JM-103 Instructions for Use Edition 12 May 2012

PROPRIETARY AND CONFIDENTIAL DRAFT 9 Nov 04

Table of Contents Section 1: Symbol Definition and Intended Use Symbol Definition... 1 - 1 Intended Use... 1 - 4 Section 2: Introduction, Features, and Specifications Introduction...2 - 1 Measuring Point...2 - 1 Explanation of the Test...2 - 2 Features...2 - 6 Controls, Indicators, and Connections...2 - 6 Display...2 - 8 Standard Features...2 - 9 Specifications...2 - 10 Standard Features...2 - 10 Regulations, Standards, and Codes...2 - 11 Device Classification...2 - 11 Electromagnetic Compatibility (EMC) Guidance and Manufacturer’s Declarations...2 - 12 Section 3: Precautions and Safety Tips Precautions...3 - 1 Electromagnetic Compatibility Precautions...3 - 3 Safety Tips...3 - 4 Warning and Caution Labels...3 - 5 Section 4: Installation and Assembly Installation...4 - 1 Charging the Battery...4 - 1 Selecting the Unit of Measurement...4 - 3 Operational Checkout of the Jaundice Meter...4 - 4 Section 5: Instructions for Use Instructions for Use...5 - 1 Taking Measurements...5 - 1

Jaundice Meter Instructions for Use (MU01380)

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Setting the Number of Average Measurements... 5 - 5 Taking Average Measurements... 5 - 6 Section 6: Cleaning, Maintenance, Replacement Parts, and Storage and Handling Cleaning... 6 - 1 Steam Cleaning... 6 - 1 Cleaning Difficult to Access Areas... 6 - 1 Disinfecting... 6 - 2 Maintenance... 6 - 2 Calibration...6 - 2 Replacement Parts... 6 - 3 Storage and Handling... 6 - 4 Disposal... 6 - 5 Section 7: Troubleshooting Service Calls... 7 - 1 Error Messages... 7 - 1 Troubleshooting... 7 - 2 Appendix A: Clinical Performance Summary Introduction... A - 1 Study Design... A - 1 Performance Data... A - 3 Conclusion... A - 17 Appendix B: Doctors’ Office Data Study Design... B - 1 Performance Data... B - 3 Conclusion... B - 8 Appendix C: Medical and Scientific References on Transcutaneous Bilirubinometry

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Jaundice Meter Instructions for Use (MU01380)

DRAFT 18 May 2005

Section 1 Symbol Definition and Intended Use

Symbol Definition This manual contains different typefaces and icons designed to improve readability and increase understanding of its content. Note the following examples: • Standard text-used for regular information. • Boldface text-emphasizes a word or phrase. • GMDN-Global Medical Device Nomenclature • UMDNS-Universal Medical Device Nomenclature System • NOTE:-sets apart special information or important instruction clarification. • The symbol below highlights a WARNING or CAUTION: Warning and Caution

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A WARNING identifies situations or actions that may affect patient or user safety. Disregarding a warning could result in patient or user injury.

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A CAUTION points out special procedures or precautions that personnel must follow to avoid equipment damage.

Jaundice Meter Instructions for Use (MU01380)

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DRAFT 18 May 2005 • The symbol below highlights a type BF applied part: Type BF Applied Part

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The instrument provides a specified degree of protection against electric shock, particularly the leakage current and reliability of the protective ground connection with an F-type applied part. An F-type applied part indicates an applied part isolated from all other parts of the instrument to such a degree that the patient leakage current allowable in a single-fault condition is not exceeded when a voltage equal to 1.1 times the highest-rated mains voltage is applied between the applied part and ground.

• The symbol below highlights an ELECTRICAL SHOCK HAZARD WARNING: Electrical Shock Hazard Warning

• The symbol below indicates INPUT RATING: Input Rating Symbol

• The symbol below indicates that the product uses a RECHARGEABLE BATTERY: Rechargeable Battery Symbol

• The symbol below indicates RESET: RESET Button Symbol

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Jaundice Meter Instructions for Use (MU01380)

DRAFT 18 May 2005 • The symbol below, when applied to the device, indicates: ATTENTION: Consult Accompanying Documents

• The symbol below, when applied to the device, indicates: ATTENTION: Consult Instructions for Use

• The symbol below, when applied to the device, indicates: Do Not Throw Away

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DRAFT 18 May 2005

Intended Use WARNING: Magnetic Resonance Imaging (MRI) procedures interfere with Jaundice Meter operation. Inaccurate readings could occur. WARNING: Do not use a mobile telephone when using the Jaundice Meter. A measurement error could occur. Intended Use of the Jaundice Meter The Jaundice Meter is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants. The device is intended for use in hospitals or doctors’ offices under a physician’s supervision or at their direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone screening device for diagnosis of hyperbilirubinemia. It is to be used as a screening device in conjunction with other clinical signs and laboratory measurements. Newborn infants whose Jaundice Meter test results are indicative of hyperbilirubinemia should be evaluated by their physician(s) for appropriate patient management. Specific neonatal patient bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations. The Jaundice Meter is not intended for home use. Limitations (Doctors’ Office Use) Use only on infants up to 14 days of age. For doctors’ office application, use only the sternum location when taking measurements. Please be aware, performance in doctors’ offices may vary from performance in hospitals.

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Jaundice Meter Instructions for Use (MU01380)

DRAFT 18 May 2005 Precocious Jaundice

Do not use this device on infants with precocious jaundice. If there is a possibility that the infant is suffering from precocious jaundice, as a result of an incompatible blood type or hemolytic jaundice, it is recommended that the total serum bilirubin be measured. Intended Use of the User Manual This manual provides instructions for installation, use, operator maintenance, and troubleshooting of the Jaundice Meter. Draeger Medical cannot be responsible for the performance of the Jaundice Meter if the user does not operate the unit in accordance with the instructions, fails to follow maintenance recommendations, or makes any repairs with unauthorized components. Only qualified service personnel should perform repair.

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DRAFT 18 May 2005

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Jaundice Meter Instructions for Use (MU01380)

DRAFT 20 June 2005

Section 2 Introduction, Features, and Specifications

To prevent kernicterus in newborn infants, it is very important to detect jaundice in its early stages. The Jaundice Meter is a non-invasive transcutaneous bilirubinometer. This hand-held device allows a quick, non-invasive estimate of bilirubin concentration, to be used as an aid for the management of jaundice in newborn infants. The measurements are taken automatically when placing the instrument’s measuring probe against the measuring site of the infant and pressing it gently; the measured value is then displayed.

Measuring Point Measurements must be taken only on the infant’s sternum (at hospital sites or physicians’ offices) or forehead (at hospital sites only) where a sufficient amount of blood is circulated. A possibility exists that the bilirubin in the subcutaneous tissue may measure low for areas with minimal blood flow or areas in which the subcutaneous tissue is subject to keratinization. Although correlation with serum bilirubin was observed for both sternum and forehead measurements, the clinical studies performed with the Jaundice Meter and referenced in Appendices A and B show consistently better results with measurements taken at the sternum versus the forehead. There is a possibility that this difference may be more pronounced for infants that have been exposed to sunlight, such as infants seen at doctors’ offices. Only sternum measurements were evaluated during the studies conducted at doctors’ offices; correlation of forehead measurements with serum bilirubin has not been evaluated, and the device is not intended for forehead measurements at doctors’ offices. NOTE: Use the sternum location when taking measurements at doctors’ offices.

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SPECIFICATIONS

Introduction

DRAFT 20 June 2005 Phototherapy WARNING: Do not use the Jaundice Meter after initiation of phototherapy or after an exchange transfusion. Results may be inaccurate under these conditions.

Explanation of the Test Measuring Principle The Jaundice Meter determines the yellowness of an infant’s subcutaneous tissue by measuring the difference in the optical densities for light in the blue (450 nm) and green (550 nm) wavelength regions. The measuring probe has two optical paths. This method allows for a more precise measurement of yellowness in an infant’s subcutaneous tissue by minimizing the influences of the melanin pigment and the skin maturity.

When the measuring probe is pressed against the sternum or forehead of the infant, the built-in xenon lamp flashes. The light from the xenon lamp passes through the glass fiber and illuminates the skin. The light scatters and is absorbed in the skin and subcutaneous tissue repeatedly, and then finally returns to the sensor side of the glass fiber. Of the light that returns, the part scattered from the shallow areas of the Page 2 - 2

Jaundice Meter Instructions for Use (MU01380)

DRAFT 20 June 2005 subcutaneous tissue passes through the inner core, or short-optical path, of the fiber. The part scattered from the deep areas of the subcutaneous tissue passes through the outer core, or long-optical path, and then reaches its corresponding photodiode. SPECIFICATIONS

By calculating the difference in the optical densities, the parts that are common to the epidermis and dermis are deducted, and as a result, the difference in the optical densities between the two wavelength regions can be obtained for the subcutaneous tissue only. Since the optical density difference shows a linear correlation with the total serum bilirubin concentration, it is converted to the estimated bilirubin concentration and is indicated digitally. The Jaundice Meter device software uses a correlation coefficient to convert the measurement difference from the dual optical path to an estimated bilirubin concentration. The calculation formula used includes the correlation coefficients α and γ. These coefficients were determined in pre-clinical testing. The equation used is as follows: Jsample = α(L-S) + γ Where L and S are the long and short optical path measurements.

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DRAFT 20 June 2005 Use of the Device Patient Population

The Jaundice Meter is indicated for use in neonatal patients born >35 weeks gestation who have not undergone transfusion or phototherapy treatment. Averaging of Measurements

Averaging measurements may allow for more precise results. Averaging three or more readings, computed automatically by the Jaundice Meter when the desired number of measurements is set (see “Setting the Number of Average Measurements” on page 5-5), provides more precise transcutaneous bilirubin measurements than using a single measurement. Assess the advantages of using average measurements at your facility. The mean of three measurements showed the highest degree of correlation (r=0.965); however, the difference compared to a single measurement was minimal with a single measurement (r=0.963). Each facility should consider the advantages of averaging multiple measurements versus using single measurements. Averaging was not evaluated in the doctors’ office study. Action Levels

Action levels are Jaundice Meter readings when the nurse must take some type of action, as determined by individual facility policy, for example: reporting results immediately to the physician, or obtaining a serum total serum bilirubin. A facility’s action level may be determined by the performance of the device in their unique population, which depends on factors such as skin color, skin thickness, infant age, and measuring site. The bias relative to serum bilirubin differs between hospital versus physicians’ office sites (see Appendices A and B). Different action levels may be appropriate for hospital versus physicians’ offices. NOTE: Using proper action levels avoids false negatives - where an infant is believed not to have significant jaundice but does, in fact, have significant jaundice that might require treatment. Calibration

The JM-103 does not require user calibration. The system includes a checker that measures the intensity of light from the device to ensure the light output is acceptable for proper use. Light intensity must be checked daily.

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Jaundice Meter Instructions for Use (MU01380)

DRAFT 20 June 2005 Processing of Measured Values

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SPECIFICATIONS

The Jaundice Meter determines the yellowness of the subcutaneous tissue by measuring the difference in the optical densities for light in the blue and green wavelength regions. The optical density difference has been shown to have a linear correlation with serum bilirubin concentration. The device computes an estimated bilirubin concentration based on this linear correlation and provides the value on the display.

DRAFT 20 June 2005

Features Controls, Indicators, and Connections

Controls, Indicators, and Connections

Name A Power switch

B

Measuring probe

C

Charger section

D Display

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Function Turns the Jaundice Meter on and off. When used with the Reset button, the device switches to Check Mode and changes the unit of measurement. Takes the measurement when pressed against the measuring point. Connects the charger unit to the charger section. Displays the measured value.

Jaundice Meter Instructions for Use (MU01380)

DRAFT 20 June 2005 Name E

Ready lamp

H DC plug

I

Checker cover

J DC jack K Charger lamp L Charger jack M Standard checker values N Checker

Illuminates to indicate that the Jaundice Meter is ready for the next measurement. Is where the strap attaches. Deletes the currently displayed measured value and prepares for the next measurement. When used with the Power switch, the device switches to Check Mode and changes the unit of measurement. Connects the charger’s DC jack to the unit. NOTE: Choose the appropriate power cord adapter for country of use. Covers the checker. Open this checker cover to check the Jaundice Meter. Connects the AC adapter to the charger. Illuminates to indicate that the Jaundice Meter is charging. Connects the main body to the charger. For reference. Checks for the intensity of light output by taking measurements in Check Mode.

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SPECIFICATIONS

F Strap attachment area G Reset button

Function

DRAFT 20 June 2005 Display

Name A AVG B Optical path indicator (•) C

Value

D Unit of measurement

E

Battery indicator

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Function Illuminates during averaging measurement. When verifying light output with the checker, (•)illuminates when the L-value appears and extinguishes when the S-value appears. Displays the measured value. NOTE: When the measured value is greater than 20 mg/dl or 340 μmol/L, the display shows “---” and the physician should be contacted. Displays the unit of measurement in either milligrams per deciliter (mg/dL) or micromoles of solute per liter (μmol/L) When the battery power is low, the battery indicator blinks. Charge the battery as soon as possible (see “Charging the Battery” on page 4-1). If only the battery indicator illuminates, the battery has run out. Go to “Charging the Battery” on page 4-1. If the power is on and the display is blank, the battery is completely exhausted. Go to “Charging the Battery” on page 4-1.

Jaundice Meter Instructions for Use (MU01380)

DRAFT 20 June 2005 Standard Features • Jaundice Meter (JM-103) • Charger unit (Model JM-A30) with a checker SPECIFICATIONS

• AC adapter (Model JM-A32) • Carrying case and wrist strap • Power cable adapter set

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DRAFT 20 June 2005

Specifications Standard Features Feature

Dimension

Model name Measuring method

JM-103 Determines the yellowness of the subcutaneous tissue by using two optical paths to measure the optical density difference at two wavelengths 0.0 mg/dL to 20 mg/dL or 0 μmol/L to 340 μmol/L ± 1.5 mg/dL or ± 25.5 μmol/L

Measurement range Clinical Data Standard Error of Estimate (SEE) * Light source Light source life Detectors Power source Protection type and level Minimum number of measurements when fully charged Operating temperature range Operating relative humidity range Storage temperature range Storage relative humidity range Dimensions Weight, including Ni-MH battery AC adapter input Expected service life

Pulse xenon arc lamp 150000 measurements Silicon photodiodes 2.4 V, Special Ni-MH battery Internally-powered instrument, BFtype 400 single measurements 10°C (50°F) to 40°C (104°F) 30% to 95% non-condensing -10°C (14°F) to 50°C (122°F) 30% to 95% non-condensing 4.8 cm (1.9") wide x 15.4 cm (6.0") high x 3.2 cm (1.2") deep 150 g (5.3 oz) 100V - 240V 50/60Hz, 11-18VA 5 years

*The standard deviation shown above is based on the average of the clinical data available. On average, 66% of results fall within this range, and the remainder fall outside this range. This value can be affected by variables such as age, skin color, and preformance of the device in the hands of the user. Refer to Appendixes A and B for a detailed description of results by clinical site, measurement location, and patient Page 2 - 10

Jaundice Meter Instructions for Use (MU01380)

DRAFT 20 June 2005

Regulations, Standards, and Codes In North America, with respect to electrical shock, fire, and mechanical hazards only, this instrument complies with UL 60601-1 and CAN/CSA C22.2 No. 601.1. In Europe, this instrument complies with IEC 60601-1:2005; EN 606011:2006/AC:2010; EN 60601-1-2, and EN ISO13485, and EN ISO14971. Directive 2002/96/EC of the European Parliament and of the Council of 2003-01-27 on Waste Electrical and Electronic Equipment (WEEE) Annex IV, prEN 50419 applies.

Device Classification The Jaundice Meter (JM-103) meets the requirements for the following classifications: • Protection against electrical shock: Internally powered • Type of applied part: BF • IPX0-ordinary equipment (Degree of protection against harmful ingress of water: Not applicable.) • Not suitable for use in the presence of flammable anesthetic mixture with air or oxygen or nitrous oxide. • Mode of operation of equipment: Continuous while in use (IEC 60601-1) • Classification in accordance with EU Directive 93/42/EEC: IIa • UMDNS code/GMDN code: 16-166/35475

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SPECIFICATIONS

demographics. The SEE shown in the table are based on the clinical data available and can be affected by variables such as infant developmental age, ethnicity, etc. Therefore, we recommend that the JM-103 be used in conjunction with other clinical signs and laboratory measurements. "Specific Bilirubin Measurement" should be confirmed by other methods such as laboratory blood serum analysis.