SPO Medical PulseOx 6100 User manual

PulseOx 6100™-Hand Held User Guide
Blood Oxygen Saturation & Heart Rate Spot-Monitor
Dear User,
Thank you for pur hasing the SPO Medi al PulseOx 6100™ Hand-Held Oximeter ("PulseOx"). By
pur hasing this pulse oximeter, you have hosen a high quality devi e. SPO is onvin ed that you will be
fully satisfied with your new pulse oximeter. Please take a few moments to review the following
instru tions before using the PulseOx for the first time. If you still have questions, please onta t your
lo al dealer for assistan e or SPO Medi al at support@spomedi al. om
Attention: See Instru tions for Use
Statement of Use: Spot- he k pulse oximetry
Safety:
Please follow your physi ian's instru tions. Self-diagnosis of measured results and self-treatment
are dangerous.
Diseases that ause peripheral ir ulatory disturban e may ause in orre t readings (in luding, but
not limited to, diabetes, hyperlipidemia, hypertension and arterial s lerosis). Carboxyhemoglobin
and/or dyes may also ause erroneous readings.
The PulseOx is not intended for use as an apnea monitor.
Do not use ellular phones near the PulseOx as it may ause interferen e.
The PulseOx is a pre ision ele tro-opti al devi e that, with the ex eption of repla ing the battery, has
no user servi eable or adjustable omponents inside.
The PulseOx must be servi ed by trained SPO Medi al personnel only.
If the PulseOx is me hani ally damaged or the LCD presentation is blurred, the devi e must not be
used.
If the elasti thimble hanges olor (gray or white) or loses elasti ity (enough to fall off the finger) the
sensor must be repla ed.
 Repla ement sensors are available from our lo al dealer or SPO Medi al and sold separately.
The PulseOx is not water-proof. Water penetration invalidates the warranty.
Please note that the PulseOx in ludes batteries that should be disposed of in a ordan e with lo al
environmental regulations.
The pulse rate indi ator is not suitable for monitoring ardia pa emaker frequen y.
The PulseOx should only be used on inta t skin.
The use of the PulseOx by spe ial need patients should be supervised by his/her aregiver.
System Parts:
1. PulseOx 6100™ measuring unit (see figures 1, 2, 3)
2. Sensor (see figure 4)
3. Storage pou h sold separately
4. User instru tions
5. Manufa turer's warranty
1
Measuring Unit Com onents: (Figure 1)
A. Conne tor so ket
B. On/Off button
C. Mode button
D. Liquid rystal display (LCD)
E. Plasti asing
F. Down button
G. Up button
Measuring Unit Com onents: (Figure 2)
A. Conne tor so ket
E. Plasti asing
H. Battery over
J. Battery over s rew
Measuring Unit Com onents: (Figure 3)
A. Conne tor so ket
B. On/Off button
C. Liquid rystal display (LCD)
D. LCD window
2
Figure
1
Front View
J
Figure 2
Ba k View
Figure 3
Side View
English
EnglishEnglish
English

Sensor Com onents: (Figure 4)
I. Sili one Elasti Thimble
II. Cable
III. Conne tor Plug
Liquid Crystal Dis lay (LCD)
Indicators and Symbols: (Figure 5)
1. Pulsing heart indi ator
2. SpO2 legend
3. (M) Memory indi ator
4. (Mode) Mode indi ator
5. "Weak signal" indi ator
6. Buzzer level indi ator
7. "Battery status" indi ator
8. Sensor "off" indi ator
9. Saturation rate (%)
10. Heart rate (bpm)
3
Please Note Before Use:
All a tivity should ease prior to initiating measurements (e.g. eating, drinking, smoking, or
exer ising) sin e these, among other a tivities, may affe t the readings.
The hand should be relaxed (e.g. lying on a flat surfa e) and still during the measurement
pro ess.
Inserting a finger into the elasti thimble should be easy and omfortable, IF INSERTION IS TOO
TIGHT OR DIFFICULT, USE A SMALLER FINGER. Damage caused by force will void the
warranty.
Using the PulseOx:
Before use, the sensor must be onne ted to the measuring unit properly. Gently insert the
onne tor plug (Figure 4-III) into the so ket (Figure 3-A) ensuring that the pins are aligned
orre tly.
Gently pla e a finger into the elasti thimble (Figure 6) so that the nailbed figure is fa ing in
the upward dire tion. Slightly press on the thimble sides to ease the finger inside.
Verify that the finger feels omfortable. Do not
use for e.
Hold the hand relaxed and still.
Press the on/off button (Figure 3-B)
The SPO legend will appear (Figure 5-10),
followed by a series of flashing dashes.
The PulseOx will initiate readings within 6-8
Se onds. Data will automati ally be stores in the memory
(See memory se tion below). The devi e will ontinue
to monitor SpO2 (Figure 5-9) until the finger is
removed from the thimble (Figure 4-I)
or if the on/off button is pressed.
On e the finger is removed from the elasti
thimble, the PulseOx will automati ally turn off
within 15 se onds.
The PulseOx has an option to be stored in a
pou h; sold separately.
Set-U Memory:
The PulseOx is designed with an internal memory
whi h retains the previously sele ted buzzer and
volume and ba k illumination settings , even when the PulseOx is
turned off.
Memory:
The PulseOx has an internal memory for 10
heart rate and SpO2 readings.
Subsequent readings (e.g. 11th) delete
the earliest reading and push the latest one in memory a spa e ba k.
4
Figure 5
Figure 6

Accessing the PulseOx Memory Readings:
To a ess the memory reading, press the mode button (Figure 3-C) on e.
The LCD s reen will show "Mode 1".
Press the "arrow up" key (Figure 1-G) and M (Figure 5-3&10) will appear on the s reen. After a
few se onds the last heart rate and SpO2 reading (Figure 6-1, 2, 3, 9&10) will appear on the
s reen.
To a ess earlier readings, use the "up arrow" key (Figure 1-G). By using both
arrow keys (Figure 1-F&G) you an toggle between memory entries. The last entry
will appear as M1 and the earliest memory entries will appear after that in
hronologi al order.
Deleting Memory:
Press the mode button (Figure 3-C) four times. The LCD s reen will show Mode 4
and "dEL".
If in fa t you wish to delete the stored SpO2 and heart rate reading from the memory, press both
up and down arrow together (Figure 1- F&G). The "dEL" will flash and a double beep will sound.
The memory has been deleted.
Turning Off the Oximeter:
To turn off the PulseOx, press the on/off button (Figure 3-B) or simply remove the
finger from the elasti thimble (Figure 4-I) and wait 15 se onds for the unit to turn off.
"Off" will appear on the s reen just before the unit shuts down.
Buzzer:
Buzzer (Mode 2) an be adjusted at any time. To adjust the buzzer level, press the mode button
(Figure 3-C) twi e so that M2 appears on the s reen. To adjust the buzzer levels press on the arrow
keys (Figure 1-F&G) until the desired level is rea hed. The buzzer an be mute as well. Note: Set-up
memory maintains buzzer levels even after the PulseOx has been turned off and restarted.
Back light:
Ba k light intensity an be adjusted at any time, to adjust the ba k light intensity, press the mode button
(Figure 3-C) three times so that Mode3 appears on the s reen. Then, use the arrow keys (Figure 1-F&G)
to in rease or de rease light intensity. There are 5 levels of ba k light intensity from full to off.
Note: Set-up memory maintains ba k light intensity levels even after the PulseOx has been turned off
and restarted.
Battery Status:
Battery display indi ates the approximate power remaining in the battery.
Display of a single battery bar indi ates that the battery will soon require
repla ement
Blinking of the battery i on indi ates that the battery needs to be repla ed.
Battery requirements: 2 x 1.5V Alkaline AA batteries (1,200mAh).
Battery Re lacement Method:
Open the s rew (Figure 2-J) on the battery ompartment with a standard Phillips
s rewdriver and remove the old batteries.
5
Dis ard the used batteries a ording to lo al environmental regulations.
Insert 2 new AA batteries. Verify the battery polarization (+/-) is in a ordan e with
the battery ompartment symbols.
Repla e the battery over (Figure 2-H) by gently sliding it into pla e.
Tighten the s rew (Figure 2-J) with a standard Phillips s rewdriver.
Note: Press the On/Off button - If the unit starts and shows dashes, the batteries
have been pla e orre tly.
PulseOx Cleaning Instructions:
Wipe the exposed surfa es with a soft loth or a moistened pad with a mild detergent solution or an
isopropyl al ohol solution (70%).
Clean the inside of the elasti thimble and the opti al elements with a otton swab moistened with a
mild detergent solution or an isopropyl al ohol solution (70%).
Clean your PulseOx whenever you see any kind of soil, dirt or obstru tion in the unit.
Ensure that no dirt or blood is on the opti al omponents inside the elasti thimble.
A transparent prote tive plasti sleeve, supplied by SPO, an be pla ed on the finger if the user
sees fit.
Product S ecifications:
Effe tive Measuring Range
Saturation 40 to 99%
Heart Pulse Rate 40 to 250 bpm
Resolution 1 digit
A ura y (in l. minor motion and low perfusion)
Saturation (70%-99%) ±2% or ±2 digits
Heart Rate ±3% or ±3 digits
Display
Saturation 2 hara ters
Heart Rate 3 hara ters
Signal Indi ations: Sensor ‘OFF’ and
‘Weak Signal’
Flashing Heart I on
Battery Indi ation Full power, 1/3 and
near empty
Power Requirements 2 x 1.5V Alkaline Batteries (1,200mAh)
Me hani al
Overall Dimensions 6.3" x 1.73" x 1.06" (160 x 44 x 27mm)
Storage Temperature -4° to 158F° (-20°C to 70°C)
Operating Temperature 39° to 107F° (4°C to 42°C)
Humidity Up to 95% non- ondensing
Weight 3oz (85g) not in luding battery and sensor
Sensor Weight 1.37oz (39g)
6

SpO
2
Manufactured by
Equipment Ltd.
EC
REP
20 Hata’as St.,
Kfar Saba, Israel 44425
Email: support@spomedi al. om
Obelis S.A.
Av. De Tervuren 34, bte 44
B-1040 Brussels – Belgium
Email: [email protected]
Type BF
Applied Part
Spot
measurements
No alarms
Rx
only
Devi e Catalog Number: 90401000
Design and spe ifi ations are subje t to hange without noti e.
Copyright © 2008 SPO Medi al Equipment Ltd
Manufacturer’s End User Product Warranty - PulseOx 6100™
SPO Medi al Equipment Ltd. (the “Company”) warrants (ex ept as otherwise noted below) that its produ ts (the
“Produ t”) are free from defe ts in materials and workmanship for a period of one (1) year from the date of
pur hase by the end user. In the event that the Produ t qualifies for overage under this warranty, the Company, at
its option and at no harge, may either repair or repla e the Produ t (not in luding, shipping, handling, delivery or
installation) with an identi al produ t or produ t having similar features and fun tionality, as determined by the
Company. The warranty period for any repaired or repla ed Produ t shall be the remainder of the original warranty
term for the original produ t. Notwithstanding the above, the Company only warrants that the Company's sensor
in orporated in its Produ t known as the PulseOx 6100 sensor will be free from defe ts in materials and
workmanship for a period of 180 days from the date of pur hase by the end user.
The Company does not warranty the installation, maintenan e, or servi e of its Produ t. The Company is not
responsible for an illary equipment not supplied by the Company, whi h is atta hed to or used in onne tion with
the Company’s Produ t, or for the operation of the Produ t with any an illary equipment, and all su h equipment
and operation of su h equipment with the Produ t, is expressly ex luded from this limited warranty. Furthermore,
the Company shall not be responsible for any damage to the Produ t resulting from the use or operation of the
an illary equipment not furnished by the Company for use with the Produ t. Use of this produ t with any sensor
not supplied by Company will render the warranty void.
The Company extends this limited warranty only to the original end-user. This limited warranty and the remedies
hereunder are limited to Produ ts properly used, maintained, stored, installed and used for their intended purpose
and use only, in a ordan e with the Company instru tions. This warranty shall not apply to Produ t installed,
operated or maintained in or under abnormal onditions. This warranty is not appli able to any Produ t whi h is not
operated and/or installed in a ordan e with the Company’s spe ifi ations and or industry pra ti es and standards.
This warranty does not extend to any battery power supply in luded in / with the Produ t.
7
This warranty sets forth all of the Company’s responsibilities for the Produ t.
THIS WARRANTY IS GIVEN IN LIEU OF ALL OTHER EXPRESS WARRANTIES. IMPLIED WARRANTIES,
STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED TO THE DURATION OF
THIS LIMITED WARRANTY. IN NO EVENT, INCLUDING WITHOUT LIMITATION, IN CONTRACT, TORT,
STRICT LIABILITY OR WARRANTY, SHALL THE COMPANY BE LIABLE TO THE PURCHASER OR TO ANY
THIRD PARTY, FOR ANY DAMAGES OR FOR ANY LOSS OF USE, LOSS OF TIME, INCONVENIENCE,
COMMERCIAL LOSS, LOST PROFITS OR SAVINGS OR INCIDENTAL, CONSEQUENTIAL OR SPECIAL
DAMAGES ARISING OUT OF THE USE OR INABILITY TO USE SUCH PRODUCT. TO THE FULL EXTENT THAT
SUCH MAY BE DISCLAIMED BY LAW, COMPANY’S SOLE LIABILITY SHALL BE TO REPLACE OR REPAIR THE
PRODUCT.
Some states within the United States do not allow the ex lusion or limitation of onsequential or in idental damages,
or limitations on the duration of an implied warranty. Therefore, the limitations or ex lusions of onsequential or
in idental damages and implied warranties set forth herein may not apply to you. This warranty gives you spe ifi
legal rights, and you may also have other rights, whi h vary from state to state.
If it appears that the Produ t does not meet the terms of the limited warranty set forth above, within the Warranty
Period, the pur haser must notify the Company in writing of the warranty laim and after re eiving proper
authorization, return the Produ t to the nearest Company ertified distributor for ex hange or repair of Produ t.
FAQ's (Frequently Asked Questions) on the SPO PulseOx 6100™
1. Q: Whi h finger should be used to obtain best results?
A: Use any finger that easily fits into the thimble; do not for e the finger into the thimble.
2. Q: After I start the Oximeter, only dashes appear.
A: This is normal for the first ten (10) se onds. If the reading takes longer than 10 se onds to
appear, it may be indi ating that the thimble is too tight on the finger, ausing impairment or
restri tion of the ir ulation. Ensure that the finger is properly pla ed inside the elasti thimble
as indi ated in the user instru tions. Pull the finger out a little and the Oximeter will restart. If
the se ond try is unsu essful, repeat the insert/start pro ess on a smaller finger. If the user
has very small fingers (e.g. hildren), try using the thumb.
3. Q: I get a “weak signal” i on, what does this mean?
A: On e the Oximeter is operational and getting a reading and the sensor does not re eive a
signal for more than approximately 5 se onds this i on will appear, even though the LCD
ontinues to show the last update. The "weak signal" reading may indi ate that the unit is too
tight and the finger and is restri ting or stopping ir ulation. Please refer to FAQ # 2.
8

4. Q: The Sensor “OFF” i on is lit, what does this mean?
A: This means that the sensor is having a problem reading the signal from the finger. Ensure that
the finger is properly pla ed inside the elasti thimble as indi ated in the user instru tions. The
sensor will shut down if no signal is dete ted over a 15 se ond period. It may also indi ate that
the unit is pla ed too tight on the finger and is restri ting or stopping ir ulation. Please refer to
FAQ #2.
5. Q: How do I a ess memory reading saved in the PulseOx?
A: To a ess the memory reading, press the mode button (Figure 3-C) on e. Press the "up arrow"
key (Figure 1-G) and M1 (Figure 5-3) will appear on the s reen. After a few se onds the last
heart rate and SpO2 reading (Figure 5-1, 2, 3, 9&10) will appear on the s reen. To a ess
earlier readings, use the "up arrow" key (Figure 1-G). By using both arrow keys (Figure 1-F&G)
you an toggle between memory entries. The last entry will appear as M1 and the earliest
memory entries will appear after that in hronologi al order.
6. Q: How do I delete the memory from the PulseOx?
A: Press the mode button (Figure 3-C) four times. The LCD s reen will show Mode 4 and "dEL". If
in fa t you wish to delete the stored SpO2 and heart rate reading from the memory, press
both up and own arrow together (Figure 1- F&G). The "dEL" will flash and double beep will
sound on e. The memory has been deleted.
7. Q: How do I hoose the volume of the buzzer?
A: To adjust the level of the buzzer, press the mode button (Figure 3-C) twi e so that the message
Mode 2 appears on the s reen. There are 4 levels. To adjust the buzzer press on the up arrow
to in rease or down arrow to de rease the buzzer intensity (Figure 1 F&G) desired. The buzzer
an be muted as well. Note: It is only ne essary to set the volume level on e, as the set-up
memory maintains the buzzer levels even after the PulseOx has been turned off and
restarted.
8. Q: How do I turn the buzzer off ompletely?
A: The buzzer off level is number one of the four buzzer level modes. See FAQ #7 above for
adjustment of the buzzer volume.
9. Q: How do I hoose the intensity of the ba klight?
A: To adjust the s reen illumination, press the mode button (Figure 3-C) three times so that the
message Mode 3 appears on the s reen. Then press on the up arrow to in rease or down
arrow to de rease (Figure 1 F&G) for the ba k light intensity desired. There are 5 levels of light
intensity from full to off. Note: It is only ne essary to set the light intensity on e as the set-up
memory maintains the light intensity level even after the PulseOx has been turned off and
restarted.
9
10. Q: How do I hange the battery?
A: Using a standard Phillips s rewdriver, arefully remove the s rew (Figure 2-J) that affixes
the battery over (Figure 2-H). Then slide off the over. Carefully remove the old batteries.
Dis ard the used batteries a ording to lo al environmentally regulations. Insert 2 new AA
batteries into the battery ompartment. Ensure that the battery polarization (+/-) is in
a ordan e with the symbols within the battery ompartment. Slide the battery over ba k into
its pla e and return the s rew to the hole and affix in pla e. Press the On/Off button A working
PulseOx indi ates orre t battery pla ement.
11. Q: Where an I pur hase a new battery?
A: AA batteries are readily available in most stores. It is re ommended to pur hase high
quality and long lasting batteries (1,200mAh) to ensure the proper fun tion of the PulseOx.
12. Q: Where an I pur hase a repla ement sensor for the PulseOx?
A: Conta t your lo al dealer or send an e-mail to support@spomedi al. om and your query will
be dire ted a ordingly.
13. Q: What is the normal range for ea h display (SpO2 and heart rate)?
A: Individual normal ranges should be defined by you physi ian.
14. Q: Can I put the PulseOx on a wet (or bloody) finger?
A: No. This model is not water resistant and, therefore, exposure to ex essive moisture will
damage the PulseOx and void the warranty. Wipe all moisture from the finger before
inserting it into the thimble. If finger is injured or bleeding, use a different finger.
15. Q: The PulseOx dropped into water. What an I do?
A: Turn the unit immediately off and remove the batteries.
Dis ard the unit at your lo al ele troni s re y ling enter.
Do ument # 004-DMR-004-04 RL: 02 Mar-16-2008
10