- The device must be able to deliver an appropriate tidal volume.
Specifications:
1.1 The tidal volume air delivery must be in the range of 0 liters to 500 mL less than the volume capacity of the bag (for 2L bag, 1.5 L; for 1L bag, .5 L).
Justifications:
1.1 BVM standard adult sizing is 1L or 2L bags [26]. Delivering a proper tidal volume is essential to the objective device function.
- The device must be able to detect a proximal pressure of air being delivered by the BVM.
2.1 Must measure proximal pressures between 0-45 cmH2O.
2.1 Pressure monitoring is required for the calculation of air flow and to ensure positive pressure is being delivered to the patient. Additionally, high PIP (>35 cmH2O can result in airway injury and have hemodynamic consequences.
3. The device must cyclically deliver air volume with the tidal volume range recommended by the AHA for BVM Use
Specification:
3.1 The delivered tidal volume must be within 400 and 1000 mL.
3.2.1 The volume of air must be delivered over 1 to 2 seconds.
3.2.2 The inspiratory/expiratory ratio must be between 1:1 and 1:4.
3.3 Breaths must be delivered at a rate of 6 to 40 breaths per minute.
Justification:
3.1 AHA recommendation: Volumes: > 400 mL maintains adequate arterial oxygen saturation depending on if oxygen supply is attached and the size of the patient, <1000 mL to reduce the risk of gastric inflation. I/E ratios between 1:1 and 1:4 are recommended by the standard AAMI/CR501:2020.
3.2.1 Delivering volume over 1-2 seconds reduces risk of gastric inflation.
3.2.2 An I/E ratio of 1:2 is required by standard AAMI/CR501:2020, but a range of 1:1 to 1:4 is suggested.
3.3 A range of 6-40 is required by standard AAMI/CR501:2020.
4. Air must be delivered according to user-set parameter values (see requirement 3).
Specification:
4.1 Tidal volume within 400-1000ml (±50ml) in increments of 100ml.
4.2 Delivered over 1 to 2 seconds (±50ml) in increments of 100ml.
4.3 Inspiratory/Expiratory ratio between 1:1 and 1:4 (± 25%) with increments of 1:(1,2,3,4).
4.4 Breaths per minute between 6 to 40 (±1) with increments of 5.
Justification:
4. The device automated air delivery by the BVM in a volume-controlled setting, therefore TV, I/E ratio, BPM must have the ability to be manipulated by the user and delivered with accuracy, per the functionality of the device.
5. The device must give visual and audio feedback to the user when proximal pressure is outside the range of safe pressure.
Specification:
5.1 When proximal pressure is outside the range of 5-40 cmH2O an alarm of at least 54 dB will sound.
5.2 When proximal pressure falls outside the range of 5-40 cmH2O, a red light signal (IEC 60601-1, 7.8.1) will be deployed.
Justification:
5.1.1 According to AAMI/CR501:2020, failure conditions must result in an alarm and permit conversion to manual clinician override.
5.1.2 The environment on the scene of an accident, in an ambulance, or in a hospital can be louder than a typical home environment. A typical ambulance that is stationary has a noise level of up to 54 dBa, and 84 dBa when the cab windows are down, and sirens are in use.
5.2 According to IEC 60601-1 a red light is the universal indicator of an emergency.
6. The device’s battery power components must comply with current medical device electrical standards.
Specification:
6.1 Input voltage should not exceed 60 V (DC) according to IEC 60601-1 3.1 (8.4.2c).
6.2 Batteries used should conform to the standard for rechargeable batteries used in medical devices, IEC 62133.
Justification:
6.1 Standard IEC 60601-1.
6.2 Standard IEC 62133
7. The device must fit the current standard adult AmbuBag BVM.
Specification:
7.1 The device must fit a BVM with circumference of the AmbuBag: 16 inches. The device must be larger than circumference of the bag.
Justification:
7.1 AmbuBag is one of the most widely used models of the BVM used by EMTs. These are the size specifications of the AmbuBag.
8. The device must allow for the attachment of the face mask, intake reservoir valve, and oxygen enrichment ports without complications.
Specification:
8.1 Must maintain 1 cm distance away from mask connection port and oxygen port.
Justification:
8.1 The standard structure of a BVM has the bag separated from the ports. The bag connects to a 15 mm port on the mask. Oxygen port and intake reservoir valve located on the back side of the bag opposite to the mask.
9. The device must maintain the portability of the BVM.
Specification:
9.1 Must be less than 6.4 pounds.
9.2 Must be less than 3.5 feet3.
Justification:
9.1 Weight of device and BVM should be able to be carried with ease. The maximum average acceptable weight of life for side carrying is reported to be 25.5lbs. The device should not exceed 25% of this maximum. Other objects considered “portable” such as an oxygen tank weigh up to 130lbs.
9.2 Device size should support ease of storage. The minimum required stowage of a Star of Life Federally regulated ambulance if 35ft3. The device should not exceed 10% of that space.
10. The automated bag compression device must easily attach to the BVM.
Specification:
10.1 Must be able to be attached and started in under 18 seconds.
Justification:
10.1 When delivering chest compressions at a rate of 100 compressions per minute (with 30 compressions per round), a single round of compressions would last 18 seconds. Attaching the device during one compression cycle would result in uninterrupted breaths.
11. The device must be rechargeable; a single charge must last more that the duration of a single call.
Specification:
11.1 For a single CPR call, battery life should be at least 1.5 hours.
Justification:
11.1 Out-of-hospital cardiac arrest typically lasts a maximum of 55 minutes.
12. The device must allow the user to provide a proper face more easily than without the device.
Specification:
12.1 The device must allow for a proper face seal and be greater than 1cm away from mask/patient interface.
Justification:
12.1 The TE (thenar eminence) technique leads to improved ventilation as opposed to the traditional E-C grip.
13. The device must be able to be cleaned for reuse.
Specification:
13.1 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff. 2015. U.S. Food and Drug, 1-38.
Justification:
13.1 Device must follow the guidelines set forth by the FDA for a non-critical device to ensure their device is properly cleaned before reuse.