Assessments - 3, GPA: 3.7
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. . . . . . . . . . . . . . . . . . . . . . . . . . 2 Warnings and Cautions . . . . . . . . . . . . . . . . . . 3 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 4 Controls, Connectors and Visual Indicators . . . . 5 Operating Procedure . . . . . . . . . . . . . . . . . . . . 6 Cleaning and Disinfection . . . . . . . . . . . . . . . . 7 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Preventive Maintenance and Troubleshooting Guide 9 Warranty and Service . . . . . . . . . . . . . . . . . . . 2 3 6 10 14 15 16 18 7 1 SECTION 1 INTRODUCTION The Emerson CoughAssist™ Mechanical In-Exsufflator (MI-E) assists patients in clearing retained bronchopulmonary secretions by gradually applying a positive pressure to the airway, then rapidly shifting to a negative pressure. This rapid shift in pressure, via a facemask, mouthpiece or an endotracheal or tracheostomy tube, produces a high expiratory flow rate from the lungs, simulating a cough, a technique referred to as “mechanical insufflation-exsufflation.” The automatic CoughAssist MI-E (CA-3000, CA-3200) has timing mechanisms to automate the inspiratory and expiratory cycles as well as a manual control. The manual CoughAssist MI-E (CM-3000, CM-3200) uses a manually operated valve to shift from positive to negative pressure and back. Those who might benefit from the use of the CoughAssist MI-E include any patient with an ineffective cough due to muscular dystrophy, myasthenia gravis, poliomyelitis, or other neurologic disorder with some paralysis of the respiratory muscles, such as spinal cord injury. It may also be used to treat ineffective cough due to other bronchopulmonary diseases, such as emphysema, cystic fibrosis and bronchiectasis. It is effective for both trached and non-invasively ventilated patients. V Indications for Use: Any patient unable to cough or clear secretions effectively due to reduced peak cough expiratory flow (less than 2 to 3 liters per second), resulting from high spinal cord injuries, neuro-muscular deficits or severe fatigue associated with intrinsic lung disease, is a candidate for this device. V Contraindications: Any patient with a history of bullous emphysema, known susceptibility to pneumothorax or pnuemo-mediastinum, or known to have had any recent barotrauma, should be carefully considered before use. 2 SECTION 2 WARNINGS AND CAUTIONS EQUIPMENT CLASSIFICATION Per IEC 60601-1, Medical Electrical Equipment, General Requirements for Safety, the CoughAssist MI-E is classified as follows: Class 1 Equipment: Equipment in which protection against electric shock does not rely on basic insulation only, but includes a grounding pin on the power cord. For ground reliability always plug the power cord into an AC grounded outlet. Type BF Equipment: Type B piece of equipment with an F-Type applied part. A Type B piece of equipment is one that provides a particular degree of protection against electric shock, particularly regarding allowable leakage current and reliability of the protective earth connection (grounding). F-Type applied part is one that extends from the patient into the equipment and is isolated from all other parts of the equipment. Water Ingress: This device does not have protection against ingress of water. Disinfection: With the exception of the patient circuit, this device can be disinfected using 70% isopropyl alcohol or equivalent. (See Section 6: Cleaning and Disinfection.) Flammable Anesthetics: This device is not suitable for use in the presence of a flammable anesthetic mixture with air, or in the presence of a flammable anesthetic mixture with oxygen or nitrous oxide. Intermittent Operation: This device is designed for Intermittent Operation Only and not for continuous use. The device should not be cycled continuously for more than 5 minutes. After such time, the unit should either be turned off or left idling with the blower on for at least 5 minutes. 3 IMPORTANT SAFEGUARDS DEFINITIONS Throughout this guide the following definitions apply: • Warning/DANGER: A condition that could cause electrocution or injury to a user or operator if instructions are not followed. • CAUTIONS: A condition that could cause damage to equipment or cause inaccurate function. WARNINGS V Patients known to have cardiac instability should be monitored for pulse and oxygen saturation very closely. V Soreness and/or pain in the chest from a pulled muscle may occur in patients using the CoughAssist MI-E for the first time if the positive pressure used exceeds pressures, which the patient normally receives during Positive Pressure Therapy.1 Such patients should start at a lower positive pressure during treatment, and gradually (over several days, or as tolerated) increase the positive pressure used. V Do not use in the presence of flammable anesthetics. V Connection should be made to a grounded outlet only. V Do not place or store the device where it can fall or be pulled into a tub or sink. V If the device comes i...
Este manual também é adequado para os modelos :equipamento de bombagem - CA-3000, CA-3200, CM-3000, CM-3200 (563.62 kb)