Ohmeda Biox 3700 Operating instructions

Ohmeda Biox 3700 Pulse Oximeter
Operating /Maintenance Manual
Ohmeda j^TS - (tOto) 3VS- Z?£>& p/n 3§M>900-001
PO Box 914 ^~ (1118-300)
Boulder CO 80303 Revision F
303-44^9842- fg^'lOOi
800 652 2469 All specifications subject
Telex 296 445 BTI UR to change without notice.
BOC Health Care Printed in USA

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1118-301
TABLE OF CONTENTS
LIST OF ILLUSTRATIONS
'* 1-2
DEFINITIONS
* Sr:::::::: 3
4-5
USER RESPONSIBILITY/TRACEABILITY
INTRODUCTION/GENERAL DESCRIPTION
PRINCIPLES OF OPERATION
8-12
DEFAULT SETTINGS
13
PREOPERATIVE CHECKLIST
'•••• ••••• 14-16
GENERAL OPERATION GUIDELINES (Quick Start Dp) 17.19
FEATURES AND CONTROLS OF THE FRONT PANEL AND REAR PANEL 20-25
HANDLE POSITIONING
26-27
SPECIFICATIONS
28-31
SIGNAL AND DATA VALIDITY.. (DfPORTAIITrREAD THIS SECTION) 32-34
SET UP
35-36
PREPARING THE PATIENT n, lfx
* Attachment of the Ear Probe 17 ™
* Attachment of the Finger Probe [[[ oqfn
* Attachment of the Flex Probe 41 7n
Adult Application \]\\\ 4J J
Removing the Flex Probe [] 45_46
Neonatal Application \,\\ 47-49
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TABLE OF CONTENTS
1118-301
LIST OF ILLUSTRATIONS
DEFINITIONS 3-5
* Warnings
* Cautions " !
•••••• 4-5
USER RESPONSIBILITY/TRACEABILITY
• • .....6
INTRODUCTION/GENERAL DESCRIPTION 7
PRINCIPLES OF OPERATION 0 ,„
DEFAULT SETTINGS 13
PREOPERATIVE CHECKLIST ,, %,
•• • 14-16
GENERAL OPERATION GUIDELINES (Quick Start Dp) 17.19
FEATURES AND CONTROLS OF THE FRONT PANEL AND REAR PANEL 20-25
HANDLE POSITIONING .,, .,
SPECIFICATIONS
SIGNAL AND DATA VALIDITY.. (WPORTAHTrRKAD THIS SECTION) 32-34
SET UP 35-36
PREPARING THE PATIENT
•* • •••• 37-49
* Attachment of the Ear Probe 37 o8
* Attachment of the Finger Probe \\\\\\\ 39I40
* Attachment of the Flex Probe .".".".".".'!.".*.'."41-49
Adult Application !!!!!!!!!!!*" 41-44
Removing the Flex Probe \\\\\\\\\\\\45-46
Neonatal Application !!!!!!!.47-49
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TABLE OF CONTENTS
STRESS AND EXERCISE TESTING.,,, cn c/
* Set-up Patient «-n .,
* Set-up Oximeter Z,,
A*> • 54
MESSAGES.* „ ,
55-63
* Status Messages Description 55-58
* Alarm Messages Description..... !!.!!!!..*!59-63
Patient Alarm Limit Condition •!!!!!!!!...59
Probe Alarm Condition !!!!!!!!!!!*" 59
Device Failure Alarm Cpndition !1!!!!!!!!!!!!!!!59
TREND 20/60 ,. ..
v' . . ... . ,,. , „v,#•••••••••♦••••••••••••• .64-66
* Description ,. ,
* Restoring Previous Trend Data "!"!^*""!**^!!!65-66
OHMEDA SINGLE OR DUAL CHART RECORDER CONNECTION 67-70
CONNECTION WITH CHART RECORDERS, POLYGRAPHS
AND OTHER RECORDING EQUIPMENT 71
ANALOG OUTPUT OF TREND DATA ....72-73
DIGITAL INTERFACE
•• •••••••• •••.••••• .74
COMPUTER INTERFACE V>-$>1
* Connection with an IBM PC • 7S 7Q
* Auto-Dump Mode i!!!.*!!.".".*!!."."!!,. 80
* Trend-Dump Mode.(Digital Output) !!! qi
* Slave Mode •••?;
* Control Mode !!!!!!!!!!!!!!!. 82
MAINTENANCE Q, Q,
* Cleaning and Sterilization 83-84
* Recharging the Battery *!*!!!*!!!!!!!...85
* Calibration Procedure ....!!!!!!* 86
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1118-301
TABLE OF CONTENTS
PARTS LIST „... , . %>7X-.: 'VA ..2-iTi."
""•'•<••••. g7
REPAIR POLICY AND PROCEDURE <e • -.'•'•- -~' QQ
APPENDIX OF MESSAGES "*• "
* 89-91
TABLE OF KEYS -, -.-* /. „„„
• 92-93
INDEX r ••• B-c ,
• *• • • • • • i i 94-98
WARRANTY . ....
c •'•••'• • 99
,....; . 1 » * » * 5 • » » * -> " J *- ' * - ' " '
. x • -j
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•'-••iCi' vv.- _
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LIST OF ILLUSTRATIONS
TRACEABILITY REGISTRATION CARD......... „....wrtr....
-.. ..... ... ...^^-^. .» 6
EXTINCTION V.S. WAVELENGTH GRAPH
FRONT PANEL.
20, 23, 24
GRAPHIC DISPLAY 20
DIGITAL DISPLAY... 22
REAR PANEL
OXIMETER POSITIONED ON FLAT SURFACE o*
FRONT OF OXIMETER RAISED 0,
HAND CARRY 26
HOOKED ON TO BED RAIL
TYPICAL PHOTO-PLETHYSMOGRAPHIC WAVEFORM 32
NOISY PHOTO-PLETHYSMOGRAPHIC WAVEFORM 33
NOISY PHOTO-PLETHYSMOGRAPHIC WAVEFORM. (Noise Spikes) 33
PLACEMENT OF EAR PROBE ON THE EAR LOBE.(Side View) 37
CORRECT FINGER PROBE ATTACHMENT
FLEX PROBE ATTACHMENT.(ADULT) 4l_44
REMOVING THE FLEX PROBE
• ••••••••••••• 4ij
FLEX PROBE ATTACHMENT. (NEONATAL) 47.49
ATTACHMENT OF STABILIZER TO EAR PROBE 50
PLACEMENT OF THE EAR PROBE ON THE EAR LOBE.(Side View) 51
PLACEMENT OF THE EAR PROBE ON THE EAR LOBE.(Back View) 51
STRESS TESTING - PATIENT SET-UP.(Side View) 52
STRESS TESTING - PATIENT SET- UP.(Side View) 52
20 MINUTE TREND GRAPH
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LIST OF ILLUSTRATIONS
60 MINUTE TREND GRAPH
20 MINUTE TREND GRAPH OF RESTORED TREND DATA ,.*...... 66
OHMEDA CHART RECORDER CONTROL PANEL ,-, ,R
REAR PANEL '
............71
CHART PAPER WITH TICK MARK
DIGITAL INTERFACE CONNECTOR...1
•••••••••• i. ...74
:'Hf, '4
*•' 1?
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1118-301
WARNINGS
A WARNING INDICATES A POTENTIALLY HARMFUL SITUATION.
ELECTRICAL SHOCK HAZARD: Do NOT remove top cover. Refer to
qualified personnel.
FAILURE OF OPERATION: If the oximeter fails to respond as
described do NOT use it until the situation has been corrected
by qualified personnel. (See Page 14, 18)
EXPLOSION HAZARD: Do NOT use in the presence of flammable
anesthetics. (See Page 17)
DATA VALIDITY: Do NOT expose the probe detector to strong
ambient light while it is being used to monitor a patient. A
poor signal may result.
(See Page 19, 51)
fnff^^r00 KI •"«*«" P"be to the same limb with an
inflated blood pressure cuff. Valid data will NOT be received
when cuff, is inflated. Attach probe to the limbTpposite the
site used for the blood pressure cuff. (See Page 35)
PATIENT SAFETY: Patient condition may require changing the
probe test site periodically. This should diminish the possi
bility of pressure necrosis of the test site.
(See Page 35, 47-48)
PATIENT SAFETY: Exercise extreme care to assure continued cir
culation distal to probe site after application. (See Page 47)
ELECTRICAL SHOCK HAZARD: Always turn the power OFF before
cleaning the oximeter. (See Page 83)
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1118-301
CAUTIONS
A CAUTION INDICATES A CONDITION THAT MAY LEAD TO
EQUIPMENT DAMAGE OR MALFUNCTION.
Federal law in the U.S.A. and Canada restricts this device to
sale by or on the order of a licensed medical practitioner.
(See Page 6)
Use only the probes supplied for this model of Oximeter. Check
the Identification Number/Serial Number Tag (A) which is located
MOD «?9 9Cannv ""on^6 connector- The model number must read: "'
MOD 8 22-00X or 8 21-00X (X represents a digit from 1 through
5). (See Pages 15, 17, 22, 36)
<C.
ll.T^Tel^TlTsT)che probe cable* (See Pages 18,36j 38>
Check rear panel voltage setting before connecting the Oximeter
to AC mains power (USA 120 VAC). (See Page 25)
Avoid storing the Oximeter and probes at temperatures exceeding
-20 degrees C (-4 degrees F) to 60 degrees C (140 degrees F).
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1118-301
CAUTIONS
A CAPTION INDICATES A CONDITION THAT MAY LEAD TO
EQUIPMENT DAMAGE OR MALFUNCTION.
Federal law in the U.S.A. and Canada restricts this device to
Page 6) °r °n thS °rder °f llcensed medical Petitioner. (See
Use only the probes supplied for this model of oximeter. Check
the Identification Number/Serial Number Tag (A) which is located
SSn fl?95annv ^n^T"0^ ^ model nuraber mus* read:
MOD 8122-OOX or 8121-OOX (X represents a digit from 1 through
5). (See Pages 15, 17, 22, 36) 8
Do NOT apply tension to the probe cable.
40, 44, 46, 49, 51, 53)
(See Pages 18, 36, 38,
Check rear panel voltage setting before connecting the oximeter
to AC mains power (USA 120 VAC). (See Page 25)
Avoid storing the oximeter and probes at temperatures exceeding
-20 degrees C (-4 degrees F) to 60 degrees C (140 degrees F).
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1118-301
USER RESPONSIBILITY
This Product conforms to its operation and design specifications as
described in-this manualand any accompanying labels and/or inserts, when
operated, maintained, and repaired in accordance with the instructions
lllllnt 1? J*" USe a d6feCtive Prod-<- ^place parts that are broken,
missing, plainly worn, distorted or damaged in any way immediately. This
product or any of its components should be repaired by Ohmeda trained
^r0nf!i' t*7 excePtlons t0 thls recommendation must be made according to
bv cZl* r i"Stru"ions Provided by Ohmeda. When service is not provided
by Ohmeda Customer Service Personnel, the user of this product shall have
the sole responsibility for any losses incurred during unauthorized main
tenance, as a result of improper repair, damage, or alteration.
TRACEABILITY
Federal law in the U.S.A. requires traceability of this equipment. Please
Jm. °Ut/h! "^"addressed traceability registration card included with
this product and return it to Ohmeda Boulder. If additional cards are
required, order stock number 380-0900-005.
SAMPLE CARD
NOTE:
Traceability Registration/WarrantyInformation
Federal law requires traceability ofthis equipment.
Federal regulations require u0 to obtain this information in order to maximize our O
raaponsa to youinthe avant ofarecall ™™nuw our w
FacttltyName: ^EITIHIQIDII lfl|T| MoIsIpIi ItUIU IIIIIII|| a1
ContectNama: [jTqIhIhI IdJOIkI III TTTTTTTI Dapt: (bIBSIpI |
Addraaa: [JBiff IsIqIuItIhI llfU|||M| IsItI.I I I I I I I I II I I *
CUy: lYl^Uim iTioh.lHl II IJJJ ~" " LU' • LLI III
Country: |u|s|a| I 1 I I I | | | | 1
Oparator'a Manual PartNo. &Revision:
Service ManualPart No. atRevision:
Date Received: _M_/ D / V
Signature: ^ StU.
H] state: |gg zip: (alblalbli
SarialNo.:[TTl|6|-|7lolololon
hlililal-lslolol/lDl I I I I
lilililel-lalolal/lBl I I I I I
Date: M / p / y
CADTIOH Federal law in the U.S.A. and Canada restricts this
device to sale by or on the order of licensed medical
practitioner.
The Oximeter serial number is located on the rear panel.
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INTRODUCTION
This manual describes the proper operation and maintenance for the Ohmeda
Biox 3700 Pulse Oximeter. Operators, please read this manual before using
the Pulse Oximeter, paying attention to all details of correct operation
along with precautionary measures recommended. All maintenance procedures
in this manual are designed to be performed by the operator of the
oximeter.
GENERAL DESCRIPTION
The Ohmeda Biox 3700 Pulse Oximeter is a stand alone, noninvasive, arterial
oxygen saturation monitor. Ear, finger or flex probes connect the monitor
to the patient, and provide continuous oxygen saturation (Sa02) and pulse
rate readings.
The oximeter determines a patient's arterial oxygen saturation and pulse
rate by measuring the absorption of selected wavelengths of light. The
light generated in the probe passes through the tissue and is converted
into an electronic signal by the photodetector. The electronic signal
passes to the oximeter and is amplified. Analog and digital signal pro
cessing converts the light intensity information into Sa02 and pulse rate
values. Two liquid crystal displays (LCD) present patient data and status
information. The numeric digital LCD displays Sa02 and pulse rate, while
the graphic LCD displays the plethysmography waveform, trend data, status
messages and alarm messages.
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1118-301
PRINCIPLES OF OPERATION
THEORY
thaVhemoSn °V!* T™** B±°X 37°° °Ximeter is based ™ «*• assumption
that hemoglobin exists in two principle forms in the blood:
* oxygenated (with 02 molecules loosely bound) or Hb02
* reduced (with no molecules bound) or Hb.
Arterial oxygen saturation (Sa02) is defined as the ratio of oxygenated
^TesTii .•n.ss irsr tHb°2+Hb (+ ocher "£wz-
)]
Hb02
SaO-
Hb02 + Hb (+ other forms of hemoglobin
present in arterial blood)
iVthroueh Tllvltl M6 abs0rp"on °f ••l«ct«l wavelengths of light pass
ing through a living tissue sample. Since oxygenated heraoelobin and
reduced hemoglobin absorb light as known functions of wavefengtns the
relative percentage of these two constituents, and SaO, are cflcuiated
differentiating w '" T1!""8 °XiBetry £he°r* lnt° -di^l^ev e'is
alobin and It* I? '"! absorPtion due « oxygenated and reduced hemo
globin and the absorption due to all other tissue constituents.
The Ohmeda Biox 3700 solves this problem with a patented two waveleneth
calculations, by using the pulsatile portion of the incoming signal"
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1118-301
Two wavelengths of light, red and infrared, are utilized to gauge the
presence of oxygenated and reduced hemoglobin.
600
700 800 900
WAVELENGTH (ran)
(INFRARED)
840nm
1000
EXTINCTION versus WAVELENGTH GRAPH
Oxygenated hemoglobin (Hb02) exhibit markedly different
absorption (extinction) characteristics to red light @
660nm and infrared light @ 940 nm.
InH Son ?I Phot°detector converts the light, which is partially absorbed
and modulated as it passes through the tissue sample, into an electronic
signal. Since Hb02 and Hb allow different amounts of light to reach the
photodetector at the selected wavelengths, the electronic signal varies
heC^Mn0" tk Ught S°UrCe iS "°n" and the oxy^nation of the arterial
hemoglobin. The oximeter amplifies the electronic signals received.
Mni°? !n c igUai Si?nal Processin« averts the light intensity informa-
front panel 2 * "" ValU6S ^ disPlays thera on the oximeter
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FUNCTIONAL COMPONENTS
The Ohmeda Biox 3700 uses electriral M„,„rtnM» *
discussion explains the function ol! C°np0nents ln siS^l processing. This
* the probe
* the analog and digital electronics
* the calculations the microprocessor makes.
TIMING
CONTROL
DIGITAL
PROCESSING
PROBE
ANALOG
PROCESSING
A/D
CONVERTER
DISPLAY
PROBE
The probe consists of: the light source, and the photodetector.
IT Hfm em,ittln* diodes <LEDs> impose the light source of the Ohmeda
Biox 3700 oximeter:
*one Red (R)
* one Infrared (IR).
The photodetector is a photodiode: An electronic device that produces an
electrical current proportional to incident light intensity.
The photodetector sees only light energy and does not distinguish between
light wavelengths. The timing circuitry sequences the Red and Infrared
light sources on and off. The established timing sequence is:
* red LED on
* infrared LED on
* both LEDs off.
This sequence repeats itself. This cycling occurs 480/400 (60/50 Hertz)
times per second allowing the photodetector to quantify the light energy at
the appropriate wavelengths by producing a current at appropriate points in
the cycle. The on/off LED cycling also determines the effect of ambient
light hitting the photodetector. The off point or "dark" portion in the
light sequence is measured and utilized to eventually cancel the effects of
the ambient light. The photodetector produces current and an operational
amplifier in the oximeter converts it to voltage for further processing.
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1118-301
ANALOG PROCESSING
The cycling routine takes many measurements and two separate voltage
"channels" emerge:
* one for Red light
* one for Infrared light.
sentefbeJowt8"31 generated" as le relates t0 "•*' absorption, is repre-
>a«",*/a«o
,o a
TIMt
vwuabli A8soivt:ch cr
AATSHAL BLCCO
AaseR.*t:cN oox to
VWCW ILOCO
A3S0WTXCN OOX TO 0THI3
TISSUE '
The photodetector detects changes in light
intensity indicating absorption.
inlrJ^r 0g % "" Pul8atile ">"•*• levels (one for red and one for
infrared) are left to pass "downstream" for further processing.
The A/D Converter takes the pulsatile sisnala fmm .h. mi.
them to digital sienals A J^ZZ™™ signals from the filters and converts
h«i-»™<-7 Zu Slgnals' A microprocessor performs complex calculations
determining the saturation of measured arterial blood. cai=u"tions
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1118-301
DIGITAL PROCESSING
A. From theory, oxygen saturation calculates as:
Sa02 = KIR2 + K2R + K3
where R- A red and K1 f K2, K3 are
A *R constants
where oxygen saturation at any point in time is a function of the
change in the red channel divided by the change in the infrared
S?iK«M °P«?aJ characteristics of hemoglobin are the basis of the
in«™? COefficlents: K1> K2» ™* K3. The oximeter processes the
" t;na2?J 0Xyfn ^turation values to produce the "average saturation
vaiues. This value appears on the oximeter's digital display.
One key digital processing function is to properly average the instan
taneous oxygen saturation values. A running average gives a reasonable,
but not excellent result. A weighted average of instantaneous values pro
vides for a much more acceptable result. Perfusion at the test site and
the current average saturation are the basis for the weight assigned to
each instantaneous calculation. For example, movement at the probe site
can create signal distortion, thus creating some erroneous instantaneous
oxygen saturation values.
Since there are many saturation measurements per second, it is possible to
discard bad values away and the displayed saturation remains stable. The
weighting function provides a stable reading, with low sensitivity to
11 ie/etain!ng the caPabilitv ot responding quickly to saturation
£«£/? \ V1/^ ,ngt wei*hted average uses data over a six/three (Slow
Mode/Fast Mode) of data and is updated every 0.67/0.33 (Slow Mode/Fast
Mode) seconds.
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1118-301
DEFAULT SETTINGS
matilaUv Tf ™l '"V '° * V°lume LeVel or Hi^^ "*™ Umit auto
matically set by the oximeter when it is turned on.
PARAMETERS
High Sa02 Limit
Low Sa02 Limit
High Pulse Rate
Low Pulse Rate
Alarm Volume
Pulse Volume
DEFAULT SETTINGS
OFF indicated by
90%
OFF indicated by
50 BPM
4
4
B.P.M. » Beats Per Minute
- 13 -
RANGES
70 - 100%
50 - 100%
70 - 250 BPM*
40 - 200 BPM
1-10
OFF - 10
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PREOPERATIVE CHECKLIST
Perform the following tests daily to assure proper operation of the ^
oximeter. Do NOT use the oximeter-if it fails any test. Remove it from
use until the situation has been evaluated, and the product repaired and
checked for correct operation.
WARNING FAILURE OF OPERATION: If the oximeter
fails to respond as described, do NOT use
it until the situation has been corrected
by qualified personnel.
OXIMETER
VISUAL INSPECTION
1. Inspect the oximeter case for damage.
2. Ensure the display windows are clean. (See page 83)
FUNCTIONAL INSPECTION
1. Connect a probe to the oximeter. Attach the probe to either finger
2.
3.
4.
Turn the oximeter on. Verify that the oximeter disolavs "OHMFnA-RTnY
00 REVISION: X SYSTEM CHEcl IN PROCESS" "riV^ d^agnos^c* ^
seir-test. Verify that the Status Message "SYSTEM OPERATIONAL"
appears on the Graphic Display after the diagnostic self-test.
Adjust the displays with the Viewing Angle Thumbwheel Adjustment if
necessary. J
^H£y that high and low Sa02 and pulse rate alarm limits and read
ings appear on the Digital Display.
Verify that the Patient Alarms are functional. Set the high and low
Sa02 and pulse rate alarm limits beyond the patient readings. Ensure
the alarm tone sounds, and the violated alarm limit and reading
flashes on the Digital Display.
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