Dräger JM-105 User Manual

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Dräger Jaundice Meter JM-105
Sample Usage Protocol Template
Purpose
This Sample Usage Protocol is provided as a template for creating a facility
or department-specific protocol for using the Dräger Jaundice Meter JM-105.
Description and Intended Use
The Dräger Jaundice Meter JM-105 is intended for use as a screening device
for jaundice in the newborn. The Jaundice Meter JM-105 provides a
transcutaneous measurement of bilirubin in mg/dL or µmol/L, identifying
neonates who require a serum bilirubin measurement.
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 For the intended use please refer to the instructions for use
Screening for Hyperbilirubinemia
When combined with a systematic assessment of the risk factors for
hyperbilirubinemia, the Dräger Jaundice Meter JM-105 can identify neonates
who are at increased risk for more severe hyperbilirubinemia in the first
week of life, and who might require closer monitoring.
Two protocols are suggested for using the Dräger Jaundice Meter JM-105 as
a screening device for hyperbilirubinemia. One is based on risk factors, the
other is universal screening.

Dräger JM-105 Specifications

General

Type	Transcutaneous Jaundice Meter
Display	LCD
Data Storage	Up to 100 measurements
Power Supply	Rechargeable battery
Accuracy	±1.5 mg/dL
Storage Temperature	-20°C to +50°C

Summary

Purpose and Intended Use

Description and Intended Use

Explains the Dräger Jaundice Meter JM-105 as a screening device for neonatal jaundice.

Screening for Hyperbilirubinemia

Details how the meter identifies neonates at risk for hyperbilirubinemia based on assessment.

Testing Procedure

Prepare the Jaundice Meter JM 105 for Use

Outlines the daily operational checkout procedure for the Jaundice Meter JM-105.

Configure the Jaundice Meter JM-105

Describes how to configure device settings for memory and measurement averaging.

Take a Transcutaneous Bilirubin (TcB) Measurement

Provides step-by-step instructions for performing a TcB measurement.

Plot the Result on the Transcutaneous Bilirubin Nomogram

Explains how to plot TcB results on a nomogram to determine percentile ranges.

Staff Competency and Validation

Staff Competency Validation

Details the training requirements and process for personnel using the Jaundice Meter JM-105.

New or Serviced Device Validation

Recommends validating the device against serum bilirubin readings for accuracy.