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

BiliChek Service Manual

3

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 newborns 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

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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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In order to maintain optimal battery performance and battery
life, the battery packs should periodically be fully drained of
power. The charger base has the ability to manually drain the
battery by using the Charge/Deep Discharge switch located
on the bottom of the charger base. It is recommended by the
manufacturer to discharge each battery pack every month. To
drain a battery pack of power, place the Deep Discharge switch
in the right ( ) position and place the battery pack in the
charger base. The discharge/recharge cycle will take approxi­mately 4.6 to 9.2 hours depending on the amount of the charge
in the battery pack.

The green light will illuminate when the battery pack has
completely discharged and recharged. After both battery packs
have been discharged, place the Deep Discharge switch in the
left ( ) position.

Caution: Leaving the Deep Discharge switch in the right
( ) position at all times will drain the battery pack before
every recharge. This will increase the duration of the recharg­ing cycle and may reduce the overall life of the battery packs.

NOTE: If the battery pack is moved or bumped during the
recharge phase of the deep discharge cycle, the deep discharge
cycle may begin again.

BiliCal
Individual
Calibration Tip

The Battery Status Indicator (BSI)

BSI Color Battery Charger Mode Solutions

OFF

Green

Amber

Amber Flashing

Battery pack not sensed in
well or charger base not
properly connected to power
supply.

Battery pack is fully charged.

Battery pack in the well is
charging but not ready for use.

Battery pack in the well is
deep discharging.

Ensure battery pack is
properly seated in
well, check power
connections. Try
another battery if BSI
is still off. If BSI is
still off with second
battery, the Charger
base itself has
malfunctioned and
requires service.

Battery pack is ready
for use.

Continue charging
until BSI color is
green.

Continue discharging
and recharging until
BSI color is green.
NOTE: BSI will
become steady amber
when deep discharge
phase of cycle is
ended and charging is
in progress.

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Red Flashing

BiliChek Service Manual

Bad battery pack in the
charger base.

Replace the battery
pack. If the problem
is still present with a
new battery pack, the
charger base itself has
malfunctioned and
requires service.

12

NOTE: When Deep Discharging the battery pack, the BSI
will blink amber during the discharge cycle, become constant
amber when recharging, and then green when fully charge.

NOTE: IF the BSI is flashing red when the battery pack is in
place, try resetting the battery pack in the charging well. If the
problem persists, try another battery pack. If the problem
continues, the charger base has malfunctioned and needs
service.

8.0 Initial Set-Up

♦ Visually inspect that all components are without

physical damage.

♦ Plug the power cord into the power supply and then

into a grounded outlet.

♦ To install the battery pack, insert the bottom of the

battery pack into the bottom of the BiliChek
hand held unit and then rotate battery and snap it into
place.

♦ To remove the battery pack press the release latch at

the top of the battery pack and rotate it out of the
BiliChek hand-held unit.

♦ Connect the power supply to the charger base by

inserting the plug into the socket on the rear of the
charger base. The Battery Status Indicator (BSI) lights
will flash red, green, amber, and then off (approxi
mately 1 second each) to indicate proper operation.

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BiliChek Service Manual

Before the initial use, both battery packs should be fully
charged. After installing one of the battery packs into the
BiliChek hand-held unit, insert the hand-held unit into the
charger base well A, as shown on page 12 of this manual.
The indicator light will glow amber to indicate that the battery
pack is being charged (consult section 11.2 Troubleshooting
Flow Chart of this manual if the indicator is blinking red or
not illuminated). Now insert the auxiliary battery pack into
well B as shown on page 12 of this manual. The BSI will
glow amber to indicate that it is charging. Charge both battery
packs fully until green lights are displayed on both BISs
(page 12)

13

9.0 Set-Up Mode

To initially set up the BiliChek® or to customize it for a spe­cific institution, the following list of features can be changed
from the initial factory settings.

♦ Select audio On/Off
♦ Select the measurement units (mg/dl or µmol/L)

♦ Set the automatic power-off time interval

(60 or 120 seconds)

♦ Select the time format (12H or 24H)
♦ Set the current time
♦ Select the date format (MO/DA or DA/MO)
♦ Set the current date

To Turn The Unit On

♦ Install a fully charged battery pack. Ensure that the

battery pack is fully in place and latched. If EOO is
displayed, see Section 11.0 of this manual.

♦ Press and release either F1 or F2
♦ The unit will turn on and boot up the system. During

this boot-up, the software checks the main software,
activates the measurement light bulb, Measurement
Status Indicator, and all LCD indicators. The current
software revision and current configuration are dis
played. The boot-up will end at the home screen dis
playing the last measurement, time and date, or display
an error code message.

NOTE: The BiliChek hand-held unit does not have an OFF
switch. The power will automatically shut off if it is left idle
for a specified period of time (60 or 120 Seconds).

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BiliChek Service Manual

(teal)

14

To Access the User Set-Up Function

♦ Press F1 and F2 at the same time, hold for one second,

(until the display changes) and then release to access
the set-up mode.

♦ Use the F1 button to advance to the next item and the

F2 button to change the value of the current item.

♦ To exit the set-up mode, press F1 and F2 at the same

time. All changes that were made will be saved and
displayed.

Audio On/Off

♦ This function allows the user to turn the internal beeper

on or off.

♦ Press F2 to toggle the speaker (beeper) on and off, and

F1 to accept your choice and advance to the next
function.

♦ Press F2 to toggle between values, and F1 to accept

your choice and advance to the next function.

Automatic power-off time interval

To conserve battery power, the unit has an automatic time-out
feature which turns the unit off if it is idle for a specified time
period.

NOTE: The default time is set at 120 seconds.

♦ Press F2 to toggle between the 60 or 120 second

choices, and F1 to accept your choice and advance to
the next function.

Setting the measurement units.

The display will read SET, and either mg/dL or µmol/L will

be displayed

NOTE: The default value is mg/dL.

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BiliChek Service Manual

Selecting the time format

The system will display time in either the 12 hour or 24 hour
format.

NOTE: The 12 hour format is the default setting.

15

♦ Press F2 to toggle between the formats, and F1 to

accept your choice and advance to setting the time.

Setting the time

After choosing the time format SET appears on the display
and the current clock time will be shown.

♦ The hour digits will be flashing
♦ Press F2 to scroll through the hours.
♦ Press F1 to accept the hour and the minute digits will

begin flashing.

♦ Press F2 to scroll through the minutes.
♦ Press F1 to accept your choice and advance to the next

function.

♦ Press F2 to toggle between the formats, and F1 to

accept and to advance to setting the date.

Setting the date

Depending on the format selected, the current month or day
digit will flash.

♦ Press F2 to scroll through the choices.
♦ Press F1 to accept and the next digit will begin

flashing.

♦ Press F2 to scroll through the choices.
♦ Press F1 to accept, and the first year digit will begin

flashing.

♦ Press F2 to scroll through the digits.
♦ Press F1 to accept and the second year digit will begin

flashing.

♦ Press F2 to scroll the digits.
♦ Press F1 to accept and the date will be saved and the

display will return to the home screen.

Selecting the date format

The unit will display the date in the Month/Day format or the
Day/Month format.

NOTE: the Month/Day format is the default setting.

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10.0 Operation Of The Device

10.1 Performing A Calibration

♦ Apply a new BiliCal  Individual Calibration Tip

to the unit.

♦ Firmly press the BiliCal tip onto the BiliChek hand-

held unit to ensure proper seating of the Tip.

♦ Press and release either F1 or F2.

The unit will perform its self test displaying all
LCD indicators and end at the home screen

♦ Press and release the TRIGGER to start the

calibration cycle.

♦ Three dashes (---) will flash in the display window

and the MSI will be amber if a BiliCal Tip is in
place, indicating the system is ready to calibrate. If
a BiliCal Tip is not in place the MSI will be red,
indicating that a new BiliCal tip should be applied.

♦ Press and release the TRIGGER button. The dashed

lines will stop flashing indicating that the unit is
calibrating.

♦ When calibration is complete the MSI will be

amber, you will hear a beep (if the audio is on), and
the display window will read "005".

NOTE: If an error message is displayed during calibration,
refer to section 11.0 of this manual for troubleshooting.

WARNING: It is critical to calibrate the unit and apply a new
BiliCal Individual Calibration Tip immediately prior to per­forming a test. Inaccurate test results will occur if this is not
done. Removal of the tip after calibration and prior to a
patient measurement will result in loss of calibration. The
entire calibration sequence must be repeated with a new
calibration tip.

10.2 Performing A Measurement

♦ After performing a calibration, peel the protective

cover from the BiliCal Individual Calibration Tip and
dispose of it.

♦ Press and release the TRIGGER button. The unit is

now activated and ready to take a measurement.
Gently press the tip against the infants forehead. The
Measurement Status Indicator (MSI) will change
from amber to green when proper pressure is applied.
Do not continue to increase pressure, this will result in
an E04 error message.

♦ The display will read 005 and will stop blinking

when proper pressure has been applied. The measure
ment should take less than 2 seconds. At the end of the
measurement, a beep will sound (if audio is on) and
the display will change to "004".

♦ Take 005 readings by lifting and replacing the tip on

the forehead and pressing the TRIGGER button for
each measurement. The current measurement will be
indicated on the display (005-004-003-002-001)

♦ When the 5 measurements are complete, a beep will

sound (if the audio is on) and the results will be dis
played with the current date and time.

♦ Place the protective cover onto the BiliChek per

manufacturer's recommendation. (If the protective cap
is lost a BiliCal may be used to protect the fiberoptic
probe.)

♦ The unit will turn off automatically.

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17

11.0 Troubleshooting Guide

11.1 Troubleshooting Guide

Display

Display Window Indication Solution

Window

E00 No user set-up information identified. Install a charged battery pack into the HHU. Press

E01 Calibration measurement is unacceptable. Press and release F1 and F2 at the same time.

E02 Patient measurement is unacceptable. Press and release F1 and F2 at the same time. Take another

E03 BiliCal Individual Calibration Tip removed Press and release F1 and F2 at the same time.

between calibration and measurement scan. Remove the BiliCal Individual Calibration Tip.

E04 Too much movement during measurement. Press and release F1 and F2 at the same time.

E05 High Measurement is out of clinically proven range. Obtain a Total Serum Bilirubin level (TSB)
E10 Light bulb is burned out. Replace measurement light bulb (see section 14.1 for instructions). If

E99 System error is detected. Call for Service.

Low battery pack. Maximum of 10 measurements left. Replace current battery pack with a fully

Discharged Battery pack. Replace current battery pack with a fully charged one from the charger
No measurements can be taken. base. Place the discharged battery pack into well B for charging.

Indication

Solution

F1 and F2 at the same time, hold for one second and then release. This
places the HHU in the Set-up mode. Enter settings specific to your
institution. See section 10.0 of this manual for Set-up Mode
instructions.

Ensure BiliCal tip is in place and retry the calibration. If the error
continues: 1. Place a fully charged Battery Pack in the HHU, install a
new BiliCal Tip, and try again to calibrate several times.

2. Remove and rotate the BiliCal tip and retry. 3. Replace the measurement
light bulb (see Section 14.1 for instructions) and retry. If the error is still
present, the HHU has malfunctioned and requires service. Call
Respironics or your distributor.

measurement. If E02 occurs again, replace the BiliCal tip, repeat
calibration and retry the measurement. If the error is still present, the
HHU has malfunctioned and requires service. Call
Respironics or your distributor.

Replace with a new tip and recalibrate.

Perform another measurement.

error continues, the HHU has malfunctioned and requires service. Call
Respironics or your distributor.

charged battery pack from the charger base and place the discharged
battery in well B for charging.

1014988

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18

11.2 Troubleshooting Flow Chart

A

B

Hand Held Unit (HHU)

Make sure there is a fully
charged battery pack in the
HHU

Press and release eith er
button on top of the HHU
(F1 or F2).

the MSI light glow ? See

The HHU is operating
correctly, and can be
returned t o use.

Does

section 10.0 of this

manual

Yes

Does the

display come

on?

Yes

Record the display
information.
Refer to
Troubleshooting
guide, Section 11.1

Will the HHU

calibrate

Yes

Take 5 skin
measurements .

OK ?

Yes

NOTE: After the second
battery pack try, check the
battery pack output with a
multimeter. It should be
between 7 and 7.5 Volts DC.

Try another
Battery pack.

No

NOTE: If the display is
fragmented ( segments
missi ng), the H HU is
defectiv e. Contac t your
distributor for ins tructions on
the retur n of defective HH U
to Respironics for repair..

Try several times. If still no
calibration, remove and rotate the
BiliCal tip and try again to calibrate. If
the error is s till present, change the
measurement light bulb and try to
calibrate. NOTE:

No

trys to calibrate after a light bulb
change. If the err or is st ill presen t,
record the error/sub error code
information found in section 11.0 and
conta ct you r dis tribu tor to reques t
instructions for returning the
defective HHU to Respironics for repair.

No

B

It will take several

If the HHU will not take
skin measurements,
contact your distributor
and request instructions
for returning th e defectiv e
H H U t o Respironics fo r
repair.

No

Place a batter y
pack in the HHU
and place the H HU
in the ch arger
base left hand
well. Well "A"

Charger Base

Place a batter y
pack in the
charger base in
the right hand well.
Well "B".

Does the r ight hand

BSI ligh t glow ?

Does the left h and

BSI ligh t glow ?

No

Remove all battery packs
and unplu g the charger
base. Reconnect the
charger base to power
while observing the BSI
lights.

The BSI light
sequence should
be: BOTH

- Red - Gree n ­Amber - Off

Insert a battery
pack into t he
charger base right
hand well. Well "B".

LIGHTS

OK ? No

Yes

C

NOTE: The indicator ligh t will

take about 3 seconds to
illuminate.

Yes

Observe the color of
indicator:
Amber = charging
Green = Fully charged

Yes

Red = Defective Battery

pack
(See page 12 for amplification)

C

The charger
base or the
power supply
is defect ive.

D

1014988

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19

Troubleshooting Flow Chart (continued)

C

Is the BSI

illuminated ?

Yes

Is the BSI

Green ?

NOTE: Allow about 3
seconds for the BSI light(s)
to illuminate.

Check to ensure that the
batte ry pac k is sea ted i n the
well and power is applied to
the charger base. Try a nother
battery pack. If the BSI

No

illuminates w ith the second
battery pack , first battery pac k
is defective. Order a
replacement ba ttery pack fr om
your distributor.

The battery pack is fully

Yes

charged and is ready
for use in an HHU.

D

Test the power supply in the following
manner. Check the incoming line voltage
from the mains circ uit. It will be either
115 VAC or 220 VAC depending on your
locale. If the incoming power is OK , plug
in the power supply and check it's output
voltage at the connector that plugs into
the charger base. It should be approx. 12
VDC. If the output is incorrect, the power
supply is defective and must be replaced.
Contact your distributor for a
replacement.

1014988

No

Is the BSI

Amber ?

No

Is
the BSI
blinking

Red ?

If the power supply is operating correctly,
connec t the pow er suppl y to the char ger

The battery pack is
charging. Leave it in
the charger base untill

Yes

the BSI light glows
green. See note 1.

below.

Try another battery pack. If the second
battery pac k gives the prop er indication,
the first battery pack is defective. Order
a replacement battery pack from your

Yes

distributor. If the BSI continues blinking
red with the second battery pack, t he
charger base is defect ive and must be
repaired or replaced.

NOTES:

1. Ensure that the black switch located on the bottom of the
charger base is in the left ( ) position (charge only). If the
BSI is blinking amber, the charger is in the deep discharge/
recharge mode and the battery pack is discharging. The BSI will
glow steady amber w hen the battery pack is charging, and gree n
when the battery pack is fully charged.

2. Ensure that all contacts on both the battery pack and the
charger base are clean, not bent over or broken off, and free of
any obstructions.

base. If the BS I lights do not illuminate,
the charger base is defective and must
be repaired or replaced. For repair, see
section 11.3 of this manual (schematics
and drawings), and for replacement
contact your distributor.

BiliChek Service Manual

20

11.3 Drawings and Schematics

Votage Readings

11.3.1 Battery Pack Electrical Schematic

Using a standard Digital Voltmeter, the following voltage
readings will be obtained from a fully charged battery:

Pin 1 to Pin 4 = 7.0 VDC (± depending on polarity of leads)
Pin 5 to Pin 7 = 7.0 VDC (± depending on polarity of leads)
Pin 5 to Pin 6 = 7.0 VDC (± depending on polarity of leads)
Pin 6 to Pin 7 = 0.0 VDC

NOTE: The battery packs have three (3) contacts on one end
and four (4) contacts on the other end. Holding the battery pack
with the contacts towards you, the contacts are numbered from
left-to-right.

1014988

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21

11.3.2 Charger Base Exploded Views

Charger Base Assembly

REF: B800-21

12V

BiliChek

C

ETL LISTED 9800845

CONFORMS TO

ANSI/UL-2601

CERTIFIED TO

CAN/CSA C22.2 NO. 601.1

Rx ONLY

100-250V ~ 50/60 Hz

, .75 - 2.75 A

SN

1014988

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22

11.3.3 Charger Base PCB Schematic

1014988

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23

Charger Base PCB Schematic (continued)

5

D D

COAX POWER

J1

J3

1
2
3

C C

B B

A A

4
5
6
7
8
9
10

*

C9

18pF

C10

18pF

+5V

C14
.1uF

R51
10K

1%

1

OSC1

R43
10M

Y1

4Mhz

2

OSC2

20

RESET

19

IRQ

9

+5V

Vdd

10

Vss

R16

2.05K

1%

+3V +1.7V +0.5V

R17

R52

1.05K

15K

1% 1%

1%

5

1
2
3

U1

68HC05J1

R53

9.53K

1%

R54

1.05K

MRA4003

PA7
PA6
PA5
PA4
PA3
PA2
PA1
PA0

PB5
PB4
PB3
PB2
PB1
PB0

4

+V

R49

D8

68

1/4 W

D7
P6SMB15AT3

IRQ*

11
12
13
14
15
16
17
18

3
4
5
6
7
8

D12

+

C1

8.2v

10

10uF

MR2*

MR1*

J2

1
2
3
4
5
6
7
8
9

MMSZ5237BT1

RD1

GN1

+5V

3

A1

TPS7350

3

IN1

4

IN2

C2
.1uF

RD2

GN2

EN2GND1RST

8

SENSE

OUT2
OUT1

OT2*

7
6
5

+

C17

C4

C3

.1uF

.1uF

10uF

R50 10K

R34

RST*

R35 10K

PF2*

R36 10K

MM2*

R37 10K

CM2*

R38

R39

R40 10K

R41

PF1*

2

REV CN DESCRIPTION DATE DRAWN BY CHECKED BY APPROVED BY
0 EDMS INITIAL, WAS SPECTRX 1001062 6/2/03 C.HALLWIRTH EDMS EDMS

+5V +5V

C18
.1uF

+5V

1K

10K

10K

10K

R42

10K

OT1*

CM1*

MM1*

+V

2
3
4
5
6
7
8
9

1

19

+5V

+V

GND

U2

A1
A2
A3
A4
A5
A6
A7
A8

G1
G2

MM74HC541

18

RED1

Y1

17

Y2

16

GREEN1

Y3

15

Y4

14

GREEN2

Y5

13

Y6

12

RED2

Y7

11

Y8

+5V

20

+5V

1

*

NOTES:

1. - INDICATES ITEMS NOT INSTALLED.

*

THIS SCHEMATIC WAS CREATED
USING ORCAD TO REPLACE THE
SCHEMATIC DEVELOPED USING
SCHEMA. THIS SCHEMATIC WAS
NOT USED FOR BOARD LAYOUT.

4

3

2

Title

Size D ocument Number Rev

Date: Sheet

RESPIRONICS

BILICHEK CHARGER PCA

S1014726

13Wednesday, October 30, 2002

1

0

of

1014988

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24

Charger Base PCB Schematic (continued)

5

Q1
IRLML2402

+5V

A4
ICS1702

OPRF
SEL0
SEL1
AUX0
AUX1
DTSEL
RC
MRN

3

1

A2

LM317

VIN

ADJ

VSS8AVSS

20

VDD

9

Q2

1
2

R15
16K

C15
.1uF

R55

1K

C7
100pF

SW1

IRLML5103

R1
10K

+5V

4
3

5

+1.7V

17

7
10
14
15
13
12
11

+V

D D

C C

+5V

B B

J8

2
1

*

+5V

A A

VOUT

C12

.1uF

DCHG

THERM

CHG

PFN
MMN
CMN

OTN

4

R3

D1

6.8

2

1W

MRA4003

+

1
2
18

VIN

16
3

PF1*

4

MM1*

5

CM1*

6

OT1*

R4A
62

1W 1W 1W 1W 1%

C5
1uF

R5
10K

+.05V

3

REV CN DESCRIPTION DATE CHECKED BY APPROVED BY

R4B

R4C
62

Q3
IRLML2402

R23
10K

R22
10K

R57
10K

R56
10K

R4D
62

62

+3V

R6

12.1K

R7

3.01K

1%

R24
1M

5

+

6

-

R58
1M

3

+

2

-

SEE SHEET 1

+5V

+5V

84

A6B

7

LM393A/SO

+5V

84

A6A

1

LM393A/SO

+5V

R19
100K

1%

R46

6.19K

1%

R45

*

MMBD914LT1

2

D3
P6SMB6.8AT3

R25
10K

D10

GREEN1

RED1

DRAWN BY

D4
P6SMB15AT3

R27
1K

R26
1K

1

POGO PINS

1

1

1

1

1

1

J6

3
2
1

*

3
2
1

MOLEX 3

PP1

PP2

PP3

J4

RESPIRONICS

Title

Size Document Number Re v

4

3

Date: Sheet

BILICHEK CHARGER PCA

S1014726

2

of

23Wednesday, October 30, 2002

1

0

1014988

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25

Charger Base PCB Schematic (continued)

5

3

1

Q4
IRLML2402

A3

LM317

VIN

ADJ

VOUT

Q5

R59

1K

C16
.1uF

IRLML5103

R8
10K

+V

D D

C C

4

R10

D2

6.8

2

1W

MRA4003

+

C6
1uF

R11A

62

1W 1W 1W 1W 1%

R12

10K

3

REV CN DESCRIPTION DATE CHECKED BY APPROVED BY

R11D

R11B

R11C

62

62

Q6
IRLML2402

SEE SHEET 1

+5V

R13

62

12.1K

R14

3.01K

1%

R21
100K

1%

R47

*

R48

6.19K

1%

2

D5
P6SMB6.8AT3

DRAWN BY

D6
P6SMB15AT3

1

POGO PINS

1

1

1

1

1

1

J7

3
2
1

PP4

PP5

PP6

1014988

+5V

R20
16K

+5V
C8
100pF

J9

B B

2
1

*

A A

+1.7V

A5
ICS1702

17

OPRF

7

SEL0

10

SEL1

14

AUX0

15

AUX1

13

DTSEL

12

RC

11

MRN

5

C13

+5V

.1uF

20

VDD

VSS8AVSS

9

CHG

DCHG

THERM

PFN
MMN
CMN

OTN

1
2
18

VIN

16
3

PF2*

4

MM2*

5

CM2*

6

OT2*

4

+.05V

R29

R30

10K

R28
10K

R61
10K

R60
10K

1M

5

6

R62
1M

3

2

3

+3V

+5V

R31
10K

D11

MMBD914LT1

GREEN2

RED2

R33
1K

R32
1K

+

-

+

-

+5V

84

A7B

LM393A/SO

+5V

84

A7A

LM393A/SO

7

1

RESPIRONICS

Title

Size Document Number Re v

Date: Sheet

BILICHEK CHARGER PCA

S1014726

2

33Wednesday, October 30, 2002

*

J5

3
2
1

MOLEX 3

0

of

1

BiliChek Service Manual

26

11.3.4 Charger Base PCB Component Layout

1014988

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27

11.4 Hand Held Unit (HHU) Error Code List with Explainations

NOTE: All sub errors are displayed in the date field unless specified otherwise in each section. See Illustration at the top of

page 32.

Error: E01 Calibration
Sub Errors Description

000001 Reference component out of range. Install a fully charged battery pack and try several calibrations with

new BiliCal tips. If error persists, HHU requires service.

000002 Dynamic integration time out of range. Install a fully charged battery pack and try several calibrations

with new BiliCal tips. If error persists install a new measurement light bulb and try calibration several
times. If the error still persists, the HHU requires service.

000004 Shape index above threshold. Try a fully charged battery pack and a new BiliCal tip. If error persists,

HHU requires service.

000008 Peak pixel not found. Install a fully charged battery pack and try several calibrations with new BiliCal

tips. If error persists, HHU requires service.

008192 Stray Light Slope Error. Install a fully charged battery pack and try several calibrations with new BiliCal

NOTE: Firware

Version ≥ 2.4/3.8

Only

016384 Mean of dark scan data above threshold. Install a fully charged battery pack and try several calibrations

tips. If error persists, HHU requires service.

with new BiliCal tips. If error persists, HHU requires service.

1014988

BiliChek Service Manual

28

Error: E02 - Measurement
Sub Errors Description

000001 Light intensity below lower threshold specified in data configuration parameters. Try several calibrations

and measurements. If error persists, try on another patient. If error persists on several patients, HHU
requires service.

000002 Light intensity above upper threshold specified in data configuration parameters. Same as in 000001.

000008 BiliChek bilirubin measurement below lower limit. Same as in 000001.

008192 Stray Light Slope Error. Try several calibrations and several BiliCal tips. If error persists, HHU requires

NOTE: Firware

Version ≥ 2.4/3.8

Only

service.

016384 Mean of dark scan data above threshold. Try several calibrations and measurements. If error persists,

HHU requires service.

Error: E03 - Disposable

Disposable tip removed after calibration and before measurements completed. Ensure tip is firmly attached an try another
calibration and measurement. NOTE: This error can also occur if HHU is operated in sunlight or other bright light. Cover the
IRDA port on the front of the HHU and perform another calibration and another measurement.

Error: E04 - Movement

Excessive movement detected during measurement. Take another measurement ensuring no movement of the BiliChek hand-
held unit while the MSI is green.

Error: E05 - BiliChek Bilirubin Measurement High

BiliChek Bilirubin measurement is above the upper threshold. The BiliChek Non-Invasive Bilirubin Analyzer has an upper
threshold of 20 mg/dl or 340 µmol/L set in the software. If readings are above this threshold, a blood sample must be

taken to measure the TSB level.

1014988

BiliChek Service Manual

29

HHU Error Code list with Explanations (continued)

Error: E10 - No Lamp Current

Measurement lamp burned out. Replace measurement lamp and perform several calibrations until HHU calibrates. If HHU
will not calibrate after numerous tries, HHU requires service.

Error: E99 - Fatal

Fatal software error. The HHU must be returned for service. Contact your distributer to request instructions to return to
Respironics for repair.
The following tables are for information only. If an E99 occurs, record the sub error and place a note with the HHU when
returning it for service.

Error: E99 - Fatal (Sub Error Tables)

Sub Errors Description

0001 System configuration parameters are not valid
0002 Timer could not be allocated
0004 Audio could not be initialized
0008 RTC could not be initialized
0016 Serial port could not be initialized
0032 LCD could not be initialized
0064 Switches could not be initialized
0128 Microspectrometer configuration data is not valid
0256 Internal reference voltage is out of range
0512 System RAM check failed
1024 Checksum error in boot firmware
2048 Checksum error in main firmware
4096 Firmware version in boot block not found
8912 Watchdog timer could not be initialized
16384 Watchdog timer timed-out

1014988

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30

NOTE: The following sub errors are displayed in the date field.

Firmware version 2.3/3.6 and below

Sub Errors Description
0256 External reference voltage outside of limits
0512 5V analog supply below limit
1024 Programming voltage below limit
2048 Clinical Error
4096 Internal system error detected during clinical testing
8192 Microspectrometer SN = 000000

Firmware version 2.4/3.8 and above

Sub Errors Description
0016 Peak pixel range > 25
0032 External reference voltage outside of limits
0064 5V analog supply below limit
0128 Programming voltage below limit
0256 Clinical error
0512 Internal system error detected during clinical testing
1024 Microspectrometer SN = 000000

1014988

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31

12.0 Routine (Operator) Cleaning

13.0 Maintenance and Repair and

The BiliChek System is made of an easy-to-clean material
with a smooth, textured surface. One of the following clean­ing agents is recommended for cleaning the exterior of the
HHU, Battery Charger Base, and Battery Packs:

♦ KleenaSeptic
♦ Cavicide
♦ 70 to 90% Isopropyl Alcohol solution
♦ 1% Bleach solution

Spray the cleaning agent on a soft damp cloth and wipe clean
the BiliChek system. The same procedure can be used to
clean the display window.

Caution: Clean the measurement tip with 90% or higher
Isopropyl Alcohol using a soft optical surface cleaning wipe.

WARNING: Do not immerse any part of the system in water
or other liquid. If liquids spill onto the unit, wipe with a damp
cloth and allow to dry prior to using the system.

WARNING: Do not attempt to clean and/or reuse the
BiliCal Individual Calibration Tip.

®

®

Replacement

13.1 Hand Held Unit (HHU) Measurement Light Bulb
Replacement

If the instrument bulb is not working and error code E01 or
E10 (refer to the troubleshooting section 11.4) is displayed, it
is necessary to replace the measurement light bulb. A Re­placement Bulb Kit (RI P/N B800-22) is available from
Respironics or your local distributor.

WARNING: The BiliChek® Non-Invasive Bilirubin
Analyzer is to be used only with the approved Replacement
Bulb Kit from Respironics. Do not over-tighten the lamp
cap.

♦ Remove the battery pack from the bottom of the HHU.
♦ Remove the protective label covering the lamp

assembly.

♦ Remove the lamp cap using a flat tip screwdriver.
♦ Grab the loop of the light bulb with forceps or similar

tool/instrument and gently pull to remove the lamp
assembly.

♦ Insert the replacement lamp assembly using caution

not to touch bulb with fingers. Be sure to place bulb
into socket firmly. DO NOT use the lamp
cap to tighten bulb into place.

♦ Apply the new lamp cap and protective label furnished

in the kit.

♦ Insert a fully charged battery pack into the bottom of

the HHU.

1014988

BiliChek Service Manual

32

13.1 HHU Measurement Light Bulb Replacement (continued)

♦ Attach a new BiliCal Individual Calibration Tip to

the BiliChek hand held unit.

♦ Turn the instrument on and perform repeated calibra

tions as outlined in Section 10.1 of this manual, until a
successful calibration is achieved.

WARNING: There are no serviceable components in the
HHU. Removal of the junction screw and attempting to
separate the upper and lower housings of the HHU can cause
irreversible damage to the internal fiber-optics and will
invalidate the manufacturers warranty.

13.2 Charger Base Repair and
Replacement

The BiliChek charger base is a micro-processor controlled
smart charger with Deep Discharge and Recharge capabili­ties. It requires a 12VDC 0.75 Amp (Domestic) input from
the power supply.

Defective charger bases will be replaced at no charge during
the warranty period. After the warranty period, if desired, the
charger base may be repairable, however, attempts to remove
the main PCB can cause permanent damage to the charger.
To open and inspect/repair the charger base the following
procedure must be followed. To reassemble, reverse the
procedure.

♦ Gently remove the 4 clear plastic feet to expose the

4 assembly screws.

♦ Using a small tipped Philips screwdriver, remove the

4 screws.

♦ Gently separate the upper and lower case.
♦ Inspect the LED connections to ensure that they are

securely connected.

♦ Connect the charger base to the power supply being

careful not to short the PCB to tools etc. Note: Anti­Static protection is required to prevent possible
damage to the micro-processor.

♦ Using the Schematic in Section 11.3.3 of this manual,

a standard Digital Multi-meter, Oscilloscope, and
small electronic service hand tools perform problem
diagnosis and repair.

♦ Re-apply power to the charger base and place battery

in well. Monitor BSI for correct indication (see
section 12). Reassemble the charger base.
The small spring-loaded battery contact pins in the
charger base wells can be removed and replaced in the
event they become bent or broken.

NOTE: Use only the power supply specified by Respironics.

1014988

BiliChek Service Manual

33

♦ Gently grasp the pin with a pair of small needle-nose

pliers or equivalent and pull straight up. Once the pin
is removed, a new pin can be inserted in the same
manner. New pins (RI P/N 1014776) can be ordered
from Respironics or your local distributor.

13.3 Hand-Held Unit (HHU) Repair

The Hand-Held unit (HHU) is not field-serviceable with the
exception of the measurement light bulb. The unit must be
returned to Respironics for service. If the HHU is opened, the
accuracy of the instrument cannot be guaranteed and any
remaining warranty will be voided.

13.4 Power Supply Repair/Replace­ment

The power supply has no serviceable components. In the
event of failure, it must be replaced. If the failure occurs
during the warranty period of the system, it will be replaced at
no charge by Respironics. Out of warranty replacements can
be purchased from Respironics or your local distributor.

13.5 Battery Pack Repair/Replacement

The BiliChek battery pack contains 5 Ni-Cd batteries and is a
sealed unit. Any attempt to open will destroy the pack. It is
not repairable and will be exchanged at no charge during
warranty. Out of warranty replacements may be purchased
from Respironics or your local distributor.

NOTE: For diagnosis of suspected battery pack failure, see
section 11.1 and section 11.3.1.

NOTE: Batteries must be disposed of properly and in accor­dance with local ordinance. Do not incinerate or throw in
trash or land fills.

14.0 Software Upgrades

As software upgrades are required for system options or
enhancements, instructions, software, and any required tools
or equipment needed for the upgrade will be sent if requested.
NOTE: There may be a charge for software upgrades that are
not required for product safety or effectiveness. Check with
your local distributor for information regarding upgrades.

1014988

BiliChek Service Manual

34

15.0 Respironics Customer Service and
Product Support Contact
Information

Respironics is committed to customer satisfaction and may be
contacted with any questions or for technical support. For
technical assistance contact Respironics Customer Satisfaction

US and Canada

Phone: [phone]

Fax: [phone]

International

Phone: [phone]

Fax: [phone]

Visit respironics Home Page on the World Wide Web at:

1014988

www.respironics.com

or e-mail:

[e-mail]

or

[e-mail]

BiliChek Service Manual

35

www. respironics.com

Reorder # B800-25 Revision# 1014988

DS 07/14/03