(263 days)
The Revivator resuscitator is intended for pulmonary resuscitation.
The adult resuscitator is for people with a body weight of more than 30 kg (66 lbs)
The child resuscitator is for children with a body weight between 7 and 30 kg (15-66 lbs)
The infant resuscitator is for infants with a body weight up to 7 kg (15 lbs)
A resuscitator is a device using positive pressure to inflate the lungs of an unconscious person who is not breathing, in order to keep him oxygenated and alive. The manual resuscitators basically consist of a mask and a large hand-squeezed plastic bulb using ambient air, or supplemental oxygen. The air and oxygen flows into the resuscitator bag. And compressing the bag, the patient is ventilated. In order not to apply a high pressure to the patient's airways, the resuscitators include a pressure-limiting valve.
1. Acceptance Criteria and Reported Device Performance
The device, "Revivator" manual resuscitator, claims substantial equivalence to predicate devices based on compliance with the ISO 10651-4:2002 standard for lung ventilators. The acceptance criteria are derived from this standard. The reported device performance is compared against these criteria and the performance of predicate devices.
| Acceptance Criteria (ISO 10651-4:2002) | Revivator Performance (Adult, Child, Infant) | Predicate Device Performance (Ambu & Mercury Medical Resuscitators) |
|---|---|---|
| Pressure-limiting valve for 10 kg body weight: Not higher than 6 kPa (60 cm H2O) (if included, optional) | Adult: 6 kPa (60 cm H2O) | Adult: 4.0 kPa (Ambu Spur II); Optional for small adults (Mercury Med) |
| Max. tidal volume for 40 kg body weight: At least 600 mL | Adult: 1000 mL | Meets standard |
| Delivered oxygen concentration (with O2 source) : At least 85% (V/V) (with attachment) | Without reservoir: 39-88% O2 (at 2-15 L/min O2 flow); With reservoir: 98-100% O2 (at 2-15 L/min O2 flow) | Claimed to meet standard (reservoir volume contributes) |
| Apparatus dead space: Shall not exceed 5 mL + 10 % of the minimum delivered volume | Lower than 7 mL | Between 5 and 7 mL |
| Expiratory resistance: Shall not exceed 5 cm H2O | 0.09 cm H2O (at 5 L/min); 1.76 cm H2O (at 50 L/min) | Values much lower than admissible |
| Inspiratory resistance: Shall not exceed 5 cm H2O below atmospheric pressure | 0.37 cm H2O (at 5 L/min); 3.48 cm H2O (at 50 L/min) | Values much lower than admissible (Ambu Spur II adult/pediatric 5 cm H2O at 50 L/min) |
| Patient connectors: 22/15 mm | 22mm male / 15mm female | In conformity (Ambu) |
| Expiratory connectors: 30 mm male | 30mm male (PEEP/AGSS) | In conformity (Ambu) |
| Bag refill valve connectors: 32 mm female conical | 32 mm female | In conformity (Predicate devices) |
| Storage temperatures: -40°C to +60°C (with 40%-95% r.h.) | -40°C to +70°C | All resuscitators meet; Revivator & Ambu reusable can store at 70°C |
| Operating temperatures: -18°C to +50°C (with 40%-95% r.h.) | -20°C to +60°C | All resuscitators meet; Revivator & Ambu reusable can operate at -20°C |
| Dismantling & reassembly: Functional test after reassembly | Includes functional test in labeling | Includes functional test in labeling |
| Patient Valve function after contamination with vomitus: In conformity with standard | In conformity with standard | In conformity with standard |
| Drop test: In conformity with standard | In conformity with standard | In conformity with standard |
| Immersion in water: In conformity with standard | In conformity with standard | In conformity with standard |
| End-expiratory pressure: If > 0.2 kPa, value in instructions; pressure gradient |
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).