Operators Manual
201 Pages
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OPERATOR’S MANUAL
0413 P/N 210-4004
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PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
Table of Contents User Responsibility ...1 Contact Information...2 Software Site License Agreement ...3 Contraindications, Warnings and Cautions ...4
SECTION 1
Indication for Use and Introduction ...9
SECTION 2
System Components and Physical Design ...11
SECTION 3
Densitometry and the Two-Compartment Model in Infants Using Body Density to Estimate Body Composition...15 Mass Measurement ...17 Volume Measurement ...17 Thoracic Gas Volume ...19 Surface Area Artifact ...20 Clothing and Hair...21
SECTION 4
System Setup Selecting a Testing Location ...23 System Accessories ...25 Inspection and Setup...26
SECTION 5
Operating the System Starting the PEA POD Application...27 Logging In and Out ...28 Warming-Up the PEA POD ...30 Monitoring Temperature and CO2 in the PEA POD ...31 Navigating the PEA POD Application ...33 Interrupting PEA POD Activities ...36 Using the Emergency Off Switch ...38 Exiting the PEA POD Application ...39 Shutting Down the PEA POD ...39
SECTION 6
Quality Control Quality Control Procedures ...41 Subject/Test Preparation ...44 Body Composition Test Description...45
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
Table of Contents SECTION 7
Software Activities Introduction...55
SECTION 8
7.1
Test > Body Composition ...55
7.2
Test > Mass ...73
7.3
Data Management > View Subject Results ...80
7.4
Data Management > Modify Subject Results ...85
7.5
Data Management > Delete Test ...90
7.6
Data Management > Export Results ...97
7.7
Data Management > Database Backup ... 102
7.8
System Setup > Test Profile > Create... 104
7.9
System Setup > Test Profile > Remove ...106
7.10
System Setup > Density Model > Create ... 108
7.11
System Setup > Density Model > Remove...110
7.12
System Setup > Scale Checks > Noise and Drift ... 112
7.13
System Setup > Scale Checks > Hysteresis ...114
7.14
System Setup > Inclinometer ... 118
7.15
System Setup > Facility...119
7.16
System Setup > Automatic Backup Directory...122
7.17
QC > Analyze Hardware... 124
7.18
QC > Calibrate Scale ...128
7.19
QC > Check Scale ...135
7.20
QC > Autorun ... 142
7.21
QC > Volume ... 152
7.22
QC > Export QC Results ... 162
Alarms Alarms Description ...165 Possible Alarms... 168 Alarm Table ... 170 Responding to Alarms ...171
SECTION 9
System Errors System Errors Description... 173 Possible System Errors ...174
SECTION 10
Operator Errors Operator Errors Description...177 Examples of Operator Errors...178
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
Table of Contents
SECTION 11
Maintaining the PEA POD Service Policy... 179 Operator and Service Maintenance ... 179 Air Filters Maintenance... 179 Maintenance Schedule ... 180 Cleaning Precautions ... 181 Cleaning Procedure... 182 Cleaning Solutions... 183 Emergency Tray Removal ... 184
SECTION 12
Specifications ... 185
SECTION 13
Warranty ...189
SECTION 14
Additional Unit Information ... 193
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
Table of Contents
Figures Fig. # Description 2-1
PEA POD, Components (1)...11
2-2
PEA POD, Components (2)...12
4-1
Door Strap Placement ...26
5-1
Login Screen ...27
5-2
Desktop Icon ...28
5-3
Main Menu Screen ...29
5-4
Air Circulation System Stabilizing ...30
5-5
Temperature and CO2 Display Control Box...31
5-6
Temperature and CO2 Display ...32
5-7
Activities by Menu Titles...34
5-8
Command Buttons...35
5-9
Interrupt Button ...36
5-10
Cancel Test Button...37
5-11
Emergency Off Switch ...38
5-12
Touch Pad Area ...39
6-1
Volume Phantom Placement on the Test Chamber Tray ...43
6-2
Test Chamber Door Closure ...47
6-3
Subject Placement on the PEA POD Scale...48
6-4
Subject Transfer from PEA POD Scale to Test Chamber ...48
6-5
Subject Placement in PEA POD Test Chamber Tray, Extended from Chamber with Urination Shield Opened ...49
6-6
Test Chamber Tray Extended from Chamber and Empty with Urination Shield Opened ...50
6-7
Subject Placement in PEA POD Test Chamber Tray Extended from Chamber with Urination Shield Closed...51
6-8
Subject Placement in PEA POD Test Chamber Tray Inside Chamber with Urination Shield Closed ...52
6-9
Body Composition Test Results ...53
6-10
Body Composition Test Print-Outs ...54
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
Table of Contents
Figures (cont.) Fig. #
Description
7-1-1 thru 7-1-18
Test > Body Composition...55-72
7-2-1 thru 7-2-7
Test > Mass ...73-79
7-3-1 thru 7-3-5
Data Management > View Subject Results...80-84
7-4-1 thru 7-4-5
Data Management > Modify Subject Results ...85-89
7-5-1 thru 7-5-7
Data Management > Delete Test ...90-96
7-6-1 thru 7-6-5
Data Management > Export Results ...97-101
7-7-1 thru 7-7-2
Data Management > Database Backup ...102-103
7-8-1 thru 7-8-2
System Setup > Test Profile >Create...104-105
7-9-1 thru 7-9-2
System Setup > Test Profile > Remove ...106-107
7-10-1 thru 7-10-2
System Setup > Density Model > Create ...108-109
7-11-1 thru 7-11-2
System Setup > Density Model > Remove...110-111
7-12-1 thru 7-12-3
System Setup > Scale Checks > Noise and Drift ...112-113
7-13-1 thru 7-13-7
System Setup > Scale Checks > Hysteresis ...114-117
7-14-1
System Setup > Inclinometer ...118
7-15-1 thru 7-15-3
System Setup > Facility ...119-121
7-16-1 thru 7-16-2
System Setup > Automatic Backup Directory ...122-123
7-17-1 thru 7-17-6
QC > Analyze Hardware ...124-127
7-18-1 thru 7-18-7
QC > Calibrate Scale ...128-134
7-19-1 thru 7-19-7
QC > Check Scale ...135-141
7-20-1 thru 7-20-16
QC > Autorun...142-151
7-21-1 thru 7-21-11
QC > Volume ...152-161
7-22-1 thru 7-22-3
QC > Export QC Results...162-164
8-1
Remove Subject from the Scale Alarm Message... 165
8-2
Touch Pad Alarm LED ... 166
9-1
System Error Displayed on Left Navigation Column and Main Menu... 173
10-1 thru 10-2
Operator Errors... 178
11-1
Front Tray Removal ... 184
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
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PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
User Responsibility This Product will perform as described in this Operator’s Manual and by accompanying labels and/or inserts when it is assembled, operated, maintained, and repaired in accordance with the instructions provided. This Product must be checked periodically as described in this manual. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, it is recommended that a telephone or written request for service advice be made to COSMED USA Inc. This Product or any of its parts should not be repaired other than in accordance with instructions provided by COSMED USA Inc., authorized representatives, or by COSMED USA Inc. trained personnel. The Product must not be altered without the prior written approval of the COSMED USA Inc. Quality Assurance Department. The user of this Product shall have the sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than COSMED USA Inc. authorized representatives. Any unauthorized maintenance, repairs, or equipment modifications may void the product warranty.
Disposal of Waste Equipment by Users in the European Union
This symbol indicates that this product must not be disposed of with other household waste. Instead, it is your responsibility to dispose of your waste by handing it over to a designated collection point for the recycling of waste electrical and electronic equipment. The separate collection and recycling of your waste equipment at the time of disposal will help to conserve natural resources and ensure that it will be recycled in a manner that protects human health and the environment. For more information about where you can drop off your waste equipment for recycling, please contact your local city office, your waste disposal service, or the place where you purchased the product.
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
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Contact Information
Contact Information COSMED USA makes every effort to provide prompt and professional support to our PEA POD Registered Users. Fax and email messages will usually be returned within the same day.
Address
Americas
Regions Outside of the Americas
COSMED USA, Inc.
COSMED S.r.l.
1850 Bates Avenue
Via dei Piani di Monte Savello, 37
Concord, CA 94520
00041 – Pavona di Albano Rome - Italy
Telephone
925-676-6002
+39 (06) 931 5492
1-800-426-3763 (Toll Free) 8am – 5pm, M-F (Pacific Time) Fax
925-676-6005
+39 (06) 931 5480
Web Site
www.cosmed.com
www.cosmed.com
NOTE: When at all possible, please be near the PEA POD system when contacting COSMED USA Customer Support, as access to the computer interfacing with the PEA POD is often necessary. Please have your PEA POD serial numbers available. They are located on the back of the PEA POD. COSMED USA’s Authorized Representative in the European Union is: EC
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REP
Medical Device & QA Services Ltd Altrincham. WA15 7SN. United Kingdom. Tel: +44 161 870 6751 Fax: +44 161 903 9787 Email: [email protected] www.mdqa.co.uk
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
Software Site License Agreement
License Terms This is a legal agreement between you and COSMED USA, Inc. (“COSMED USA”). COSMED USA grants you the right to use one copy of the PEA POD® Infant Body Composition System Software (“SOFTWARE”) on a single computer to operate the PEA POD Infant Body Composition System you have purchased. You may not rent or lease this SOFTWARE, but you may transfer the SOFTWARE and accompanying written material on a permanent basis provided you retain no copies and the recipient agrees to the terms of this Agreement. You may not reverse engineer, decompile, or disassemble the SOFTWARE until terminated. You may terminate the Agreement by returning to COSMED USA the original disk and any backup copies. If you breach this Agreement, COSMED USA can terminate this license upon written notification to you.
Intellectual Property The SOFTWARE is owned by COSMED USA, Inc. and is protected by United States copyright laws and other intellectual property rights. Therefore, you must treat the SOFTWARE like any other proprietary material. Furthermore, you acknowledge that the license provided under this Agreement is a limited one and in no way shall be construed to provide you an express or an implied license to any of COSMED USA’s intellectual property rights other than as expressly set forth above and in no way confers to you or anyone else any right, title, or interest to the intellectual property rights in the SOFTWARE.
Controlling Law This Agreement shall be governed by and construed in accordance with the laws of the State of California, United States of America.
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
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Contraindications, Warnings, and Cautions
Contraindications
CONTRAINDICATION: Subjects requiring life support must not be tested in the PEA POD
Warnings and Cautions WARNING: The PEA POD, while designed to safely contain a subject while performing body composition tests, is not designed to contain a subject for any length of time beyond what normal testing would allow. While the temperature in the test chamber is monitored and controlled for the subject’s comfort, this instrument is NOT an incubator and must not be used as one. WARNING: Before, during, and after PEA POD testing the operator must always monitor the subject and must never leave the subject unattended. The test subject should be removed from the PEA POD in the event of any alarm condition, system malfunction or power loss during subject testing.
WARNING: The operator should read and understand the entire PEA POD Operator’s Manual before conducting any testing. Questions regarding proper operation of the PEA POD should be referred to a COSMED USA, Inc. authorized representative.
WARNING: The PEA POD contains no operator serviceable components. To prevent electric shock, do not remove panels or boards. Unauthorized maintenance or servicing may void product warranty. All servicing should be completed by COSMED USA, Inc., authorized personnel only. Failure to use the PEA POD as specified in this Operator’s Manual may void the product warranty.
WARNING: Grounding reliability is achieved only when this equipment is connected to a grounded outlet or an equivalent receptacle marked “Hospital Grade”.
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PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
Contraindications, Warnings, and Cautions
Warnings and Cautions (cont.) WARNING: Do not apply excessive lateral force to the PEA POD when the chamber door is fully opened. Doing so may result in damage to the door hinge, which may prevent the test chamber door from closing properly. Only transport the PEA POD with the chamber door closed. WARNING: Additional transformers, power supplies or extension cords that are not specified by COSMED USA, should not be connected to the system. Use of unauthorized equipment may result in damage to the PEA POD system. Use of components other than those specified by COSMED USA may result in the system not meeting IEC 60601-1 safety standards for medical devices. CAUTION: The PEA POD is intended to only provide an estimate of a subject’s body composition (percent fat mass and percent fat free mass). It is not intended to diagnose nor monitor medical conditions or diseases. CAUTION: The PEA POD should only be operated by those properly trained on the procedures and safety guidelines for operating the equipment, including a complete review of this Operator’s Manual. CAUTION: Before operation, the operator should ensure all components are secured to the PEA POD cart, at least two casters are locked, and that the power cable is properly secured to the PEA POD cart. CAUTION: The PEA POD is sensitive to temperature changes. Do not place this device in direct sunlight, near an open window, a heater, air conditioner, or fan. The PEA POD should be installed in a room with a temperature between 20 and 28 degrees Celsius, and the room temperature should not vary by more than ±0.5 degrees Celsius during testing. CAUTION: The PEA POD is sensitive to low frequency acoustic noise. Avoid placing the PEA POD in the proximity of items that generate low frequency noise (i.e., fans, doors shutting, and floor vibration). CAUTION: Physical contact with or movement of the PEA POD during testing may produce invalid results. The PEA POD should be installed in an area that provides sufficient operator access to its front and right side, with enough room to allow the door to open completely and the test tray to fully extend from the chamber.
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
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Contraindications, Warnings, and Cautions
Warnings and Cautions (cont.) CAUTION: The PEA POD should be installed in a room with a level floor. CAUTION: The PEA POD should be installed in a room with a relative humidity between 20 and 70%. Room humidity should not vary more than ±5% relative humidity during testing. Room barometric pressure should be between 86 and 106 KPa. CAUTION: The surface area of clothing and hair can have a significant impact on subject volume measurements. Therefore, all subjects must be tested nude and with their hair flattened against their head using baby oil or must wear a head cap provided by COSMED USA, Inc. Failure to follow this protocol may result in inaccurate body composition test results. CAUTION: Failure to follow the described procedures for test subject mass measurement may result in erroneous calculation of body composition by the PEA POD. CAUTION: Quality Control (QC) procedures should be performed each day before human testing at the location where testing will occur. Failure to conduct QC procedures as described in this manual may results in inaccurate body composition test results. CAUTION: To prevent possibility of injury, keep hands away from the door hinge when closing or opening the PEA POD chamber. CAUTION: To prevent possibility of injury, the operator should verify the Test Chamber Tray is securely placed in the sliding tray frame. The operator should push or pull the tray slowly when moving the tray in and out of the testing chamber. Only COSMED USA supplied Test Chamber Trays should be used with the PEAPOD. CAUTION: To prevent possibility of injury, the operator should verify the subject’s hands and feet are away from the edges of the tray before closing the urination shield. CAUTION: The PEA POD and accessories are non-sterile products. Do not attempt to sterilize any part of the PEA POD, as sterilization may damage the device. CAUTION: Do not soak parts in cleaning solutions. Always dry parts after cleaning. Following these two recommendations will greatly extend the life of the parts.
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PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
Contraindications, Warnings, and Cautions
Warnings and Cautions (cont.) CAUTION: Do not allow excess cleaning solution to seep in between parts (especially in the PEA POD test chamber) where it cannot be easily wiped dry with a cloth. CAUTION: Use of cleaning solutions not listed in this manual, or chemicals in greater concentrations than those listed may damage the PEA POD. CAUTION: Do not load or use software other than that provided by COSMED USA on the PEAPOD computer system. CAUTION: To minimize the generation of static electricity, do not polish the top of the unit or doors with a dry cloth. CAUTION: The chamber tray and the scale tray should be cleaned after every use. The disposable scale tray pad should be replaced after the testing of an individual test subject is complete. CAUTION: Inspect the test chamber tray for cracks or damage before each use. Do not use the device if the test chamber tray is damaged in any way.
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
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Contraindications, Warnings, and Cautions
Explanation of Symbols The following explains the symbols that are found on the PEA POD System: This symbol alerts the user to the presence of a potential shock hazard. The user should consult the Operator’s Manual for more information on the potential shock hazard.
This symbol alerts the user of the presence of important operating and/or maintenance (service) instructions in the PEA POD Operator’s Manual.
This symbol alerts the user to the importance of consulting the Operator’s Manual.
This symbol indicates the “power on” position of the power switch. When the switch is depressed in this position, it indicates that under normal conditions power is on to the unit.
This symbol indicates the “power off” position of the power switch. When the switch is depressed in this position, it indicates that under normal conditions power is off to the unit.
This symbol indicates the “stand-by” mode switch on the PEAPOD unit.
This symbol represents alternating current.
This symbol indicates that the PEAPOD unit is a Type BF Applied Part.
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PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
SECTION 1 – Indication for Use and Introduction
Indication for Use The PEA POD® Infant Body Composition System (“PEA POD”) is indicated for measuring the body mass and estimating the body composition (i.e., percent and absolute amounts of fat and lean body mass) of subjects between 1 and 8 kilograms. It is not intended for use with subjects requiring life support. For the purposes of this manual, fat free mass is equivalent to and is used instead of lean body mass.
Introduction The PEA POD utilizes the principles of whole body densitometry to estimate the amount of fat and lean tissue in the body. Whole body densitometry is based on the determination of body density by measuring body mass and volume. Body mass (weight) is measured using the PEA POD electronic scale and body volume is measured in the PEA POD test chamber. Once body density is known, the subject’s percentage and absolute amounts of fat and fat free mass are automatically calculated using the principles of whole body densitometry. This is discussed in greater detail in SECTION 3 - Densitometry and the Two-Compartment Model in Infants.
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
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PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
SECTION 2 – System Components and Physical Design
Figure 2-1 – PEA POD, Components (1)
PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745
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SECTION 2 – System Components and Physical Design
Figure 2-2 – PEA POD, Components (2)
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PEA POD® Infant Body Composition System Operator’s Manual – P/N 210-4004 Rev. N - DCO 1745