Spot Light: Spo2 Functional Tester
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.
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]
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.
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
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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List of Figures
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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
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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.
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[Link]
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SpO2 Functional Tester
Accessories
Accessories
Available Product accessories are shown in Table 3 and 4.
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[Link]
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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.
- Signal + - Signal +
- Signal + - Signal +
[Link]
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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
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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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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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Battery LED
[Link]
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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]
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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
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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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