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Spot Light: Spo2 Functional Tester

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0% found this document useful (0 votes)
324 views28 pages

Spot Light: Spo2 Functional Tester

user manual

Uploaded by

Masimo Root
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

SPOT Light

SpO2 Functional Tester

Users Manual

PN 4151274
February 2012, Rev. 1
© 2012 Fluke Corporation. All rights reserved. Printed in USA. Specifications are subject to change without notice.
All product names are trademarks of their respective companies.
Warranty and Product Support
Fluke Biomedical warrants this instrument against defects in materials and workmanship for two years from the date of
original purchase. You will be charged our customary fee for such calibration. During the warranty period, we will repair or at
our option replace, at no charge, a product that proves to be defective, provided you return the product, shipping prepaid, to
Fluke Biomedical. This warranty covers the original purchaser only and is not transferable. The warranty does not apply if
the product has been damaged by accident or misuse or has been serviced or modified by anyone other than an authorized
Fluke Biomedical service facility. NO OTHER WARRANTIES, SUCH AS FITNESS FOR A PARTICULAR PURPOSE, ARE
EXPRESSED OR IMPLIED. FLUKE SHALL NOT BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES OR LOSSES, INCLUDING LOSS OF DATA, ARISING FROM ANY CAUSE OR THEORY.
This warranty covers only serialized products and their accessory items that bear a distinct serial number tag. Recalibration
of instruments is not covered under the warranty.
This warranty gives you specific legal rights and you may also have other rights that vary in different jurisdictions. Since
some jurisdictions do not allow the exclusion or limitation of an implied warranty or of incidental or consequential damages,
this limitation of liability may not apply to you. If any provision of this warranty is held invalid or unenforceable by a court or
other decision-maker of competent jurisdiction, such holding will not affect the validity or enforceability of any other provision.

7/07
Notices
All Rights Reserved
 Copyright 2012, Fluke Biomedical. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or
translated into any language without the written permission of Fluke Biomedical.

Copyright Release
Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service
training programs and other technical publications. If you would like other reproductions or distributions, submit a written request to Fluke
Biomedical.

Unpacking and Inspection


Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If damage is found, stop unpacking
the instrument. Notify the carrier and ask for an agent to be present while the instrument is unpacked. There are no special unpacking
instructions, but be careful not to damage the instrument when unpacking it. Inspect the instrument for physical damage such as bent or
broken parts, dents, or scratches.

Technical Support
For application support or answers to technical questions, either email techservices@[Link] or call 1-800- 850-4608 or 1-440-
248-9300. In Europe, email [Link]@[Link] or call +31-40-2675314.

Claims
Our routine method of shipment is via common carrier, FOB origin. Upon delivery, if physical damage is found, retain all packing materials in
their original condition and contact the carrier immediately to file a claim. If the instrument is delivered in good physical condition but does not
operate within specifications, or if there are any other problems not caused by shipping damage, please contact Fluke Biomedical or your local
sales representative.
Returns and Repairs
Return Procedure
All items being returned (including all warranty-claim shipments) must be sent freight-prepaid to our factory location. When you return an
instrument to Fluke Biomedical, we recommend using United Parcel Service, Federal Express, or Air Parcel Post. We also recommend that
you insure your shipment for its actual replacement cost. Fluke Biomedical will not be responsible for lost shipments or instruments that are
received in damaged condition due to improper packaging or handling.
Use the original carton and packaging material for shipment. If they are not available, we recommend the following guide for repackaging:
 Use a double–walled carton of sufficient strength for the weight being shipped.
 Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive material around all projecting parts.
 Use at least four inches of tightly packed, industry-approved, shock-absorbent material around the instrument.
Returns for partial refund/credit:
Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from our Order
Entry Group at 1-440-498-2560.
Repair and calibration:
To find the nearest service center, go to [Link]/service or
In the U.S.A.: In Europe, Middle East, and Africa:
Cleveland Calibration Lab Eindhoven Calibration Lab
Tel: 1-800-850-4608 x2564 Tel: +31-40-2675300
Email: globalcal@[Link] Email: servicedesk@[Link]

Everett Calibration Lab In Asia:


Tel: 1-888-99 FLUKE (1-888-993-5853) Everett Calibration Lab
Email: [Link]@[Link] Tel: +425-446-6945
Email: [Link]@[Link]
Certification
This instrument was thoroughly tested and inspected. It was found to meet Fluke Biomedical’s manufacturing specifications when it was
shipped from the factory. Calibration measurements are traceable to the National Institute of Standards and Technology (NIST). Devices for
which there are no NIST calibration standards are measured against in-house performance standards using accepted test procedures.

WARNING
Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper
operation. Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment modifications.

Restrictions and Liabilities


Information in this document is subject to change and does not represent a commitment by Fluke Biomedical. Changes made to the
information in this document will be incorporated in new editions of the publication. No responsibility is assumed by Fluke Biomedical
for the use or reliability of software or equipment that is not supplied by Fluke Biomedical, or by its affiliated dealers.

Manufacturing Location
The SPOT Light SpO2 Functional Tester is manufactured at Fluke Biomedical, 6920 Seaway Blvd., Everett, WA, U.S.A.
Table of Contents

Title Page

Introduction .................................................................................................................... 1
Intended Use .................................................................................................................. 2
Safety Information .......................................................................................................... 2
Unpack the Product ........................................................................................................ 3
Instrument Familiarization .............................................................................................. 4
Accessories .................................................................................................................... 5
How to Turn On the Product ........................................................................................... 6
How to Use the Product ................................................................................................. 6
SpO2 Sensor Placement ........................................................................................... 6
How to Set Test Parameters ..................................................................................... 8
How to Set Custom Tests............................................................................................... 9
Maintenance ................................................................................................................... 10
How to Clean the Product .......................................................................................... 11
Battery Maintenance.................................................................................................. 11
How to Charge the Battery ................................................................................... 11

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Battery Removal................................................................................................... 13
General Specifications ................................................................................................... 14
Detailed Specifications .................................................................................................. 14
Oximeter SpO2 Optical Emitter and Detector ............................................................ 14

ii
List of Tables

Table Title Page

1. Symbols................................................................................................................................. 2
2. Product Controls and Connections ........................................................................................ 4
3. Standard Accessories ........................................................................................................... 5
4. Optional Accessories ............................................................................................................. 5
5. Test Parameters .................................................................................................................... 8

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iv
List of Figures

Figure Title Page

1. Product Controls and Connections ........................................................................................ 4


2. Power-Up Screen .................................................................................................................. 6
3. Main Screen .......................................................................................................................... 6
4. Oximeter Sensor Placement.................................................................................................. 7
5. SpO2 Parameter Change ...................................................................................................... 9
6. External Battery Charging Connections ................................................................................ 12
7. Battery Removal .................................................................................................................... 13

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SpO2 Functional Tester

Introduction The Product uses light detection and emission to do tests.


The tests examine the electronics of the pulse oximeter
XW Warning and the sensor.
To prevent possible electrical shock, fire, or Table 1 is a list of the symbols used on the Product and in
personal injury, read all “safety information” this manual.
before you use the Product.
The Fluke Biomedical SPOT Light SpO2 Functional
Tester (the Product) is a compact, portable, functional
tester used to measure the performance of SpO2
monitors (pulse oximeters).

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Users Manual
Table 1. Symbols equipment manufacturers and independent service
companies that repair and service medical equipment.
Symbol Description The end user is an individual, trained in medical
instrumentation technology.
W Important information. Refer to manual.
This Product is not intended for use on patients, or to test
X Hazardous voltage. devices while connected to patients. This Product is not
intended to be used to calibrate medical equipment.
Conforms to relevant Canadian and US
) standards. Safety Information
A Warning identifies conditions and procedures that are
Conforms to relevant Australian EMC
 requirements.
dangerous to the user. A Caution identifies conditions
and procedures that can cause damage to the Product or
the equipment under test.
P Conforms to European Union directives.
XW Warning
Do not dispose of this product as To prevent possible electrical shock, fire, or
~ unsorted municipal waste. Go to Fluke’s
website for recycling information.
personal injury, follow these guidelines:
• Do not connect the Product to a patient
Intended Use or equipment connected to a patient. The
Product is intended for equipment
The Product is intended to be used to test and verify the evaluation only and should never be
basic operation of patient monitoring devices or systems used in diagnostics, treatment, or any
used to monitor SpO2. Additionally, the Product provides other capacity where the Product would
an optical signal to verify the electronics inside the pulse come in contact with a patient.
oximeter sensor are functional.
• Use the Product only as specified, or the
The intended user is a trained biomedical equipment
protection supplied by the Product can
technician who performs periodic preventative
be compromised.
maintenance checks on patient monitors in service. Users
can be associated with hospitals, clinics, original

2
SpO2 Functional Tester
Unpack the Product
• Replace the batteries when the low Not all functional testers and pulse oximeter
battery indicator shows to prevent equipment are compatible. Functional testers
incorrect measurements. can vary in pulse methods, pulse contours,
and amplitude. A functional tester might not
• Carefully read all instructions. accurately reproduce the calibration of the
• Do not use the Product around explosive pulse oximeter equipment and can yield
gas, vapor, or in damp or wet different results between pulse oximeter
environments. equipment.

• Do not use, and disable the Product if it Unpack the Product


is damaged. Carefully unpack all items from the box and check that
you have these items:
• Do not use the Product if it operates
incorrectly. • SPOT Light
• Users Manual
• Use only current probes, test leads, and
adapters supplied with the Product. • Carrying Case
• Power Cord
W Caution • AC/DC Power Supply
The pulse oximeter component of the device
is not intended to validate the SpO2 accuracy
of pulse oximeter equipment.
This device is not intended to confirm the
SpO2 accuracy of the calibration curve of the
pulse oximeter monitor or to assess the
optical characteristics of representative
pulse oximeter sensors to determine their
proper calibration.

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Users Manual

Instrument Familiarization Table 2. Product Controls and Connections


Table 2 is a list of Product controls and connections Item Description
shown in Figure 1.
1 SpO2 Artificial Finger

2 Scroll Up and Down Buttons


1 3 Select Button
5
4 LCD Display

5 Mini B USB Device Port (Service use only)


4

[Link]

Figure 1. Product Controls and Connections

4
SpO2 Functional Tester
Accessories

Accessories
Available Product accessories are shown in Table 3 and 4.

Table 3. Standard Accessories


Item Fluke Biomedical Part Number
SPOT Light Users Manual 4151274
AC/DC Power Supply 3978380
US 284174
Schuko 769422
UK 769455
AC Power Cord
Japan 284174
Australia/China 658641
[1]
Brazil 3841347

Carrying Case 4026799


[1] Product shipped to Brazil also includes a US power cord.

Table 4. Optional Accessories


Item Fluke Biomedical Part Number
Battery Pack 4026823

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SPOT Light
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How to Turn On the Product


Push  for one second to turn on the Product. The
screen shown in Figure 2 is the power-up screen. Push
 and hold for 3 seconds to turn off the Product.

[Link]

Figure 3. Main Screen

[Link] How to Use the Product


Figure 2. Power-Up Screen All Product tests are set through the controls on the main
Note screen. As each parameter is set, the test value changes
immediately.
Firmware version shown is for illustration only.
The version shown on your Product could be SpO2 Sensor Placement
different. Put the SpO2 sensor on the artificial finger as shown in
When the self test is complete and no errors are sensed, Figure 4.
the screen shown in Figure 3 shows in the display.

6
SpO2 Functional Tester
How to Use the Product

To
Patient SpO2 Cable
Fluke Biomedical Monitor
SPOT Light
LED side
of sensor
Pulse
Oximeter
Cable position changes Sensor
with sensor manufacturer.

Adjust finger on the display for maximum signal.

- Signal + - Signal +

- Signal + - Signal +

[Link]

Figure 4. Oximeter Sensor Placement

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SPOT Light
Users Manual
Put the sensor with the LEDs on the bottom of the Table 5. Test Parameters
artificial finger. While you put the sensor on the artifact
finger, monitor the signal indicator along the bottom of the Parameter Values*
Product display. Adjust the sensor on the finger for
maximum signal strength. SpO2 80%, 85%, 90%, 95%, 97%,
98%, 99%, 100%
Note
Cable position changes with sensor HR (Heart Rate) 30, 60, 80, 100, 120, 150, 180,
manufacturer and 240 BPM

PA (Pulse Amplitude) 0.2%, 2.0%, and 10%


How to Set Test Parameters
Transmission LG (Large), Med (Medium),
When you turn on the Product, all parameters are set to
their default values. To change a parameter value, push and Sm (Small) finger
 or  to move the highlight to a parameter that
Artifact None, Respiration: 2.5%,
you need to change. Push  to move the highlight to
the value of the parameter. Push  or  to Ambient light: 50 or 60 Hz
scroll through the values. With the correct parameter Type Nonin, Masimo, Nellcor, Nihon
value shown in the display, push  to set the
Kohden, Mindray, GE-Ohmeda,
parameter. Table 5 is a list of all parameters and their
values. Philips/HP, and BCI

Test Manual, Custom 1, Custom 2,


and Custom 3

* Default values are in bold type.

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SpO2 Functional Tester
How to Set Custom Tests
As one example, to change the SpO2 value to 98 %: Note
1. Push  or  to move the highlight to As each parameter is set, the artificial finger
SpO2: in the display. outputs the new parameter value immediately.
4. Push . The highlight moves back to SpO2:
2. Push . The highlight moves to the SpO2 and the value stays set at 98 %.
parameter value as shown in Figure 5.
How to Set Custom Tests
When the Test parameter is set to Manual, no parameter
values are stored. A maximum of three custom tests can
be stored in the Product.
To set up a custom test:
1. Push  or  to move the highlight to Test:
in the display.
2. Push . The highlight moves to the Test
parameter.
3. Push  or  to scroll through the test
values. Stop when Custom 1, Custom 2, or Custom 3
shows in the display.
4. Push .

[Link]

Figure 5. SpO2 Parameter Change When the Test parameter is set to Custom 1, Custom 2,
or Custom 3, each parameter you change becomes a
3. Push  or  to scroll through the SpO2 new value for that custom test.
parameter values until 98% shows in the display.

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SPOT Light
Users Manual

Maintenance • Batteries contain hazardous chemicals


that can cause burns or explode. If
The Product is an SpO2 functional tester. Try to prevent
exposure to chemicals occurs, clean
mechanical abuse that could change the test values. The
with water and get medical aid.
Product has no internal user-serviceable parts.
W Warning • Do not put battery cells and battery
packs near heat or fire. Do not put in
For safe operation and maintenance of the sunlight.
Product and to prevent personal injury:
• Do not disassemble or crush battery
• Repair the Product before use if the cells and battery packs.
battery leaks.
• Have an approved technician repair the
• Remove batteries to prevent battery Product.
leakage and damage to the Product if it
is not used for an extended period. • Use only specified replacement parts.
• Connect the battery charger to the mains • Remove the input signals before you
power outlet before the Product. clean the Product.
• Use only Fluke approved power adapters • Connect factory supplied three-
to charge the battery. conductor mains power cord to a
grounded power outlet.
• Do not short the battery terminals
together. • Do not use a two-conductor adapter or
extension cord.
• Do not keep cells or batteries in a
container where the terminals can be
shorted.
• Keep cells and battery packs clean and
dry. Clean dirty connectors with a dry,
clean cloth.

10
SpO2 Functional Tester
Maintenance
How to Clean the Product lower-right corner of the display. With the AC/DC power
supply removed from the Product, the battery icon shows
W Caution the charge level.
Do not put fluid onto the Product surface.
Fluid seepage into the electrical circuitry The battery can be charged while it is in or out of the
may cause the Product to fail. Product. The charge rate is slower when the Product is
energized and the battery charger is on. To charge the
Do not use spray cleaners on the Product. battery:
This action can force the cleaning fluid into
the Product and damage electronic 1. As shown in Figure 6, connect the ac/dc power
components. supply to the power connector on the battery pack.
2. Connect the ac/dc power supply to a power source.
Clean the Product occasionally with a damp cloth and
The battery charge LED on the battery pack shows
mild detergent. Try to prevent the entrance of liquids.
red or green when the ac/dc power supply is
Battery Maintenance connected to the battery pack. When the LED is
For peak battery performance, charge the Product to green, the battery is charged.
maximum charge a minimum of one time each month. If When you have two or more battery packs, you can
the Product is not to be used for more than a month, keep charge one battery externally while you use the other to
it connected to the charger. energize the Product.
Note
To get the specified performance, use the
specified battery charger that comes with this
Product.
When the battery gets low, a low battery message shows
in the display.
How to Charge the Battery
The battery charge level is shown in the lower-right
corner of the display when the battery pack is installed in
the Product. If the battery charges,  shows in the

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SPOT Light
Users Manual

Battery LED

[Link]

Figure 6. External Battery Charger Connections

12
SpO2 Functional Tester
Maintenance
Battery Removal
The battery pack is easy to remove and replace. To remove the battery pack:
1. Push down on the battery pack latch as shown in Figure 7.
2. Pull the battery pack from the Product.

Pull Out

Push
Down

[Link]

Figure 7. Battery Removal


To put the battery pack into the Product, align the battery pack with the guides on the Product and push it into the Product
until the latch locks.

13
SPOT Light
Users Manual

General Specifications
Temperature
Operating ............................................................ 10 °C to 40 °C (50 °F to 104 °F)
Storage ............................................................... -20 °C to +60 °C (-4 °F to +140 °F)
Humidity ................................................................. 10 % to 90 % non-condensing
Altitude ................................................................... 3,000 m (9,843 ft)
Size (W x H x D) ..................................................... 12.53 cm x 14.86 cm x 4.77 cm (4.94 in x 5.85 in x 1.88 in)
Display ................................................................... LCD Monochrome display
Communication (USB Device Virtual COM Port) .. Mini B connector for service upload of firmware
Power ..................................................................... Lithium-Ion rechargeable, 3.7 V, 10.75 Wh battery, 2900 mAh
Battery Charger ..................................................... 100 V to 240 V, 50/60 Hz input, 6 V/2.5 A output. For best performance, the battery
charger must be connected to a properly grounded ac receptacle.
Battery Life ............................................................ 10 hours (minimum)
Weight .................................................................... 0.29 kg (0.7 lb)
Safety Standards ................................................... EN/IEC 61010-1:2001
Certifications ........................................................... P, ), 
Electromagnetic Compatibility (EMC) ................. EN 61326-1:2006

Detailed Specifications
Oximeter SpO2 Optical Emitter and Detector
%O2
O2 Saturations ..................................................... 80 %, 85 %, 90 %, 95 %, 97 %, 98 %, 99 %, and 100 %
Accuracy
With oximeter manufacturer’s R-curve
Saturation within UUT specific range .......... ±(1 count + specified accuracy of the UUT)
Saturation outside UUT specific range ....... monotonic with unspecified accuracy

14
SpO2 Functional Tester
Detailed Specifications
With Fluke Biomedical R-curves
95 to 100 % ................................................. ±(3 counts + specified accuracy of the UUT)
85 to 90 % ................................................... ±(5 counts + specified accuracy of the UUT)
80 % ............................................................ ±(7 counts + specified accuracy of the UUT)
Heart Rate
Rates................................................................... 30, 60, 80, 100, 120, 150. 180, and 240 BPM
Accuracy.............................................................. ±1 % of setting
Transmission (Ratio of detector current to LED current, expressed in parts per million (ppm))
Ratios .................................................................. Large finger (12.00 ppm), medium finger (80.00 ppm), and small finger (300.00 ppm)
Accuracy.............................................................. +50 %/-30 % for compatible monitors, unspecified for others. Selected by finger size and
color: large finger, medium finger, small finger.
Pulse Amplitude
Amplutudes ......................................................... Low (0.2 %), medium (2 %), and high (10 %
Artifact
Respiration
Size ................................................................. 2.5 % of transmission
Rate ................................................................. 20 BrPM
Ambient Light Frequency .................................... 50 Hz and 60 Hz
Compatible Manufacturer Products
With manufacturer R-curve ................................. Nellcor, Masimo, Nonin, and Nihon Kohden
With Fluke Biomedical R-curve ........................... Mindray, GE-Ohmeda, Philips/HP, and BCI

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