Dräger Jaundice Meter JM-105

MEA Regional Launch - Product Training

Omar Dallal – CA NC
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
3 Competition
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
3 Competition
What is Neonatal Jaundice?

• Jaundice is “yellowness” of the skin and sclera

(whites of the eyes) caused by the build-up of
bilirubin
• Jaundice of the newborn is a common occurrence
in the neonate
• Full term infant, jaundice apparent within 2-4 days
after birth
• Presumably a consequence of metabolic and
physiological adjustments after birth
• Also called “Icterus”
Where does Neonatal Jaundice come from?

• Bilirubin is a yellow breakdown product of the metabolism of Red Blood Cells

• 75-85% of bilirubin produced by the newborn comes from breakdown of RBC(1)
• An excess amount of bilirubin in the blood is called hyperbilirubinemia
• Although jaundice and hyperbilirubinemia are not exactly the same thing, when the
bilirubin level in the blood goes up, bilirubin is deposited in the skin, resulting in
more visible jaundice

(1) Comprehensive Neonatal Nursing, A Physiologic Perspective:2003

Where does Neonatal Jaundice come from?

Bilirubin metabolism can be divided into 5 stages:

1. production of indirect bilirubin (unconjugated)
from breakdown of red blood cells and other
heme containing tissue
2. transport of water-insoluble indirect bilirubin in
the blood, primarily bound to albumin, to the liver
Where does Neonatal Jaundice come from?

Bilirubin metabolism can be divided into 5 stages:

1. production of indirect bilirubin (unconjugated)
from breakdown of red blood cells and other
heme containing tissue
2. transport of water-insoluble indirect bilirubin in
the blood, primarily bound to albumin, to the liver
3. & 4. processing by the liver to convert indirect
bilirubin to direct bilirubin (conjugated)
Where does Neonatal Jaundice come from?

Bilirubin metabolism can be divided into 5 stages:

1. production of indirect bilirubin (unconjugated)
from breakdown of red blood cells and other
heme containing tissue
2. transport of water-insoluble indirect bilirubin in
the blood, primarily bound to albumin, to the liver
3. & 4. processing by the liver to convert indirect
bilirubin to direct bilirubin (conjugated)
5. excretion of water-soluble direct bilirubin into
the intestines for removal
Where does Neonatal Jaundice come from?

The daily bilirubin load of the newborn is 2-

3 x that of the adult.

Rise in bilirubin is modified by various

factors, both genetic and acquired causes

• Bilirubin production
• Bilirubin clearance
• Enterohepatic circulation
 How common is Neonatal Jaundice?

• Newborn jaundice is
common and can have
severe consequences for
the baby.

• Two out of three newborns

will become jaundiced.

Most common reason of

readmission in the first month of life
Why worry about Neonatal Jaundice?
Why worry about Neonatal Jaundice?

• Occurs in almost all babies

• Source of anxiety and aggravation to families and doctors
• If not treated on time can lead to severe physical & brain damage

Kernicterus
Hyperbilirubinemia
Jaundice
Bilirubin
Why worry about Neonatal Jaundice?

Dangers of Hyperbilirubinemia:
• Free bilirubin can cross the blood brain barrier and settle around brain cells
• Bilirubin acid begins to affect brain cell functioning temporarily (and reversibly)
• Eventually, bilirubin enters the brain cells and kills them, causing permanent brain
damage
• Permanent brain damage from bilirubin is called kernicterus.
• Although kernicterus should almost always be preventable, cases continue to occur
Why worry about Neonatal Jaundice?

There is no cure for kernicterus.

These children have…

• Athetoid cerebral palsy

• Sensorineural hearing loss
• Impairment of upward gaze
• Defects of dental enamel

Kernicterus can be prevented with appropriate vigilance, monitoring,

treatment, and follow-up of the newborn population.

Photos from: www.amakashope.org/kernicterus.html and http://www.kernicterus.org/

Types of Jaundice Screening
Overview

There are 3 different methods to screen for Jaundice:

1. Visual assessment of jaundice

2. Universal serum bilirubin testing TsB

3. Universal transcutaneous bilirubin (TcB) testing

Types of Jaundice Screening
Visual Assessment

1) Visual Assessment
Visual assessment of jaundice with serum
bilirubin of jaundiced infants only

Disadvantage:
Visual assessment can lead to errors (overestimation
or underestimation of jaundice), resulting in
unnecessary lab tests or failure to obtain necessary
lab tests.

This is not a “universal” method of screening as

not every infant will get a bilirubin test.
Types of Jaundice Screening
TsB

2) TSB – Total Serum Bilirubin = Heel Stick (Blood Draw)

Universal serum bilirubin testing TSB
(all babies receive serum bilirubin before discharge,
TSB
with plotting on hour-specific bilirubin nomogram).

Advantage: Combined with risk factors, considered

best method of determining an infant’s risk of
developing severe hyperbilirubinemia. Blood tests for total
bilirubin measure both unconjugated and conjugated bilirubin.

Disadvantage: Cost and requirement that all babies

must have heelstick lab draw. Results can take hours.
If the testing is done within the first 24 hours, it may be too
early to determine accurate bilirubin levels & a second heel
stick will be necessary.
The Hour-Specific Bilirubin Nomogram (TSB)
“Dr. Bhutani’s Nomogram”

TSB of 10mg/dL
At 46 hours of life

American Academy of Pediatrics, 2004

When using this nomogram, remember that "risk" refers to the risk of a subsequent bilirubin level
in that infant >95%ile for age
Major risk factors
Defined by the American Academy of Pediatrics

Major risk factors: Minor risk factors

• Predischarge TSB or TcB level in the high-risk • Predischarge TSB or TcB level in the high
zone intermediate-risk zone
• Jaundice observed in the first 24h • Gestational age 37–38 wk
• Blood group incompatibility with positive direct • Jaundice observed before discharge
antiglobulin test, other known hemolytic • Previous sibling with jaundice
disease (eg, G6PD deficiency), elevated
ETCOc • Macrosomic infant of a diabetic mother
• Gestational age 35–36 wk • Maternal age ≥25 years
• Previous sibling received phototherapy • Male gender
• Cephalohematoma or significant bruising
• Exclusive breastfeeding, particularly if nursing
is not going well and weight loss is excessive
• East Asian race

AAP Guideline for Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation
http://pediatrics.aappublications.org/content/114/1/297.full.pdf+html
Types of Jaundice Screening
TcB

3) TcB – Total Transcutaneous Bilirubin = Non-invasive

Universal transcutaneous bilirubin (TcB) testing
TcB
Advantages: Non-invasive; easy to use.
No cost after initial cost to purchase instrument.
Quicker than lab draw. Results are immediate - no
waiting around hours for the lab result.
Can be plotted on hour-specific bilirubin nomogram
to determine risk of developing subsequent
hyperbilirubinemia. Can easily be repeated and
plotted to monitor TcB rise.

Disadvantages: Nurses must follow protocol to

draw serum bilirubin if TcB is > X (usually around
13-14). Requires initial and ongoing training to
ensure proper use.
The Hour-Specific Bilirubin Nomogram (TcB)
“Maisels’ Nomogram”

TSB of 10mg/dL
At 46 hours of life
Types of Jaundice Screening
Using nomograms
If customer want to use JM-105 (TcB)
with Dr. Buthani’s Nomogram (TSB),
then the 75th percentile must be used
as the critical line.
If customer uses the JM-105 (TcB)
with Dr. Maisels’s Nomogram (TcB),
then the recommended 95th
percentile must be used as the
critical line.
 Types of Jaundice Screening
TcB summary

• Although visual assessment and TsB remain prevalent, the adoption of jaundice
screening (TcB) has grown rapidly in the last 5 years as a standard practice in
hospitals to identify at risk infants.

• Many new clinical studies have surfaced to validate the efficacy of jaundice screening
(TsB). They have shown:
• Accuracy and correlation to lab results
• Cost effectiveness by reducing the frequency of lab processing, patient
readmission, and length of stay
• Introduction of a more efficient process and instantaneous access to information
for decision making
• Reduction of risk to the patients through a non-invasive approach
Types of Jaundice Screening
TcB comments

“TcB correlates significantly with TSB in preterm neonates, and interobserver precision is
significant. Routine measurement of TcB in preterm neonates may provide enhanced clinical
monitoring for hyperbilirubinemia.”
Evaluation of transcutaneous bilirubinometry in preterm neonates

Schmidt ET, Wheeler CA, Jackson GL, Engle WD.

“High early readings in newborns who may otherwise appear clinically well lead to phototherapy
being initiated prior to discharge, avoiding a potentially much sicker newborn being readmitted
at a later date”
Program helps early identification and treatment of neonatal hyperbilirubinemia

Alberta Health Services - Calgary Health Region.

“The results of this pilot study indicate that the use of a jaundice meter may be a noninvasive as
well as a cost-effective way to validate nurses' visual assessments of neonatal jaundice in the
home”
Validating assessment of neonatal jaundice with transcutaneous bilirubin measurement

Ruchala PL, Seibold L, Stremsterfer K.

Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
3 Competition
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
Overview
What‘s what?
Navigation through Main Menu
Settings
Operation
Data Transfer
Ordering & Pricing
3 Competition
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
Overview
What‘s what?
Navigation through Main Menu
Settings
Operation
Data Transfer
Ordering & Pricing
3 Competition
Jaundice Screening
TcB – the old way…

Jaundice Manual Patient Data

Screening Documentation
Jaundice Screening
TcB – the new way…

Jaundice Electronic Patient Data

Screening Documentation
Jaundice Screening
TcB – the new way…

Jaundice Electronic Patient Data

Screening Documentation
 Jaundice Screening
TcB – the new way…

Jaundice Electronic Patient Data

Screening Documentation

Neonatal patients with a

gestational age >24 weeks Easily mark & identify babies
that need special attention

Accurate & quickly input nurse’s

Data storage
and baby’s identification
information

HL7 Connectivity for

electronic medical record
Cost-efficient screening (EMR) for data transfer
JM-105
Intended Use

• Non-invasive transcutaneous bilirubinometer

• Measures yellowness of subcutaneous tissue in newborn infants
• For use in neonatal patients born >24 weeks gestation(*) who have not undergone
transfusion or phototherapy
• Provides a visual digital measurement that has been shown to correlate with serum bilirubin
in newborn infants
• Intended for use in hospitals or doctors offices under a physician’s supervision, or at their
direction
• Used as a screening device with other clinical signs and laboratory measurements

(*) Dr. Jackson & Dr. Engle, Evaluation of transcutaneous bilirubinometry in preterm neonates, 2009, Journal
of Perinatology 29
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
Overview
What‘s what?
Navigation through Main Menu
Settings
Operation
Data Transfer
Ordering & Pricing
3 Competition
What‘s what?

READY lamp

Measuring Probe
What‘s what?

Display
On/Off
Lock
Button
Button
What‘s what?

Integrated Light Source Checker

• Assuring performance of light source
• Recommended to check the light once a day
(otherwise when starting the device message pops up
for 3s „MEASURE READING CHECKER“ )
What‘s what?

Optional Barcode Scanner

• Fast and accurate way to enter the Nurse ID and the
Baby ID

• 15 characters can be entered

• Can read the following codes:

 HIBC (Health Industry Bar Code)
 EAN (European Article Number)
 Code 128
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
Overview
What‘s what?
Navigation through Main Menu
Settings
Operation
Data Transfer
Ordering & Pricing
3 Competition
Navigation through Main Menu

Navigation through Main Menu

with up & down arrows or touch
• Measure: access measuring mode
• Checker: check the light source
• History: access patient data
• Clr All: deleting internal memory
• Config: access to configuration menu
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
Overview
What‘s what?
Navigation through Main Menu
Settings
Operation
Data Transfer
Ordering & Pricing
3 Competition
Settings

Configuration menu to change the settings of the device

• Units: choice between mg/dl or μmol/L

• Average: choice between single, 2-5 measurements as an

average

• Memory:
 Off: no measured data is stored in data log
 Mem only: measured data is stored in data log
 Link on: measured data is stored in data log and sent to PC

• Nurse ID: defines the default setting if and how the Nurse ID
is entered (none, barcode, touch)

• Baby ID: defines the default setting how the Baby ID is

entered (barcode, touch)
Settings

Configuration menu to change the settings of the device

• Buzzer: activate auditory signal for touch screen

• Set time: date and time must be set when device is

switched on for the first time

• Date/Time fmt: select time/date format

• Language: display language can be changed

• Contrast: select contrast of touch screen between 1-5

• Touchscr: adjust sensitivity of touch screen by touching the

center of X
Settings

Configuration menu to change the settings of the device

• Buzzer: activate auditory signal for touch screen

• Set time: date and time must be set when device is

switched on for the first time

• Date/Time fmt: select time/date format

• Language: display language can be changed

• Contrast: select contrast of touch screen between 1-5

• Touchscr: adjust sensitivity of touch screen by touching the

center of X
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
Overview
What‘s what?
Navigation through Main Menu
Settings
Operation
Data Transfer
Ordering & Pricing
3 Competition
Operation
Taking a measurement

TcB measurement
1) Entering Nurse & Baby ID (when internal memory is activated)

• When internal memory is activated, device asks for

 Nurse ID (optional)
 Baby ID (mandatory)

• IDs can be entered via the keypad on the touch screen or by

using the Barcode scanner
Operation
Taking a measurement

TcB measurement
2) Taking the measurement

• Clean the measuring probe

• Place measuring probe perpendicular to the measuring point

(on forehead or sternum)

• If the green READY LED is on, the measurement can be

taken

• Repeat measurement for the number of times selected

(2TIMES or 5TIMES).
Operation
Patient Flagging

Patient Flagging
• Mark a patient report for special attention by touching the dots

Babies at high or intermediate risk of

hyperbilirubinemia

Not used at this time, for future use

 Clear overview for the doctor to make clinical decision

Operation
Patient History

Accessing Patient History

• Go to Main Menu and select HISTORY
• Select patient file
Operation
Patient History

Accessing Patient History

Nurse ID
Baby ID
Operation
Patient History

Accessing Patient History

Nurse ID
Baby ID
Date & TcB measurement
(up to 3 TcB measurements per patient file
Operation
Patient History

Accessing Patient History

Nurse ID
Baby ID
Date & TcB measurement
(up to 3 TcB measurements per patient file
Patient flags, data transfer status, units
Operation
Patient History

Accessing Patient History

Nurse ID
Baby ID
Date & TcB measurement
(up to 3 TcB measurements per patient file
Patient flags, data transfer status, units
Navigation between patient files
Operation
Summary

Switch on power

Perform initial settings

(if switching on the device for the Change settings if needed
first time)

Perform light check once per day

If internal memory is deactivated: If internal memory is activated:

Enter Nurse ID (optional)

Clean probe & take measurement
Enter Baby ID (mandatory)

Check & manually document data Clean probe & take measurement

Place device into docking station Place device into docking station

Transfer data to electronic medical chart system

(MEMORY must be set to LINK ON)
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
Overview
What‘s what?
Navigation through Main Menu
Settings
Operation
Data Transfer
Ordering & Pricing
3 Competition
Data Transfer

Data Transfer via HL7

• The software for data transmission JM-S1w
must be installed
• LINK ON must be activated on the device
 Data Transfer

 Take the measurement  Put the JM-105 into the  Start Data Transfer on  JM-S1w software for data transfer has to
docking station the device be installed and connected to the hospital
 Following information can be
network
transferred:  Docking station is
• Baby ID connected via USB to a  HL7 Connectivity for electronic medical
• Time of measurement computer/laptop record (EMR) to transfer data from JM-105
• Date of measurement
• Unit of measurement
• Measured value
• File number out of 100(x/100)
User configurable:
• File Transferred icon
• Post-phototherapy icon
• Priority icon
• Nurse ID
JM-105
USPs

Dräger JM-105
Neonatal patients with a gestational age >24 weeks

Use during & after phototherapy planned for 2014

Easy jaundice screening

Cost-efficient screening

Choice of average measurements

Easily mark & ID babies that need special attention with

patient flagging
Assure performance of light source with the integrated
light checker

Easy to handle and carry

Internal memory up to 100 patient files

EMR connectivity

Accurate and quickly input nurse and baby’s identification

information via touch screen or barcode scanner
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
Overview
What‘s what?
Navigation through Main Menu
Settings
Operation
Data Transfer
Ordering
3 Competition
Ordering

MU20105 Dräger Jaundice Meter JM-105 includes:

• Charger base incl. light checker
• USB cable
• Training video & Sample Usage Protocol
• PC application software JM-S1w

Optional
• Barcode scanner
• AC Adapter JM-A32
JM-105 variants

Version Languages Option

Barcode
CE1 English, German, French, Spanish, Italian Standard
scanner
Barcode
CE2 English, Dutch, Swedish, Russian, Portuguese Standard
scanner
Barcode
CE3 English, Polish, Turkish, Hrvatsky, Srpski Standard
scanner
Barcode
CE4 English, Czech, Hungarian, Norwegian, Slovak Standard
scanner
Barcode
CE5 English, Finnish, Danish, Greek, Romanian Standard
scanner
Barcode
MET English, German, French, Spanish, Italian Standard
scanner
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
3 Competition
Dräger Jaundice Meter JM-105
Agenda

1 Clinical Background
2 Product Information
3 Competition
Philips BiliCheck®
Product Overview

• Pre, during & post phototherapy

• Gestational age >27 weeks
• Numeric key pad for patient or nurse info entry
• On-board help system & access to online help
menu
• Barcode scanner for accurate entry &
verification of nurse and patient identification
information
• Interface (output) with hospital charting or lab
info systems
• Requires a disposable calibration tip (ca. $4-16)
for each patient/measurement
• Requires disposable patches (ca. $2-3) for the
use during phototherapy
Philips BiliCheck®
What they say…

Dräger Jaundice Meter JM-105

 JM-105 is smaller & lighter

 With the JM-105, the user can adjust the

display contrast & sensitivity of the touch
screen
 Faster measurement since no calibration
needed for every patient
 Patient flagging improves efficiency &
supports clinical decision making

 JM-105 is easy to use

 No need for on-board help
Philips BiliCheck®
Disposables

Unlike the Jaundice Meter JM-105, the BiliCheck:

• Requires a disposable calibration component for each patient
• Requires 5 readings to be taken on each patient
• Is larger and cumbersome to use.
• Users regularly complain about continuous error messages
JM-105 vs. BiliChek
Features

Philips BiliChek Dräger JM-105

Neonatal patients with a gestational age >27 weeks Neonatal patients with a gestational age >24 weeks

Pre, during & post phototherapy Use during & after phototherapy planned for 2014

On-board help system Easy jaundice screening

Disposable calibration tips for each patient Cost-efficient screening

5 measurements per patient Choice of average measurements

Easily mark & ID babies that need special attention with

patient flagging
Assure performance of light source with the integrated
Calibration before each patient
light checker

Easy to handle and carry

Internal memory up to 30 patient files Internal memory up to 100 patient files

EMR connectivity EMR connectivity

Input nurse and baby’s identification information via Accurate and quickly input nurse and baby’s identification
keypad or barcode scanner information via touch screen or barcode scanner
JM-105 vs. BiliChek
Technical specifications

Philips BiliChek Dräger JM-105

Measurement range: 0-20 mg/dL (0-340 μmol/L) Measurement range: 0.0-20.0 mg/dL (0.0-340 μmol/L)

Dimensions: 5.23 cm W x 20.45 cm L x 5.94 cm H Dimensions: 5,6 cm W x 16,8 cm H x 4,5 cm D

Weight: 250 g (346 g with battery pack) Weight: 203 g

Bulb Life: Minimum 30,000 measurements Light source life 150,000 measurements

8h battery recharge 2h battery recharge

1 year battery life Battery change every 2 years

Thank you for
your attention.