Model 31DT POX Manual - English: Low Res

Userʼs Manual
MEDIAID INC.
17517 Fabrica Way Suite H
Cerritos, CA 90703 USA
(Tel) 714-367-2848 (Fax) 714-367-2852
Email: info@mediaidinc.com
Website: www.mediaidinc.com
Model 31DT
Pulse Oximeter User’s Manual
17517 Fabrica Way Suite H
Cerritos, CA 90703 USA.
(Tel) 714-367-2848
(Fax) 714-367-2852
Email: info@mediaidinc.com
website: www.mediaidinc.com
© Mediaid Inc. - All rights reserved
1002-60066-000
ii
TABLE OF CONTENTS
CHAPTER 1: INTRODUCTION ........................................................................... 1
INTENDED USES ........................................................................................
GENERAL OPERATING PRINCIPLES AND CONDITIONS .......................
INTRINSIC CALIBRATION ..........................................................................
PRINCIPAL FEATURES ..............................................................................
CAUTIONS ...................................................................................................
1
1
1
1
2
CHAPTER 2: KEYS, INDICATORS, SYMBOLS AND MARKINGS .................... 5
PULSE OXIMETER FRONT, BACK & SIDE VIEW ..................................... 5
KEYS AND INDICATORS ............................................................................ 6
SYMBOLOGY AND MARKINGS ................................................................. 9
CHAPTER 3: INITIAL SETUP ........................................................................... 10
UNPACKING AND INSPECTION .............................................................. 10
LIST OF COMPONENTS ........................................................................... 10
MONITOR SETUP ..................................................................................... 10
CHARGING THE BATTERY ...................................................................... 11
POWER ON ............................................................................................... 11
SENSOR CABLE CONNECTION .............................................................. 12
CHAPTER 4: OPERATING THE MODEL 31DT PULSE OXIMETER ................ 13
MONITORING PULSE OXIMETERY ......................................................... 13
PERFORMANCE CONSIDERATIONS ...................................................... 14
ADJUSTING THE ALARM SETTINGS ...................................................... 14
CHAPTER 5: SPECIAL KEY FUNCTIONS ...................................................... 16
POWER ON FUNCTION OF A KEY .......................................................... 16
DIAGNOSTIC TEST ................................................................................... 16
CHAPTER 6: SPECIFICATIONS ....................................................................... 17
PERFORMANCE ....................................................................................... 17
ELECTRICAL ............................................................................................. 17
ENVIRONMENTAL .................................................................................... 18
PHYSICAL ................................................................................................. 18
COMPLIANCE ........................................................................................... 18
CHAPTER 7: ACCESSORIES .......................................................................... 19
SENSORS .................................................................................................. 19
BATTERY ................................................................................................... 19
iii
CHAPTER 8: TROUBLESHOOTING ................................................................ 20
CLEANING ................................................................................................. 20
TROUBLESHOOTING ............................................................................... 20
ERROR CODES ........................................................................................ 20
CHAPTER 9: PRINCIPLES OF OPERATION ................................................... 22
OXIMETRY OVERVIEW ............................................................................ 22
HOW PULSE OXIMETERS WORK ........................................................... 23
CALIBRATION OF PULSE OXIMETERS .................................................. 24
VALIDATION OF ACCURACY ................................................................... 24
CLINICAL USE OF PULSE OXIMETERS .................................................. 25
CHAPTER 10: MEDIAID INC. LIMITED WARRANTY ....................................... 26
APPLICABILITY OF WARRANTY ............................................................. 26
WARRANTY COVERAGE ......................................................................... 26
MEDIAID INC. PROBLEM CORRECTION PLAN ...................................... 26
OWNERʼS REGISTRATION ...................................................................... 27
CHAPTER 11: USER REFERENCES ............................................................... 28
CONTACT / CUSTOMER SERVICE INFORMATION ............................... 28
PRODUCT INFORMATION ....................................................................... 29
WARRANTY REGISTRATION FORM ............................................................... 31
iv
CHAPTER 1:
INTRODUCTION OF THE MODEL 31DT PULSE OXIMETER
Before using the pulse oximeter, the user should become thoroughly familiar
with the information in this manual and with all information included with the
sensor.
INTENDED USES
The Model 31DT is for prescription use only. The Mediaid Model 31DT pulse
oximeters are intended to non-invasively measure arterial oxygen saturation and
pulse rate in hospitals, physician’s offices, emergency medical facilities, or at home.
IMPORTANT NOTE:
The Mediaid Model 31DT pulse oximeter does not have storing and retrieval
of data facility such as IR, USB features.
GENERAL OPERATING PRINCIPLES AND CONDITIONS
The Mediaid Model 31DT pulse oximeter is designed to measure the percentage of
functional oxygenated hemoglobin to total hemoglobin.
Noninvasive arterial oxygen saturation measurement is obtained by directing red and
infrared light through a pulsating vascular bed. The pulsating arterioles in the path of
the light beam cause a change in the amount of light detected by a photodiode. The
pulse oximeter determines the oxygen saturation of arterial blood by measuring the
ratio of transmitted red to infrared light within the pulse waveform. The non-pulsatile
signal is removed electronically for the purpose of calculation. Therefore, skin, bone,
and other non-pulsating substances do not interfere with the measurement of arterial
oxygen saturation.
INTRINSIC CALIBRATION
The light absorption by hemoglobin is wavelength-dependent. Mediaid
red and infrared LED (light emitting diode) wavelengths are tightly
controlled by testing in production.
PRINCIPAL FEATURES
The Mediaid Model 31DT pulse oximeter is a lightweight Desk Top
instrument designed to monitor both functional arterial oxygen saturation (SpO2) and pulse rate non-invasively.
The principal features of the Model 31DT pulse oximeters are as follows:
•
Displays SpO2 percentage (%SpO ) and pulse rate (BPM: Beats per
minute) on a 3-digit, 7-segment LED Display.
•
Displays Perfusion Quality (PQ) & Pulse Amplitude (PA) in 10-bar
bargraph displays.
1
INTRODUCTION OF THE MODEL 31DT PULSE OXIMETER
•
Works with any Mediaid sensors with the CompuShield® connector.
•
Provides increased longevity and functionality to the pulse oximeter
with the removable and replaceable sensor modules.
•
The Model 31DT has visual and audible alarms for oxygen saturation
and pulse rate.
•
The Model 31DT can be powered by Standard electric power.
CAUTIONS
General Cautions
•
The Model 31DT is restricted to sale by or on the order of a physician.
It is a prescription device and is to be operated by qualified personnel
only.
•
Become thoroughly familiar with the information in this user’s manual
and all the other accompanying documents before using the pulse
oximeter.
•
Do not attempt to modify or repair the pulse oximeter – doing so voids
the warranty.
•
Dispose of this instrument and its accessories according to governmental regulations and WEEE norms.
•
Adhere to all cautions, stipulations, and instructions included with the
sensors used.
•
Explosion hazard. Do not use Model 31DT in presence of flammable
anesthetics or gases. Do not use Model 31DT in presence of any
flammable agents.
•
The use of equipment is restricted to one patient at a time.
•
Use accessories specified by our company only, otherwise; the device
may not function normally.
•
The system may not meet its performance specifications if stored or
used outside the specified temperature and humidity ranges.
•
Do not drop the Model 31DT oximeter or its accessories which may
result in certain damages.
•
Do not use a Model 31DT oximeter, AC power cord, sensor, sensor
cable or connector that appears to be damaged or broken. Failing to
comply with this may result in damage or electric shock hazard to the
user/operator as mechanical/electrical integrity of the monitor and/or its
accessories could have been hampered.
2
INTRODUCTION OF THE MODEL 31DT PULSE OXIMETER
•
Use of damaged sensor or oximeter may result in erroneous or faulty
readings or no alarm.
•
Do not attempt to lift the oximeter by its mains power cord (or) sensor
cable. Any attempt made to lift may result in the detachment of the
cables and the fall of the oximeter resulting in damage.
Environmental Cautions
•
Do not use the pulse oximeter in the presence of flammable agents or
flammable anesthetics.
•
Do not immerse in liquid and do not allow any liquid to penetrate the
pulse oximeter`s interior.
•
Operate the pulse oximeter in normal light conditions.
•
Avoid bright light or glare on the sensing area to ensure correct reading
of the displays and indicators.
•
Keep away from MRI (Magnetic Resonance Imaging) equipment.
•
Move the pulse oximeter away from other electromagnetic emitting
equipment if you experience interference problems.
•
Keep away from the equipment that emits x-ray, alpha particles, beta
particles, neutrons particles, or microwave emissions.
Battery Cautions
•
Use only Li-ion batteries specified by Mediaid. Use of any other type of
battery not specifically recommended. Use of such batteries could
damage the pulse oximeter.
•
Never dispose of batteries into fire, short-circuit the terminals, or
attempt to disassemble or heat the battery. Doing so could damage the
battery and cause a fire, injury, or environmental contamination.
Dispose as per WEEE norms.
•
Liquid leaking from battery can cause skin burns or damage the pulse
oximeter. If a battery leaks inside the instrument, return the pulse
oximeter for servicing.
•
Remove the battery during shipment or if the pulse oximeter will be
idle for several weeks.
Preventing Device Complications and Faulty Readings
•
Trim the patient`s long fingernails and remove artificial nails or thick nail
polish.
•
Insert the patient`s finger completely into the sensor.
•
Fit the sensor comfortably without constricting or compressing the
application site when using a sensor that is attached to the cable
adaptor.
•
Do not apply the sensor to anything but a well-perfused extremity.
3
INTRODUCTION OF THE MODEL 31DT PULSE OXIMETER
•
Cold extremities can affect readings. Warm up the extremity, or move
the sensor to a different site, if necessary.
•
Check for intravascular dyes, which could affect pulse oximeter
readings.
•
Turn off very bright lights, such as surgical, bilirubin, fluorescent, or
infrared heating lights if they interfere with sensor functioning. In
cases where such lights are unavoidable, cover the sensor site with an
opaque material.
•
Route sensor cords carefully.
•
Avoid applying excessive tension to the sensor or sensor cord.
•
Consider conditions affecting the hemoglobin dissociation curve when
interpreting pulse oximeter readings (such as intravascular dyes).
•
Keep patient movement to a minimum.
•
When not in use, do not wind the sensor cord around the pulse
oximeter.
4
CHAPTER 2: KEYS, INDICATORS, SYMBOLS AND MARKINGS
PULSE OXIMITER FRONT VIEW, BACK VIEW & SIDE VIEW
3
2
4
10
5
Fig 1
1
Fig 2
Fig 3
5
9
8
7
6
KEYS, INDICATORS, SYMBOLS AND MARKINGS
KEYS AND INDICATORS
1. POWER ON/OFF SWITCH
The POWER ON/OFF SWITCH is located at the left hand side of the oximeter.
When this Switch is turned OFF the oximeter gets totally isolated from AC
mains. When this Switch is turned ON, the oximeter gets powered from AC
Mains, when it is connected to AC Mains, else it gets powered by internal Li-ion
battery.
2. ON / OFF KEY
When the POWER ON/OFF SWITCH is turned ON, the unit is switched ON with
a short depression of the ON/OFF KEY. A one-second display and indicator test
is performed automatically, and all the segments of Light Emitting Diodes
(LEDs) will be illuminated. The software version number will then be displayed
as “Ver” in %SpO2 display area and the version number in display area accompanied by a long beep.
Unit switches off automatically (auto-power off) when there is no sensor
connected or no finger in sensor for more than 2 minutes.
The unit power OFF with a short-depression of the Power ON/OFF Key.
3. BATTERY LEVEL INDICATOR
The Battery level indicator displays the battery level in a scale of 3. If the unit is
connected to external power supply for charging (irrespective of whether the
power ON / OFF key Switched ON or OFF), then the level indicator glows Green
and displays the charging status. The LSB LED glows, if the charger is
connected. The LSB & Middle LEDs glow, if the unit is partially charged. All 3
LEDs LSB, Middle and MSB glow if the unit is completely charged.
If the unit is operating in Battery mode, then the battery level indicator glows in
Red. All three LEDs (MSB, Middle, LSB) glow if the battery voltage is between
95% to 100% voltage. 2 LEDs glow (middle & LSB) if the battery voltage is in the
range of 90% to 95%. One LED (LSB) glows ON if the battery voltage is in the
range of 80% to 90%.
CAUTION: Below 80% the LSB LED blinks indicating that the battery is near
depletion and it is advisable to charge the battery.
6
KEYS, INDICATORS, SYMBOLS AND MARKINGS
4. ALARM OFF (MUTE) KEY
A short depression of this key silences the alarm for a period of 60 seconds.
The ALARM OFF INDICATOR illuminates and remains on constantly, and the
oximeter monitors normally. Silenced alarms can be reactivated by a short
depression of the ALARM OFF KEY or automatically after a period of 60
seconds regardless of new alarms. Press and holding this key for more than
6 seconds activates permanent silence of Alarm.
CAUTION: Do not silence the audible alarm or decrease its volume else the patient
safety could be compromised.
5.
ALARM OFF INDICATOR
The ALARM OFF INDICATOR illuminates and remains on constantly when
audible alarms are silenced.
6.
OXYGEN SATURATION ALARM KEY
Short depression of the OXYGEN SATURATION ALARM KEY toggles the LED
display between the high and low alarm settings, and respective HI/LO ALARM
INDICATOR glows below the key. These alarm settings are adjusted using UP
ARROW and DOWN ARROW KEYS. The alarm settings are retained in memory
until reset by the user. (The default alarm settings are minimum of 85% for Low
limit and 100% for high limit respectively. The display reverts back to normal
monitoring after six seconds of key inactivity or Mute key press. The high/low
reading of Oxygen Saturation keeps blinking when the reading is above the
maximum preset value and when reading is below the minimum preset value.
NOTE:
The Mediaid Model 31DT pulse oximeter CAN INDICA INDICATE TE the SpO2
values less than 85%, but the alarm would be continuously ON.
7. PULSE RATE ALARM KEY
Short depression of the PULSE RATE ALARM KEY toggles the LED display
between the high and low alarm settings and respective HI/LO ALARM
INDICATOR to glow above the key. These alarm settings can be adjusted
using UP ARROW and DOWN ARROW KEYS. The alarm settings are
retained in memory until reset by the user. The default pulse-rate alarm
settings are as per the patient type selected: High 170 BPM and Low 40
BPM. The display reverts back to normal patient monitoring after a sixsecond period of key inactivity or Mute key press.
7
KEYS, INDICATORS, SYMBOLS AND MARKINGS
CAUTION: Each time the monitor is used, check the alarm limits to ensure that
they are appropriate for the patient being monitored.
8. UP & DOWN ARROW KEYS
The pulse-tone volumes are adjusted using the UP & DOWN ARROW KEYS.
There are 5 levels of audible (pulse) tone volume, and “off.” The pulse tone
volume is increased with the UP ARROW key, and decreased or silenced with
the DOWN ARROW key. Default pulse-tone volume level is 3. Alarm levels are
also adjusted with these keys during alarm condition but the alarm volume is
never zero unless permanent silencing is selected.
9. VISUAL HI/LO ALARM INDICATORS
HI
LO
Located besides the OXYGEN SATURATION ALARM key and PULSE RATE
ALARM key, these indicators illuminate when the patient’s oxygen saturation or
pulse rate reaches the preset high or low alarm settings. While setting alarm
limits, the appropriate indicator is illuminated. During the high or low reading of
SpO2 or pulse rate corresponding indicator would be ON.
10. BAR GRAPH DISPLAY
The 10-bar bargraph display perfusion quality and pulse amplitude of the
signal.
8
KEYS, INDICATORS, SYMBOLS AND MARKINGS
SYMBOLOGY & MARKINGS
Symbol
%SpO 2
Definition
Oxygen Saturation Percentage
Heart Beats per Minute (BPM)
PA
PQ
Pulse Amplitude Indicator
Perfusion Quality Indicator
Power On/Off Key
Alarm Off Key and Indicator
Increment Key
Decrement Key
LO
HI
Low Alarm Indicator
High Alarm Indicator
Oxygen Saturation Alarm Key
Pulse Rate Alarm Key
Low Battery Indicator (Blinking Red LED)
Partially charged Battery Indicator (1 Red LED)
Partially charged Battery Indicator (2 Red LED)
Fully charged Battery Indicator (3 Red LED)
AC Power Connection
Attention: Consult Accompanying Documents
Non-anesthetic Proof
Type BF Applied Part
SpO 2 Sensor port
Waste Electrical and Electronic Equipment
9
CHAPTER 3: INITIAL SETUP
UNPACKING AND INSPECTION
Notify the carrier if the shipping carton is damaged. Unpack the model 31DT
and components.
If anything is missing or damaged, contact Mediaid Technical Support.
LIST OF COMPONENTS
1. Model 31DT Monitor.
2. Mediaid Reusable Sensor.
3. AC Power Cord.
4. Model 31DT User’s Manual.
5. Additional Accessories as ordered, if any.
MONITOR SETUP
General Warnings
WARNING: To ensure patient safety, do not place the monitor in any position that
might cause it to fall on the patient.
WARNING: As with all medical equipment, carefully route patient cabling to
reduce the possibility of patient entanglement or strangulation.
WARNING: Disconnect the Model 31DT and Mediaid sensor from the patient
during magnetic resonance imaging (MRI) scanning. Induced current could
potentially cause burns. The Model 31DT may affect the MRI image and the MRI
unit may affect the accuracy of monitor measurements.
WARNING: To ensure accurate performance and prevent device failure, do not
subject the Model 31DT to extreme moisture, such as direct exposure to rain.
Such exposure may cause inaccurate performance or device failure.
WARNING: Follow local governing ordinances, WEEE norms and recycling
instructions regarding disposal of device components, including batteries of the
Model 31DT.
WARNING: Do not use a Model 31DT monitor, AC Power cord, sensor, Sensor
cable or connector that appears to be damaged.
10
INITIAL SETUP
WARNING: When Model 31DT monitor is used along with other patient
connected medical electronic equipment, care should be taken to ensure that
the other medical electronic equipment and its sensor cables are safe to use.
Please refer to the manufacturer’s document for more information. Failing to
comply with this may result in electrical hazard, burns to the patient.
CHARGING THE BATTERY
Connect Model 31DT to AC Mains (Refer to the section “CONNECTING THE MODEL
31DT TO AC POWER SUPPLY”) and turn ON the POWER ON/OFF switch on the left
hand side of the monitor. The battery level indicator LED in the front panel glow in
GREEN color. In this mode, the battery gets charged.
The Battery level indicator displays the battery level in a scale of 3LEDs. If
the unit is connected to AC Mains for charging, then the LSB LED indicator
should glow in Green and display the charging status. LSB & Middle LEDs
glow, if the unit is partially charged (about 70%). All three LSB, Middle and
MSB LEDs glow if the unit is fully charged.
CONNECTING THE MODEL 31DT TO AC POWER SUPPLY
The power inlet is located at the rear of the monitor. Insert one end of the power cord
to the power inlet and the other end to the AC mains supply.
POWER ON
•
•
Switch on the ON/OFF SWITCH located at the left hand side of the
oximeter
Verify that the BATTERY INDICATOR is glowing in GREEN color. If it is not,
ensure that the POWER ON/OFF SWITCH is in the “ON” position. If the indicator
still does not light or glows in RED color, check the local AC power at the wall
outlet. If the problem still persists, contact Mediaid Inc. or the Mediaid local
authorized distributor/service center
Connect the sensor to the sensor port (Refer to the section SENSOR CABLE
CONNECTION) and switch on the ON/OFF KEY located at the front of the monitor.
Internal self tests will run and the unit enters the monitoring mode.
SELF TEST STATE
Fig. 4
11
INITIAL SETUP
After the pulse oximeter is switched on, all the segments of 7 segment LED
DISPLAY, BARGRAPHS are turned ON and all LEDs in the Keypad are also
turned ON for about 2 seconds. This is as a part of self test to ensure that all
display segments are functional. On completion of visual indicator test, the
software version number is displayed with a long beep for a second to ensure
that the audio circuitry is functional.
MODEL 31DT DISPLAYING SOFTWARE VERSION
Fig. 5
CAUTION: A non-functioning LED segment will result in an incomplete numeral and
possible erroneous reading.
CAUTION: A non-functioning beeper may result in compromising of patient safety.
Do not use model 31DT when there is no beep sound during self-test
SENSOR CABLE CONNECTION
All Mediaid Pulse Oximeter sensors with Compushield® connectors are compatible with the Model 31DT. To connect a sensor to the monitor, align the sensor plug
with the jack on the monitor’s sensor port and insert gently until an audible “click” is
heard. To remove, squeeze the locking tab on the plug and slide the plug out of the
jack. Always route cords in such a way so as to prevent accidental tripping and
subsequent damage to the monitor. Now insert the finger/ monitoring site in the
sensor completely.
WARNING: Compushield® connector of the sensor should be snug fit into the
female connector of the unit (with compulsorily two click sound). Failing which, the
monitor may show erroneous readings.
WARNING: Sensor should not be connected or disconnected while the unit
is ON. The unit should be powered off, before disconnecting and reconnecting the unit.
12
CHAPTER 4:
OPERATING THE MODEL 31DT PULSE OXIMETER
Monitoring Pulse Oximetry
The Mediaid model 31DT pulse oximeter does not have storing and retrieval of
data facility such as IR, USB features.
The Monitoring mode is started by placing the finger in the sensor and powering
on the monitor. In Monitoring mode, pulse oximetry data can be viewed on the
LED DISPLAY, as follows:
•
Left 3-digit GREEN LED display indicates %SpO2.
•
RIght 3-digit RED LED display indicates BPM (Beats per minute).
•
Left 10-bar bargraph (Red Color) indicates PERFUSION QUALITY (PQ)
and the right on (Green Color) indicates PULSE AMPLITUDE (PA).
After the power-on tests, the following information shows on the pulse oximeter:
•
The PA Bar graph begins to blink, indicating the start of measurement. Then
PQ Bar Graph starts to blink to the level of perfusion at the measuring site.
•
Three dashes one each for SpO2 and BPM indicators for 2-3 seconds while
pulse oximeter gather the SpO2 and BPM values.
•
Once valid values are available, both SpO2 and BPM values are displayed.
•
Record the readings manually if required and switch off to save
battery power.
•
This completes one cycle of measurement using the Model 31DT.
•
Please follow the cleaning instructions given in the manual before making
next measurement on another patient.
NOTE: If the PQ and PA donít blink adjust the sensor position.
CAUTION: When Perfusion Quality (PQ) display is showing less than 3 LED
Bars, it indicates that the PQ is too low. Either change the monitoring site
to an alternative location or check if the sensor is applied correctly.
CAUTION: Reusing the device/sensor without prior cleaning may result in cross
contamination.
13
OPERATING THE MODEL 31DT PULSE OXIMETER
PERFORMANCE CONSIDERATIONS
Pulse oximeter readings and pulse signal can be affected by certain
ambient environmental conditions, sensor application errors, and certain
patient conditions.
Inaccurate measurements can be caused by:
•
Incorrect application of the sensor. Incorrect application may cause tissue
damage. Inspect the sensor site periodically as directed in the sensor
directions for use.
•
Ambient light.
•
Patient movement.
CAUTION: Calibration cannot be performed by the user/operator. Please contact
Mediaid.
CAUTION: Reusing the device/sensor without prior cleaning may result in cross
contamination.
ADJUSTING THE ALARM SETTINGS
The Model 31DT has an alarm for low or high readings of SpO2 or BPM which
can be set to the levels as required by the user. The following describes the
alarm settings.
AUDIBLE ALARM INDICATORS
The alarm tone is a fixed pitch, and the volume is adjustable. Alarm tones are
automatically silenced when the alarm condition goes away.
•
HIGH PRIORITY alarm tones sound 0.75 seconds for every three seconds.
HIGH PRIORITY alarms are caused by conditions such as: low/high oxygen
saturation and pulse rate; no pulse.
•
MEDIUM PRIORITY alarm tones sound for 0.75 seconds every five
seconds. MEDIUM PRIORITY alarms are caused by measuring problems
such as No finger in sensor, or a faulty sensor.
•
LOW PRIORITY alarm tones sound for one second every 10 seconds.
LOW PRIORITY alarms are caused by disconnected sensor.
14
OPERATING THE MODEL 31DT PULSE OXIMETER
ALARM OFF KEY
A short depression of this key silences the alarm for a period of 60 seconds. The
ALARM OFF INDICATOR illuminates and remains on constantly, and the
oximeter monitors normally. Silenced alarms shall be reactivated by a short
depression of the ALARM OFF KEY. Press and holding this Key for more than
5 sec. silences the alarm permanently.
ALARM OFF INDICATOR
The ALARM OFF INDICATOR illuminates and remains on constantly when
audible alarms are silenced. This indicator starts blinking when permanent
silence of alarm is selected.
OXYGEN SATURATION ALARM KEY
Short depression of the OXYGEN SATURATION ALARM KEY toggles the LED
display between the high and low alarm settings, and respective HI/LO ALARM
INDICATOR glow below the key. These alarm settings can be adjusted using
UP ARROW and DOWN ARROW KEYS. The alarm settings are retained in
memory until reset by the user. Alarm setting can be minimum 85% for Low limit
and accordingly 87% for High limit.
The default saturation alarm settings are
Saturation
High
100%
Low
85%
The display reverts back to normal monitoring after six seconds of key inactivity
or Mute key press.
PULSE RATE ALARM KEY
Short depression of the PULSE RATE ALARM KEY toggles the LED display
between the high and low alarm settings and respective HI/LO ALARM
INDICATOR glows below the key. These alarm settings are adjusted using UP
ARROW and DOWN ARROW KEYS. The alarm settings are retained in
memory until reset by the user.
CAUTION: Each time the monitor is used, check the alarm limits to ensure
that they are appropriate for the patient being monitored.
15
CHAPTER 5: SPECIAL KEY FUNCTIONS
POWER ON FUNCTION OF A KEY
•
To change patient mode (Adult / Neonatal)
Press ON/OFF KEY + PULSE RATE ALARM KEY. The Oximeter has two
modes for SpO2 & Rate alarm for two types of patients Adult or Neonatal.
The UP ARROW Key and the DOWN ARROW Key can be used to select
the desired settings.
•
To set alarm volume
Press ON/OFF KEY + MUTE KEY. To set the alarm volume, the UP ARROW key and
the DOWN ARROW key are be used to increase or decrease the alarm. There are
5 levels. The alarm volume can never be decreased to zero. Default Alarm
volume is middle level (3 in a scale of 1 to 5).
DIAGNOSTIC TEST
Turning the unit ON by simultaneously pressing the Pulse Rate Alarm key +
Oxygen Saturation alarm key will cause the unit to enter the self test mode.
Upon entry the %SpO2 LED will show ‘tst ’and the Pulse Rate LED will show the
test number “0”. The test number can be manually selected using UP/DOWN
arrow keys. After 6 seconds of key inactivity or Mute key press, the corresponding testing sequences will start. The following tests will be carried out,
TEST 0
-
Global test, initiates all user assurance tests that can be run.
TEST 1
-
Display and indicator test, each icon and display segment will be
activated. (Each segment will be set to ON one by one).
TEST 2
-
Sensor and circuitry test, all sensors and circuits are tested to
verify correct operation.
TEST 3
-
Speaker test. This initiates alarm to sound from low volume to high
volume.
TEST 4
-
Internal circuitry test, and components are tested. Upon completion, if an internal problem was detected then the display shows
“Err2”.
TEST 5
-
Internal memory test, tests all internal memory. If this test is
passed a display of “software version number” is shown.
16
CHAPTER 6: SPECIFICATIONS
PERFORMANCE
SpO2 Performance Requirements
•
Measurement Range
%SpO2 : 0 – 100%
Pulse : 25 – 255 beats per minute (BPM)
•
Resolution
%SpO2 : 1%
Pulse : 1 BPM
•
Accuracy
%SpO2 : 70 – 100%, ± 2 digits
≤ 69%, Unspecified
Pulse : 25 – 255BPM, ± 2 BPM
ELECTRICAL
AC POWER
Power Requirements
Fuses
100 – 230 VAC, 50/60 HZ
2 Qty,2.0A,250 volts,fast-blow,
IEC (5 x 20 mm)
Note: Always use a 3 pin power cord with Proper Earthing Pin.
BATTERY
•
Battery Type
: Lithium-ion
•
No. of Batteries
:1
•
Nominal Battery Voltage
: 7.4 Volts DC
•
Battery Capacity
: 1050 mAh.
•
Minimum Battery Run Time
: Approx. 10 hours using fully Charged battery
•
Battery Recharge time
: 4 hours maximum (internal protection
available to avoid over-charging)
•
Battery Cutoff Voltage
: Approx. 6.0 Volts DC
•
Low Battery Warning Level
: Approx. 7.0 Volts DC
•
Time to Shutdown from
low battery
: Approx. 1 hour
17
SPECIFICATIONS
ENVIRONMENTAL CONDITIONS
Acceptable Conditions for Operating, Storage and Transport
•
Operating Temperature
0 – 40 ºC (32 – 104 ºF)
•
Storage & Transport Temperature
-30 – 65 ºC (-22 – 149 ºF)
•
Atmospheric pressure
770 – 282.45 mmHg or 1026 – 377 hPa
•
Relative Humidity
5 – 95% (non condensing)
PHYSICAL CHARACTERISTICS
•
Weight
1.26 kgs. (without Accessories)
1.63 kgs. (with Accessories)
•
Dimensions
11.8 (L) x 8 (W) x 3.3 (H) inch
or
30 (L) x 20.3 (W)x8.4 (H) cm
COMPLIANCE
•
: Class 1 (on AC power)
Type of Protection
Internally powered (on battery power)
Type BF – Applied Part - SpO2 sensor
•
Degree of Protection
: IPX1
Enclosure, Degree of Ingress
Protection from Solids/Liquids
•
Mode of operation
: Continuous
•
The equipment is designed to comply with
: ISO 13485:2003, ISO 9001:2000
18
CHAPTER 7: ACCESSORIES
SENSORS
Use only Mediaid sensors with the device. Use of other sensors may result IN faulty
data/injury to the user damage to the device
S.No.
Sensor
Part Number
1
Universal Hinged Sensor, Compushield connector, 30" cable
POX050-100S
2
Universal Hinged Sensor, Compushield connector, 96" cable
POX050-105S
3
Spot Check Soft Sensor, Compushield connector, 30" cable
POX050-150S
4
Great Toe Sensor, Compushield connector, 96" cable
POX050-220S
5
Small Soft Sensor, Compushield connector, 96" cable
POX050-300S
6
Large Soft Sensor, Compushield connector, 96" cable
POX050-400S
7
Pediatric Soft Sensor, Compushield connector, 96" cable
POX050-310S
8
Earlobe Clip Sensor, Compushield connector, 96" cable
POX050-710S
9
Pediatric Adjustable Sensor, Compushield connector, 96" cable
POS050-530S
10
Tape-on Sensor, Compushield connector, 96" cable
POX050-850S
11
Adult R-Adhesive Sensor, Compushield connector, 96" cable
POX050-905S
12
Pediatric R-Adhesive Sensor, Compushield connector, 96" cable
POX050-820S
13
6 Feet Extension Cable, Compushield to Compushield connector
POX055-600S
CAUTION: Use of damaged/broken sensor may result in faulty or erroneous readings. Reuse of sensors beyond lifetime may deteriorate the
performance and hence the sensors must be used within the lifetimementioned in the sensor instructions.
CAUTION: Reuse of single patient use disposable sensors may result in cross
contamination.
BIOCOMPATIBILITY TESTING
Biocompatibility testing has been conducted on Mediaid sensors in compliance
with ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation
and Testing. The sensors have passed the recommended biocompatibility
testing and are therefore in compliance with ISO 10993-1.
BATTERY
Single 7.4 Volt Li-ion battery with a connector.
19
CHAPTER 8: TROUBLESHOOTING
CLEANING
The pulse oximeter and the sensor can be wiped clean with a soft cloth lightly
dampened with isopropyl alcohol, a glutaraldehyde solution, or soap and water.
Do not immerse in liquid or allow any liquid to penetrate the interior of the pulse
oximeter. Avoid caustic or abrasive cleaners that could damage the case,
keypad, or sensors. Use extra care in cleaning the LED DISPLAY window to
avoid scratching the finish.
CAUTION: Do not attempt to clean the unit while in use. May result in damage to
unit/user. Before and after every use any excess moisture has to be wiped off.
WARNING: In case of accidental wetting of the equipment ensure that the
equipment is switched off and excess liquid/moisture is wiped off/cleaned. Allow
the unit to dry before using it again. In case of “Not Functioning” or unit not turn ON,
contact local Mediaid technical support.
WARNING: If you are uncertain about the accuracy of any measurement, check
the patient’s vital signs by alternate means; then make sure the monitor is functioning correctly.
CAUTION: Reusing the device/sensor without prior cleaning may result in cross
contamination.
TROUBLESHOOTING
Whenever an error occurs, the pulse oximeter displays the letters Err (error) in
% SpO2 LED and displays the error code by blinking in BPM LED.
CAUTION: There are no user-serviceable parts or adjustments inside the Model
31DT. Do not attempt to open the instrument voids the Mediaid warranty. Refer to
the information in “Mediaid Problem Correction Plan”, in Chapter 10, for service
information.
ERROR CODES
Whenever an error occurs the display shows the letters “Err” and the corresponding error number.
20
TROUBLESHOOTING
ERROR CODE
2
3
4, 5, 6, 7, 8, 9, 10, 12,
13, 14, 15
ERROR CODE MESSAGE
The instrument will not power off
The oximeter cannot detect the
sensor because of sensor malfunction
or sensor not properly attached
An internal failure has occurred
21
SOLUTION
Remove the battery
and contact Mediaid
Technical Support
Replace/Reattach the
sensor. If the error
code persists, contact
Mediaid
Technical Support
Contact Mediad
Technical Support
CHAPTER 9: PRINCIPLES OF OPERATION
OXIMETRY OVERVIEW
Pulse oximeters provide a spectrophotometric assessment of functional arterial
Hemoglobin oxygenation (SpO2). Pulse oximetry is based on the following two
principles. First, hemoglobin (Hb) and oxygenated hemoglobin (HbO2) differ in
their absorption of red and infrared light. Second, the volume of arterial blood in
tissue (and therefore, light absorption by the hemoglobin) changes during the
pulse. Therefore, a pulse oximeter passes red and infrared light into an arteriolar
bed, measures changes in light absorption, and determines SpO2.
Fig. 6: Principles of Pulse Oximetry
22
PRINCIPLES OF OPERATION
HOW PULSE OXIMETERS WORK
Pulse oximeter sensors have red and infrared low voltage light-emitting diodes
(LEDs) which serve as light sources. The emitted light is transmitted through the
tissue, and then detected by the photodetector where it is then sent to the
microprocessor of the pulse oximeter (Fig. 6). All constituents of the human
body, venous and arterial blood and tissue absorb light (Fig. 7). The pulsating of
arterial blood results in changes in the absorption due to added hemoglobin (Hb)
and oxygenated hemoglobin (HbO2) in the path of the light. Since (HbO2) and
(Hb) absorb light to varying degrees, this varying absorption is translated into
plethysmographic waveforms at both red and infrared wavelengths (Fig. 8). The
relationship of red and infrared plethysmographic signal amplitude can be
directly related to arterial oxygen saturation. For example, when the plethysmographic amplitude at 660nm and 910nm are equal and the ratio R/IR=1, the
SpO2 is approximately 85% (Fig. 9).
Fig. 7: Light Absorption
23
PRINCIPLES OF OPERATION
Fig. 8: Varying Absorption by (HbO2) & (Hb)
Fig. 9: Pleth Amplitude at 660nm & 910nm
CALIBRATION OF PULSE OXIMETERS
The light absorption by hemoglobin is wavelength dependent. Mediaid red and
infrared LED wavelengths are tightly controlled by testing each individual
sensor. In addition, the LED intensity recorded at the detector is automatically
adjusted for amplitude. This allows Mediaid pulse oximetry sensors to be used
interchangeably without calibration.
VALIDATION OF ACCURACY
Mediaid pulse oximeters and sensors are tested for accuracy at the Anesthesia
Research Laboratory of the University of California Medical Center in San
Francisco. Validation consists of inducing hypoxemia in healthy subjects and
comparing pulse oximeter readings (SpO2) to co-oximeter readings (SpO2)
using arterial samples. Figure 10 and Figure 11 compare results from a typical
Mediaid pulse oximeter and a Competitor`s pulse oximeter. Both instruments
show a small bias and similar distribution of sampling points.
24
PRINCIPLES OF OPERATION
Fig. 10: Mediaid by Hemoximeter
Fig. 11: Competitor by Hemoximeter
CLINICAL USE OF PULSE OXIMETRY
Pulse oximeters may be used in a variety of situations that call for monitoring
oxygenation and pulse rates. Pulse oximeters increase patient safety by alerting
the hospital staff to the onset of hypoxia during or following surgery. Oximeters
confirm adequate oxygenation during mechanical ventilation. Physician and
dental offices utilize pulse oximetry for spot checking respiratory status, as well
as for monitoring during procedures that call for sedation. Truly, pulse oximetry
is the fifth vital sign, essential to complete patient monitoring.
25
CHAPTER 10:
Mediaid Inc.
Limited Warranty
APPLICABILITY OF WARRANTY
This warranty covers only the Mediaid Model 31DT pulse oximeter and accessories as
indicated. It is not extended to other products or components that the customer uses in
conjunction with Mediaid products. This warranty shall not apply if the manufacturer
determines that the product has been damaged due to abuse, misuse, misapplication,
accident, negligence, tampering, or as a result of service or modification by anyone other
than an authorized Mediaid Inc. service technician. Opening of the sealed enclosure or
altering of the serial number voids the Mediaid Inc. Warranty. Use of equipment contrary
to or inconsistent with the User’s Manual will also void the warranty.
WARRANTY COVERAGE
Mediaid Inc. warrants that the Model 31DT enclosed with this warranty will conform to the
manufacturer’s specifications and will be free from defects in workmanship and materials for a period
of 1 year from the date of purchase. Batteries and accessories are excluded from this warranty. The
Sensors are warranted according to information on their respective instruction sheets.
This warranty does not cover any damage done to the equipment during shipping, which shall be
the sole responsibility of the transportation company.
There are no warranties, expressed or implied, which extend beyond the warranties set forth herein.
Mediaid Inc. makes no warranty of merchantability or fitness for a particular purpose with respect to
the product or parts thereof. This warranty gives you specific legal rights. You may have other legal
rights which vary from state to state (or country to country). Mediaid Inc. will not be liable to the user
for incidental or consequential damage or loss arising out of the user’s inability to use this product.
MEDIAID INC. PROBLEM CORRECTION PLAN
Should the Mediaid product prove to be defective, contact Mediaid Inc. at:
Mediaid Inc.
17517 Fabrica Way Suite H
Cerritos, CA 90703 USA
(Tel) 714-367-2848
(Fax) 714-367-2852
www.mediaidinc.com
E-mail: info@mediaidinc.com
26
MEDIAID INC. LIMITED WARRANTY
Have the product and serial numbers available when calling. Mediaid Inc. will then issue a
Return Authorization Number (RAN). Return the pulse oximeter securely packaged in its
original shipping carton (or equivalent packaging), and include the RAN.
Mediaid Inc. will repair any faulty workmanship and will either repair or replace (at our option)
any defective part with new or refurbished parts. For non-warranty repairs, the customer will be
charged the current repair rate at the time of receipt by Mediaid Inc. All transportation charges
shall be the customer’s responsibility.
ALWAYS READ THE USER’S MANUAL CAREFULLY. The information included in the User’s
Manual will assist the user in preventing equipment misuse and ensuring patient safety.
Operation of the equipment in a manner contrary to or inconsistent with the User’s Manual voids
the warranty.
OWNER’S REGISTRATION
To assist Mediaid Inc. in better serving the user, please complete the included Warrant
Registration Card and return it to:
Mediaid Inc.
17517 Fabrica Way Suite H
Cerritos, CA 90703 USA
(Tel) 714-367-2848
(Fax) 714-367-2852
www.mediaidinc.com
E-mail: info@mediaidinc.com
27
CHAPTER 11:
USER REFERENCES
CONTACT/CUSTOMER SERVICE INFORMATION
For information on other Mediaid Inc. products, visit the Mediaid Inc. home page on
the web at www.mediaidinc.com, or contact us at:
Customer Service & Returns Department
Mediaid Inc.
17517 Fabrica Way Suite H
Cerritos, CA 90703 USA
Telephone
714-367-2848
Fax
714-367-2852
Email
info@mediaidinc.com
28
USER REFERENCES
PRODUCT INFORMATION
To better assist customers, Mediaid Inc. recommends writing down all pertinent
product and warranty information in the spaces provided below:
Model 31DT
Product Number: POX010-31DT
Serial Number: ___________________________________________
Warranty Expiration Date: __________________________________
Universal Hinged Sensor
Product Number: POX050-105S
Serial Number: ___________________________________________
Warranty Expiration Date: __________________________________
29
30
WARRANTY REGISTRATION FORM
Please return to Mediaid Inc. / local distributor for validation
MEDIAID INC.
17517 Fabrica Way Suite H; Cerritos, CA 90703 USA
(Tel) 714-367-2848 (Fax) 714-367-2852
Email: info@mediaidinc.com Website: www.mediaidinc.com
Model ______________________
Serial Number ___________________________
Date of Purchase _____________________________________________________
Institution/Physician
__________________________________________________
Address ____________________________________________________________
___________________________________________________________________
___________________________________________________________________
Contact Department
Telephone
__________________________________________________
__________________________________________________________
Distributor _________________________ Phone __________________________
Comments __________________________________________________________
___________________________________________________________________
___________________________________________________________________
1007-60001-002
31