Abbott Proclaim 3660 Clinician Manual
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Abbott Proclaim 3660 Clinician Manual

Abbott Proclaim 3660 Clinician Manual

Implantable pulse generator
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Proclaim™ Implantable Pulse Generator
Models 3660, 3661, 3662, 3663, 3665, 3667
Clinician's Manual

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Summary of Contents for Abbott Proclaim 3660

  • Page 1 Proclaim™ Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667 Clinician's Manual...
  • Page 2 State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov. ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner.

  • Page 3: Table Of Contents

    Contents Prescription and Safety Information ................1 Intended Use ........................1 Indications for Use ....................... 1 Contraindications ......................... 1 MRI Safety Information ......................1 Warnings ..........................1 Precautions .......................... 3 Adverse Effects ........................6 System Overview ....................... 6 Product Description ....................7 Package Contents ........................
  • Page 4 Appendix E: Safety and Effectiveness Studies ............29 Clinical Summary for the Genesis™ (IPG) Neurostimulation System for SCS ......29 Clinical Summary for BurstDR™ Stimulation ............... 32 Appendix F: Symbols and Definitions ............... 73...

  • Page 5: Indications For Use

    MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient.
  • Page 6 Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Electrosurgery.

  • Page 7: Precautions

    Device modification. Equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service.
  • Page 8 Return any suspect components to Abbott Medical for evaluation. Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion.
  • Page 9 Hospital and Medical Environments High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG. Ultrasonic scanning equipment.

  • Page 10: Adverse Effects

    Adverse Effects In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by  stimulation at high outputs (If either occurs, turn off your IPG immediately.) Undesirable changes in stimulation, which may be related to cellular changes in tissue ...

  • Page 11: Product Description

    The following image shows how the major system components are intended to interact. Figure 1. Interaction among main system components 1. Clinician programmer or patient controller 2. IPG 3. Leads 4. Patient magnet NOTE: This manual provides instructions for implanting the IPG. For instructions for using other components, see the applicable manuals for those components.

  • Page 12: Package Contents

    IPG is facing toward you, contains a code in the following format: SJMLN. ‘SJM’ designates Abbott Medical as the manufacturer; ‘LN’ is a letter and a number combination that identifies the model family (see the following figure).

  • Page 13: Connecting A Lead Or Extension To The Ipg

    For IPGs that connect to Abbott Medical leads or extensions, the first contact band (at the tip) of the lead or extension extends slightly past the first header contact and is visible, the windows between each of the header contacts are clear, and the ninth contact band of the lead or extension is not visible.
  • Page 14 Figure 3. Correct versus incorrect insertion of the lead or extension (IPGs with Abbott Medical leads or extensions) Fully inserted 1. First contact band (tip) is visible past the first header contact 2. Window between each header contact is clear 3.

  • Page 15: Implanting The Ipg

    Figure 5. Tighten the setscrew clockwise If implanting two leads, repeat the previous steps. If implanting a single lead only, insert the header port plug into the unused port, and use the torque wrench to tighten the setscrew until the torque wrench clicks. Figure 6.

  • Page 16: Replacing The Ipg

    Extension to the IPG” (page 9) and “Implanting the IPG” (page 11). Disposing of Explanted Components Explanted Abbott Medical components should be returned to Abbott Medical for proper disposal. To return an explanted component, place it in a container or bag marked with a biohazard label and coordinate the return with your Abbott Medical representative or Technical Support.

  • Page 17: Technical Support

    +1 855 478 5833 (toll-free within North America)  +1 651 756 5833  For additional assistance, call your local Abbott Medical representative. Appendix A: Product Specifications NOTE: Not all models are available in all countries. Contact your local representative for more information.

  • Page 18: Ipg Specifications

    IPG Specifications The Proclaim™ IPGs have the following physical specifications. Table 3. IPG specifications Model MRI Status Upgradeabl Compatibl e Features, e Header Burst Capable 3660 3662 Conditional 3661 3663 MR Unsafe 3665 3667 MR Unsafe Height 5.55 cm 6.68 cm (2.19 in) (2.63 in) Length...

  • Page 19: Compatibility Guidelines For Ipgs With Compatible Headers

    The IPG has the following operating parameters. Table 4. Operating parameters for the IPG Parameter Tonic Range Tonic Steps Burst Range* Burst Steps* Pulse width 20–1000 µs 10 µs 50–1000 µs 50 µs (20–500 µs range) 50 µs (500–1000 µs range) Frequency 2–200 Hz...

  • Page 20: Appendix B: System Components And Accessories

    NOTE: The model 3661 and 3663 IPGs are compatible only with the leads and extensions listed in "Compatibility Guidelines for IPGs with Compatible Headers" (page 15). They are not compatible with Abbott Medical leads and extensions. IPGs 3660 Proclaim™ XR 5 implantable pulse generator 3661 Proclaim™...

  • Page 21: Adapters

    1192 Swift-Lock™ anchor 1194 Cinch™ anchor 1701 SCS accessory kit 1803 Lead and extension insertion tool Adapters 2311 8-channel adapter, M, 10 cm 2316 8-channel adapter, M, 60 cm Trial System 3599 St. Jude Medical™ External Pulse Generator Trial System Accessories 1203 Cleaning cloths 1212 Coin cell batteries 1213 Pouch with adhesive (5)

  • Page 22: Appendix C: Battery Longevity Information

    Appendix C: Battery Longevity Information The longevity of the IPG battery depends on the following factors: Programmed settings, such as frequency, pulse width, amplitude, and number of active  electrodes Program impedance  Hours of stimulation per day  Shelf life of the device between the dates of manufacture and implant ...

  • Page 23: Energy Factors For Tonic Stimulation Parameters

    Energy Factors for Tonic Stimulation Parameters The following tables show energy factors according to various stimulation parameters for tonic programs. NOTE: Energy factors are for IPGs that provide 12 hours of daily stimulation. For an IPG that is providing 24 hours of daily stimulation, double the energy factor shown in the table. Table 6.
  • Page 24 Table 7. Energy factors for various tonic stimulation parameters (500-ohm impedance) Pulse Width (µs) Amplitude (mA) Frequency (Hz)
  • Page 25 Table 8. Energy factors for various tonic stimulation parameters (700-ohm impedance) Pulse Width (µs) Amplitude (mA) Frequency (Hz)
  • Page 26 Table 9. Energy factors for various tonic stimulation parameters (1000-ohm impedance) Pulse Width (µs) Amplitude (mA) Frequency (Hz) 1126...

  • Page 27: Energy Factors For Burstdr™ Stimulation Parameters

    Energy Factors for BurstDR™ Stimulation Parameters The following tables show energy factors according to various stimulation parameters for BurstDR™ stimulation programs. NOTE: Energy factors represent IPGs that provide 24 hours of daily stimulation using default values for the Burst Frequency, Intra-burst Rate, and Pulse Width settings. NOTE: In neurostimulation therapy, “dose”...
  • Page 28 Table 12. Energy factors for various BurstDR stimulation parameters (700-ohm impedance) Intermittent Dosage (On Time/Off Time) Amplitude Continuous (mA) Dosage 5 s/15 s 15 s/45 s 30 s/90 s 60 s/180 s 30 s/150 s 30 s/180 s 30 s/360 s Table 13.

  • Page 29: Battery Longevity Graphs

    Battery Longevity Graphs The following figure shows the estimated battery longevity of a newly implanted IPG. Figure 7. Estimated battery longevity by energy factor for Proclaim™ IPGs (from time of implant) 1. Estimated battery longevity (years) 2. Energy factor 3. Models 3660, 3661, and 3665 4.

  • Page 30: Appendix D: Regulatory Statements

    Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger ecosystem. Return the device to Abbott Medical at the end of its operating life.

  • Page 31: Wireless Technology Information

    Table 14. Registration identification information Identifier Type Registration Identifier FCC registration number RIASJMRFC Industry Canada (IC) registration number IC: 8454A-M3660123 Wireless Technology Information ® The following table summarizes the technical details of the Bluetooth Smart wireless technology as it is implemented in the device. Table 15.

  • Page 32: Quality Of Service For Wireless Technology

    The radio receiver in the device is using the same frequency and bandwidth as the transmitter. Cables and transducers: Cables and transducers are not used during normal use of the device nor while programming the device. Quality of Service for Wireless Technology ®...

  • Page 33: Appendix E: Safety And Effectiveness Studies

    Close the clinician programmer or patient controller application, and turn the clinician  programmer or patient controller off and on Wait a few minutes and try connecting again  Do not operate other wireless devices (i.e., laptop, tablet, mobile phone, or cordless phone) ...
  • Page 34 In addition, three patients from this study had their stimulators repositioned due to pain at the original location. Three patients had reoperations to adjust lead position; one patient required two reoperations, one to have the device removed due to infection and later to have a new device implanted.
  • Page 35 The following table depicts the number of patients, the number of events observed, and the percentage of occurrences of each event compared to the total number of patients. It should be noted that several studies include both IPG and RF systems. The clinical experience reported in the literature on RF systems is relevant to determining the safety of totally implantable IPG systems.

  • Page 36: Clinical Summary For Burstdr™ Stimulation

    406. Clinical Summary for BurstDR™ Stimulation Abbott Medical performed a clinical study to establish reasonable assurance of safety and effectiveness of BurstDR™ stimulation for the treatment of chronic, intractable pain of the trunk and/or limbs. The following sections present information and results for the SUNBURST™ study.
  • Page 37 Subjects were implanted with the permanent Prodigy neurostimulation system, and the device remained off during a recovery period. After the recovery period, subjects were randomized to receive either burst stimulation or tonic stimulation. The implanted system was then activated and programmed accordingly.
  • Page 38 Exclusion Criteria Subjects were excluded if they met any of the following criteria: Subject was participating in a clinical investigation that included an active treatment arm.   Subject had previously been implanted with a neurostimulation system or participated in a trial period for a neurostimulation system.
  • Page 39 The secondary endpoints that were assessed included Determining superiority of burst stimulation compared to tonic stimulation using VAS pain  diary scores for average daily overall pain (after non-inferiority was demonstrated) Comparing the responder rate, which is defined by a 30% decrease in the VAS pain diary ...
  • Page 40 Accountability of Subject Cohort A total of 173 subjects consented and enrolled at 20 investigational sites. Of the 141 subjects completing the baseline evaluation, 121 underwent an evaluation using an SCS trial system with tonic stimulation. After the SCS trial evaluation, 101 subjects met the standard criteria for success and were implanted with the Prodigy™...
  • Page 41 SUNBURST™ Study Demographics and Pain Baseline Characteristics A total of 141 subjects had a baseline visit in this study, 100 of whom were randomized (45 to receive tonic stimulation then burst stimulation [tonic/burst] and 55 to receive burst stimulation then tonic stimulation [burst/tonic]). The following tables show subject demographics and primary diagnosis.
  • Page 42 Table 17. Demographics and primary diagnosis Randomization Variable Subjects with Arm 1: Arm 2: -value Baseline Visit Tonic/Burst Burst/Tonic (N=141) (N=45) (N=55) Marital Status, n/N (%) Married 107/141 39/45 41/55 (75.9%) (86.7%) (74.5%) Separated/divorced 13/141 (9.2%) 2/45 (4.4%) 4/55 (7.3%) 0.479 Single 8/141 (5.7%)
  • Page 43 Table 18. Pain duration and origin Randomization Pain History Subjects with Arm 1: Arm 2: -value Baseline Visit Tonic/Burst Burst/Tonic (N=141) (N=45) (N=55) How long has the subject experienced chronic pain (years)? Mean ± SD 12.8±10.9 11.1±9.5 15.1±12.1 (141) (45) (55) 0.075 Minimum, Median,...
  • Page 44 Table 19. Pain treatment history Randomization Pain History Subjects with Arm 1: Arm 2: -value Baseline Visit Tonic/Burst Burst/Tonic (N=141) (N=45) (N=55) Other 55/141 19/45 23/55 0.968 (39.0%) (42.2%) (41.8%) At least on non-invasive 141/141 45/45 55/55 — intervention (100.0%) (100.0%) (100.0%) Invasive Nonsurgical Interventions...
  • Page 45 Table 19. Pain treatment history Randomization Pain History Subjects with Arm 1: Arm 2: -value Baseline Visit Tonic/Burst Burst/Tonic (N=141) (N=45) (N=55) Discectomy (open, 24/141 11/45 microdiscectomy, laser, 6/55 (10.9%) 0.073 (17.0%) (24.4%) coblation nucleoplasty, etc.) Other 26/141 13/55 6/45 (13.3%) 0.191 (18.4%) (23.6%)
  • Page 46 Table 20. Summary of all AEs AE Description Number of Number of Percent of Events Subjects Subjects (n/N**) All AEs total 38.7% (67/173) * Some subjects experienced more than one event; therefore, the number of subjects experiencing an event is not equal to the number of events in the neighboring column. ** Subjects at risk out of subjects enrolled in study Two (1.2% of total number of subjects at risk) SAEs were reported that were categorized as study- related.
  • Page 47 Table 22. Summary of non-study related SAEs Event Description Number of Number of Percent of Events Subjects Subjects (n/N) Following activation Bladder tumor 1.04% (1/96) Broken femur 1.04% (1/96) Cancerous tumor on vocal chords 1.00% (1/100) Death 1.04% (1/96) Infection 1.00% (1/100) Loss of speech and memory, and 1.00% (1/100)
  • Page 48 The following table identifies all 62 nonserious AEs that were study-related. Table 23. Summary of study-related, nonserious AEs (following activation) Event Description Number of Number of Percent of Subjects Events Subjects (n/N) Charger stopped working 1.00% (1/100) Device pocket heating while 1.00% (1/100) charging †...
  • Page 49 The following table identifies non-serious study-related AEs. Of all the stimulation-related non- serious AEs, 13 occurred with burst stimulation and 16 occurred with tonic stimulation. Fewer non-serious AEs were noted for burst stimulation mode than tonic stimulation mode. Table 24. Summary of stimulation-related, nonserious AEs (activation to 24 weeks) Event Description Number of Number of...
  • Page 50 Device and Device Usage Data Surgery and device data were collected for the 100 subjects that were randomized and received a permanent implant. As shown in the following tables, randomization groups showed a similar number of implanted leads and similar IPG placement. Table 25.
  • Page 51 Programming and stimulation mode data were collected at follow-up visits including unscheduled programming visits. The following table shows a summary of the burst stimulation settings through 24 weeks. The 100 randomized subjects underwent 350 programming sessions, and the programmed parameters were within the ranges recommended in the protocol (pulse width of 1000 µs, burst rate of 40 Hz, intra-burst frequency of 500 Hz, and burst train of 5 pulses).
  • Page 52 Table 27. Summary of IPG recharging for all available subjects IPG Recharging Burst Tonic Week 12 Recharged 52/52 (100.00%) 45/45 (100.00%) Frequency Daily 7/52 (13.5%) 1/45 (2.22%) 2–3 times a week 16/52 (30.8%) 11/45 (24.4%) Weekly 23/52 (44.2%) 29/45 (64.4%) Every other week 5/52 (9.62%) 2/45 (4.44%)
  • Page 53 Table 27. Summary of IPG recharging for all available subjects IPG Recharging Burst Tonic Week 24 Recharged 45/45 (100.00%) 50/51 (98.04%) Frequency Daily 3/45 (6.67%) 2/50 (4.00%) 2–3 times a week 13/45 (28.9%) 8/50 (16.0%) Weekly 25/45 (55.6%) 32/50 (64.0%) Every other week 4/45 (8.89%) 7/50 (14.0%)
  • Page 54 Three (3) subjects underwent an invasive procedure for a new clinically significant or  disabling chronic pain problem, and their overall VAS score was imputed using the hot deck method or the last observation carried forward (LOCF) method, which replaces missing values by using the last value observed for the score.
  • Page 55 In addition to demonstrating non-inferiority, superiority was also shown. The following table contains the results of testing the superiority hypothesis for burst over tonic stimulation. The difference in the overall VAS score between burst and tonic stimulation is -5 points, with a 95% UCB of -1.14, which is less than 0 and results in a rejection of the hypothesis that burst stimulation is not superior to tonic stimulation (p=0.017).
  • Page 56 Figure 10. Main overall VAS score with 95% CI by visit (left) and by stimulation mode (right) Secondary Effectiveness The following table compares responder rates for burst stimulation versus tonic stimulation, where "responder rate" is defined as a decrease in the overall daily VAS score from baseline by at least 30%.
  • Page 57 The following figure shows the percentage of pain relief for burst stimulation (left graph) and tonic stimulation (right graph) in individual subjects overall from baseline through week 24. For this figure, the responder rate was defined as a 30% or more reduction in the overall VAS score. Figure 11.
  • Page 58 Figure 12. Percentage reduction (≥30% responder rate) in overall VAS score at week 12 from baseline The following figure shows the percentage of pain relief from tonic stimulation (left graph) and burst stimulation (right graph) in the individual subjects for week 24, using a responder rate definition of 30%.
  • Page 59 Figure 13. Percentage reduction (≥30% responder rate) in overall VAS score at week 24 from baseline Data for paresthesia coverage at both 12 and 24 weeks were available for 73 subjects. More than half of the subjects (45 out of 73 [61.6%]) were paresthesia-free using burst stimulation, while only 2 subjects (2.7%) were paresthesia-free using tonic stimulation.
  • Page 60 The mean percentage of paresthesia coverage for burst is significantly lower than that for tonic. The following table summarizes the results of the test of the hypothesis of equality between burst and tonic stimulation. On average, subjects reported only 4.5% of the mapped body segments had paresthesia with burst stimulation compared to 22.7% with tonic stimulation.
  • Page 61 Table 33. Change in overall VAS score from baseline to week 12 Arm 1: tonic/burst Arm 2: burst/tonic Randomization Stimulation Tonic Burst VAS at Baseline Mean ± SD (N) 72.7±11.4 (45) 76.3±11.3 (55) Minimum, Maximum 44.4, 90.3 43.9, 98.9 VAS at Week 12 Mean ±...
  • Page 62 The following figure shows the percentage of pain relief for burst stimulation (left graph) and tonic stimulation (right graph) in individual subjects overall from baseline through week 24. For this figure, the responder rate was defined as a 50% or more reduction in the overall VAS score. Figure 14.
  • Page 63 Figure 15. Percentage reduction (≥50% responder rate) in overall VAS score at week 12 from baseline The following figure shows the percentage of pain relief from burst stimulation (left graph) and tonic stimulation (right graph) in the individual subjects at week 12, using a responder rate definition of 50%.
  • Page 64 Figure 16. Percentage reduction (≥50% responder rate) in overall VAS score at week 24 from baseline The following table summarizes the proportion of subjects with a decrease in overall VAS score by <30%, ≥30% and <50%, and ≥50% under each stimulation mode. Overall, more subjects experienced a reduction in overall VAS score of ≥50% while using burst stimulation than while using tonic stimulation (39 versus 32) and fewer subjects experienced reduction in overall VAS score by <30% while using burst stimulation (40 versus 49).
  • Page 65 Table 35. Summary of decrease in overall VAS score from baseline by three categories Decrease in Overall VAS From Baseline Burst Tonic All Subjects <30% 40/100 (40.0%) 49/100 (49.0%) ≥30%, <50% 21/100 (21.0%) 19/100 (19.0%) ≥50% 39/100 (39.0%) 32/100 (32.0%) The following two tables summarize trunk VAS scores for the randomization subject population and only from baseline to 12 weeks.
  • Page 66 Table 37. Change in trunk VAS score from baseline to week 12 Arm 1: tonic/burst Arm 2: burst/tonic Randomization Stimulation Tonic Burst VAS at Baseline Mean ± SD (N) 70.4±17.2 (45) 77.0±11.6 (55) Minimum, Maximum 19.3, 98.3 42.6, 97.1 VAS at Week 12 Mean ±...
  • Page 67 Table 39. Change in limb VAS score from baseline to week 12 Arm 1: tonic/burst Arm 2: burst/tonic Randomization Stimulation Tonic Burst VAS at Baseline Mean ± SD (N) 68.1±21.0 (44) 72.5±21.6 (54) Minimum, Maximum 0.4, 93.0 2.1, 98.3 VAS at Week 12 Mean ±...
  • Page 68 Device Satisfaction and Stimulation Preference At each follow-up visit, subjects specified their overall level of satisfaction with the device, and they specified their preference with the stimulation mode at the week-24 visit. The following tables show that most subjects were satisfied with the device therapy during both stimulation modes (78.1%), few subjects were dissatisfied with the device (4.2%), and a similar number of subjects had opposite responses for burst and tonic.
  • Page 69 Psychosocial Health and Physical Function Measures The PGIC questionnaire was completed at the week-12 and week-24 visits and was used to evaluate the subject’s impression of change since beginning the study treatment. The following table shows the summary of responses to this questionnaire pooled across the two arms. Overall, the proportion of subjects whose global impression was moderately better, better, or a great deal better was comparable between the two stimulation modes (72/97 for burst versus 71/96 for tonic).
  • Page 70 Table 44. Components of SF-36 quality of life physical and mental scores Randomization Arm 1: Arm 2: Pooled tonic/burst burst/tonic Tonic Mean ± SD (N) 36.1±8.0 (42) 35.6±10.1 (47) 35.8±9.2 (89) 18.9, 34.4, Minimum, Median, Maximum 22.3, 36.1, 55.6 — 64.6 Burst-Tonic Mean ±...
  • Page 71 The following table shows a summary of ODI scores. Subjects experienced a reduction in ODI scores from baseline during both stimulation modes. However, neither burst nor tonic stimulation produced clinically meaningful changes on the ODI. One reason for this observation may be the relatively low baseline scores observed in this population.
  • Page 72 Table 46. Summary of SF MPQ-2 scores Randomization Arm 1: Arm 2: Pooled tonic/burst burst/tonic Burst Mean ± SD (N) 2.0±2.0 (44) 2.2±1.4 (51) 2.1±1.7 (95) Minimum, Median, Maximum 0.0, 1.3, 8.0 0.0, 2.2, 5.3 — Tonic Mean ± SD (N) 2.2±1.8 (44) 2.4±1.7 (51) 2.3±1.8 (95)
  • Page 73 Table 47. Summary of PCS scores Randomization Arm 1: Arm 2: Pooled tonic/burst burst/tonic Burst-Tonic Mean ± SD (N) -2.2±10.3 (45) 3.1±11.8 (51) — Minimum, Median, Maximum -24.0, 0.0, 31.0 -22.0, 2.0, 52.0 — Burst-Tonic Average ± Pooled SD 0.5±5.6 Across Arms 95% CI -1.8, 2.7...
  • Page 74 Pain Medication In the first 12 weeks, 6 subjects (2 using tonic stimulation, 4 using burst stimulation) increased pain medication. Between weeks 12 and 24, 15 subjects (5 using burst stimulation, 10 using tonic stimulation) increased pain medication. Altogether, 12 tonic stimulation subjects and 9 burst stimulation subjects increased pain medication.
  • Page 75 Programming parameters for tonic stimulation are based on long-term experience and subject-optimization needs, while burst programming parameters for pulse width and frequency were selected from feasibility studies and did not allow subject-specific customization except for amplitude adjustment. Future studies that optimize burst programming may show additional reduction in paresthesia.
  • Page 76 Further, the nonclinical laboratory studies that Abbott Medical conducted, when combined with the clinical experience, provide assurance that a Prodigy™ neurostimulation system using burst stimulation is safe and effective when treating chronic pain.

  • Page 77: Appendix F: Symbols And Definitions

    Appendix F: Symbols and Definitions The following symbols may be used in this document and on some of the products and packaging: Table 50. Symbols and definitions Symbol Definition Caution, consult accompanying documents Consult instructions for use Follow instructions for use on this website Magnetic Resonance (MR) Conditional, an item with demonstrated safety in the MR environment within the defined conditions.
  • Page 78 Authorized European representative European conformity, affixed according to the relevant provisions of AIMD directive 90/385/EEC and RE directive 2014/53/EU Annex II. Hereby, Abbott Medical declares that this device complies with the essential requirements and other relevant provisions of these directives.
  • Page 80 Abbott Medical Abbott Medical 6901 Preston Road The Corporate Village Plano, Texas 75024 USA Da Vincilaan 11 Box F1 +1 855 478 5833 1935 Zaventem +1 651 756 5833 Belgium +32 2 774 68 11 2019-09 ARTEN600060791 A *600060791*...

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