CareFusion Bird Sentry User Manual

Bird Sentry™ Blender
User’s Guide
Bird Sentry™ Blender
This document is protected by United States and International Copyright laws.
This document is for informational purposes only and should not be considered as replacing or supplementing the terms and conditions of the License Agreement.
© 1997–2010 CareFusion Corporation or one of its subsidiaries. All rights reserved. The CareFusion logo and Bird Sentry are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries. All other trademarks are the property of their respective owners.
USA
CareFusion 22745 Savi Ranch Parkway Yorba Linda, California 92887-4668
Authorized European Representative
CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg, Germany District Court Wuerzburg HRB7004
800.231.2466 tel +1.714.283.2228 tel +1.714.283.8493 fax
carefusion.com
Literature number: L1383 Revision D
+49.931.4972.0 tel
+49.931.4972.423 fax
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Revision History
Date Revision Description
February 1997 A Initial release.
March 1997 B
January 1998 C
September 2010 D Rebranded the document to the CareFusion style.
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Warranty
THE BIRD SENTRY™ BLENDER IS WARRANTED TO BE FREE FROM DEFECTS IN MATERIAL AND WORKMANSHIP AND TO MEET THE PUBLISHED SPECIFICATIONS FOR ONE (1) YEAR.
The liability of CareFusion under this warranty is limited to replacing, repairing or issuing credit, at the discretion of CareFusion, for parts that become defective or fail to meet published specifications during the warranty period; CareFusion will not be liable under this warranty unless (A) CareFusion is promptly notified in writing by Buyer upon discovery of defects or failure to meet published specifications; (B) the defective unit or part is returned to CareFusion, transportation charges prepaid by Buyer; (C) the defective unit or part is received by CareFusion for adjustment no later than four (4) weeks following the last day of the warranty period; and (D) examination by CareFusion of such unit or part shall disclose, to its satisfaction, that such defects or failures have not been caused by misuse, neglect, improper installation, unauthorized repair, alteration or accident.
Any authorization of CareFusion for repair or alteration by the Buyer must be in writing to prevent voiding the warranty. In no event shall CareFusion be liable to the Buyer for loss of profits, loss of use, consequential damage or damages of any kind based upon a claim for breach of warranty, other than the purchase price of any defective product covered hereunder.
CareFusion warranties as herein and above set forth shall not be enlarged, diminished or affected by, and no obligation or liability shall arise or grow out of the rendering of technical advice or service by CareFusion or its agents in connection with the Buyer's order of the products furnished hereunder.
Limitations of Liabilities
This warranty does not cover normal maintenance such as cleaning, adjustment or lubrication and updating of equipment parts. This warranty shall be void and shall not apply if the equipment is used with accessories or parts not manufactured by CareFusion or authorized for use in writing by CareFusion, or if the equipment is not maintained in accordance with a prescribed schedule of maintenance.
The warranty stated above shall extend for a period of one (1) year from date of shipment with the following exceptions:
1. Components for monitoring of physical variables such as temperature, pressure, or flow are warranted for ninety (90) days from date of receipt.
2. Elastomeric components and other parts or components subject to deterioration, over which CareFusion has no control, are warranted for sixty (60) days from date of receipt.
THE FOREGOING IS IN LIEU OF ANY WARRANTY, EXPRESSED OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, EXCEPT AS TO TITLE, AND CAN BE AMENDED ONLY IN WRITING.BY A DULY AUTHORIZED REPRESENTATIVE OF CareFusion.
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EMC Notice
This equipment generates, uses, and can radiate radio frequency energy If not installed and used in accordance with the instructions in this manual, electromagnetic interference may result. The equipment has been tested and found to comply with the limits set forth in IEC 601-1-2 for Medical Products. These limits provide reasonable protection against electromagnetic interference when operated in the intended use environments described in this manual.
MRI Notice
This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic fields.
Do not operate the Bird Sentry blender unattended in an MRI environment or in the vicinity of high­frequency surgical diathermy equipment, defibrillators, or shortwave therapy equipment. Electromagnetic interference could disrupt the operation of the Bird Sentry blender.
Regulatory Notice
Federal law restricts the sale of this device except by and on order of a physician.
Declaration of Conformity Notice
This medical equipment complies with the Medical Device Directive, 93/42/EEC, and the following Technical Standards, to which Conformity is declared:
IEC 601-1-2
IEC 601-1-2: 1993
ISO 9001: 1994
EN 46001, MDD-Annex-II
Type of Equipment: Medical Equipment, O
Blender/Monitor
Trade name: Bird Sentry
Model No.: 15625 Series
If you have any questions regarding the Declaration of Conformity for this product, please contact CareFusion Corporation.
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Read this entire manual before attempting to operate or service the Bird Sentry™ blender:
Attempting to operate the Bird Sentry blender without fully understanding its features and functions may result in unsafe operating conditions.
Read the Safety Information section. It lists warnings, cautions, and notes pertinent to the safe servicing of the Bird Sentry blender.
If you have a question regarding the installation, setup, operation, or maintenance of the Bird Sentry blender, contact customer service at the following numbers:
Technical Support
Hours: 7:00 a.m. to 4:30 p.m. (PST), Monday through Friday
Tel.: 714.283.2228 or 800.231.2466 (Follow the prompts to technical support.)
Fax: 714.283.8471
support.vent.us@carefusion.com
CareFusion Helpline
Hours: 24 hours, 7 days a week
Tel.: 800.231.2466 or 800.328.4139
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Safety Information
Review the following safety information before operating the Bird Sentry blender:
Definitions
Warning! Identifies a condition or practice that could result in serious adverse reactions or
potential safety hazards.
Caution! Identifies a condition or practice that could result in damage to the Bird Sentry blender
or other equipment.
Note: Identifies supplemental information to help you better understand how the Bird Sentry
blender works.
Warnings
The following warnings apply any time you operate or service the Bird Sentry blender:
To avoid explosion, do not operate the Bird Sentry blender in the presence of flammable
anesthetics or in an atmosphere of explosive gases. Operating the Bird Sentry blender in flammable or explosive atmospheres may result in fire or explosion.
Do not operate the Bird Sentry blender unless qualified personnel are in attendance to promptly
respond to alarms, inoperative conditions, or sudden malfunctions. Patients on life-support equipment should be visually monitored at all times.
Do not ignore audible alarms occurring by the Bird Sentry blender. Alarms indicate conditions
that require your immediate attention.
Do not use parts, accessories, or options that have not been authorized for use with the Bird
Sentry blender. Using unauthorized parts, accessories, or options may be harmful to the patient or damage the Bird Sentry blender.
Check all audible and visual alarms daily to make sure they are operating properly. If an alarm
fails to activate, contact your CareFusion Certified Service Technician.
Consult a physician to determine concentration of inspired oxygen to be delivered.
Do not operate the Bird Sentry blender without setting the adjustable alarms. All adjustable
alarms must be set to ensure safe operation.
Explosion hazard. DO NOT gas sterilize the Bird Sentry blender.
DO NOT steam autoclave or otherwise subject the Bird Sentry blender to temperatures above
122°F (50°C).
If the air or oxygen gas source fails, the pressure differential alarm will sound alerting the
clinician that a condition has occurred that may significantly alter the FIO, and flow output from the Bird Sentry blender.
If either the air or oxygen source pressure is reduced or increased sufficiently to create a
pressure differential of 20 PSI or more, an audible alarm will sound. This condition may significantly alter the FIO and flow output from the Bird Sentry blender.
DO NOT use humidified oxygen to calibrate this system. If calibrated with humidified oxygen,
subsequent oxygen readings will be higher than the true oxygen level.
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DO NOT tape, obstruct or remove the reed alarm during clinical use.
DO NOT occlude the sensor port on the side of the Bird Sentry blender.
Do not routinely disconnect or remove O
sensors from the Bird Sentry blender. If the sensor
2
must be disconnected, the full "warm-up" period, as stated in the sensor specifications, may be required after the sensor is reconnected.
The mixed gas bleed continuously bleeds to atmosphere at the oxygen concentration setting of
the control knob. Bleeding oxygen into any closed area could increase the risk of fire or explosion. Do not operate this device in the presence of any flame or source of ignition; or when using devices such as electrosurgical equipment or defibrillators.
Cautions
Do not attempt to clean the Bird Sentry blender with cleaning agents that contain phenols,
ammonia chloride, or chloride compounds, or that contain more than 2% glutaraldehyde. These agents may damage the plastic components and control panel overlays.
Dropping or severely jarring the sensor after calibration may shift the calibration point enough
to require recalibration.
Using the Bird Sentry blender to analyze and monitor oxygen concentrations other than at the
sensor port of the unit will require recalibration of the sensor.
Always operate the Bird Sentry blender with clean, dry medical grade gases. Contaminates or
moisture can cause defective operation. Oxygen should have a minimum dew point of -80°F (­62°C) or moisture content less than 7.9 PPM (0.0059mg/L). Oxygen "purity" should be at least
99.6% and air used should be medical grade. Water vapor content must not exceed a dew point of 5°F (3°C) below the lowest ambient temperature to which the delivery system is exposed. Particulate content must not exceed that which would be found immediately downstream of a 15 micron absolute filter. Refer to CGA commodity specifications G-4.3 and G7.1 for more information. Water vapor content of medical air or 0, supply to the blender must not exceed 5.63 x 103 milligrams H2O per cubic meter of non-condensable gas.
When disassembling, care must be exercised to prevent damaging the printed circuit board. All
work must be accomplished in a static safe environment.
This device has not been tested in the presence of gases other than air or oxygen.
Notes
The Bird Sentry blender is tested for compliance with ISO 11195:1995, clause 6, and meets
requirements regarding reverse gas flow as delivered.
Applicable parts used in the Bird Sentry blender have been cleaned and degreased for oxygen
service. Any lubricants used are designed specifically for the application. Do not use anything other than CareFusion specified lubricants when servicing the Bird Sentry blender.
As long as the total pressure of the gas mixture being monitored is constant, the Bird Sentry
blender will accurately read oxygen concentrations. However, if the total pressure varies the reading will fluctuate proportionately as the sensor actually measures the partial pressure of oxygen in the mixture. The sensor readings will also change proportionately with barometric pressure changes. Because of this, daily calibration of the sensor is recommended.
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Users are advised to use pressure regulators, set to 50 ±5 PSIG(3.4± .4 BAR), which display
system pressure.
All specifications assume the following standard environ mental conditions, unless specified
otherwise. Ambient and sample gas temperatures of 77°F (25°C); barometric pressure of 30:Hg (760mmHg); sea level altitude; ambient relative humidity of 50%; sample gas relative humidity of 0%
It is important to note that the oxygen concentration selection scale is provided only as a
guideline for selecting 0, concentrations. The clinician should use the display panel of the Bird Sentry blender to adjust the O
Equipment Symbols
The following symbols appear on the Bird Sentry blender.
Symbol Compliance Meaning
concentration to the desired setting.
2
IEC 578 Symbol #03- O
2
IEC 417 Symbol #5016
IEC 417 Symbol #5034
IEC 878 Symbol #01-08
IEC 878 Symbol #01-07
Attention, consult the accompanying documents.
Fuse
Input
Standby (circuitry off) position of the On/Off switch. It does NOT switch the blenders mixing ability to turn power off.
On condition for the display circuitry of the equipment.
CareFusion products symbol Lock (used to prevent accidental
changes to set values.) The front panel Lock icon is
illuminated when the control panel is locked.
CareFusion product symbol Silence condition of the audible alarm
for a period of up to two minutes (120 sec.)
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Contents
Revision History .............................................................................................................. iii
Warranty ....................................................................................................................... iv
Limitations of Liabilities .................................................................................................. iv
EMC Notice .................................................................................................................... v
MRI Notice ...................................................................................................................... v
Regulatory Notice ............................................................................................................ v
Declaration of Conformity Notice .................................................................................... v
Technical support ........................................................................................................... vi
CareFusion helpline ........................................................................................................ vi
Safety Information ......................................................................................................... vii
Chapter 1: Introduction ....................................................................................................... 1
Intended Use .................................................................................................................. 1
Front Panel Functional Description ................................................................................... 2
Bottom View ................................................................................................................... 4
Disposable Galvanic O
Sensor ......................................................................................... 5
2
What You Will Need to Operate the Blender .................................................................... 6
What to Do If the Blender Fails ........................................................................................ 6
How to Get Help ............................................................................................................. 6
Chapter 2: Operating Procedures ......................................................................................... 7
Monitoring ..................................................................................................................... 7
Alarm Setting Procedure .................................................................................................. 7
Basic Operation ............................................................................................................... 8
Alarms and Conditions .................................................................................................... 8
Calibration Procedures .................................................................................................... 9
Automatic Calibration to Known Concentration ............................................................. 10
Chapter 3: Pressure Differential Alarm/Bypass Check .......................................................... 11
Chapter 4: Troubleshooting ............................................................................................... 13
Chapter 5: Cleaning the Bird Sentry Blender ...................................................................... 15
Chapter 6: Servicing and Maintaining the Bird Sentry Blender ............................................. 17
Maintenance ................................................................................................................. 17
Disposable Galvanic O
Sensor Cable ............................................................................. 17
2
Servicing ....................................................................................................................... 18
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Chapter 7: Appendices ...................................................................................................... 19
Glossary ....................................................................................................................... 19
Specifications ................................................................................................................ 19
Setup and Installation ................................................................................................... 21
Theory of Operations .................................................................................................... 22
Flow Characteristics ...................................................................................................... 25
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