Respironics BiliChek User manual
www.respironics.com
Service Manual
This BiliChek system is the subject of U. S. Patent #US patent 5.353.790 5,792,049 5,860,421 5,924,981 6.002.482
6,045,502 6,192,734 and patents pending. BiliChek is a trademark of Respironics, Inc.
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Limited Warranty
Respironics warrants that the BiliChek® device shall be free from defects of workmanship and materials and will perform in
accordance with the product specifications for a period of one year from the date of sale by Respironics. If the product fails to
perform in accordance with the product specifications, Respironics will repair or replace -at its option - the defective material or
part. Respironics will pay customary freight charges from Respironics to the dealer location only. This warranty does not cover
damage caused by accident, misuse, abuse alteration, and other defects not related to materials or workmanship.
Respironics disclaims all liability for economic loss, loss of profits, overhead, or consequential damages which may be claimed
to arise from any sale or use of this product. Some states do not allow the exclusion or limitation of incidental or consequential
dames, so the above limitation or exclusion may not apply to you.
This warranty is given in lieu of all other express warranties. In addition, any implied warranty, including any warranty of
merchantability or fitness for the particular purpose, is limited to years. Some states do not allow limitations on how long an
implied warranty lasts, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may
also have other rights which vary from state to state.
The warranty for repairs is ninety days for labor and one year on the part(s) that was replaced.
To exercise your rights under this warranty, contact Respironics Inc. at 1-800-345-6443 (US and Canada only) or 1-724-387-
4000.
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Visit Respironics Home Page on the World Wide Web: www.respironics.com
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Table of Contents
1.0 Symbols ............................................................. 5
2.0 Purpose of the Device ....................................... 6
3.0 Theory of Operation ......................................... 6
11.1 Troubleshooting Guide ....................................... 18
11.2 Troubleshooting Flow Chart ...................... 20
11.3 Drawings and Schematics .......................... 22
11.3.1 Battery Pack Electrical Schematic ......... 22
11.3.2 Charger Base Exploded View Drawing . 23
11.3.3 Charger Base PCB Schematic ................ 24
11.3.4 Charger Base PCB Component Layout 28
11.4 HHU Error Code List................................. 29
4.0 Warnings and Precautions ............................... 8
5.0 Description of the BiliChek® System................ 9
6.0 System Specifications ....................................... 10
7.0 Functional Description ..................................... 11
8.0 Initial Set-up...................................................... 13
9.0 Set-up Mode ...................................................... 14
10.0 Operation of the Device .................................... 17
10.1Performing a Calibration.......................... 17
10.2Performing a Measurement ...................... 17
11.0 Troubleshooting ................................................ 18
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12.0 Routine Operator Cleaning ................................... 33
13.0 Maintenance and Repair/Replacement ................ 33
13.1 HHU Measurement Bulb Replacement .... 33
13.2 Charger Base Repair .................................. 34
13.3 Hand Held Unit (HHU) Repair ................. 35
13.4 Power Supply Repair/Replacement .......... 35
13.5 Battery Pack Repair/Replacement ............ 35
14.0 Software Upgrades ................................................. 35
14.1 Upgrade Instructions .................................. 35
15.0 Customer Service and Product Support
Contact Information ............................................... 36
4
1.0 Symbols
• Symbol for Attention. • Symbol for Battery Deep Discharge
See Instructions For Use and Recharge
• Symbol for Use With • Symbol for battery Charging
Table of Contents
• Symbol for Do Not Reuse • Symbol for Rechargeable Battery
• Symbol for Use By • Symbol for Do Not Throw in Trash
• Symbol for Batch Code • Symbol for Nickel Cadmium Battery
• Symbol for Recycle • Symbol for Indoor Use
• Symbol for Serial Number • Symbol for Class B
• Symbol for Catalog Number • Symbol for Date of Manufacture Mfd:
• Symbol for Storage Conditions • Denotes this system is ETL Listed
Recycle Corporation
and conforms to ANSI/UL STD.
2601. Certified to CAN/CSA C22.2
STD. NO. 601.1.
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2.0 Purpose of the Device
The BiliChek®Non-Invasive Bilirubin Analyzer accurately
determines bilirubin levels in newborn patients without a
blood sample regardless of their skin color, gestational age,
or post-natal age. This product provides rapid, point-of-care
bilirubin measurements as a replacement for traditional
clinical chemistry methods. These results are achieved with
no trauma to the patient, no risk of infection, and potentially
reduced cost of monitoring serum bilirubin by minimizing the
use of hospital personnel and supplies.
3.0 Theory of Operation
The BiliChek works by directing white light into the skin of the
newborn and measuring the intensity of the specific wavelengths
which are returned. By knowing the spectral properties of the
components within the skin, one can subtract out the interfering
components and determine the concentration of bilirubin.
Each photon has a characteristic wavelength. As light enters
skin tissue it can collide with the structural components such as
collagen fibers. When a collision occurs, the photon loses energy
and direction of travel is changed. This is called a scattering
event. If enough of these scattering events occur, the photon
completely loses its energy and is absorbed. If a photon is
scattered such that it is re-emitted from the skin, it is reflected.
Photons with longer wavelengths (in the red region of the
spectrum) are scattered less than photons with shorter
wavelengths (in the blue region of the spectrum). This
phenomenon is called wavelength-dependent scattering and
explains why the skin appears red when you shine a bright light
through it. It is also one of the reasons why the optical properties
of the newborns skin changes with advancing gestational and
post-natal age. As the skin matures, it becomes thicker and
there is greater keratinization of the cell membranes which
increases the scattering of incident light.
Photons of specific wavelengths are also preferentially absorbed
by certain molecules. By plotting the absorption against the
wavelength one can visualize characteristic absorption spectra
of the particular molecules. For example, melanin has a nearlinear absorption spectrum in the visible spectrum and, like the
scattering phenomenon, there is greater absorption of photons
with shorter wavelengths than in the red region of the spectrum.
Conversely, hemoglobin is a much more complicated absorber
which is compounded by the fact that oxyhemoglobin and
deoxyhemoglobin have different profiles. The peak absorption
of photons by bilirubin occurs at a wavelength of 460nm. This
is in the blue portion of the spectrum and is the reason why blue
lights are sometimes preferred for phototherapy. It is also in
the region of the spectrum at which hemoglobin absorption is
relatively low.
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Theory of Operation (continued)
The light reflected from the skin of neonates and collected by
the BiliChek Non-Invasive Bilirubin Analyzer is analyzed with
a highly sophisticated, proprietary algorithm to generate a serum
bilirubin measurement. The major skin components which
impact the spectral reflectance in newborns are (1) dermal
maturity, (2) melanin, (3) hemoglobin, and (4) bilirubin. The
intensity of the reflected light is converted to absorbance units,
Optical Density (OD), for analysis. The total OD at each
measured wavelength is equal to the sum of the component ODs.
This is represented mathematically as: OD
OD
MEL
+OD
HEME
+OD
By utilizing known spectral
BILI
TOTAL
= OD
DERM
+
characteristics of each component, the contribution to the total
OD can be sequentially subtracted until bilirubin is all that is
remaining.
Non-Invasive Skin Spectral Components
1
Each of these components have also been considered in the
development of the algorithm by which the BiliChek NonInvasive Bilirubin Analyzer computes the bilirubin measurement.
By measuring the intensity of the reflected light at more than
100 individual wavelength bands across the visible spectrum, a
spectral analysis can be performed. By normalizing against a
reference standard, the BiliCal® Individual Calibration tip, the
variations over time of the bulb and the photo-detectors are
eliminated. The peak absorption of the bilirubin is at
approximately 460nm as measured by subtracting the absorption
of the other components from the total skin absorption. This is
represented by the equation below.
OD
BILI
= OD
TOTAL
-OD
MEL
-OD
HEME
-OD
DERM
The absorption of light by a molecule is proportional to its
concentration. Therefore, the absorption of bilirubin, as
calculated above, is proportional to the concentration of bilirubin
in the subcutaneous capillary beds and subcutaneous tissue. By
subtracting the contribution of the aforementioned components,
the bilirubin absorbance can be quantified and is correlated to
the laboratory total serum bilirubin levels.
1
Jacques, S., Saidi, I., Ladner, A., and D. Oelberg. Developing and optical
fiber reflectance spectrometer to monitor bilirubinemia in meonates.
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4.0 Warnings and Cautions
Caution: US Federal Law restricts this device to sale
by or on the order of a physician.
Warnings
The BiliChek Hand-Held Unit is to be operated only in
conjunction with Respironics approved charger base,
battery packs, power supply, and BiliCal Individual
Calibration Tips.
Do not point at eyes while taking a measurement.
Not suitable for use in the presence of a flammable
anesthetic mixture with air or with nitrous oxide.
Do not use in areas of the skin with visible brusing.
If you suspect BiliChek is interfering with other electronic
devices or vice versa, try the following measures to
correct it:
Relocate the device until the interference stops.
Move the BiliChek further away from the device.
Plug the BiliChek power supply into a different
power outlet so that the BiliChek power supply
and the device are on different breaker or fuse
circuits.
Do not puncture or incinerate the battery pack or dispose
of in a landfill. Batteries should be disposed of properly
according to local guidelines.
Do not use outdoors or place in direct sunlight.
The charger base unit (battery charger) should be plugged
into a properly grounded outlet. Do not operate with
damaged plug or cord.
Cautions
The BiliCal Individual Calibration Tip should not be
exposed to light for extended periods of time. Keep
BiliCal Tip in package prior to use.
If the product is dropped and frequent error messages
occur, it should be inspected for proper operation by an
authorized service representative.
Do not immerse in water or other liquid.
Do not let power cord hang over edge of counter or table
as this may pose a tripping hazard.
Contraindications
Avoid using measurement sites when the following
conditions since they can produce erroneous results:
Brusing
Birthmarks
Hematomas
Excessive hairiness
The BiliChek should not be used on patients who have
undergone an exchange transfusion.
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5.0 Description of the BiliChek® System
-40
°C
60
°C
The BiliChek System (REF B809 or B801) consists of a hand-held unit (REF B800-13) and the following items:
Quantity Description REF Number
2 Rechargeable Battery Packs B800-20
1 Charger Base B800-21
1 Power Supply (International) B800-17
1 Power Supply (Domestic) B800-16
1 Table Top Power Supply (100/250V) 47/63Hz (optional) B800-18
1 Bag of 10 Disposable Calibration Tips B800-10
1 Bag of 10 BilEclipse Phototherapy Protective Patch B800-12
1 User Instruction Manual B800-19
1 BiliChek Manual, International 1 B800-23
1 BiliChek Manual, International 2 B800-24
Bag of 10
10
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6.0 System Specifications
BiliChek System:
♦Total Weight ............................................... 974g
BiliChek Hand-Held Unit:
♦Weight (with battery pack) ........................ 346g
♦Dimensions ................................................ See figure below
Battery Packs:
♦Type ........................................................... Ni-Cd
♦Dimensions
♦Height ............................................ 6.5cm
♦Depth ............................................. 4.8cm
♦Width ............................................. 3.5cm
♦Weight ............................................ 147g
♦Voltage ....................................................... 6V
♦Capacity ..................................................... 700mA Hrs
♦Measurements per full charge.................... Minimum 100
on a single
charge
♦Life Span.................................................... Minimum 1 year
♦Recharge Cycle .......................................... 4.6 hours
maximum
♦Discharge and Recharge Cycle .................. 9.2 hours
maximum
Charger Base:
♦Dimensions
♦Height ............................................ 7.6cm
♦Depth ............................................. 12.1cm
♦Width ............................................. 12.4cm
♦Weight ........................................................ 264g
Light Bulb:
♦Type ........................................................... Tungsten
♦Bulb Life .................................................... Minimum
measurements
Power Supply:
Domestic
♦Input ............................................... 120V, 60Hz
♦Output ............................................ 12 VDC, 0.75 Amp
International
♦Input ............................................... 100-240 VAC ± 10%
47-63 Hz
♦Output ............................................ 12 VDC, 2.75 Amp
Environmental Conditions for Use:
BiliChek System and BiliCal Individual Calibration Tip may
be stored at -40°C to 60°C (-40°F to 140°F) with
noncondensing relative humidity of 95% for a duration of at
least 24 hours.
BiliChek System and BiliCal Individual Calibration Tip are
intended to operate between temperatures of 5°C to 40°C
(41°F to 104°F) with 0% to 85% relative humidity without
condensation.
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7.0 Functional Description
BiliChek Hand-Held Unit (HHU):
The BiliChek Hand-Held Unit consists of the following functional components:
5. Battery Pack - Located in the bottom portion of the
handle,it provides the electrical energy to operate the
variouscomponents
1. TRIGGER button - The single button on the bottom of
the unit is called TRIGGER. It is used to initiate
calibration and patient measurement.
2. FUNCTION buttons - The two buttons on the top side
are FUNCTION buttons. The teal button on the left is
referred to as F1, and the gray button on the right as F2.
These are used to initiate non-routine functions such as
set-up, changing time and date etc.
3. BiliCal Individual Calibration Tip - This tip serves five
purposes:
a. device calibration before each patient measurement.
b. protection of the fiber-optic probe,
c. protection of the surface of the calibration material,
d. positioning aid to ensure proper placement of the
probe.
e. a clean surface for each patient measurement.
4. Display window - The display window shows the
bilirubin measurement, time and date, audio and
battery icons, Measurement Status Indicator (MSI) as
well as other system and error messages.
.
(teal)
Charger Base:
The charge base contains two wells, A and B, which
recharge the battery pack in the BiliChek HHU and a spare
battery pack, respectively. The two small lights on the
front of the charger base (Battery Status Indicators or BSI)
indicate the operation of the battery charger and battery
charge status.
♦ The BiliChek HHU is placed in the left hand well
A with the display window facing the operator.
♦ The spare battery pack is placed in the right hand
well B with the latch up and facing the operator.
Caution: The BiliChek Hand-Held unit will not fit in well
B of the charger base. The battery pack can fit into well
A, but may not make correct connection to the charger
base.
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