CCM Express Operator Manual Rev C

The MEDGRAPHICS CCM Express Operator Manual is Part No. 142156-001 Rev C. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician if it is to be used for diagnosis and/or prescribing of therapy. MEDGRAPHICS® is a registered trademark of Medical Graphics Corporation.

Medical Graphics Corporation makes no claim for use of the product other than for those uses specified herein and disclaims any liability resulting from other uses. Observe all warnings and cautions.

Copyright© Medical Graphics Corporation 2009. All rights reserved. Unauthorized use, copying, or distribution is prohibited.

Medical Graphics Corporation 350 Oak Grove Parkway St. Paul, Minnesota 55127 +(651) 484-4874 (800) 950-5597 +(651) 484-8941 (Fax) www.medgraphics.com

European Union (EU) Regulatory Representative Medical Product Service GmbH Borngasse 20 35619 Braunfels 49-6442-962073 49-6442-32578 (Fax)

0086

European Medical Device Directive Devices are compliant with the European Medical Directive (93/42/EEC) regarding safety and EMC.

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Contents CHAPTER 1: INTRODUCTION ...5 Features ...5 Intended Use ...5 CHAPTER II: SYSTEM CONNECTIONS ...6 Electrical Connection ...6 Umbilical Connection ...6 Mask Connection ...6 Syringe Connection ... ...6 CHAPTER III: SYSTEM POWER ...7 System Power ...7 Powering Up ...7 Powering Down ...7 CHAPTER IV: SOFTWARE ...8 Functions & Controls ...8 Main Screen ...9 Patient Entry Screen ...10 Patient Search Screen ...11 CHAPTER V: PRE-TEST PROCEDURES ...12 Flow Sensor Calibration ...12 Flow Sensor Calibration Screen ...13 Calibration Procedure ...14 Flow Sensor Calibration Interpretation ...15 Troubleshooting a Failed Calibration ...15 Gas Calibration ... ...16 Patient Connections ...17 CHAPTER VI: TESTING PROCEDURES ...18 Resting Metabolic Testing using the PreVent Face Mask ...19 Canopy Testing ...20

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Ventilator Testing ...23 Direct Fick Testing ...26 Reports ...27 CHAPTER VII: QUALITY CONTROL ...29 Gas Exchange System Validator ...29 Biologic Controls ...29 CHAPTER VIII: SYSTEM TOOLS ...30 Tools screen ...30 Calibration Menu ...31 Site Name and Division Name Editor ...33 Database Tools Menu ...33 Functions within Database Tools ...34 Predicteds Setup Menu ...39 Units of Measure ...41 TROUBLESHOOTING GUIDE ...42 CHAPTER IX: NUTRITION GLOSSARY OF TERMS ...44

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CHAPTER 1 INTRODUCTION The MEDGRAPHICS® CCM Express includes a gas exchange analyzer module for measuring oxygen consumption and carbon dioxide production.The patient interface is through the DirectConnect™ flow sensor and a patient umbilical. The system can be connected to a printer via a USB cable to create full-color printouts of patient data.

Features • Intuitive, full color graphical user interface • Real-time viewing of resting metabolic data • Compact design • Operates with AC power connection • Primary care operating mode • Database management interface • Printable calibration reports • Multiple report formats • DirectConnect patient interface

Intended Use The CCM Express uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, optimize nutritional support and quantify substrate utilization. The CCM Express can provide Direct Fick determination of cardiac output using real-time oxygen uptake measurements. Direct Fick cardiac output measurements provide a hemodynamic profile for rapid, non-invasive assessment of cardiac function, assessment of ventilation/perfusion mismatching and shunt formation and evaluation of congenital heart defects.

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CHAPTER II SYSTEM CONNECTIONS Electrical Connection Plug the electrical cord on the CCM Express system into a power outlet marked “Hospital Grade” or “Hospital Use.”

Umbilical Connection The umbilical (Part Number 701066-015) is connected directly to the back of the system (See Figure 2-1) and to the DirectConnect flow sensor (See Figure 5-2).

Umbilical Connection

System Power Switch

Power Connection Umbilical Sample Line Connection Keyboard and Mouse Connections Analog Signal Connection

Figure 2-1. Back Panel

Mask Connection The connection to the preVent® mask is via a circular adaptor. (Part Number 701240-001).

Syringe Connection The connection of the DirectConnect flow sensor to the syringe rubber coupler is via a circular adaptor. (Part Number 536003-001).

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CHAPTER III SYSTEM POWER System Power Turn on the System Power switch located on the back panel directly above the power connection. (See Figure 2-1.)

Powering Up Before applying power to the CCM Express, check the following 1. All cables are connected 2. Power cords are plugged into the appropriate electrical outlets 3. The CCM Express must be warmed up for 30 minutes prior to calibration and testing.

Powering Down Power down the system as follows: 1. Click the “Power Off” icon

in the lower right corner

2. Click “Yes” at the prompt (See Figure 3-1) 3. Turn off system power switch on back panel 4. System may be unplugged and transported at this time.

Power Off Computer Icon Figure 3-1. Power Down Procedure CCM Express Operator Manual

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CHAPTER IV SOFTWARE Functions & Controls The CCM Express operates with a user-friendly LCD touch screen and stylus. If desired, a mouse and keyboard can be connected to the back of the system. (Refer to Figure 2-1 for mouse and keyboard connection location).

The main application software is opened by touching the CCM Express Screen. (See Figure 4-1).

Figure 4-1. Desktop Screen

Touch the CCM Express splash screen to enter the software.

Figure 4-2. Splash Screen

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Main Screen The Main Screen displays a list of patients in the database that can be sorted by Patient ID, Last Name, First Name, Middle Name, and Visit Date. The icons at the bottom of this screen allow the user to view and modify patient data. (See Figure 4-3).

Figure 4-3. Main Screen

Opens the new patient entry screen, allowing the user to enter new patient data

Opens a new visit for the highlighted patient

Opens an existing visit for the highlighted patient

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Opens a panel to search for a patient

Opens the Tools menu

Powers off the CCM Express

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Patient Entry Screen The Patient Entry Screens contain the fields for entering patient data using a touch screen keyboard. (See Figure 4-4 a, b, c). Use the

icon to view environment conditioning and to view and modify physician, technician, and ventilator information.

Figure 4-4 b. Patient Entry Screen

Figure 4-4 a. Patient Entry Screen

Figure 4-4 c. Patient Entry Screen

Returns to the Previous Screen

Opens the Ventilator Testing Screen

Zeros the Flow sensor

Opens the Direct Fick Testing Screen

Opens the Resting Metabolic Screen

Opens the Report Menu

Opens Canopy Testing Screen

Moves to the Next Patient Entry Screen

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Patient Search Screen The Patient Search Screen contains all fields for searching patient records and a touch screen keyboard. Searches can be performed using Patient ID, Last Name, or Visit Date. (See Figure 4-5).

To sort data click on desired column header

Returns to main screen

Figure 4-5. Patient Search Screen

Figure 4-5

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CHAPTER V PRE-TEST PROCEDURES

Before performing a test, the CCM Express software and/or testing protocol must be properly configured, and all patient connections must be checked to provide accurate results. Regular and attentive pre-test procedures will both ensure the integrity of test results and provide a method to monitor changes in system performance.

Flow Sensor Calibration Flow Sensor Calibration The ability of the CCM Express to accurately measure volume is an important factor in providing accurate testing results. To ensure best results, the American Thoracic Society (ATS) recommends performing a system calibration at least daily with a calibrated 3 liter syringe. The first step to calibrate the flow sensor is to set a zero reference.This ensures that the system is reading zero flow when no flow is being introduced. Second, perform a volume calibration with a 3 liter syringe.The calibration routine consists of introducing a known volume into the flow sensor several times at different flow rates from slow to fast. The system requires three injections and withdrawals to complete the flow calibration.

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Flow Sensor Calibration Screen The calibration screen provides guidelines to ensure variation of flow results. Calibration screen icons allow the user to control calibration functions and print a calibration report to maintain detailed system records. (See Figure 5-1).

Figure 5-1. Calibration Screen

Saves the calibration and returns to the previous screen

Resets the calibration factors

Starts the calibration

Prints the calibration report

Zeros the flow sensor

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Calibration Procedure 1. Allow the system to warm-up for 30 minutes. 2. Connect the DirectConnect flow sensor to the umbilical clip. (See Figure 5-2). 3. Connect the flow sensor assembly to the calibration syringe by inserting the flow sensor into the circular adapter. Then connect to the rubber coupler. (See Figure 5-3). 4. Press the “Syringe” icon

in the tools menu to perform a flow calibration.

5. Enter the appropriate syringe size in liters if different from the default. Umbilical Clip

Figure 5-2. Umbilical Clip/DirectConnect flow sensor DirectConnect Flow sensor

Figure 5-3. Syringe Adaptor

Tip: Set the syringe on a solid surface during calibration to ensure acurate results.

6. Press the “Start” icon

to begin

7. A message appears prompting to withdraw or pull back the syringe plunger. Pull back smoothly on the plunger, being certain to withdraw the complete volume of the syringe. During the withdrawal, the flow should trace downward. If it does not trace downward, the flow sensor or flow sensor umbilical are connected incorrectly. 8. A message appears prompting to inject, or push forward on the syringe plunger. Push in smoothly and evenly on the plunger, being certain to inject the complete volume of the syringe. 9. Repeat steps and until three injections and withdrawals are recorded. The injections and withdrawls should be performed at different flows to demonstrate the linearity of the flow device. 10. The sequence stops automatically after three injections and withdrawals. 11. Press the “Printer” icon 12. Press the “Back” icon

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to print a calibration report, if desired. to save the calibration and return to the previous screen.

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Flow Sensor Calibration Interpretation The calibration results are shown in the data tables at the top of the screen. (See Figure 5-4).

Figure 5-4. Calibration Results

Mean Volume The average of the sampled volumes in liters.

Percent Error The percent error of the average measured volume from the actual syringe volume.The calibration will fail if the percent error is greater than 2%.

Gain The number by which the measured volume must be multiplied to arrive at the actual volume during the volume calibration of the flow sensor.

Troubleshooting a Failed Calibration Troubleshooting a Failed Flow Calibration 1. Click the “flow sensor” icon

, then click the “start” icon

and perform a calibration. Click the “start” icon

again and perform second full calibration. Ensure there is a pause between each withdrawl and inject of the syringe. 2. Replace flow sensor and repeat calibration. 3. Replace umbilical and repeat calibration.

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Gas Calibration The CCM Express utilizes an external gas calibration device for calibration with 2 gases. It requires reference gas (21% O2, Bal N2) and calibration gas (12% O2, 5% CO2, Bal N2). The gas calibration device is interfaced through a USB cable. The umbilical clip is connected to the calibration home port on the gas calibration device. (See Figure 5-7).

Calibration Procedure 1. Connect the gas calibration device to CCM Express through a USB connection. 2. Connect calibration/reference gas cylinder lines to the gas calibration device. 3. Ensure both tanks are open with appropriate line pressure (5 psi)

Figure 5-7. Gas Calibration Device Gas Calibration results are displayed below. (See Figure 5-8).

4. Ensure the umbilical clip is attached to the calibration home port on top/front of gas calibration device. 5. Press the “GX Autocal” icon.

Figure 5-8. Gas Calibration Results

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Patient Connections The patient circuit is made up of two elements:

• DirectConnect flow sensor • Umbilical.

Note: A circular adaptor is needed to attach the DirectConnect flow sensor to the canopy and facemask: P/N 701240-001 Figure 5-9 shows the DirectConnect flow sensor connected to the umbilical clip Figure 5-10 shows the mask connection Figure 5-11 shows the canopy/face tent connection Figure 5-12 shows the ventilator connection

Figure 5-9. Umbilical Connections

Figure 5-10. Mask Connection

Figure 5-11. Canopy/Face Tent Connection

Figure 5-12.Ventilator Connection

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CHAPTER VI TESTING PROCEDURES The CCM Express performs four basic resting metabolic tests (RMR): The patient interface is shown with the appropriate test icon.

1. Face Mask

2. Direct Fick Cardiac Output

3. Canopy/Face Tent

4. DirectConnect to a Ventilator

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Resting Metabolic Rate Testing using the PreVent Face Mask Patient Measurement Conditions

• Patients should have rested in a supine position for at least 30 minutes prior to testing • There should be no food or parenteral feedings for at least two hours before an RMR test • Patients on continuous feeds can be tested at any time • There should be no voluntary muscle activity during the test

Test Procedure 1. Ensure the system has been on for 30 minutes prior to testing. 2. From the main screen, create a New Patient File or New Visit File by pressing one of the icons listed below.

Create a New Patient

Create a New Visit for an Existing Patient

3. Enter or edit patient information (upper half of Figure 6-1).

Figure 6-1. Patient Information Screen 4. Press the “Resting Metabolic Rate” Icon. 5. Attach the umbilical clip to the gas calibration device and press the “GX Autocal” icon

to perform a gas calibration.

6. Connect the umbilical clip to the DirectConnect flow sensor and then connect it to the face mask using the circular adapter. 7. Connect the patient to the facemask. Allow 1-2 minutes for the patient to adjust to the facemask.

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8. Once the patient appears relaxed, press the “Start” icon to start data collection. The data will update with each breath.

9. During the test, monitor the following:

• Observation of the resting state. • Patient comfort and movement during test. • Values in coherence with the subject’s clinical status. • Results within normal physiological range. 10. Once the test in complete, press the “Stop” icon

to end the test.

Canopy Testing Canopy testing provides an alternative to conventional mouthpiece and nose clip, or mask collection devices for expired gas collection and analysis. By reducing the patient’s awareness of breathing effort and avoiding the discomfort of direct contact with the face, nose and mouth, canopy testing provides optimal gas exchange measurements in spontaneously breathing patients. (See Figure 6-2). During canopy data collection, room air and expired air is drawn through the face tent collector by a fan. Expired air is sampled at the DirectConnect flow sensor and combined with the appropriate flow measurements to calculate oxygen consumption and carbon dioxide production on a breath-by breath basis.

Express CCM Canopy Kit 800703-002 (Includes parts listed below)

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1. DirectConnect flow sensor 2. Coupler 3. Adapter for DirectConnect

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4. Elbow Assembly 2

5. Fan Control 6. Flex Flow Tube 7. Face Tent

3

Figure 6-2. 4

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6

7

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