DRAFT 20 June 2005
Page 2 - 10 Jaundice Meter Instructions for Use (MU01380)
Specifications
Standard Features
*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
demographics. The SEE shown in the table are based on the clinical data
Feature Dimension
Model name JM-103
Measuring method Determines the yellowness of the
subcutaneous tissue by using two
optical paths to measure the optical
density difference at two wave-
lengths
Measurement range 0.0 mg/dL to 20 mg/dL or 0 μmol/L
to 340 μmol/L
Clinical Data Standard Error of
Estimate (SEE) *
± 1.5 mg/dL or ± 25.5 μmol/L
Light source Pulse xenon arc lamp
Light source life 150000 measurements
Detectors Silicon photodiodes
Power source 2.4 V, Special Ni-MH battery
Protection type and level Internally-powered instrument, BF-
type
Minimum number of
measurements when fully charged
400 single measurements
Operating temperature range 10°C (50°F) to 40°C (104°F)
Operating relative humidity range 30% to 95% non-condensing
Storage temperature range -10°C (14°F) to 50°C (122°F)
Storage relative humidity range 30% to 95% non-condensing
Dimensions 4.8 cm (1.9") wide x 15.4 cm (6.0")
high x 3.2 cm (1.2") deep
Weight, including Ni-MH battery 150 g (5.3 oz)
AC adapter input 100V - 240V 50/60Hz, 11-18VA
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