Clinicians Manual
124 Pages
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Ami® and Ami® Plus Infant Central Apnea/Heart Rate Monitors
Clinician’s Manual 21-02-0116 Rev. 03 01/04
WARRANTY CAS Medical Systems, Inc. warrants to the owner that the Ami or Ami Plus monitor, exclusive of expendable parts and other accessories, shall be free from defects in material and workmanship for one year from the original date of sale. CAS’ sole obligation, with respect to any such defect, is limited to the repair or, at CAS’ option, replacement of the monitor. Purchaser pays return freight charges. This warranty is made on the condition that prompt notification of a defect is given to CAS within the warranty period, and that CAS has the sole right to determine whether a defect exists. This warranty is conditional on the performance of periodic maintenance, as specified in the maintenance section of this manual, by qualified service personnel. The warranty does not apply to monitors that have been partially or completely disassembled; altered; subjected to misuse, negligence, or accident; or operated other than in accordance with the instructions provided by CAS. This includes repair by unauthorized personnel. This warranty represents the exclusive obligation of CAS and the exclusive remedy of the purchaser regarding defects in the monitor. “This warranty is given in lieu of any express or implied warranties, including any warranty of merchantability or fitness for a particular purpose.” No person is authorized to modify, in any manner, CAS Medical Systems’ obligation as described above.
Contacts for CAS Medical Systems 44 E. Industrial Road Branford, CT 06405 USA Phone: (800) 227-4414 (U.S. only) (203) 488-6056 Fax: (203) 488-9438 Web: www.casmed.com Email: Customer Service: CUSTSRV@casmed.com Sales: SALES@ casmed.com Technical Support: TECHSRV@casmed.com
CAUTION: In the United States of America, Federal Law restricts this device to sale by or on the order of a physician.
Ami, Ami Plus, CAS and the CAS Logo are registered trademarks of CAS Medical Systems, Inc. All other products and company names are trademarks or registered trademarks of their respective companies. ©2002 CAS Medical Systems, Inc. All rights reserved. No part of this manual may be reproduced without the permission of CAS Medical Systems, Inc.
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Contents Figures
v
Tables
vii
Introduction
1
Introduction... 1 - 1
Apnea Monitoring
2
Apnea Monitoring... 2 - 1
Electromagnetic Interference
3
Electromagnetic Interference... 3 - 1 Testing for Electrical Interference... 3 - 2 Electrostatic Discharge... 3 - 2
What The Caregiver Must Know 4 What the Caregiver Must Know... 4 - 1
Description of the Monitor
5
Description of the Monitor... 5 - 1 Front Panel... 5 - 2 Back Panel... 5 - 3 Bottom Panel... 5 - 4
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Labels... Sample Label... UL Label... Serial Number...
Using the Monitor
5-5 5-5 5-7 5-7
6
Using the Monitor... 6 - 1 Plugging in the Monitor... 6 - 1 Turning the Monitor On... 6 - 2 Turning the Monitor Off... 6 - 3 System Check... 6 - 3 Using the Monitor Effectively... 6 - 3
Setting Parameters
7
Setting Parameters... 7 - 1
Connecting The Monitor
8
Connecting The Monitor... 8 - 1 Important Points to Remember... 8 - 1 Tips for Use of Disposable Electrodes... 8 - 1 General Electrode Placement... 8 - 2 Tips For Use of Reusable Electrodes... 8 - 3 Reusable Carbon Patch Electrode Placement... 8 - 3
Transmitting The Data
9
Transmitting The Data... 9 - 1 Modem Connection Indication... 9 - 1 Auxiliary Connections... 9 - 2
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Alarms
10
Alarms... 10 - 1 Human Alarms... Apnea... Bradycardia... Tachycardia...
10 - 1 10 - 2 10 - 2 10 - 2
Equipment Alarms... Low Battery... Loose Leads... Memory Full... Power Failure...
10 - 2 10 - 2 10 - 3 10 - 3 10 - 3
Service Alarms... 10 - 4
Power
11 Power... 11 - 1
Cleaning
12
Cleaning... 12 - 1 Monitor... 12 - 1 Monitor Exterior... 12 - 1 Monitor Display... 12 - 1 Patient Cables and Lead Wires... 12 - 2 Reusable Electrodes... 12 - 2 Electrode Belt... 12 - 2
Maintenance
13
Maintenance... 13 - 1 Functional Testing... Equipment Required... Monitor Setup... Impedance/Monitor Tester Setup... Connection / Power Up... Testing Procedure...
13 - 1 13 - 1 13 - 1 13 - 2 13 - 2 13 - 2
Bench Testing... 13 - 3 Changing the Battery Pack... 13 - 4 Changing the Fuse... 13 - 6
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Troubleshooting and Error Messages
14
Troubleshooting... 14 - 1 Error Messages... 14 - 4
Device Specifications
15
Device Specifications... 15 - 1
Accessories
16
Accessories... 16 - 1
FCC Part 68 Information
17
FCC Part 68 Information... 17 - 1
Index
iv
I-1
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Figures Figure 5-1 Front Panel... 5 - 2 Figure 5-2 Back Panel... 5 - 3 Figure 5-3 Bottom Panel... 5 - 4 Figure 5-4 Sample Label... 5 - 5 Figure 5-5 UL Label... 5 - 7 Figure 5-6 Serial Number... 5 - 7 Figure 6-1 Connecting the Monitor to the Power Cord... 6 - 1 Figure 6-2 Connecting the Power Cord to the Wall Outlet... 6 - 2 Figure 6-3 Press Power to Turn Monitor On... 6 - 2 Figure 6-4 Turning the Monitor Off... 6 - 3 Figure 8-1 Placement of Electrode... 8 - 2 Figure 8-2 Electrode with Lead wire... 8 - 3 Figure 8-3 Belt Placement... 8 - 4 Figure 8-4 Electrode Placement... 8 - 5 Figure 8-5 Wrapped Belt... 8 - 5 Figure 8-6 Lead Wires and Patient Cable... 8 - 6 Figure 8-7 Patient Cable and Monitor... 8 - 6
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Figure 8-8 Baby and Sleeper... 8 - 7 Figure 8-9 Power... 8 - 7 Figure 9-1 Auxiliary Connections... 9 - 2 Figure 13-1 Warranty Void If Damaged Sticker... 13 - 4 Figure 13-2 Tamper-Resistant Seal... 13 - 5 Figure 13-3 Battery Capture Screw... 13 - 5 Figure 13-4 Tab... 13 - 5 Figure 13-5 Battery Assembly Date... 13 - 6 Figure 13-6 Fuse Holder... 13 - 7 Figure 16-1 Carbon Electrodes... 16 - 1 Figure 16-2 Lead Wires... 16 - 2 Figure 16-3 Patient Cable... 16 - 2 Figure 16-4 Patient Belt... 16 - 2 Figure 16-5 Remote Alarm... 16 - 3 Figure 16-6 Power Cord... 16 - 3 Figure 16-7 Carrying Case... 16 - 4 Figure 16-8 Direct Connect Cable... 16 - 4
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Tables Table 5-1 Description of Front Panel... 5 - 2 Table 5-2 Description of Back Panel... 5 - 3 Table 5-3 Description of Bottom Panel... 5 - 4 Table 5-4 Description of Label... 5 - 6 Table 9-1 Description of Auxiliary Connections... 9 - 2 Table 10-1 Service Light Indicators... 10 - 4 Table 15-1 Device Specifications... 15 - 1
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Section 1
Introduction1
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Introduction
Introduction This manual is for clinicians and health care providers involved with the setup and maintenance of the Ami or Ami Plus Infant Central Apnea/ Heart Rate Monitor. It provides detailed information for physicians and other clinical personnel about the installation, safe use, and verification of the operation of the Ami and Ami Plus Infant Central Apnea/ Heart Rate Monitors. It also provides caregiver guidelines for the use of the monitors. This manual must be completely read and understood before operating the Ami or Ami Plus monitors. Use these instructions in conjunction with those set by the patient’s physician. No instruction in this manual is intended to replace accepted medical practice regarding the use of the monitor or the care of the patient. In this manual, the following conventions are used.
WARNING Directions that warn of conditions that put the patient or caregiver at risk.
CAUTION Directions that help you avoid damaging your monitor or losing data. Note: Directions that make it easier to use your monitor.
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Section 2
Apnea Monitoring2
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Apnea Monitoring
Apnea Monitoring The Ami and Ami Plus monitors are intended for use with infants in the home, hospital, or portable environments. The Ami and Ami Plus monitors are to be operated in accordance with all product labeling contained in this manual. When used according to its directions, the monitors are intended to sound an alarm when episodes of central apnea, bradycardia, or tachycardia are detected. The monitors are not intended to detect episodes of obstructive apnea. The Ami and Ami Plus monitors detect central apnea by monitoring breathing patterns as an infant’s chest expands and contracts. When the monitor detects central apnea, it means that the infant has stopped all efforts to breathe and the chest is not expanding or contracting. After the alarm delay set by the clinician, the monitor sounds a central apnea alarm. Everyone caring for the monitored infant must know how to respond to the alarms. All caregivers must be trained in CPR (Cardiopulmonary Resuscitation) for infants. If any caregivers of the monitored infant have not received this training, have them contact an organization that can provide certified training prior to use of the monitor.
WARNING Not for use in an explosive atmosphere.
CAUTION Instruct the caregiver not to rely on the monitor while the patient is subject to motion (use of baby swing, car travel over rough roads, etc.). Motion artifact may prevent any impedance monitor from accurately detecting respiration or heart rate.
CAUTION Federal Law (U.S.A.) restricts this device to sale or use by or on the order of a licensed physician. The Ami and Ami Plus monitors are able to detect central apnea through a process called impedance pneumography. Breathing effort is sensed by sending a constant current between electrodes placed across the thorax. The corresponding impedance changes due to the expansion and contraction of the chest during breathing effort is then measured. The Ami and Ami Plus monitors reject all respiratory effort less than 0.1 ohms; for details, refer to
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Apnea Monitoring Section 15, Device Specifications. When used according to directions, the monitors do not interfere in any way with an infant’s normal breathing effort. It is very important that people or pets do not sleep with a monitored infant. Movements caused by the breathing effort of other people or pets may be interpreted by the monitor as breathing effort from the infant. All caregivers of a monitored infant must be informed that individuals or pets cannot sleep with a monitored infant. It is important to remember that the Ami and Ami Plus monitors may not detect all episodes of inadequate breathing. The monitor may sometimes detect false breathing signals called “artifact.” The monitor could interpret an artifact as breathing, even though the infant has stopped all effort to breathe. This may delay or prevent an apnea alarm. However, the monitor also monitors the child’s heart rate using the same electrodes that monitor breathing. A slow heart rate, due to stopped breathing, may cause a slow heart rate alarm. You must individually evaluate each patient for the effectiveness of the heart slow settings as secondary modality. It is important to consider factors such as age and medications which cause changes in heart rate. False signals or alarms can be caused by other reasons. The monitor may not be able to detect shallow breathing effort from the abdominal region and may sound an apnea alarm. If the electrodes have not been properly placed on the infant’s chest, the monitor may not be able to properly detect breathing effort or an episode of apnea. If an infant’s chest movement is restricted, the monitor may not be able to detect a breathing effort.
WARNING Caregivers must closely watch patients who are subject to obstructive apnea. Devices using impedance pneumography, including the Ami and Ami Plus monitors, can not reliably detect episodes of obstructive apnea. It is very important to closely watch infants who may develop airway obstructions, to guard against an episode of obstructive apnea. Infants who are subject to seizures may also develop airway obstructions which may prevent airflow. Infants at risk for seizures need to be closely watched to protect them from obstructive apnea during a seizure. All caregivers of infants who may experience seizures must be given specific instructions on what to do during a seizure to prevent obstruction of the airway. It is very important that the parents and other caregivers of the monitored infant be educated on the normal operation of the monitor, its hazards and limitations. 2-2
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Section 3
Electromagnetic Interference
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Electromagnetic Interference
Electromagnetic Interference WARNING The Ami and Ami Plus monitors may be affected by electromagnetic interference (EMI) from household appliances, for example, static from a television set. This interference may keep the monitor from working properly. The monitor is an electronic device. Electronic devices can be affected by electrical interference from household appliances. Loose electrodes can exacerbate electromagnetic interference. Although interference is unlikely, no device is completely immune. The monitor was tested and conforms to industry guidelines. The Ami or Ami Plus monitors should not be operated near: •
television sets
•
citizens band and amateur radios
•
microwave ovens
•
paging transmitters
•
radio/TV station transmitters
•
emergency vehicle two way radios
•
air conditioners
•
radio-controlled toys
•
hand-held transceivers (i.e. walkie-talkies, security, emergency)
•
Electronic Article Surveillance (EAS) (found in many stores as security devices)
•
cordless or cellular telephones
•
food processors
•
wireless computer links communications/data transmitters
•
other Ami or Ami Plus monitors (4 ft. minimum separation)
Using the monitor near these appliances may cause the monitor to fail to alarm. To prevent this, move the appliance as far away as possible from the monitor. Watch the Respiration and Heartbeat LEDs on the monitor. Compare with baby’s breathing and pulse. If they do not match, it may be due to electromagnetic interference. Carefully watch the child and call the homecare dealer or CAS Medical Systems for assistance. The monitor should not share electrical outlets with any of these appliances. This may cause electrical interference with the monitor and cause the monitor to fail to alarm. 21-02-0116 Rev. 03 01/04
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Electromagnetic Interference Breath and/ or ECG detection may be impaired if more than one apnea monitor is on the same patient.
Testing for Electrical Interference
The test procedure described below should be followed by the homecare dealer during the initial setup of the Ami or Ami Plus monitor. Periodic testing should also be done to make sure the monitor is not susceptible to electrical interference. If the monitor is determined to be susceptible to electrical interference, immediate action must be taken to correct the incidence of electromagnetic interference. To test for electrical interference at the intended use-site, follow the steps below. 1. Set the monitor apnea duration to 20 seconds. 2. Connect the monitor to a patient simulator with all cables in an extended rather than coiled configuration. 3. Determine if the monitor detects normal respiration and heart beats. 4. Place the patient simulator in the apnea mode for two minutes. 5. Determine that the monitor continues to alarm for apnea at full volume beginning at 20 seconds. Breath and/ or ECG detection may be impaired if more than one apnea monitor is on the same patient. Alarming at reduced volume, false heart rate alarms, or self-silencing of the apnea alarm prior to the end of the simulated apnea constitute failure of this test. If the monitor fails this test, verify that the caution statements found in the Electrical Interference section have been carefully followed and repeat the test. If the monitor continues to fail the test, it is an indication that the monitor may not function properly in its current environment. Contact CAS Technical Service for further assistance.
Electrostatic Discharge
Electrostatic Discharge (ESD) is the small electric shock caused by static electricity. ESD happens when you touch an object, like the monitor, after walking across a carpeted floor when the weather is cool and dry. Touching a wall or the crib before handling the monitored child or the Ami Monitor can prevent this. Whenever possible, use cotton bed sheets for the baby and a fabric softener in the laundry. The use of a spray Static Guard in carpeted floor areas can help the minimize this type of interference.
CAUTION The Ami and Ami Plus monitors should be used only with accessories provided by CAS Medical Systems. Do not use any accessories with the monitor that are not provided by CAS Medical Systems. Using accessories other than those provided by CAS Medical Systems with the monitor may prevent the monitor from working properly.
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What The Caregiver Must Know
What the Caregiver Must Know Parents and other caregivers of the monitored infant must be educated on the normal operation of the monitor, its hazards and limitations. All caregivers must have read and understood the full contents of the Caregiver’s Manual. Everyone caring for the monitored infant must be able to hear and know how to respond to the alarms. All caregivers must be trained in CPR (Cardiopulmonary Resuscitation) for infants. If any caregiver of the monitored infant has not received this training please contact an organization that can provide certified training prior to use of the monitor. It is very important that people or pets do not sleep with a monitored infant. Movements caused by the breathing of other people or pets may be interpreted by the monitor as breathing effort from the infant. All caregivers of a monitored infant must be informed that individuals or pets cannot sleep with a monitored infant. Do not connect the monitor to an electrical outlet controlled by a switch. Do not connect the monitor to an electrical outlet through a power strip. The Ami and Ami Plus monitors cannot reliably detect episodes of obstructive apnea. It is very important to closely watch infants who are subject to airway obstructions in order to guard against episodes of obstructive apnea. Infants at risk for seizures need to be closely watched to protect them from obstructive apnea during a seizure. The Ami and Ami Plus monitors may be affected by electrical interference from household appliances. Electronic interference may keep the monitor from working properly. Do not rely on the monitor while the patient is subject to motion (use of baby swing, car travel over rough roads, etc.). The Ami and Ami Plus monitors should be used only with accessories provided by CAS Medical Systems. Using accessories other than those provided by CAS Medical Systems with the monitor may prevent the monitor from working properly. Unprotected lead wires and cables should not be used with this device. Inappropriate electrical connections may pose an unreasonable risk of adverse health consequences or death.
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Section 5
Description of the Monitor5
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Description of the Monitor
Description of the Monitor The Ami and Ami Plus monitors are intended for use in the home, hospital, or on family outings. The monitor records events and alarms which can be viewed in log format and graphic waveforms using CAS Express software. Note: The ECG waveform, as displayed by the CAS Express software, is not diagnostic quality. There are two input switches on the front panel of the monitor unit. These two switches are marked RESET and POWER. The patient cable outlet is located on the monitor’s front panel. The front panel of the monitor includes warning LEDs and other indicators of the monitor’s operating status. When lit, green LED’s indicate that the monitor is properly connected and that the monitor is detecting normal breathing effort and heart rate. Red LED’s indicate an alarm condition or an equipment malfunction. These red LED’s will indicate a specific occurrence when an alarm sounds. There are ten LED’s on the front of the monitor. •
APNEA - Red LED indicates an episode of central apnea.
•
HEART FAST - Red LED indicates a Tachycardia event.
•
HEART SLOW - Red LED indicates a Bradycardia event.
•
LOOSE LEAD - Red LED indicates that a lead wire, electrode, belt, or
patient cable is loose or disconnected. •
SERVICE - Red LED indicates that the monitor is in need of service. If
possible, download the monitor data and check the log for a description of the alarm condition. •
LOW BATTERY- A constant red LED indicates that there is insuffi-
cient power to properly operate the monitor. A flashing LED indicates that the monitor has enough battery power to operate properly for a minimum of 60 minutes. •
MEMORY FULL- A constant red LED indicates that the memory
capacity of the monitor is full. A slow flashing LED indicates that data has been lost. A fast flashing LED indicates the modem connection is active. •
RESPIRATION- Green LED indicates that the monitor has detected a
breathing effort. •
HEARTBEAT- Green LED indicates that the monitor has detected a
heartbeat. •
CHARGING- Green LED indicates that power is being supplied from
an AC outlet and the battery is being charged.
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