patient s carbon dioxide level respiration rate and capnogram if applic
187. v C Appendix C Wi Fi Radio Module Information If this defibrillator contains an optional low power Wi Fi radio module it transmits information between the defibrillator and a wireless network infrastructure mode The module complies with the following standards e Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation of the radio function e RSS 210 of Industry amp Science Canada Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation of the radio function 9650 0912 05 Rev C ZOLL R Series Operator s Guide C 1 APPENDIX C WI FI RADIO MODULE INFORMATION This page intentionally left blank C 2 www zoll com 9650 0912 05 Rev C
188. vices and public domain databases recorded with electrode systems and ECG signal processing characteristics similar to the R Series Data records were of appropriate length to allow for satisfactory analysis The algorithm sequence takes approximately 9 seconds and proceeds as follows e Divides the ECG rhythm into 3 second segments e Filters and measures noise artifact and baseline wander e Measures baseline content waviness at the correct frequencies frequency domain analysis of signal e Measures QRS rate width and variability e Measures amplitude and temporal regularity autocorrelation of peaks and troughs Determines if multiple 3 second segments are shockable and then prompts the operator to treat the patient Table A 4 Clinical Performance Results Adult Patients Rhvthms Sample Performance Observed 90 One sided Lower y Size Goals Performance Confidence Limit Shockable Sensitivity Coarse VF 536 gt 90 100 0 99 4 Rapid VT 80 gt 75 100 0 96 3 Nonshockable Specificity NSR 2210 gt 99 100 0 99 9 AF SB SVT heart block 819 gt 95 99 9 99 4 idioventricular PVCs Asystole 115 gt 95 100 0 97 4 Intermediate Fine VF 69 Report only 89 996 81 896 Other VT 28 Report only 96 496 84 296 9650 0912 05 Rev C ZOLL R Series Operator s Guide A 29 APPENDIX A SPECIFICATIONS A 30 Table A 5 Clinical Performance Results Pediatric Patients Sample 90 One sided
189. with an organized rhythm where See Thru CPR effectively filters out artifact created by CPR Raw ECG i Raw ECG Filtered ECG Filtered ECG CPR CPR Raw ECG 7 Raw ECG Filtered ECG l Filtered ECG CPR CPR 0 12 Raw ECG Raw ECG Filtered ECG Filtered ECG cPR CPR 0 24 12 5 mm sec 5 mm mV www zoll com 9650 0912 05 Rev C Chapter 8 Noninvasive Temporary Pacing Optional e 4 When ZOLL hands free therapy electrodes are used the patient connection is considered to be defibrillation protected Type BF ei ECG leads are a defibrillation protected Type CF patient connection WARNING To avoid risk of electrical shock do not touch the gelled area of the hands free therapy electrodes while pacing Therapy electrodes should be replaced periodically Consult electrode directions for specific recommendations Prolonged pacing in excess of 30 minutes particularly in neonates or adults with severely restricted blood flow may cause burns Periodic inspection of the underlying skin is recommended If the unit was NOT turned off and less than 10 minutes have elapsed since the pacing mode was last used reactivating the pacer mode causes pacing to resume immediately at the previously selected mA and ppm settings 9650 0912 05 Rev C ZOLL R Series Operator s Guide 8 1 CHAPTER 8 NONINVASIVE TEMPORARY PACING OPTIONAL Noninvasive Temporary Pacing R Series defibrillators with the p
190. y Report R Series also records the full disclosure CPR sensor and parameter waveforms Full disclosure recordings are erased at the same times as Summary Reports Incident Logs An incident log is an abbreviated list of all major events recorded in summary report You can print an incident log that includes the following events and their time of occurrence e Unit powered on e Defibrillation advisory message issued for example CHECK PATIENT or SHOCK ADVISED e Shock delivered and energy level e PACER mode selected e Alarm triggered e Stripchart printing started Code marker entered In addition the incident log lists the following e System serial number e Device identification number e Report start time when the summary data was last erased e Time of the last recorded event Total number of shocks delivered e Total cumulative pacing time Printing an Incident Log To print an incident log press the Report Data softkey then press the Print Log softkey The log is printed on the stripchart starting with the oldest entry 10 8 www zoll com 9650 0912 05 Rev C Erasing Summary Report and Full Disclosure Erasing Summary Report and Full Disclosure Summary information can be erased either manually or automatically Manual Erasure You can manually erase summary records and full disclosure data from memory in preparation for collecting data for a new patient Note When the event summary memory and full di
191. y level is displayed on the monitor A Sync marker 4 appears on the monitor above each detected R wave to indicate where discharge will occur Verify that the markers are clearly visible on the monitor and their location is appropriate and consistent from beat to beat If necessary use the LEAD and SIZE buttons to establish settings that yield the best display 9650 0912 05 Rev C ZOLL R Series Operator s Guide 5 3 CHAPTER 5 SYNCHRONIZED CARDIOVERSION A SYNC XXXJ SEL message appears on the display If DEFIB XXXJ SEL appears press the Sync On Off softkey If your unit supports Remote Sync you must also press the Syne softkey Two quick beeps sound M M SYNC 120J SEL 00 01 Code Sync Options Param Marker Alarms On Off Unless otherwise configured the unit automatically exits Sync mode after each shock and when the Mode Selector is moved to MONITOR PACER or OFF To reactivate Sync mode press the Sync On Off softkey again If your unit supports Remote Sync press the Sync softkey again Changing the selected energy levels does not cause the unit to leave Sync mode Note that the unit can be configured to stay in Sync mode after defibrillation if desired Refer to the R Series Configuration Guide for instructions 2 Charge Defibrillator 5 4 Press the CHARGE button on the front panel or on the apex paddle handle o SHOCK 2997 E CHARGE el or A ENERGY SELECT a SR To abor

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R Series® ALS Operator`s Guide