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s e r i e sSpO2 SensorsValidation Report

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Validation Report for TruLink SpO2 Sensors

TruLink SpO2 sensors have been found to be Substantially Equivalent to Nellcor®

SpO2 Sensors by the Food and Drug Administration. Substantially equivalent in

this case means that the device manufactured is technically equivalent to the

original device.

Extensive clinical testing was completed prior to submission of Substantial

Equivalence notification and all testing demonstrated the compatibility of the

Spacelabs Medical TruLink SpO2 Sensors to Nellcor pulse oximeters.

TruLink SpO2 Sensors

Accuracy … … … … … … … … … … … … … … … … … … … … 8

Biocompatibility … … … … … … … … … … … … … … … … … 15

Operating Temperature … … … … … … … … … … … … … … … 17

Monitor Compatibility/Ordering Information … … … … … … … … 18

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Description

TruLink 015-0660-00Adult Reusable Finger Clip

Reusable finger sensor providesmaximum patient comfort. Patientweight range >40 Kg. Latex free.

TruLink 015-0661-00Reusable Multisite Y-Sensor& Reusable Ear-ClipAccessory

Reusable “Y” sensor for place-ment on fingers, toes, sides ofhand or foot (infant/neonatalapplication). All patient weightranges. Ear-clip for use only onpatient weight ranges >30 Kg.Latex free.

TruLink 015-0663-00and 015-0662-00Vinyl & Foam AdultDisposable Sensor

Adhesive finger sensor for singlepatient use. Patient weight range>30Kg. Latex free.

The following are descriptions of the complete line

of TruLink SpO2. In succeeding sections, clinical and

bench testing data are discussed.

7Spacelabs Medical TruLink™ SpO2 Sensor Line: Design Performance

Descriptions

TruLink 015-0664-00 and 015-0665-00(Vinyl & Foam) PediatricDisposable Sensor

Adhesive finger sensor for singlepatient use. Patient weight range10-50 Kg. Latex free.

TruLink 015-0666-00(Cloth) Infant DisposableSensor

Adhesive sensor for singlepatient use. Placements includefinger, thumb, toe, side of hand,and side of foot. Patient weightrange 3–20 Kg. Latex free.

TruLink 015-0667-00(Cloth) NeonatalDisposable Sensor

Adhesive sensor for singlepatient use. Placements includeside of hand or foot. Patientweight range <30 Kg. Latex free.

8

Accuracy

SpO2 Accuracy Validation

Spacelabs Medical TruLink SpO2 Sensors have been clinically validatedusing the Nellcor N-395 Pulse Oximeter in an industry standardbreathe-down protocol.

Validation was conducted in a breathe-down protocol at theMilwaukee Veterans Hospital, Anesthesia Research Service (PhilipClifford, PhD, Principal Investigator). SpO2 values displayed by ModelN-395 production units were compared against SaO2 values from arte-rial blood samples assayed on a gold-standard Radiometer OSM-3Co-oximeter. Scientific accuracy was demonstrated by statisticallycomparing Model N-395 SpO2 values to functional SaO2 values.Volunteers participated in the breathe-down protocols at rest (i.e. nomotion) while fully conscious at SaO2 values ranging from 70-100%.

Volunteers were recruited to the breathe-down protocol based uponMilwaukee Veterans IRB rules and regulations. Informed consent wasobtained from each volunteer prior to study commencement. A radialarterial line was placed into the volunteer’s wrist for blood sampling.TruLink SpO2 Sensors were placed on the same-side or opposite-sidehand (or ear) as the radial arterial line. Reusable and single use sensors (adult and pediatric) were placed at the tip of each volunteersubject’s middle fingers (2nd, 3rd, and 4th digits). Infant, neonatal, and“Y” sensors were placed at the tips of the pinky and thumb (1st and5th digits). “Y” sensors were also placed on volunteer’s ear-lobes usingthe reusable ear-clip accessory.

Ambient light covers were placed over the sensors (finger locationsonly), to prevent sensor-to-sensor cross talk.

OSM3 Radiometer Cooximeter (front)and reference blood gas analyzer(rear).

Nellcor N-395 Pulse Oximeters TruLink SpO2 Sensor


SpO2 Accuracy

A non-rebreathing system attached to an Oxygen (‘O2’)/Nitrogen(‘N2’)/Air gas delivery apparatus provided the hypoxic gas mixture tothe volunteer, via a facemask held in place by a fabric-elastic head cradle.If the volunteer felt uncomfortable at any time during the protocol, thefacemask was simply removed and the subject began breathing room-air again. Seven H-size tanks containing pre-mixed gases were connected to a custom gas manifold, terminating at the facemaskthrough which the volunteer inspired.

Gas tanks were prepared by a certified gas mixing and filling facility, tocontain O2/N2/Air mixtures. Room-air (FiO2 0.21) was used to collectroom-air SaO2 values, and to resaturate the volunteers followinghypoxic sequences. Pure O2 was delivered to provide SaO2 valuesabove those collected at room-air, and to occasionally resaturate volunteers after hypoxic episodes. The inspired gases were varied toprovide SaO2 values from 70-100% as clinically tolerated by each volunteer subject.

The IRB-approved breathe-down protocol allowed twenty blood samplesto be drawn per subject. During 20 one to three minute steady-stateperiods at desired SaO2 plateaus, a radial arterial blood specimen waswithdrawn from the subject and analyzed by co-oximetry. Generally, atwo-step breathe-down method was utilized, which involved the low-ering of SaO2 gradually, desaturating by titrating various FiO2 gas mix-tures, during which blood samples were drawn when SaO2 plateauswere observed. Between each two-step breathe-down sequence, thevolunteer subject was resaturated with either room-air (FiO2 = 0.21) orpure O2. Functional SpO2 vs. Functional SaO2 samples were analyzed from each volunteer subject.

Black-Felt Ambient Light Covers Mixed Gas Delivery SystemFacemask Application

Clinical monitor placing sensors

10

Accuracy

Bland-Altman Statistical Analysis is used to demonstrate accuracythrough the calculation of Arms (SpO2 Accuracy [root mean square]),Bias and Precision values. Model N-395 Pulse Oximeter SpO2 Arms

values are compared against the Nellcor N-395 Device SpecificationRequirements. All data are analyzed using Microsoft ExcelSpreadsheet Software. A representative Histogram is shown in Figure1.5, displaying the number of data points collected at various SaO2

saturations. Bland-Altman Plots are shown in Figures 1.1 through 1.4,comparing gold standard SaO2 values on the x-axis to (SaO2 – SpO2)values on the y-axis (N-395/compatible sensor data). These findingsare summarized below:

TruLink 015-0660-00SpO2 Accuracy = 2.0%


Ear-Clip Accessory with015-0661-00SpO2 Accuracy = 3.5%

TruLink 015-0663-00and 015-0662-00SpO2 Accuracy = 2.0%

Nellcor DS-100A:SpO2 Accuracy = 2.0%

Nellcor D-YS:SpO2 Accuracy = 3.0%

Nellcor D-YSE:SpO2 Accuracy = 3.5%

Nellcor D-25:SpO2 Accuracy = 2.0%

↔↔ ↔↔ ↔↔ ↔↔


Accuracy

TruLink 015-0665-00 and015-0664-00 SpO2 Accuracy = 2.0%



Nellcor D-20:SpO2 Accuracy = 2.0%

Nellcor I-20:SpO2 Accuracy = 2.0%

Nellcor N-25:SpO2 Accuracy = 2.0%

↔↔ ↔↔ ↔↔

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Accuracy-Bland Altman Plots

Figure 1.1

Figure 1.2

• All Points (n=241)nn Valid Points (n=229)# Subjects: 15

• All Points: 220nn Valid Points: 203# Subjects: 10


Accuracy

Figure 1.3

Figure 1.4



14

Accuracy

Figure 1.5

Milwaukee Veterns Hospital Breathe-Down: SaO2 Distribution Histogram

Num

ber o

f Sam

ples

Functional OSM3 Cooximeter SaO2

25

20

15

10

5

0

<70

70<x<

72

72<=x<

74

74<=x<

76

76<=x<

78

78<=x<

80

80<=x<

82

82<=x<

84

84<=x<

86

86<=x<

88

88<=x<

90

90<=x<

92

92<=x<

94

94<=x<

96

96<=x<

98

98<=x<

100


Biocompatibility

Materials Biocompatibility

TruLink SpO2 Sensors are manufactured in a facility that has acquiredcertifications/tested the sensors’ materials in accordance to ISO &FDA biocompatibility requirements.

The devices are manufactured to meet the description set forth in ISO10993-1 section 4.1.2 as skin contact only and section 4.2 a) as single use or contact (likely to be up to 24 hours). Table 1 - Initial eval-uation tests for consideration suggests three tests for this category ofproduct: cytotoxicity, sensitization and irritation.

Section 5.1 b) 6) states: “The choice of test procedures shall take intoaccount the existing information based on the literature, experienceand non-clinical tests.”

TruLink SpO2 Sensors consist of the following external parts (refer totable) that will come in skin contact with the patient in two differentmodes:

Direct – Continuous contact for full time or intermittently during theperiod of use.

Indirect – May contact only under special conditions during the periodof use or not at all.

In accordance with ISO 10993-1 and the nature of the application ofthis sensor, it was deemed necessary for all ‘Direct’ contact materialsto pass the Skin Irritation, Sensitization, and Cytotoxicity requirements(see table).

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Biocompatibility

External Sensor Patient Contact Description Biocompatibility Test PassedComponent Type Cytotoxicity Sensitization Irritation

015-0660-00 Direct Medical Grade Liquid Silicone X X XFinger Pads and Rubber, white color White Paddle (barium sulfate) [no natural latex

rubber proteins]

015-0661-00 Direct Medical Grade Liquid Silicone X X XBlack Paddle Rubber, black color (carbon black)

[no natural latex rubber proteins]

Clear Backfill for Direct Medical Grade Liquid Silicone X X X015-0660-00 electronics, Rubber, clear color 015-0661-00 Paddles, [no natural latex rubber proteins]and 015-0661-00 Cable-Paddle Exits

Ear-Clip Housing Indirect Black NA NA NAArms (Supplied with 015-0661-00 only)

Narrow Fabric Indirect Flesh-colored PET cotton/nylon NA NA NATape (top component) cloth single coated with medical (Supplied with 015-0661-00) grade polyacrylate adhesive

Wide Fabric Tape Indirect Tan woven fabric single coated NA NA NA(top component) with latex-free medical grade (Supplied with 015-0661-00, rubber adhesive0666, and 0667)

Bottom Component Direct Clear film with 1.0 mil acrylic X X Xfor both cloth tapes adhesive

White Bottom Tape Direct White pearlescent tape X X X015-0662-00/0663/06640665/0666/0667

Vinyl Top Tape Direct Vinyl tape X X X015-0663-00 and 015-0665-00

Foam top tape Direct Microfoam Tape X X X015-0662-00 and 015-0664-00

Additional biocompatibility information can be requested through an authorized Spacelabs Medical representative.

Criteria followed for Acceptability in Test Results:Cytotoxicity, Sensitization, and Skin Irritation: Studies of new or changed materials must be conducted based upon the International Organization ofStandardization (ISO) Biological Evaluation of Medical Devices, parts:Part 5: Tests for In Vitro Cytotoxicity, EN/ISO 10993-5, 1999.Part 10: Tests for Irritation and Sensitization; EN/ISO 10993-10, 1996.Part 12: Sample Preparation and Reference Materials; EN/ISO 10993-12, 1997.


Operating Temperature

Operating Temperature

The purpose of this testing is to determine the LED/skin interface temperature maximum for the TruLink SpO2 Sensor Nellcor CompatibleSensor Line. The LED/skin interface temperature is affected by ambienttemperature, monitoring site perfusion, body temperature, and LEDheat dissipation. Per “Protection of Patient’s Skin Against ExcessiveTemperatures” from ASTM 1415 (Draft No. 10.1): recommends 41°Cis the maximum LED/skin interface temperature for continuous moni-toring (4 hours) in patients under one year of age and for continuousmonitoring (8 hours) in patients older than one year.

The maximum operating temperature specified for TruLink SpO2

Sensors is 35°C, and is chosen as the ambient testing temperature.Lowered monitoring site perfusion increases local heating at the mon-itoring site because the blood flow is reduced and less able to carryheat away. The Nonin Phantom Finger®, 80% Sp02 model is used asa low perfusion finger analog. The temperature of the Phantom Fingerand sensor-under-test at start of test is 35°C. The LEDs are driven totheir maximum operating currents to produce the maximum heat dis-sipation. In this scenario, the sensor is rotated about the PhantomFinger such that the point at which no light penetrates the black sidesof the unit (rotated completely away from translucent central area) andthe oximeter no longer receives signal is reached. Then, the sensor isrotated back towards center, until the signal is just barely received bythe monitor (forcing the monitor to drive the sensor LEDs at maximumcurrent). The Phantom Finger is taped manually or by an automatictaping device to produce a pulse rate.

Per “Protection of Patient’s Skin Against Excessive Temperatures”from ASTM 1415 (Draft No. 10.1): recommends 41°C is the maximumLED/Skin interface temperature for continuous monitoring.

Actual Results

The temperature data for the TruLink SpO2 Sensors follows:

Temperature (°C )Sensor Ambient Emitter015-0660-00 Sensor 35.1 39.8015-0661-00 Sensor 35.0 39.3015-0663-00, 015-0662-00, 015-0664-00, 015-0665-00 Sensors 35.6 39.3015-0666-00, 015-0667-00 Sensor 35.2 38.3

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Monitor Compatibility/Ordering Information

Monitor Compatibility/OrderingInformation

TruLink SpO2 Sensors are compatible with the Spacelabs Ultraviewand UltraviewSL Command Modules, as well as earlier generations ofSpacelabs SpO2 modules.

TruLink SpO2 Sensors are also compatible with Nellcor N-395 and ear-lier generations of Nellcor oximeters; these sensors are not compatiblewith Nellcor N-595 oximeters.

Additionally, TruLink SpO2 Sensors are compatible with a wide varietyof monitors from Philips and GE.

TruLink SpO2 Sensors are terminated in a 9-pin sensor connector thatplugs into Nellcor OEM patient cables and other Nellcor compatiblepatient cables.

Spacelabs Medical TruLink SpO2 Sensor part numbers (for reorder),description and quantity per box ordered are provided below.

SL Part # Product Description Quantity/Box

015-0660-00 Finger sensor, adult, reusable 1

015-0661-00 Y-multisite sensor with ear clip, reusable 1

015-0662-00 Sensor, adult, foam, SPU 24

015-0663-00 Sensor, adult, vinyl, SPU 24

015-0664-00 Sensor, pediatric, foam, SPU 24

015-0665-00 Sensor, pediatric, vinyl, SPU 24

015-0666-00 Sensor, infant, cloth, SPU 24

015-0667-00 Sensor, neonate, cloth, SPU 24

©2005 Spacelabs Medical, Inc. TruLink is a trademark of Spacelabs Medical, Inc. Other brands and product names are trademarks of their respective owners.

Corporate Headquarters

5150 220th Ave SEPO Box 7018Issaquah, WA 98027-7018 Telephone: 425-657-7200 Fax: 425-657-7212In NA: 800-522-7025

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