Drive Medical Clini-Ox II Instruction Manual

Clini-Ox II
FINGERTIP PULSE
OXIMETER
Instructions to User
Item # 18708
www.drivemedical.com

Dear Users,
This manual is written for the Clini-Ox II Fingertip Pulse Oximeter, part
number 18708. In case of modifications and software upgrades, the
information contained in this document is subject to change without
notice.
The manual describes, in accordance with the Clini-Ox II’s features and
requirements, main structure, functions, specifications, correct meth-
ods for transportation, installation, usage, operation, repair, mainte-
nance and storage,etc.as well as the safety procedures to protect both
the user and equipment.Refer to the respective chapters for details.
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Please read the manual very carefully before using this equipment.
These instructions describe the operating procedures to be followed
strictly,failure to follow these instructions can cause measuring abnor-
mality, equipment damage and personal injury. The manufacturer is
NOT responsible for the safety, reliability and performance issues and
any monitoring abnormality, personal injury and equipment damage
due to user’s negligence of the operation instructions. The manufac-
turer’s warranty service does not cover such faults.
This expected service life of this device is 3 years.
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• An uncomfortable or painful feeling may occur if using the device
ceaselessly, especially for the micro-circulation barrier patients.It is
recommended that the sensor should not be applied to the same
finger for over 2 hours.
• For the individual patients, there should be a more prudent in-
specting in the placing process.The device cannot be clipped on the
edema and tender tissue.
• The light (the infrared is invisible) emitted from the device is harm-
ful to the eyes, so the user and technician, should not stare at the light.
• Patient should not use enamel or other makeup.
• Patient’s fingernail should not be too long.
WARNING
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• Please read the relative content about the clinical restrictions and
caution.
• This device is not intended for treatment.
CAUTION: Federal law restricts this device to sale by or on the order
of a physician.
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1. Safety..............................................................................................
1.1 Instructions for Safe Operations............................................
1.2 Warnings...........................................................................................
1.3 Attentions........................................................................................
1.4 Indication for Use.........................................................................
2. Overview........................................................................................
2.1 Classification..................................................................................
2.2 Features............................................................................................
2.3 Environment Requirements...................................................
3. Principle and Caution..................................................................
3.1 Principle of Measurement.......................................................
TABLE OF CONTENTS
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14
15
16
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18
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3.2 Caution...............................................................................................
3.3 Clinical Restrictions......................................................................
4. Technical Specifications................................................................
5. Accessories.....................................................................................
6. Installation.....................................................................................
6.1 View of the Front Panel..............................................................
6.2 Battery................................................................................................
6.3 Mounting the Hanging Rope..................................................
7. Operating Guide...........................................................................
8. Repairing and Maintenance........................................................
9. Troubleshooting.........................................................................
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24
27
28
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29
30
31
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37-40

10. Key of Symbols...........................................................................
11. Function Specification..............................................................
Appendix...........................................................................................
Warranty............................................................................................
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41-43
44-46
47-56
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1. SAFETY
1.1 Instructions for Safe Operations
» Check the main unit and all accessories periodically to
make sure that there is no visible damage that may affect
user’s safety and monitoring performance about cables and
transducers. It is recommended that the device should be
inspected once a week at least.When there is obvious damage,
stop using the monitor.
» Necessary maintenance must be performed by qualified
service engineers ONLY. Users are not permitted to maintain
it by themselves. For the individual patients, there should be
a more prudent inspecting in the placing process. The device
cannot be clipped on the edema and tender tissue. 8

» The oximeter cannot be used together with devices not
specified in User’s Manual. Only the accessory recommended
and suppled by the manufacture can be used with this device.
» This product is calibrated before leaving factory.
1.2 Warnings
» Explosive hazard—DO NOT use the oximeter in environ-
ment with inflammable gas such as some ignitable anesthetic
agents.
» DO NOT use the oximeter while the patient is measured by
MRI and CT.
» The person who is allergic to rubber cannot use this device.
» The disposal of scrap instrument and its accessories and
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packing (including battery, plastic bags, foams and paper
boxes) should follow the local laws and regulations.
» Please check the packing before use to make sure the
device and accessories are totally in accordance with the pack-
ing list, or else the device may have the possibility of working
abnormally.
1.3 Attentions
» Keep the oximeter away from dust, vibration, corrosive
substances, explosive materials, high temperature and mois-
ture.
» If the oximeter gets wet, please stop operating it.
» When it is carried from cold environment to warm or
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humid environment, please do not use it immediately.
» DO NOT operate keys on front panel with sharp materials.
» High temperature or high pressure steam disinfection
of the oximeter is not permitted. Refer to User Manual in the
relative chapter for instructions of cleaning and disinfection.
» Do not have the oximeter immersed in liquid. When it
needs cleaning, please wipe its surface with medical alcohol by
soft material. Do not spray any liquid on the device directly.
» When cleaning the device with water, the temperature
should be lower than 140°F (60°C).
» As to the fingers which are too thin or too cold, it would
probably affect the normal measure of the patients’ SpO2
and pulse rate, please clip the thick finger such as thumb and
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middle finger deeply enough into the probe.
» Do not use the device on infant or neonatal patients.
» The product is suitable for children above four years old
and adults.
» The device may not work for all patients. If you are unable
to achieve stable readings, discontinue use.
» The update period of data is less than 5 seconds, which is
changeable according to different individual pulse rate.
» The waveform is normalized. Please read the measured
value when the waveform on screen is equably and steady-go-
ing. Here this measured value is optimal value. And the wave-
form at the moment is the standard one.
» If some abnormal conditions appear on the screen during
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test process, pull out the finger and reinsert to restore normal
use.
» The device has normal useful life for three years since the
first electrified use.
» The hanging rope attached the product is made from
Non- allergy material, if particular group are sensitive to the
hanging rope, stop using it. In addition, pay attention to the
use of the hanging rope, do not wear it around the neck to
avoid potential patient injury.
» The instrument does not have low-voltage alarm function;
it only shows the low-voltage. Please change the battery when
the low battery warning appears.
» Batteries must be removed if the device is going to be
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stored for more than one month, or else batteries may leak.
» A flexible circuit connects the two parts of the device. Do
not twist or pull on the connection.
1.4 Indications for Use
The Clini-Ox II Fingertip Pulse Oximeter is a non-invasive device
intended for the spot-check of oxygen saturation of arterial hemo-
globin (SpO2) and the pulse rate of adult and pediatric patients in
home and hospital environments (including clinical use in internist/
surgery, anesthesia, intensive care ect.). This device is not intended
for continuous monitoring.
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2. OVERVIEW
The pulse oxygen saturation is the percentage of HbO2in the total
Hb in the blood, so-called the O2concentration in the blood. It is
an important bio-parameter for the respiration. For the purpose of
measuring the SpO2more easily and accurately, the Clini-Ox II Pulse
Oximeter was developed. At the same time, the device can measure
the pulse rate simultaneously.
The Clini-Ox II Pulse Oximeter convenient operation, low power
consumption, and is compact and portable. It is only necessary for
patient to put one of his fingers into a fingertip photoelectric sen-
sor for diagnosis, and a display screen will directly show measured
value of Hemoglobin Saturation.
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2.1 Classification
» Class II b, (MDD93/42/EEC IX Rule 10)
2.2 Features
» Operation of the product is simple and convenient.
» The product is small in volume, light in weight (total
weight is about 1.8oz (50g) including batteries) and conve-
nient in carrying.
» Power consumption of the product is low and the two
originally equipped AAA batteries can be operated continu-
ously for 20 hours.
» The product will automatically be powered off when no
signal is in the product within 5 seconds.
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» 4 directions display mode without waveform.
» Waveform display mode as line drawing or filling manner.
The product is not suitable for use in continuous supervision
for patients.
The problem of overrating would emerge when the patient
is suffering from toxicosis which caused by carbon monoxide,
the device is not recommended to be used under this circum-
stance.
2.3 Environment Requirements
Storage Environment
a) Temperature: -40° F ~ 140° F (-40° C ~60° C)
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b) Relative humidity: ≤95%
c) Atmospheric pressure: 500hPa ~ 1060hPa
Operating Environment
a) Temperature: 50° F ~ 104° F (10° C ~40° C)
b) Relative Humidity: ≤ 75%
c) Atmospheric pressure: 700hPa ~ 1060hPa
3. PRINCIPLE AND CAUTION
3.1 Principle of Measurement
Principle of the Oximeter is as follows: An experience formula of
data process is established taking use of Lambert Beer Law accord-
ing to Spectrum Absorption Characteristics of Reductive Hemoglo-
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bin (Hb) and Oxyhemoglobin (HbO2) in glow & near-infrared zones.
Operation principle of the instrument is: Photoelectric Oxyhemo-
globin Inspection Technology is adopted in accordance with Ca-
pacity Pulse Scanning & Recording Technology, so that two beams
of different wavelength of lights can be focused onto human nail
tip through perspective clamp finger-type sensor. Then measured
signal can be obtained by a photosensitive element, information ac-
quired through which will be shown on screen through treatment
in electronic circuits and microprocessor.
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