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.*1
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.

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1. Risk Factors
Neonates with the following risk factors should be screened for
hyperbilirubinemia with the Jaundice Meter JM-105*3:
Jaundice within 1st 24 hours (also send TSB to laboratory)
Blood group incompatibility/+DAT (also send TSB to laboratory)
Visible jaundice after 24 hours of age
≤38 weeks gestation
Bruising/vacuum extraction/cephalhematoma
Breastfeeding
Inadequate feeding/excessive weight loss
Sibling with jaundice
East Asian race
Ethnic group at risk for G6PD deficiency (African-American male,
Greek/Mediterranean, Italian, Middle Eastern)
When risk factors are used, the neonate with risk factors should be
screened with the Dräger Jaundice Meter JM-105 prior to discharge, or
earlier if jaundice is noted.
2. Universal Screening
Screen all neonates with the Jaundice Meter JM-105 prior to discharge.
Note: neonates with jaundice in the first 24 hours of life should be screened
immediately and also have a serum bilirubin sent to the laboratory.
Testing Procedure
Prepare the Jaundice Meter JM 105 for Use – Perform the Daily
Operational Checkout Procedure
1. Remove the Jaundice Meter JM-105 from the docking station.
2. Press the power switch on.
3. Select CHECKER and touch OK to save selection.
4. Open the checker lid on the charging unit.
5. When the green READY light illuminates, place the tip of the Jaundice
Meter perpendicular on the reading checker circle. Press down until
you hear a click.
6. The display screen shows the “L” (long), “S” (short), and Delta values.
The meter must read within the reference values posted under the
checker lid. If so, the unit is ready to use. If not, clean the tip and
repeat. If values are still out of range, do not use the unit (contact
the Dräger service department).

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Configure the Jaundice Meter JM-105
1. Press the power switch on.
2. If you want to change your file storage option, configure the device as
desired by selecting CONFIG > MEMORY > OK > your desired setting
(OFF, MEM ONLY, or LINK ON) > OK. If not, go to step 4.
3. Press the MENU button to exit the CONFIG screen.
4. Determine whether or not you want to average your measurements
and how many measurements you want to take. Configure the device
as desired by selecting CONFIG > AVERAGE > OK > your desired
setting (SINGLE through 5TIMES) > OK.

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5. Determine the current setting for measurements that are out of range.
Select CONFIG > UNIT. One of the screens below will appear. The
default for devices with SW 1.20 or higher is HI: >20 or HI: >340,
depending on the unit configured. For devices with SW 1.10 or lower,
the default is not editable and will only be a blinking zero.
NOTE: To change this setting to blinking zero (HI: -0-), refer to the
instructions for use. It must be changed using the data transmission
software, SW JM-S1w. Requires JM-S1w version 1.40 or higher.

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Take a Transcutaneous Bilirubin (TcB) Measurement
1. Clean the tip of the probe with an alcohol swab.
2. Press the power switch on.
3. Select MENU, select MEASURE, and press OK. The letters AVE with the
number of measurements selected will appear in the display.

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4. Select measurement site:
Hospital Nursery/Postpartum/Family Birth Center – the neonate’s mid-
sternum is preferred but the forehead can be used.
Physician’s Office/Clinic/Outpatient Setting/Emergency Room – use
only the neonate’s mid-sternum. Rationale: these neonates have been
discharged from the hospital and their faces have been exposed to
more ambient sunlight.
5. Place the Jaundice Meter JM-105 probe tip flat against the baby’s skin,
not at an angle, and press lightly until you hear a click. Lift the
Jaundice Meter JM-105 from the skin between measurements and
pause until the green READY light illuminates again. Repeat the
testing procedure until the required number of measurements has
been taken.
6. If the measured value is out of the measuring range (0 to 20 mg/dL
or 0 to 340 µmol/L), a blinking value appears. The blinking value
depends on the preference set, -0-, >20, or >340.
NOTE 1: Blinking >20 and >340 are only available on devices with SW
1.20 or higher.
NOTE 2: To check this setting, refer to Configure the Jaundice
Meter JM-105, step 5.

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Plot the Result on the Transcutaneous Bilirubin Nomogram
(Neonates Up to 96 Hours of Age Only)*4
(35 weeks of gestation)
On the horizontal axis, find the baby’s age in hours. Follow this line up
along the vertical axis to the point where it meets the transcutaneous
bilirubin meter reading you just obtained. Make a small circle where these
two values intersect. You can now see into which percentile range the
baby’s TcB value falls.
In the example above, the baby’s TcB is 10 mg/dL at 50 hours of age. This
places the baby just at the edge of the 95th percentile. [A TSB should be
obtained on this baby.]
Consult your department policy or routine orders regarding when to send a
total serum bilirubin to the laboratory, and/or report these TcB results to the
baby’s physician.
Subsequent TcB measurements should also be plotted on the graph to allow
detection of an unusual trend such as a rapidly rising TcB.

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Staff Competency Validation
All clinical personnel responsible for performing Jaundice Meter JM-105
testing must be properly trained prior to using the device in a clinical setting.
Training will be completed as follows:
1. Staff responsible for using the Jaundice Meter JM-105 will receive a
demonstration of the JM-105 by an experienced Jaundice Meter JM-
105 operator OR will view the Jaundice Meter JM-105 training video.
Learners are also responsible for reading the information provided in
the Operating Instructions Manual.
2. Learners will perform a return demonstration on three infants in the
presence of an experienced Jaundice Meter JM-105 operator and
complete the attached Skills Checklist.
3. Successful completion of training will be documented in the employee’s
education record.
New or Serviced Device Validation
It is recommended that users validate the Jaundice Meter JM-105 in their
individual patient populations prior to putting it into clinical use. You can do
this by taking transcutaneous bilirubin readings with the Jaundice Meter on
infants who are already scheduled to have blood drawn for serum bilirubin
analysis by the lab. The time gap between the transcutaneous bilirubin
readings and the blood sample should not be greater than one hour.
Record the reading along with the serum bilirubin results from the lab on a
data collection sheet like the one attached to this document.
When you have recorded enough simultaneous jaundice meter readings and
serum bilirubin, you can use this information to develop a protocol for use of
the jaundice meter in your facility.
References
1. Dräger Jaundice Meter Model JM-105 Instructions for Use.
2. E T Schmidt, C A Wheeler, G L Jackson and W D Engle, Evaluation of transcutaneous
bilirubinometry in preterm neonates, Journal of Perinatology 29 : 564-569 March 2009.
3. Management of Hyperbilirubinemia in the Newborn Infant 35 or More
Weeks of Gestation. Pediatrics Vol. 114 No. 1 July 2004
4. Maisels MJ, Kring E. Transcutaneous bilirubin levels in the first 96 hours in a normal
newborn population of ≥35 weeks' gestation. Pediatrics. 106;117(4):1169-117.

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Dräger Jaundice Meter JM-105
Data Collection Sheet
Please write your Jaundice Meter SN #: ____________________________
Site for all Jaundice Meter measurements:__________________________
- Patient #
- Hours of Age &
- Race or Skin Color
JM-105
reading
TcB
Time / Date
JM-105
Reading
taken*
Serum
Bilirubin
analysis
Result
TSB
Time/ Date
blood
sample
drawn*
Staff Initials and
Comments:
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*The time gap between the Jaundice Meter JM-105 readings and the blood sample should not be greater than one hour.
MU25261_3_RI05/ 10.2017/ Printed in United States / Chlorine-free – environmentally compatible / Subject to modifications / ©Draeger Medical Systems, Inc.