System Characteristics
The following information is provided to assist the clinician to more fully understand the characteristics of the Cardea SOLO™ ADX S400 system that transform electrode potentials into ECG tracings and beat and rhythm findings.
System Bandwidth and Baseline Wander Filtering
The Sensor electronics digitizes ECG voltages at 250 samples/sec with 3.1 μVolt resolution. Raw data is flat to DC with no low-frequency filtering. After recording, Cardea SOLO™ ADX S400 Software applies a 0.05 Hz High Pass single-pole Butterworth filter to remove long period baseline wander.
The nominal system bandwidth is 0.05 to 65 Hz.
AC Line Filtering
Cardea SOLO™ ADX S400 Software removes AC line signals by estimating and eliminating them using an adaptive filter. This approach prevents distortions and limitations of narrow notch filters and adapts slowly to prevent significant ringing. The AC line frequency can be set in the administrative functions.
Beat and Rhythm Sensitivity and Positive Predictive Value
ECG algorithms within Cardea SOLO™ ADX S400 Software were tested following ANSI/AAMI EC57:2012 guidelines, using PhysioNet databases. These stats help physicians analyze ECG trace data, but performance varies based on quality and complexity. Review rhythm strips and tracings as part of clinical assessment.
PPV: Positive Predictive Value.
Slowest Heart Rate
A rhythm strip for the slowest heart rate is always added to the report. If the heart rate is below the Bradycardia rate (default = 50 bps), for at least 20 seconds, then the strip will be included in the Bradycardia section of the report. Otherwise, the first strip in the Example Rhythm Strips will highlight the lowest observed heart rate.
Maintenance
Cleaning the Smart Cable
To clean the Smart Cable, dampen a cloth with Isopropyl alcohol or use an alcohol wipe and thoroughly wipe down the unit, being sure to remove any accumulated dust from the Electronics Module connection well. Dry with a clean, soft, and dry cloth.
- Fluid Hazard. Do not immerse. Fluids must not be allowed to enter the Smart Cable. If fluids have penetrated the device it should be replaced or inspected by a Cardiac Insight qualified technician before use.
- Equipment Damage warning. Do not use ether, strong bleach, acetone, benzene, or similar solvents to clean the Smart Cable.
- Equipment Damage warning. Do not use ether, strong bleach, acetone, benzene, or similar solvents to clean the Smart Cable.
- Use only the following cleaning agents: Isopropyl alcohol (70% solution in water) or mild soap and water.
- Equipment Damage. Do not hot sterilize the Smart Cable.
NOTE: Do not wipe the exposed connector.
EMC Declaration Tables – Smart Cable, Sensor
The Cardea SOLO™ ADX system is intended for use in the electromagnetic environment specified below:
Electromagnetic Emissions
| Emissions test | Compliance |
| RF emissions CISPR 11 | Group 1 |
| RF emissions CISPR 11 | Class B |
Electromagnetic Immunity for Sensor
| Immunity Test | Basic EMC Standard or test method | Immunity Test Levels for Home Healthcare Environment from IEC 60601-1-2:2020 |
|---|---|---|
| Rated power frequency magnetic fields | IEC 61000-4-8 | 30 A/m 50Hz and 60Hz |
| Proximity to magnetic fields | IEC 61000-4-39 |  |
Electromagnetic Immunity for Smart Cable
| Immunity Test | Basic EMC Standard or test method | Immunity Test Levels for Professional Healthcare Facility Environment from IEC 60601-1-2:2020 |
|---|---|---|
| Electrostatic discharge (ESD) | IEC 61000-4-2 | ±8 kV contact 15 kV air |
| Radiated RF IEC 61000-4-3 | IEC 61000-4-3 | 3 V/m 80 MHz – 2.7 GHz 80 % AM at 1 kHz |
| Rated power frequency magnetic fields | IEC 61000-4-8 | 30 A/m 50Hz and 60Hz |
| Proximity to magnetic fields | IEC 61000-4-39 |  |
| Immunity Test | Basic EMC Standard or test method | Immunity Test Levels for Professional Healthcare Facility Environment from IEC 60601-1-2:2020 |
| Proximity fields from RF wireless communications equipment | IEC 61000-4-3 |   |
Recommended Separation Distances
The following table provides the recommended separation distances between portable and mobile RF communications equipment and the Cardea SOLO™ ADX S400 system.
Cardea SOLO™ ADX S400 is designed for controlled RF disturbances. Maintain minimum distance between portable/mobile RF communication equipment and the Cardea SOLO™ ADX system to prevent electromagnetic interference. Follow recommended distance according to output power.
| Rated maximum output power (P) of transmitter
W | Separation distance according to frequency of transmitter | ||
| 150 kHz to 80 MHz d = 1.2 √ P | 80 MHz to 800 MHz d = 1.2 √ P | 800 MHz to 2.7GHz d = 2.3 √ P | |
| 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 (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) 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 affected by absorption and reflection from structures, objects and people. | |||
| a. 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 Cardea SOLO™ ADX is used exceeds the applicable RF compliance level above, then Cardea SOLO™ ADX should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating Cardea SOLO™ ADX. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.c. Amplitude modulated at 80% with a modulation frequency of 1 kHz per EN 60601-1-2. | |||
FCC Notice
This equipment complies with Class B digital device limits, as per Part 15 of the FCC Rules. It offers protection against harmful interference in residential installations. Improper installation or use may cause interference with radio communications. Interference cannot be ruled out in all installations. If radio or TV reception is affected, try correcting it by turning the equipment off and on or taking other measures.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help
Environmental Specifications
Transport Environment – Sensor
- Temp Range: -25º C to 50º C (-13º F to 122º F)
- Humidity: 10% to 90% (non-condensing)
- Pressure: 500 hPa to 1060 hPa
Storage Environment (Recommended) – Sensor
- Temperature: 5º C to 50º C (41º F to 122º F)
- Humidity: 10% to 90% (non-condensing)
- Pressure: 500 hPa to 1060 hPa
Operating Environment – Sensor
- Temperature: 5º C to 50º C (41º F to 122º F)
- Humidity: 10% to 90%
- Pressure: 500 hPa to 1060 hPa
- Ingress of Solids and Liquids: IEC 60529 Ed. 2.1:2001, IP27 (protected against intrusion from fingers and small objects, and from the effects of temporary immersion in water)
Transport Environment – Smart Cable
- Temperature: -25º C to 50º C (-13º F to 122º F)
- Humidity: 10% to 90% (non-condensing)
- Pressure: 500 hPa to 1060 hPa
Storage Environment (Recommended) – Smart Cable
- Temperature: 5º C to 50º C (41º F to 122º F)
- Humidity: 10% to 90% (non-condensing)
- Pressure: 500 hPa to 1060 hPa
Operating Environment – Smart Cable
- Temperature: 10º C to 50º C (50º F to 113º F)
- Humidity: 10% to 90% (non-condensing)
- Pressure: 500 hPa to 1060 hPa