Masimo Rainbow 4D DC Reusable Sensor Directions for Use

Masimo Rainbow® 4D DC Reusable Sensor

dominant middle finger; dominant middle finger. NOTE: When using the finger gauge, It is preferable to start with the ring finger of the non-dominant hand. Refer to Fig. 1. The finger gauge consists of attached front and back cards with an opening for the finger. Hold the card so that L (Large), M (Medium) and S (Small) are visible to the clinician.

+70 C

-40 C +1060 hPa - +500 hPa 795 mmHg - 375 mmHg

NON STERILE

DIRECTIONS FOR USE

+70 C

-40 C +1060 hPa - +500 hPa 795 mmHg - 375 mmHg

5%-95% RH

Reusable

This product does not contain natural rubber latex

LATEX

5%-95% RH

INDICATIONS LATEX The Masimo Rainbow% SET® Pronto-7 Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb®). The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospitals, hospital-type facilities, %home, clinics, physician offices and ambulatory surgery centers). The sensor is indicated as follows: 5%

95%

Title: Graphics, Sensor/Cable symbols, 03/06 GR-14231 DRO-13914

5%

Title: Graphics, Sensor/Cable symbols, 03/06 GR-14231 DRO-13914

Sensor

If the finger fits snugly, use a large sensor. If not, move the edge of the back card to “M” or “S”. Move only the card, not the finger. Remove the gauge from the finger BEFORE sensor application.

NON STERILE

95%

Application Site

With the arrow of the front card pointing to “L” , insert the finger into the finger gauge opening. The edge of the opening should touch the area where the cuticle meets the nail bed.

4D DC

Ring Finger or Middle Finger

Sensor color (indicates correct sensor, based on finger size): Small/Yellow:

8 mm - 12 mm (.31 in. - .47 in.) diameter

Medium/Red:

12 mm - 16 mm (.47 in. - .63 in.) diameter

Large/Gray:

16 mm - 20 mm (.63 in. - .79 in.) diameter

SpO2 Saturation Accuracy (70-100%)

± 2%

Pulse Rate Accuracy (30 - 250 bpm)

± 3 bpm

NOTE: Choosing the correct sensor size is vital to obtaining an accurate reading. Use of the finger gauge is recommended for every patient.

B) Attaching the sensor to instrument Connect the sensor directly to the instrument. C) Attaching the sensor to the patient 1. Refer to Fig. 2. Open the sensor by pressing on hinge tabs. Position the finger into the sensor as shown. Place the selected finger over the sensor window of the sensor. The fleshiest part of the finger should be covering the detector window in the lower half of the sensor. The top half of the sensor is identified by the cable. 2. Refer to Fig. 3. Check the arrangement of the sensor to verify correct positioning. The patient’s finger should slide into the sensor until reaching the finger stop. Before initiating the test, gently squeeze the top and bottom of the sensor to ensure the inside sensor pads and finger skin are touching and the sensor is hugging the finger. Complete coverage of the detector window is needed to ensure accurate data. 3. Refer to Fig. 4. Orient the sensor so that the cable will be running over the top of the patient’s hand. The emitter and detector should be vertically aligned. The hand should be resting on a stable surface, as close to heart level as possible. NOTE: The patient should be in a seated position for a minute prior to, and during testing. Do not allow the patient to talk, laugh, cough or move during testing. If this occurs, stop and re-test. NOTE: The sensor is not intended for use across a child’s hand or foot

Disconnecting the sensor from the instrument 1. Refer to Fig. 5. Place thumb on top of the connector and index finger underneath the connector. 2. Press fingers together firmly on the connector and pull to remove the connector from the instrument. Removing the sensor from the patient Open the sensor by pressing on hinge tabs. Remove the sensor from the finger and follow the cleaning instructions, if necessary.

SpHb Concentration Accuracy Normal Sensitvity Mode

± 1.0 g/dL (6 g/dL to 18 g/dL)

Max Sensitivity Mode

± 1.1 g/dL (4.5 g/dL to 20 g/dL)

CONTRAINDICATIONS The Masimo Rainbow Pronto-7 Direct Connect-Spot Check (4D DC) Reusable Sensor is contraindicated for use on active patients or for prolonged periods of use. If the circulatory condition or skin integrity is compromised, the sensor should be applied to a different site. 4D DC is contraindicated for continuous use.

WARNINGS • Variation in hemoglobin measurements may be profound and may be affected by sample type, body positioning, as well as other physiological conditions. As with most hemoglobin tests, Pronto-7 test results should be scrutinized in light of a specific patient’s condition. Any results exhibiting inconsistency with the patient’s clinical status should be repeated and/or supplemented with additional test data. • Exercise extreme caution with poorly perfused patients; skin erosion and pressure necrosis can be caused when the sensor is not frequently moved. Sensor is not intended to be left on the patient’s finger for durations of time longer than several consecutive spot checks. • The Pronto-7 is not intended for serial measurements. The sensor should not be left on the finger for time periods beyond the device’s standard test modes. • For best test results, perform testing only after the patient and instrument have acclimated to the ambient temperature in which the test is to be performed. • During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead to pressure necrosis. • Do not use tape to secure the sensor to the site; this can restrict blood flow and cause inaccurate readings. Use of tape can cause skin damage, and/or pressure necrosis or damage the sensor. • Misapplied sensors or sensors that become partially dislodged may cause either over or under reading of actual SpO2 or SpHb measurements. • Misapplied sensors or sensors that become partially dislodged may lead to inaccurate measurements. • With very low perfusion at the monitored site, the reading may lead to inaccurate measurements. • Failure to apply the sensor properly may lead to inaccurate measurements. • Do not loop the sensor cable into a tight coil or wrap around the device, as this can damage the sensor cable. • Do not twist the sensor cable, as this can cause the sensor to become misaligned or damaged. • A misaligned sensor may lead to inaccurate measurements. • Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpHb and SpO2 measurements. • Elevated levels of Methehemoglobin (MetHb) may lead to inaccurate SpHb and SpO2 measurements. • Elevated Bilirubin levels may lead to inaccurate SpHb or SpO2 measurements. • Hemoglobin synthesis disorders, hemoglobinopathy and/or Peripheral Vascular Disease may cause inaccurate SpHb readings. • Intravascular dyes or externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc., may lead to inaccurate SpO2 and SpHb measurements. • Sensors applied too tightly may cause erroneously low readings. • Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper venous outflow from monitored site. Sensor should not be below heart level (e.g. sensor on hand of a patient in a bed with arm dangling to the floor). • Intra-aortic balloon support can alter the pulse rate measurement on the instrument. Verify patient’s pulse rate against the ECG heart rate. • Venous pulsations may cause erroneous low SpO2 readings (e.g. tricuspid value regurgitation). • The sensor should be free of visible defects. Never use a damaged sensor or one with exposed electrical circuitry. • Carefully route sensor cable to reduce patient entanglement or strangulation. • Avoid placing the sensor on any extremity with an arterial catheter or blood pressure cuff. • If using the instrument during full body radiation, keep the sensor out of the radiation field. If sensor is exposed to the radiation, the reading might be inaccurate or the unit might read zero for the duration of the active irradiation period. • Do not use the sensor during MRI scanning. • Do not use the sensor during electrocautery. • Do not use the sensor during defibrillation. • High intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow the Pronto-7 to obtain readings. • High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of the sensor. • Check for possible EMI radiation interference such as, computer displays and/or LCD/plasma TVs. • Do not place the Pronto-7 on electrical equipment that may affect the Pulse CO-Oximeter, preventing it from working properly. • To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required. Failure to take this precaution in high ambient light conditions may result in inaccurate measurements. • Do not expose the sensor to excessive humidity. It should be used and stored in a cool, dry place. • Do not modify or alter the sensor in any way. Alteration or modification may affect performance and/or accuracy. • Do not attempt to reprocess, recondition or recycle the 4D DC sensor. This process may damage the electrical components, potentially leading to patient harm. INSTRUCTIONS A) Site Selection • Do not use on an anatomically incorrect finger (e.g. damaged, clubbed, deviated, etc.). • Do not use on a finger with occlusive jewelry, such as a ring. • Site should be cleaned of debris and dry prior to sensor placement. • Choose a site that is well perfused and least restricts a conscious patient’s movements. • Select the patient’s testing finger in the following priority: Non-dominant ring finger; dominant ring finger; non-

CLEANING To clean the sensor, first remove it from the patient and disconnect it from the instrument. Clean the sensor by wiping it with a 70% isopropyl alcohol pad. Allow the sensor to dry prior to placement on a patient. To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not sterilize. ENVIRONMENTAL CONDITIONS Operating Temperature

41°F to 104°F (5°C to 40°C)

Humidity

5% to 95% noncondensing

Operating Altitude

500 mbar to 1060 mbar -1000 ft to 18,000 ft (-304 m to 5,486 m)

SPECIFICATIONS When the rainbow 4D DC sensor is plugged into the Pronto-7 Instrument for finger sizes 8 mm - 20 mm (.31 in. - .79 in.) in diameter, the accuracy for SpO2 in the range of 70-100% is ± 2% (1 Std. Dev.) for adults and pediatrics, and the accuracy for SpHb in the Normal Sensitivity Mode from 6 g/dL to 18 g/dL is ± 1.0 g/dL (1 Std. Dev.), in the Max Sensitivity Mode from 4.5 g/dL to 20 g/dL is ±1.1 g/dL( 1 Std. Dev.). The accuracy for Pulse Rate (PR) in the range of 30-250 bpm is ± 3 bpm (1 Std. Dev.) The range for Perfusion Index (PI) is 0.02% - 20%. Accuracy specifications are statistically distributed, about two thirds of the measurements can be expected to fall between the value measured by a laboratory CO-Oximeter. INSTRUMENT COMPATIBILITY This sensor is intended for use only with the Pronto-7 Instrument. Use of this sensor with other Instruments may result in no or improper performance. WARRANTY Masimo warrants to the initial buyer only that these products, when used in accordance with the directions provided with the Products by Masimo, will be free of defects in materials and workmanship for a period of six (6) months. THE FOREGOING IS THE SOLE AND EXCLUSIVE WARRANTY APPLICABLE TO THE PRODUCTS SOLD BY MASIMO TO BUYER. MASIMO EXPRESSLY DISCLAIMS ALL OTHER ORAL, EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. MASIMO’S SOLE OBLIGATION AND BUYER’S EXCLUSIVE REMEDY FOR BREACH OF ANY WARRANTY SHALL BE, AT MASIMO’S OPTION, TO REPAIR OR REPLACE THE PRODUCT. WARRANTY EXCLUSIONS This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the product, or has been subject to misuse, neglect, accident or externally created damage. This warranty does not extend to any product that has been connected to any unintended instrument or system, has been modified, or has been disassembled or reassembled. This warranty does not extend to sensors or patient cables that have been reprocessed, reconditioned or recycled. IN NO EVENT SHALL MASIMO BE LIABLE TO BUYER OR ANY OTHER PERSON FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS), EVEN IF ADVISED OF THE POSSIBILITY THEREOF. IN NO EVENT SHALL MASIMO’S LIABILITY ARISING FROM ANY PRODUCTS SOLD TO BUYER (UNDER A CONTRACT, WARRANTY, TORT OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY BUYER FOR THE LOT OF PRODUCT(S) INVOLVED IN SUCH CLAIM. In no event shall Masimo be liable for any damages associated a product that has been reprocessed, reconditioned or recycleD. THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED TO PRECLUDE ANY LIABILITY THAT, UNDER APPLICABLE PRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED BY CONTRACT. NO IMPLIED LICENSE Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables that would, alone, or in combination with the device, fall within the scope of one or more of the patents relating thereto. By acceptance or use of this device, you acknowledge your acceptance of these terms. SENSORS LICENSED FOR MONITORING USE ONLY Sensors designated for monitoring only are licensed to you under patents owned by Masimo to be used for patient monitoring, in an unmodified form as originally received from Masimo, and no license is granted to have Masimo’s sensors reprocessed or otherwise modified, unless specifically authorized by Masimo. There is no license, implied or otherwise, that would allow use of licensed sensors beyond their intended duration. After use of sensors through their designated duration, there is no further license granted by Masimo to use the sensors and the sensors must be discarded or returned to Masimo for reprocessing. CLEARED USE ONLY The device, software, sensors and related disposable accessories may not be used for any processes, procedures, experiments or any other use for which the device is not intended or cleared by the Food and Drug Administration (FDA), or in any manner inconsistent with the instructions for use or labeling. CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. The following symbols may appear on the product or product labeling: