CoughAssist ® User Guide
Table of Contents Introduction.................................................................................................................................................. 3 Warnings & Cautions................................................................................................................................. 4 Controls, Connectors, Visual Indicators............................................................................................... 6 Accessories..................................
Symbol Key The following symbols appear on this device. Follow Instructions for Use Canadian/US Certification Fuse AC Power Type BF Applied Part | Power On O Power Off Full Inhalation Flow Setting Reduced Inhalation Flow Setting Located next to the terminal inside the unit to identify the protective earth connection. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. © 2008 Respironics, Inc. and its affiliates. All rights reserved.
Introduction Intended Use For use on any patient unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a face mask or mouthpiece, or with an adapter to a patient’s endotracheal or tracheostomy tube.
Warnings & Cautions Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. Warnings A warning indicates the possibility for injury to the user or the operator. • Always check time and pressure settings before each treatment. • Always use a new filter when using the device on a new patient. • Patients known to have cardiac instability should be monitored for pulse and oxygen saturation very closely.
Cautions A caution indicates the possibility of damage to the device. • Position the CoughAssist MI-E so that the air intake ports on the side and rear of the unit are not blocked. • Never operate the device unless a bacterial/viral filter is attached to the patient circuit. • 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.
How to Contact Respironics If you need to contact Respironics directly, call the Respironics Customer Service department at 1-800-345-6443 (U.S. and Canada only) or 1-724-387-4000. You can also use the following address: Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 Visit the Respironics web site at: www.respironics.com Controls, Connectors, Visual Indicators CA-3000, CA-3200 - Automatic Model Front Panel Controls The items numbered in the illustration below are explained on the next page.
Symbol or Word Purpose MANUAL Manual Mode AUTO Automatic Mode 2 INHALE Inhale Phase Sets time interval (in seconds) for Inhale phase of automatic cycling. Not operative in the manual mode. 3 EXHALE Exhale Phase Sets time interval (in seconds) for Exhale phase of automatic cycling. Not operative in the manual mode. 4 PAUSE Pause Phase Sets time interval (in seconds) for Pause phase of automatic cycling. Not operative in the manual mode.
CM-3000, CM-3200 - Manual Model Front Panel Controls Item Symbol or Word Purpose 1 PRESSURE Pressure: EXHALE Exhale Phase INHALE Inhale Phase O Off Switch Designates the OFF position. I On Switch Designates the ON position. When the device is turned on, the green switch light illuminates. 4 -- Handle 5 -- Patient Port Connection for the patient circuit. Full Setting Full Inhalation Flow Setting.
Back Panel Controls (All Models) 1. Cord Wrap/Breathing Hose Holder 2. Warning label with fuse information shown below. 3. Power Cord Receptacle: Securely connects the power cord to the receptacle. 4. Replacement fuse location 1 2 3 4 Replacement Fuses Follow the detailed steps on page 18 to replace the fuses. The fuse for your CoughAssist is either 3.15 amp or 3.0 amp. To determine the correct replacement fuse for your device, refer to the label on the back of the unit. 3.
Accessories The following replacement accessories may be obtained from Respironics. For additional accessories visit www.respironics.com or http://coughassist.respironics.com CoughAssist MI-E Patient Circuit (Part No. 325-9217) The CoughAssist MI-E Patient Circuit consists of one 3-ft (1 m) long flexible smooth bore tube, a bacterial/viral filter, an adult face mask and an adapter. Breathing Hose (Part No. 732-1136) 3-ft (1 m) long flexible smooth bore tubing with 22 mm interior diameter.
Operating Procedure Initial Set-up 1. Install the power cord right angle connector to the receptacle on the rear of the device. Run the cord inside of the lower cord wrap to act as a strain relief. 2. Position the unit on a suitable surface within easy reach of the patient, or the operator of the unit. CAUTION: Position the device so that the air intake ports on the side and rear of the unit are not blocked. a. b. o c. 3. 4.
Daily Use CAUTION: This unit 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. Manual Operation (All Models) 1. Attach the appropriate patient interface to the patient. 2. On automatic models only, shift manual/auto switch to the manual position. 3.
Treatment WARNING: Always check the time and pressure settings before each treatment. Treatment usually consists of 4 or 5 coughing cycles in succession. The patient is then allowed to rest for 20 to 30 seconds, which helps avoid hyperventilation. The cycles can then be repeated 4 to 6 times for a full treatment.
Pressure Adjustment Each patient may require special settings for the maximum positive (inhalation) and negative (exhalation) pressures. For a patient using this device for the first time, it is advisable to begin with lower pressures, such as 10-15 cm H2O positive and negative, to familiarize the patient with the feel of mechanical insufflationexsufflation. During subsequent treatments, pressures can be increased as necessary to achieve adequate secretion clearance. See the Warnings section of this guide.
Timing Adjustment (Automatic Models Only) If the device’s automatic feature is to be used, adjust the times as follows: 1. Each cough cycle consists of an inhalation phase, an exhalation phase and a pause phase, after which inhalation begins again. The time for each phase is set with the three knobs on the left side of the front panel.
Preventive Maintenance This device has been designed to provide virtually maintenance-free operation for extended periods of time. Sharp blows to the unit or dropping the unit are to be avoided. No routine maintenance is required. 1. Keep the unit’s exterior clean. 2. Check that the air intake ports are not blocked. 3. Keep the device away from curtains, blankets or any heat generating device. WARNING: Do not remove the cover. There are no serviceable parts inside the unit.
Cleaning External Housing The exterior of the device may be washed with a mild detergent and water, or with a bactericidal cleaning solution such as 70% isopropyl alcohol. CAUTION: Do not sterilize the device with ethylene oxide gas or steam. Patient Circuit WARNING: Do not attempt to sterilize the patient circuit. Always use a new filter when using the device on a new patient.
Troubleshooting Guide 1. Pressure Gauge Adjustment: If the pressure gauge does not return to zero when the device is turned off, it must be readjusted. Remove the adhesive cover over the pressure gauge zero adjust and turn the adjustment screw to “0” using a screwdriver. If you are unable to make this adjustment, the unit should be returned for servicing. 2.
Specifications Dimensions: 11.5 x 11 x 16.5 in. (29.2 x 27.9 x 41.9 cm) Weight: CA-3000, CA-3200: CM-3000, CM-3200: 24 lbs. (11 kg.) 20.6 lbs. (9.3 kg.
Equipment Classification Per IEC 60601-1, Medical Electrical Equipment, General Requirements for Safety, the device is classified as follows: • Class I Equipment • Type BF Applied Part • IPX0: Ordinary protection against ingress of liquid. 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. This device is designed for Intermittent Operation Only and not for continuous use.
EMC Information CAUTIONS • Medical Electrical Equipment needs special precautions regarding Electromagnetic Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in the Accompanying Documents (see below). • Portable and mobile RF Communications Equipment can affect Medical Electrical Equipment. Guidance and Manufacturer’s Declaration - Electromagnetic Emissions: The device is intended for use in the electromagnetic environment specified below.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity: The device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment.
Limited Warranty Respironics, Inc. (“Respironics”) warrants that for a period of one (1) year from the date of sale by Respironics to the dealer, the CoughAssist MI-E system shall be free from defects in materials and workmanship and will perform in accordance with the product specifications. CoughAssist MI-E system accessories purchased from Respironics are warranted to be free of defects in materials and workmanship for a period of 90 days from the date of purchase.
1050903 AM 4/24/08 EN-DOM
