Environmental and Temperature Requirements
Environmental Requirements
| Description | Operational | Non operational | Storage and transport |
|---|---|---|---|
| Temperature | 0°C to +35°C | -40°C to +70°C | -40°C to +70°C |
| Humidity | 10–90% | 10–95% | 10–95% |
| Air pressure | 54 kPa to 106 kPa | 50 kPa to 106 kPa | 50 kPa to 106 kPa |
Transient Operating Conditions
Permissible transient environmental operating conditions: Following storage at temperatures ranging from -20°C to +50°C, the device will within 10 minutes after being returned to room temperature (20 ± 2°C), function for a minimum of 20 minutes
Avoid exposing the unit to saline moisture. In case of exposure to saline moisture, clean the unit as described in Cleaning and Disinfection. Image on the display device hosting the Vscan Air app is dependent on ambient light; avoid direct sunlight or reflections from other light sources on the display when scanning and reviewing images. The display viewing angle should be as small as possible. If you are having difficulty seeing the image due to the lighting conditions try to change brightness of the display device or change your position/location of use.
Acclimatization Time
Allow the Vscan Air CL to acclimate for approximately 30 minutes, if stored at temperatures outside the transient environmental operating conditions -20°C to +50°C.
Other environment: Aircraft Ambulance/ Road Ambulance
The Vscan Air ultrasound system can be used in an emergency medical services environment, including road and air ambulances.
- The Vscan Air CL is not certified for being mounted or fixed inside a road or air ambulance.
- The Vscan Air CL can be used in emergency medical services environments.
- The Vscan Air CL probe is not certified for being charged inside a road- or air ambulance.
- The AC Adapter must not be operated above 5000m.
Temperature Requirements
The table below indicates the maximum probe temperature.
Maximum Vscan Air CL temperature
| Probe | Max Temp (°C) (Simulated use) | Max Temp (°C) (Still air) |
|---|---|---|
| Vscan Air CL – Curved array transducer (for deep scanning) | 40.5 | 45.3 |
| Vscan Air CL – Linear array transducer (for shallow scanning) | 41.1 | 44.8 |
Measurement uncertainty and probe variation: 2.0 °C.
The probe will stop scanning, if exceeding an applied part surface temperature of 43°C
Lens temperature is measured under conditions per IEC 60601-2-37, Ed2.1
- Thermocouple was placed at the geometric center of the lens
- Thermal phantom at not less than 33°C or in the range 20-33°C for external probes. Maximum Vscan Air CL temperature rise is measured and added to 33°C. Maximum Vscan Air CL temperature (Simulated use) is <43°C.
- With Vscan Air CL transmitting in air, temperature rise is measured and added to 23°C. Maximum Vscan Air CL temperature (Still air) is <50°C. Lens temperature is monitored for 30 minutes.
Vscan Air CL placed in contact with a thermal phantom made of tissue-mimicking material is referenced in IEC60601-2-37, Ed2.1
The information herein is not intended to replace the product’s User Manual. Please consult the User Manual for comprehensive information and cautionary guidance about the product’s operation and use.