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ENVOY is intended for use as a multiparameter physiological patient monitoring system.

The ENVOY can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the ENVOY to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.

Functions include display of multiparameter waveforms, vital signs, alarm & status messages.

The Mennen Medical ENVOY is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring.

The following are examples of intended clinical applications:

• · Critical Care Patients
• · Cardiac Step-down/Telemetry Units
• Emergency Departments
• · Intra-operative (Anesthesia) Monitoring
• · Post Anesthesia Care

The Envoy is a multiparameter physiological patient monitor, capable of monitoring:

• · ECG/Heart Rate
• · invasive blood pressure
• · non-invasive blood pressure
• · respiration
• · pulse oximetry
• · two temperature channels
• · cardiac output
• · eTCO2

The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays.

ENVOY vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the ENVOY display unit. Vital signs and waveform information are displayed simultaneously on the ENVOY Display Unit. Up to 8 traces can be displayed at any one time.

The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure and EtCO2 Modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA.

Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, Waveform, Vital Sign Numeric Value, Alarm Status Message.

Operation of the ENVOY is accomplished by interaction with front panel controls on the main processor unit. A quick-knob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is display.

ENVOY is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, nor life sustaining device; nor is it implantable and therefore sterility is not a consideration.

ENVOY complies with IEC 601-1 Medical Electrical Equipment, IEC 601-2-2-27 Safety of Electrocardiographic monitoring, IEC 601-2-30 Requirements for Automatic Cycling Indirect Blood Pressure monitoring, AAMI/ANSI SP-10/A1 Electronic or Automated Sphygmomanometers, IEC 601-2-34 Requirements for Invasive Blood Pressure monitoring, AAMI/ANSI ES1 Safe Current Limits for Electromedical Apparatus, and AAMVANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms. ENVOY is not a kit, does not contain any drug or biological products and is not for prescription use.

The ECG/Resp. module is the source of all ECG data in the Envoy bedside monitor. ECG is measured using a multi-lead cable via electrodes attached to the patient's chest.

Monitoring the ECG produces a continuous waveform of cardiac electrical activity to enable an accurate assessment of a patient's current physiological condition. With the ECG module, you can use a 3, 5 6 or 10 lead electrode ECG cable set to display up to 12 selectable ECG leads in up to three channels.

The 12 Lead ECG/Resp. module is housed in the Envoy module rack, where it occupies a single slot. It includes ECG and respiration monitoring.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "ECG/HEART RATE": {
      "Monitored Leads": {
        "Acceptance Criteria": "Same as predicate (3/5/6-leads)",
        "Device Performance": "3/5/6/12 leads"
      },
      "Sampling Rate and Resolution": {
        "Acceptance Criteria": "641 Hz sampling rate, 22 bit resolution",
        "Device Performance": "The same"
      },
      "Frequency Response - analog output": {
        "Acceptance Criteria": "Diagnostic: 0.05 to 150 Hz; Monitor: 0.5 to 40 Hz; Exercise: 1.0 to 25 Hz (According to ANSI/AAMI EC11 para.3.2.7.2)",
        "Device Performance": "The same"
      },
      "Input Impedance": {
        "Acceptance Criteria": "20M ohm typical; 5M ohm differential, dc to 10Hz; 2.5M ohm differential 10 to 100 Hz (as per ANSI/AAMI EC13 para.3.2.9.2)",
        "Device Performance": "The same"
      },
      "Common Mode Rejection (CMR)": {
        "Acceptance Criteria": "120 dB, minimum; Lead Fault Detection based on impedance",
        "Device Performance": "The same"
      },
      "Baseline Recovery": {
        "Acceptance Criteria": "within 3 sec, 1 sec after lead switch",
        "Device Performance": "The same"
      },
      "Gain Levels": {
        "Acceptance Criteria": "250 - 8000",
        "Device Performance": "The same"
      },
      "Pacemaker Detection and Rejection": {
        "Acceptance Criteria": "Amplitude: 2 mV to 700 mV; Width: 0.1 ms to 2.0 ms (as per ANSI/AAMI EC13 para.3.1.4); Pacemaker flag inserted into displayed waveform",
        "Device Performance": "The same"
      },
      "Patient Isolation": {
        "Acceptance Criteria": "Meets ANSI/AAMI ESI-1985 standard for Safe Current Limits for Electromedical Apparatus (5kV dc, 2.5kV AC)",
        "Device Performance": "The same"
      },
      "Heart Rate (HR) Counting": {
        "Acceptance Criteria": "20 to 300 BPM",
        "Device Performance": "The same"
      },
      "HR Accuracy": {
        "Acceptance Criteria": "± 2 BPM. Values below 20 are recorded as zero",
        "Device Performance": "The same"
      },
      "QRS Detection Range": {
        "Acceptance Criteria": "0.25 to 5.0 millivolt height; 70 to 120 milliseconds width",
        "Device Performance": "The same"
      },
      "Leads analyzed for: Hear Rate and Arrhythmia Configuration": {
        "Acceptance Criteria": "Top two displayed",
        "Device Performance": "The same"
      },
      "HR Alarm Settings": {
        "Acceptance Criteria": "20 (low) to 250 (high), non-overlapping",
        "Device Performance": "The same"
      },
      "Lead Fault Sense": {
        "Acceptance Criteria": "when ECG electrode is interrupted or becomes marginal",
        "Device Performance": "The same"
      },
      "Defib. Pulse Protection": {
        "Acceptance Criteria": "5KV (as per ANSI/AAMI EC13, clause 3.2.2.2 and per IEC 601-2-27, clause 17,101 and 102)",
        "Device Performance": "The same"
      },
      "Degree of protection against electrical shock": {
        "Acceptance Criteria": "Type CF",
        "Device Performance": "The same"
      },
      "Electrosurgical Interference Suppression Provided": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "The same"
      },
      "Dynamic Range": {
        "Acceptance Criteria": "differential voltage of up to ± 5mv at a rate up to ±320 mV/sec (as per ANSI/AAMI EC13, para. 3.2.9.1)",
        "Device Performance": "The same"
      },
      "Noise": {
        "Acceptance Criteria": "<30 microVp-p (ANSI/AAMI EC13, para.3.2.9.3)",
        "Device Performance": "The same"
      }
    },
    "RESPIRATION": {
      "Monitored Leads": {
        "Acceptance Criteria": "RA-LA (transthorac) or RA-LL (transabdominal)",
        "Device Performance": "The same"
      },
      "Frequency Response": {
        "Acceptance Criteria": "0.13 to 2.5 Hz (-3 dB)",
        "Device Performance": "The same"
      },
      "Impedance Range": {
        "Acceptance Criteria": "100 to 3000 ohm @ 100 kHz",
        "Device Performance": "100 to 1500 ohm @ 65 kHz"
      },
      "Respiration Sensitivity Range": {
        "Acceptance Criteria": "0.2 ohm to 5.0 ohm",
        "Device Performance": "The same"
      },
      "Respiration Rate Counting Range": {
        "Acceptance Criteria": "8 to 150 BPM",
        "Device Performance": "8 to 120 BPM"
      },
      "Overload Recovery Time": {
        "Acceptance Criteria": "typically 1 sec, max 10 sec",
        "Device Performance": "The same"
      },
      "Lead Fault Sense": {
        "Acceptance Criteria": ">3K ohm",
        "Device Performance": "The same"
      },
      "Manual Threshold Mode": {
        "Acceptance Criteria": "0.2 ohm/1000 ohm (0.02%) to 5 ohm/1000 ohm (0.5%) at 20 BPM",
        "Device Performance": "0.2 ohm/1500 ohm (0.013%) to 5 ohm/1000 ohm (0.33%) at 20 BPM"
      },
      "Automatic Threshold": {
        "Acceptance Criteria": "0.35 ohm/1000 ohm (0.035%) to 5 ohm/1000 ohm (0.5%) at 20 BPM",
        "Device Performance": "The same"
      },
      "Alarm Settings": {
        "Acceptance Criteria": "Low rate: 0 - 150 BPM; High rate: 8 - 150 BPM",
        "Device Performance": "Low rate: 0 - 120 BPM; High rate: 8 - 120 BPM"
      },
      "Apnea Alarm Delay": {
        "Acceptance Criteria": "10 - 90 sec, selectable (default 10 sec.)",
        "Device Performance": "The same"
      },
      "Apnea Alarm Reset": {
        "Acceptance Criteria": "Automatic as defined by System administrator (default 3 breaths)",
        "Device Performance": "The same"
      }
    },
    "DISPLAYED PARAMETERS": {
      "ECG": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "Yes"
      },
      "Heart Rate": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "Yes"
      },
      "Respiration": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "Yes"
      }
    },
    "ALARM INDICATIONS": {
      "ECG": {
        "Acceptance Criteria": "Visual & Sound",
        "Device Performance": "Visual & Sound"
      },
      "Heart Rate": {
        "Acceptance Criteria": "Visual & Sound",
        "Device Performance": "Visual & Sound"
      },
      "Respiration": {
        "Acceptance Criteria": "Visual & Sound",
        "Device Performance": "Visual & Sound"
      }
    },
    "DISPLAY FUNCTIONS": {
      "Change ECG Lead Selection": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "Display of Arrhythmia Information": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "Data Review: Trends": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "Data Review: Tabular": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "User Defined Configuration Setup": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "User Defined Default Settings": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      }
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document states that the 12 Lead ECG/Resp. module 'has also been clinically tested and evaluated in a local hospital.' However, it does not specify the sample size of the test set nor the specific country of origin, or if it was retrospective or prospective.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "This information is not provided in the document.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "This information is not provided in the document.",
  "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "No MRMC comparative effectiveness study is mentioned. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The device's proprietary algorithms for ECG, Respiration, and Invasive Blood Pressure are stated to be 'based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions.' This suggests standalone testing of the algorithms was performed, but specific details of this testing are not provided for the modified device.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "For the algorithms, 'well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions' were used. This implies a ground truth based on established clinical examples and likely expert-validated data, though the exact method is not detailed.",
  "8. The sample size for the training set": "The document does not explicitly mention a training set, but refers to algorithms being 'based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases'. The sample size of these databases is not specified.",
  "9. How the ground truth for the training set was established": "The ground truth for the underlying algorithms was established using 'well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions.' The specific methodology for establishing this ground truth (e.g., expert consensus, independent validation) is not detailed for the original databases."
}

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