Directions for Use
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MAX-IR Infant Oxygen Sensor
MAX-NR Neonatal/Adult Oxygen Sensor
Directions for Use
Directions for Use !
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Indications/Contraindications The Nellcor® OXIMAX® neonatal/adult oxygen sensor, model MAX-NR, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 3 kg or adults weighing more than 40 kg. The MAX-NR is contraindicated for use on patients who exhibit allergic reactions to the adhesive tape. Instructions for Use 1. Remove plastic backing from the MAX-NR and locate transparent windows (b) on the adhesive side. Windows cover optical components. Note corresponding alignment marks (a) on nonadhesive side and dashed line (c) midway between the marks . 2. Orient the MAX-NR so the dashed line is on the lateral edge of the site (b): Neonates: The preferred site is a foot. Alternatively, use a hand. The window next to the cable goes on the sole of the foot as shown . Adults: The preferred site is an index finger. Alternatively, other fingers may be used. The window next to the cable goes on the nail side, distal to the first joint. Do not place on a joint. Note that the cable must be positioned on the top of the hand . Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood pressure cuff, or intravascular infusion line. 3. Wrap the MAX-NR firmly, but not too tightly around the foot or finger. Windows must oppose each other. 4. Plug the MAX-NR into the oximeter and verify proper operation as described in the oximeter operator’s manual. Note: If the sensor does not track the pulse reliably, it may be incorrectly positioned-or the sensor site may be too thick, thin, or deeply pigmented, or otherwise deeply colored (for example, as a result of externally applied coloring such as nail polish, dye, or pigmented cream) to permit appropriate light transmission. If any of these situations occurs, reposition the sensor or choose an alternate Nellcor sensor for use on a different site. Reapplication The MAX-NR can be reused on the same patient as long as the adhesive tape attaches without slippage. Enclosed adhesive “dots” are provided for reapplication. Place a transparent dot over each window as shown, then remove the protective paper that covers each dot . The sensor is now ready to be reapplied to the same patient.
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Adult, Pediatric, Infant, Neonate
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Indications/Contraindications The Nellcor® OXIMAX® infant oxygen sensor, model MAX-IR, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 3 and 20 kg. The MAX-IR is contraindicated for use on patients who exhibit allergic reactions to the adhesive tape. Instructions for Use 1. Remove plastic backing from the MAX-IR and locate transparent windows (b) on the adhesive side. Windows cover optical components. Note corresponding alignment marks (a) on the nonadhesive side and the dashed line (c) midway between the marks . A great toe is the preferred MAX-IR location. Alternatively, apply the sensor to another digit of similar size, for example, a thumb. Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood pressure cuff, or intravascular infusion line. 2. Orient the MAX-IR so the window next to the cable is aligned on the bottom of the great toe as shown. The cable should extend towards the heel . 3. Wrap the MAX-IR firmly, but not too tightly around the toe. Windows must oppose each other . 4. Wrap any excess tape loosely around toe. Use additional tape provided to secure cable across bottom of foot, loosely enough to maintain good circulation . 5. Plug the MAX-IR into the oximeter and verify proper operation as described in the oximeter operator’s manual. Note: If the sensor does not track the pulse reliably, it may be incorrectly positioned-or the sensor site may be too thick, thin, or deeply pigmented, or otherwise deeply colored (for example, as a result of externally applied coloring such as nail polish, dye, or pigmented cream) to permit appropriate light transmission. If any of these situations occurs, reposition the sensor or choose an alternate Nellcor sensor for use on a different site. Reapplication The MAX-IR can be reused on the same patient as long as the adhesive tape attaches without slippage. Enclosed adhesive “dots” are provided for reapplication. Place a transparent dot over each window as shown, then remove the protective paper that covers each dot . The sensor is now ready to be reapplied to the same patient.
Infant Max-IR
Adult/Neonatal Max-NR
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Reprocessed device for single use. Reprocessed by:
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Tyco Healthcare Group LP Nellcor Puritan Bennett Division Pleasanton, CA U.S.A. 1-800-NELLCOR www.nellcor.com © 2006 Nellcor Puritan Bennett Incorporated. All rights reserved. 10013597A-0906
WARNINGS • If the sensor is wrapped too tightly or supplemental tape is applied, venous pulsations may lead to inaccurate saturation measurements. • Do not use the sensor or other oximetry sensors during MRI scanning. Conducted current may cause burns. Also, the sensor may affect the MRI image, and the MRI unit may affect the accuracy of oximetry measurements. • Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy. • Do not use a damaged sensor or pulse oximetry cable. Do not use a sensor with exposed optical components. Cautions • Failure to apply the sensor properly may cause incorrect measurements. • High oxygen levels may predispose a premature infant to develop retinopathy. Therefore, the upper alarm limit for oxygen saturation must be carefully selected in accordance with accepted clinical standards and must consider the accuracy range of the oximeter being used. • While the sensor is designed to reduce the effects of ambient light, excessive light may cause inaccurate measurements. In such cases, cover the sensor with opaque material. • Circulation distal to the sensor site should be checked routinely. The site must be inspected every 8 hours to ensure adhesion, skin integrity, and correct optical alignment. If skin integrity changes, move the sensor to another site. • Intravascular dyes or externally applied coloring such as nail polish, dye, or pigmented cream may lead to inaccurate measurements. • Excessive motion may compromise performance. In such cases, try to keep the patient still, or change the sensor site to one with less motion. • Do not immerse in water or cleaning solutions. Do not resterilize. • For additional warnings, cautions or contraindications when using this sensor with Nellcor-compatible instruments, refer to the instrument operator’s manual or contact the manufacturer of the instrument. • In the event of damage to the sterile packaging, do NOT resterilize. Follow local governing ordinances and recycling instructions regarding disposal or recycling of sensors.
Sensor Features and Capabilities Use this sensor only with Nellcor instruments and instruments containing Nellcor oximetry, or with instruments licensed to use Nellcor sensors (Nellcor-compatible instruments). Consult individual manufacturers for features and compatibility of particular instruments and sensor models. Each manufacturer of Nellcor-compatible instruments is responsible for determining whether and under what conditions its instruments are compatible for safe and effective use with each Nellcor sensor model. This may include different specifications and/or warnings, cautions, or contraindications. Refer to the instrument operator’s manual or consult manufacturer for complete instructions for use of this sensor with their Nellcor-compatible instrument. Compliance When used with the appropriate Nellcor pulse oximetry monitors, patient monitors containing Nellcor oximetry, or with patient monitors licensed to use Nellcor oximetry, the pulse oximeter system is compliant with ISO 9919:2005 provided other requirements of the standard are met. Accuracy Specifications The accuracy of the reprocessed OxiMax sensor during no motion is ± 2 digits (± 1 Std. Dev.) for adults and ± 3 digits (± 1 Std. Dev.) for neonates from 70% to 100% SpO2. Pulse Rate accuracy from 25 to 240 bpm is ± 3 digits (± 1 Std. Dev.). However, if the accuracy of the pulse oximeter to which the sensor is connected is lower, the accuracy specification will decrease. Neonatal accuracy is increased by ± 1 digit as compared to adult usage. All specifications validated with the Nellcor N-595 Pulse Oximeter. Remanufacturable Sensors "R" in the product number denotes remanufacturable sensors. The sensors in this carton include reprocessed sensors and may also include new sensors. Additional Copies of Instructions Additional copies of these Instructions are available at no charge by calling Nellcor or its authorized distributors. Also, permission is hereby granted under Nellcor Puritan Bennett copyrights to Purchasers of products obtained from Nellcor or its authorized distributors to make additional copies of these instructions for use by such purchasers. Symbols Latex Free
MAX-A(L)R Adult Oxygen Sensor
MAX-PR Pediatric Oxygen Sensor
Directions for Use
Indications/Contraindications The Nellcor® OXIMAX® adult oxygen sensor, model MAX-A(L)R is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg. The MAX-A(L)R is contraindicated for use on patients who exhibit allergic reactions to the adhesive tape. Instructions for Use 1. Remove plastic backing from the MAX-A(L)R and locate transparent windows (a) on the adhesive side. Windows cover optical components . An index finger is the preferred MAX-A(L)R location. Alternatively, apply the sensor to a small thumb, smaller finger, or great toe. Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood pressure cuff, or intravascular infusion line. 2. Orient the MAX-A(L)R so the dashed line in the middle of the sensor is centered on the tip of the digit . Wrap adhesive flaps on non-cable end around the digit. Note that the cable must be positioned on the top of the hand. 3. Fold cable end over top of digit so that windows are directly opposite each other. Wrap adhesive securely around sides of digit . 4. Plug the MAX-A(L)R into the oximeter and verify proper operation as described in the oximeter operator’s manual. Note: If the sensor does not track the pulse reliably, it may be incorrectly positioned-or the sensor site may be too thick, thin, or deeply pigmented, or otherwise deeply colored (for example, as a result of externally applied coloring such as nail polish, dye, or pigmented cream) to permit appropriate light transmission. If any of these situations occurs, reposition the sensor or choose an alternate Nellcor sensor for use on a different site.
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Indications/Contraindications The Nellcor® OXIMAX® pediatric oxygen sensor, model MAX-PR, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg. The MAX-PR is contraindicated for use on patients who exhibit allergic reactions to the adhesive tape. Instructions for Use 1. Remove plastic backing from the MAX-PR and locate transparent windows (a) on the adhesive side. Windows cover optical components . An index finger is the preferred MAX-PR location. Alternatively, apply the sensor to a small thumb, smaller finger, or great toe. Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood pressure cuff, or intravascular infusion line. 2. Orient the MAX-PR so the dashed line in the middle of the sensor is centered on the tip of the digit . Wrap adhesive flaps on non-cable end around the digit. Note:that the cable must be positioned on the top of the hand or foot. 3. Fold cable end over top of digit so that windows are directly opposite each other. Wrap adhesive securely around sides of digit . 4. Plug the MAX-PR into the oximeter and verify proper operation as described in the oximeter operator’s manual. Note: If the sensor does not track the pulse reliably, it may be incorrectly positioned-or the sensor site may be too thick, thin, or deeply pigmented, or otherwise deeply colored (for example, as a result of externally applied coloring such as nail polish, dye, or pigmented cream) to permit appropriate light transmission. If any of these situations occurs, reposition the sensor or choose an alternate Nellcor sensor for use on a different site.
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