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USER’S GUIDE

MODELS CA-3000&CA-3200

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MODELS CM-3000&CM-3200

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MEDICAL PRODUCT INNOVATIONS SINCE1928

T A B L E O F C O N T E N T S

S E C T I O N

1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . .

 

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 . . . . . . . . . . . . . . . . . . .

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SECTION 1

I N T R O D U C T I O N

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 “mechanicalinsufflation-exsufflation.”The automatic CoughAssistMI-E(CA-3000,CA-3200)has timing mechanisms to automate the inspiratory and expiratory cycles as well as a manual control. The manual CoughAssistMI-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-Einclude 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 andnon-invasivelyventilated patients.

VIndications 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-musculardeficits or severe fatigue associated with intrinsic lung disease, is a candidate for this device.

VContraindications: Any patient with a history of bullous emphysema, known susceptibility to pneumothorax orpnuemo-mediastinum,or known to have had any recent barotrauma, should be carefully considered before use.

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SECTION 2

W A R N I N G S A N DC A U T I O N S

E Q U I P M E N T C L A S S I F I C AT I O N

Per IEC 60601-1,Medical Electrical Equipment, General Requirements for Safety, the

CoughAssist MI-Eis 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 anF-Typeapplied 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-Typeapplied 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 forIntermittent 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.

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I M P O R TA N T S A F E G U A R D S

 

 

 

D E F I N I T I O N S

 

 

 

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.

 

 

 

W A R N I N G S

 

 

 

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-Efor 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 into contact with water, unplug the unit.

 

 

 

 

 

 

 

V

Never operate the CoughAssist MI-Eif it has a damaged cord or plug, is not work-

 

 

 

 

 

 

 

 

ing properly, or has been dropped, damaged or immersed in water.

 

 

 

 

 

 

 

1 Positive Pressure Therapy includes the use of a volume ventilator, nasal or mask ventilation or CPAP (Continuous

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Positive Airway Pressure), or IPPB (Intermittent Positive Pressure Breathing).

 

 

 

 

 

 

 

 

W A R N I N G S A N DC A U T I O N S

VReplace fuses only with ones having the same ratings for blow characteristics, current and voltage.

VDo not remove the cover; there are no serviceable parts inside the unit. Refer all service to authorized personnel.

VAlways check time and pressure settings before each treatment.

C A U T I O N S

Federal Law (USA) restricts this device to use by, or at the direction of a physician.

Position the CoughAssist MI-Eso 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.

Always use a new filter when using the device on a new patient.

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.

Turn the unit off when not in use.

Keep the cord away from heated surfaces.

Do not sterilize with ethylene oxide gas or steam sterilize the pump or pump housing.

This device should only be used by trained personnel.

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SECTION 3

S P E C I F I C A T I O N S

Maximum Positive Pressure:

60 cm H2O (44 mm Hg)

 

 

Maximum Negative Pressure:

60 cm H2O (44 mm Hg)

 

 

Standards:

Conforms to UL STD 2601-1,certified to CAN/CSA - STD C22.2 No.601.1-M90,

0413

Maximum Inhalation Flow:

3.3 liters/second with inhale flow set to minimum; if set to maximum inhalation, the flow is

 

the same as the exhalation flow

 

Maximum Exhalation Flow Capacity:

10 liters/second; actual flow depends on maximum pressure and on airway resistance

 

Pressure Gauge:

-70to 0 to +70 cm H2O; accuracy+/-2%of full scale

 

Mode of Operation:

Models CA-3000,CA-3200:Automatic and Manual Timing

 

 

Models CM-3000,CM-3200:Manual Timing

 

Inhalation, Exhalation, Pause Times:

CA-3000,CA-3200:Automatic mode, 0 to 5 seconds

 

 

CM-3000,CM-3200:User variable

 

“Off” Position:

Yes - connects to ambient

 

 

Blower Type:

Two-stagecentrifugal blower with AC/DC universal motor

 

Input Voltage:

CA-3000,CM-3000:100-120VAC, 60Hz

 

 

CA-3200,CM-3200:220-240VAC, 50Hz

 

Input Power:

CA-3000,CM-3000:300 VA

 

 

 

CA-3200,CM-3200:600 VA

 

 

Dimensions:

292mm x 279mm x 419mm (HxWxD)

 

 

(11.5” x 11” x 16.5”)

 

 

Weight:

CA-3000,CA-3200:11 kg (24 lbs)

 

 

CM-3000,CM-3200:9.3kg (20.6 lbs)

 

Temperature Specifications:

Operating temperature range:

+10 to +40°C (+50 to +104°F)

 

 

Storage temperature range:

-20to +50°C(-4to +122°F)

 

Humidity Specifications:

Operating humidity range:

30% to 75%

 

 

Storage humidity range:

10% to 90%

 

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SECTION 4

CO N T R O L S, C O N N E C T O R S& V I S U A L I N D I C AT O R S

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C A - 3 0 0 0 , C A - 3 2 0 0

F R O N TPA N E LC O N T R O L S

1.Manual/Auto: Changes the cycling mechanism to either manual or automatic mode.

2.Inhale: Sets time interval (sec) for Inhale phase of automatic cycling.

Not operative in the manual mode.

3. Exhale: Sets time interval (sec) for Exhale phase of automatic cycling. Not operative in the manual mode.

4.Pause: Sets time interval (sec) for Pause phase of automatic cycling. Not operative in the manual mode.

5.Power: The power switch turns on or off the CoughAssistMI-E.The “I” symbol on the switch designates the on position. When activated a green light within the switch will illuminate. The “O” symbol designates the off position.

6.Manual Control Lever: Use to manually cycle the unit to inhale or exhale. Not operative in the automatic mode.

7.Pressure: Varies the inhalation and exhalation pressures together (also see Inhale Pressure).

8.Handle: Recessed carrying handle.

9.Patient Port: Connection for patient circuit.

10.: Symbol for Type B Equipment with F-Typeapplied part.

11.Inhale Flow: There are two inhalation flow settings: Full () and Reduced ().

NOTE: When using reduced inhalation flow there will be a small reduction in inhale pressure.

12.Inhale Pressure: Varies the inhalation pressure between 50% and 100% of the exhale pressure.

13.Pressure Gauge Zero Adjust: Access to “zero” adjustment on the pressure gauge. Use only if the gauge does not return to “O” when the unit is turned off (see Section 8).

14.Pressure Gauge: Indicates pressure in the patient circuit calibrated in cm H2O.

C M - 3 0 0 0 , C M - 3 2 0 0

F R O N TPA N E LC O N T R O L S

1.Pressure: Varies the inhalation and exhalation pressures together (also see Inhale Pressure).

2.Manual Control Lever: Use to manually cycle the unit to inhale or exhale.

3.Power: The power switch turns on or off the unit. The “I” symbol on the switch designates the on position. When activated a green light within the switch will illuminate. The “O” symbol designates the off position.

4.Handle: Recessed carrying handle.

5.Patient Port: Connection for patient circuit.

6. : Symbol for Type B Equipment withF-Typeapplied part.

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7.Inhale Flow: There are two inhalation flow settings: Full () and Reduced (). NOTE: When using reduced inspiratory flow there will be a small reduction in inspiratory pressure.

8.Inhale Pressure: Varies the inhalation pressure between 50% and 100% of the exhale pressure.

9.Pressure Gauge Zero Adjust: Access to “zero” adjustment on the pressure gauge. Use only if the gauge does not return to “0” when the unit is turned off (see Section 8).

10.Pressure Gauge: Indicates pressure in the patient circuit calibrated in cm H2O.

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B A C KPA N E L( A L L M O D E L S)

1.Cord Wrap/Breathing Hose Holder

2.Power Cord Receptacle: Securely connects the power cord to the receptacle.

3.Replacement fuse location

4.This symbol, located next to the protective earth terminal inside the unit, signifies that the device is earthed (grounded).

5. This symbol signifies the year of manufacture of the device. The name and address of our authorized representative for Europe appears below it.*

6. Marking of conformity to European Medical Device Directive, plus the4-digitnumber signifying the applicable notified body.*

7.Listing of product safety standards

8.Product Label Description: