Predictika · MRI-conditional pacemakers and CRT-Ps

An AI scheduling agent's MRI scan booking, checked before it goes out

An AI scheduling agent prepares a booking for an MRI scan of a patient with an implanted pacemaker or CRT-P: which device and leads are implanted, which scanner and field strength, the scan limits and the patient conditions. Before it goes out, the agent sends it to Predictika, which checks it against a declarative model of the manufacturer's public ProMRI System Technical Manual and returns a verdict, every reason and the field strength the system allows. This is a demonstration of the rules, not clinical advice.

Scope: BIOTRONIK ProMRI pacemakers and CRT-Ps (bradycardia, HF-T and HF-T QP devices) with their leads, checked against the ProMRI System Technical Manual. See everything this validator covers

This validator models MRI scan bookings for patients with a BIOTRONIK ProMRI pacemaker or CRT-P and its leads, as set out in the public ProMRI System Technical Manual, not just the scenarios shown below.

  • Devices — the pacemakers Eluna, Entovis, Edora 8, Evity 8 and 6, Enitra 8 and 6, Amvia Sky, Amvia Edge and Solvia Rise, and the CRT-Ps Edora 8, Evity 8, Enitra 8 and Amvia Sky (HF-T and HF-T QP) and Amvia Edge (HF-T QP).
  • Leads and positions — the right atrial and ventricular leads in the manual (Setrox, Safio, Dextrus, TILDA, Siello and Solia, including the T, JT and CSP leads), where each is ProMRI (for example JT 45 only in the atrium, T 60 only in the ventricle, CSP only for left bundle branch area pacing), and the left ventricular leads for CRT-Ps (Corox OTW 85 BP with HF-T devices, Sentus quadripolar leads with HF-T QP devices).
  • Field strength — 1.5 T for every system; 3.0 T for every listed device except Eluna and Entovis, and not with a Siello JT 45 or Solia JT 45 lead.
  • Scanner and patient conditions — cylindrical bore, Normal Operating Mode, gradient slew rate and spatial field gradient, whole-body and head SAR, leads implanted at least 6 weeks, pectoral implant, pacing threshold, battery status, no abandoned leads, extenders or adapters, other implants, the device in an MRI mode, continuous patient monitoring and resuscitation equipment.

Any scan booking for these pacemakers and CRT-Ps that touches these rules is in scope — not only the scenarios pictured here. Not covered: ICDs, CRT-Ds and insertable cardiac monitors, blind plugs, the Corox OTW 75 BP leads (the printed table shows only 3.0 T for them with HF-T CRT-Ps, which does not fit the neighboring rows, so they are left out), prices (the manual is clinical labeling, not a price list, so this validator produces no price build-up, line-item quote or stated figure to compare), and the difference between MRI AutoDetect and MRI Guard 24/7. Assumptions: a missing documented indication is routed to approval rather than blocked, which is this model's choice, and leads whose table row carries no position note are treated as allowed in either position. This is a demonstration of the manual's rules, not clinical advice; every real scan decision belongs to the clinicians and the manufacturer's labeling.

The AI sales agentBuilds the scan booking from the scheduling request and says it is ready.
Predictika validatorChecks every rule at once and returns the verdict, each finding, and the computed figures.

7 scenarios in 3 groups · each group runs from the agent’s first attempt to the outcome · click one to switch

What the agent proposes

The AI sales agent says

Illustrative agent statement. The validator receives the structured request below.

Proposing agent: AI sales agent (scripted)

Before sending, the agent must call Recorded run

Predictika validator


      

        
        
        
      

      
Waiting for the call.

      
    

  

  
  

    
Where rules-based CPQ gets it wrong
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Our assessment of what a typical rules-based CPQ (product rules, price rules and validation rules, as in Salesforce CPQ) does with the same cases. It is a judgment about effort and reliability, not a claim that nothing can be built.

    
What the validator caughtTypical rules-based CPQPredictika
A 3.0 T limit that depends on the device and on one lead in the systemOnly with workarounds
The limit belongs to the whole combination, so a rule on the device line has to look at every lead line and take the most restrictive answer, and each new device or lead adds more of those cross-line rules.		The allowed field strength is derived from the device and every lead on each call and compared with the field requested.
Leads that are ProMRI only in certain positionsOnly with care
Position is a property of where the lead is used, so each lead needs its own position rule, and the rule is easy to leave out when a lead is added.		Each lead is checked in the position it is recorded in on every call.
Lead types that fit only some CRT-P devicesOnly with care
Bipolar and quadripolar leads fit different device families; this is a product-compatibility rule for every device and lead pair, and it needs maintaining as the lists change.		The pairing is checked from the device and the lead on each call.
Scanner limits and patient conditions: SAR, slew rate, weeks since implant, thresholdOnly with workarounds
These are not product attributes of a catalog product. They need custom fields and validation rules, and are usually checked at the end of the flow rather than together with the device rules.		They travel in the same request as the device and leads and are checked together on every call.
Every problem returned in one answerOnly with workarounds
Rules tend to fire as the booking is saved or a step is completed, so a coordinator often fixes one error and meets the next.		All findings come back together, whatever order the choices arrived in.

  

  

    
What this validator catches: findings from its test cases
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Every rule is checked on every call, in any order the choices arrive; one problem never hides another. Blocking findings stop the quote; approval findings need a person to sign off; everything else is computed.

    
13.0 T scanning is not allowed with this device; Eluna and Entovis pacemakers are ProMRI at 1.5 T only.
23.0 T scanning is not allowed with a Siello JT 45 or Solia JT 45 lead; those leads are ProMRI at 1.5 T only.
3A Siello JT 45 or Solia JT 45 lead is ProMRI only in the right atrium, but it is recorded in the right ventricle.
4A Siello T 60 or Solia T 60 lead is ProMRI only in the right ventricle, but it is recorded in the right atrium.
5A Solia CSP lead is ProMRI only for left bundle branch area pacing, but it is recorded in the right atrium or right ventricle.
6No ProMRI combination is listed for a pacemaker with a left ventricular lead; the left ventricular leads in the manual are for CRT-P devices.
7A Sentus quadripolar lead is not a listed ProMRI combination with an HF-T CRT-P; the manual lists the Corox OTW 85 BP leads for it.
8A Corox bipolar lead is not a listed ProMRI combination with an HF-T QP CRT-P; the manual lists the Sentus quadripolar leads for it.
9A 7.0 T scanner is not allowed; ProMRI systems are cleared at 1.5 T, or at 3.0 T for certain device and lead combinations.
10A 1.0 T scanner is not allowed; ProMRI systems are cleared at 1.5 T, or at 3.0 T for certain device and lead combinations.
11The scanner must be a clinical system with a cylindrical bore.
12The scan must run in Normal Operating Mode.
13The scanner gradient slew rate is 250 T/m/s per axis; the maximum is 200 T/m/s.
14The maximum spatial field gradient is 35 T/m; the maximum is 30 T/m.
15The whole-body SAR is 2.4 W/kg; the maximum is 2.0 W/kg.
16The head SAR is 3.6 W/kg; the maximum is 3.2 W/kg.
17The leads were implanted 5 weeks ago; at least 6 weeks are required.
18The device system must be implanted pectorally.
19The measured bipolar pacing threshold is 2,400 mV at 0.4 ms; the maximum is 2,000 mV (2.0 V).
20The battery status is at the elective replacement indicator or end of service; neither is allowed.
21The patient has an abandoned lead, lead extension or lead adapter; none is allowed.
22Another implant is not identified as MR conditional by its manufacturer.
23A metal implantable device longer than 5 cm is within 5 mm of a lead electrode.
24The device must have MRI Guard 24/7 or be programmed to an MRI mode (ON or AUTO) before the scan.
25The patient must be monitored continuously during the scan by oxygen saturation, blood pressure or ECG.
26Emergency resuscitation equipment and certified staff must be available during the scan.
27No clear indication for the MR scan is documented; a cardiology professional and a radiology professional must confirm that the benefit outweighs the risk.
28The leads were implanted 3 weeks ago; at least 6 weeks are required.
29The whole-body SAR is 2.6 W/kg; the maximum is 2.0 W/kg.

  

  

    
Scenarios and results
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The recorded result of the validator for each scenario on this page: the request the AI agent sent, the verdict, and every finding, in the order they appear above.

    
1. Pacemaker at 3.0 T: Evity 8 pacemaker with a Solia JT 45 atrial lead, booked at 3.0 T

    
The agent's request. Please book a 3.0 T MRI scan for a patient with an Evity 8 pacemaker, with a Solia JT 45 lead in the right atrium and a Solia S 60 lead in the right ventricle, implanted 14 weeks ago with a pacing threshold of 1000 mV at 0.4 ms. The scanner has a gradient slew rate of 150 T/m/s, a maximum spatial field gradient of 20 T/m, a whole-body SAR of 2.4 W/kg and a head SAR of 2.5 W/kg. It is ready to send.

    
Verdict: Blocked.

    
    
      
  • 3.0 T not allowed with this lead. 3.0 T scanning is not allowed with a Siello JT 45 or Solia JT 45 lead; those leads are ProMRI at 1.5 T only.
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  • Whole-body SAR too high. The whole-body SAR is 2.4 W/kg; the maximum is 2.0 W/kg.
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  • Device not set to an MRI mode. The device must have MRI Guard 24/7 or be programmed to an MRI mode (ON or AUTO) before the scan.
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2. Pacemaker at 3.0 T: The agent resubmits after fixing the errors

    
The agent's request. Please book a 1.5 T MRI scan for a patient with an Evity 8 pacemaker, with a Solia JT 45 lead in the right atrium and a Solia S 60 lead in the right ventricle, implanted 14 weeks ago with a pacing threshold of 1000 mV at 0.4 ms. The scanner has a gradient slew rate of 150 T/m/s, a maximum spatial field gradient of 20 T/m, a whole-body SAR of 1.8 W/kg and a head SAR of 2.5 W/kg. It is ready to send.

    
Verdict: Allowed.

    
    
      
  • Field strength for this system. This device and lead combination is ProMRI at 1.5 T only; the scan is requested at 1.5 T.
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3. CRT-P with a quadripolar lead: Amvia Sky HF-T QP CRT-P with a Sentus lead, booked at 3.0 T

    
The agent's request. Please book a 3.0 T MRI scan for a patient with an Amvia Sky HF-T QP CRT-P, with a Solia JT 53 lead in the right atrium, a Solia S 60 lead in the right ventricle and a Sentus OTW QP L-85 lead in the left ventricle, implanted 26 weeks ago with a pacing threshold of 1000 mV at 0.4 ms. The scanner has a gradient slew rate of 250 T/m/s, a maximum spatial field gradient of 20 T/m, a whole-body SAR of 1.5 W/kg and a head SAR of 3.6 W/kg. It is ready to send.

    
Verdict: Blocked.

    
    
      
  • Gradient slew rate too high. The scanner gradient slew rate is 250 T/m/s per axis; the maximum is 200 T/m/s.
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  • Head SAR too high. The head SAR is 3.6 W/kg; the maximum is 3.2 W/kg.
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  • No continuous patient monitoring. The patient must be monitored continuously during the scan by oxygen saturation, blood pressure or ECG.
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4. CRT-P with a quadripolar lead: The agent resubmits after fixing the errors

    
The agent's request. Please book a 3.0 T MRI scan for a patient with an Amvia Sky HF-T QP CRT-P, with a Solia JT 53 lead in the right atrium, a Solia S 60 lead in the right ventricle and a Sentus OTW QP L-85 lead in the left ventricle, implanted 26 weeks ago with a pacing threshold of 1000 mV at 0.4 ms. The scanner has a gradient slew rate of 180 T/m/s, a maximum spatial field gradient of 20 T/m, a whole-body SAR of 1.5 W/kg and a head SAR of 2.8 W/kg. It is ready to send.

    
Verdict: Allowed.

    
    
      
  • Field strength for this system. This device and lead combination is ProMRI at 1.5 T or 3.0 T; the scan is requested at 3.0 T.
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5. Documented indication: Entovis pacemaker scanned at 1.5 T

    
The agent's request. Please book a 1.5 T MRI scan for a patient with an Entovis pacemaker, with a Setrox S 60 lead in the right ventricle, implanted 20 weeks ago with a pacing threshold of 1000 mV at 0.4 ms. The scanner has a gradient slew rate of 150 T/m/s, a maximum spatial field gradient of 20 T/m, a whole-body SAR of 1.5 W/kg and a head SAR of 2.5 W/kg. It is ready to send.

    
Verdict: Needs approval.

    
    
      
  • No clear indication documented. No clear indication for the MR scan is documented; a cardiology professional and a radiology professional must confirm that the benefit outweighs the risk.
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  • Field strength for this system. This device and lead combination is ProMRI at 1.5 T only; the scan is requested at 1.5 T.
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6. Documented indication: The agent resubmits after fixing the errors

    
The agent's request. Please book a 1.5 T MRI scan for a patient with an Entovis pacemaker, with a Setrox S 60 lead in the right ventricle, implanted 20 weeks ago with a pacing threshold of 1000 mV at 0.4 ms. The scanner has a gradient slew rate of 150 T/m/s, a maximum spatial field gradient of 20 T/m, a whole-body SAR of 1.5 W/kg and a head SAR of 2.5 W/kg. It is ready to send.

    
Verdict: Allowed.

    
    
      
  • Field strength for this system. This device and lead combination is ProMRI at 1.5 T only; the scan is requested at 1.5 T.
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7. Implant history: Eluna pacemaker with an abandoned lead

    
The agent's request. Please book a 3.0 T MRI scan for a patient with an Eluna pacemaker, with a Siello S 60 lead in the right atrium and a Siello S 60 lead in the right ventricle, implanted 5 weeks ago with a pacing threshold of 2400 mV at 0.4 ms. The scanner has a gradient slew rate of 150 T/m/s, a maximum spatial field gradient of 20 T/m, a whole-body SAR of 1.5 W/kg and a head SAR of 2.5 W/kg. It is ready to send.

    
Verdict: Blocked.

    
    
      
  • 3.0 T not allowed with this device. 3.0 T scanning is not allowed with this device; Eluna and Entovis pacemakers are ProMRI at 1.5 T only.
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  • Leads implanted less than 6 weeks. The leads were implanted 5 weeks ago; at least 6 weeks are required.
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  • Pacing threshold too high. The measured bipolar pacing threshold is 2,400 mV at 0.4 ms; the maximum is 2,000 mV (2.0 V).
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  • Abandoned leads, extenders or adapters. The patient has an abandoned lead, lead extension or lead adapter; none is allowed.
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Narration transcript
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The text of the narrated walkthrough, step by step.

    
    
      
  1. Welcome to a demo of Predictika's Validator. An AI scheduling agent prepares a booking for an MRI scan of a patient with an implanted pacemaker or CRT-P: which device and leads are implanted, which scanner and field strength, the scan limits and the patient conditions. Before it goes out, the agent sends it to Predictika, which checks it against a declarative model of the manufacturer's public ProMRI System Technical Manual and returns a verdict, every reason and the field strength the system allows. This is a demonstration of the rules, not clinical advice.
    2. 
      
  2. I will start with the first request by the agent.
    3. 
      
  3. The agent says. Please book a 3.0 T MRI scan for a patient with an Evity 8 pacemaker, with a Solia JT 45 lead in the right atrium and a Solia S 60 lead in the right ventricle. The scanner has a gradient slew rate of 150 T/m/s, a maximum spatial field gradient of 20 T/m, a whole-body SAR of 2.4 W/kg and a head SAR of 2.5 W/kg. The rest of the request is on screen.
    4. 
      
  4. Before it goes out, the agent calls the validator.
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  5. Blocked, with three findings, all in one answer. 3.0 T scanning is not allowed with a Siello JT 45 or Solia JT 45 lead; those leads are ProMRI at 1.5 T only. The whole-body SAR is 2.4 W/kg; the maximum is 2.0 W/kg. The device must have MRI Guard 24/7 or be programmed to an MRI mode (ON or AUTO) before the scan.
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  6. The validator returned three blocking findings in one answer. A check that reads one field at a time would pass most of this; it shows only when the choices in the quote are checked against each other.
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  7. What this shows: for a 3.0 T limit that depends on the device and on one lead in the system, a rules-based CPQ can do this only with workarounds.
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  8. Now the agent resubmits.
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  9. The corrected request. It changes the scanner field strength to 1.5, the Whole-body SAR to 1.8 and the device in an MRI mode to yes.
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  10. It calls the validator again.
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  11. This time the validator clears it.
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  12. All three earlier findings are cleared.
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  13. Three problems caught in one call, fixed in one pass, and a clean quote. That is the value of Predictika's validator: catching mistakes before they reach the customer. Now you can try the other scenarios yourself.
    14.