MedLinket AM801 Guide De Démarrage Rapide

English
Temp-Pulse Oximeter BZ0300A REV:C.2 June. 10, 2020
Instruction for Use
Model: AM801 (REF: AM-806)
CONTENTS
Foreword ........................................................................
Warning ...........................................................................
Latex Content Statement ......................................................
About This Manual ...............................................................
Section1-Overview...............................................................
Intended Use .....................................................................
About the Pulse Oximeter ......................................................
Identification of Front Panel, Left Panel Buttons and Symbols ............
Equipment Symbols ...............................................................
Technical Specifications .........................................................
Product parts and accessories...................................................
Principle of Measurement......................................................
Clinical Restrictions...............................................................
Attentions........................................................................
Unpacking and Inspection......................................................
Included in the package.........................................................
Section 2- Operation............................................................
Installation and Verification......................................................
General Operation...............................................................
Safety..............................................................................
Function Setting Introduction...................................................
Menu Setting.....................................................................
Section 3- Troubleshooting...................................................
Section 4- Electromagnetic Environment....................................
Electromagnetic Interference Caution..........................................
Electromagnetic Environment...................................................
Section 5- Measurement Validation..........................................
Subject Demographics............................................................
ARMS Results.....................................................................
Graphs..............................................................................
Section 6- Service and Maintenance..........................................
Cleaning and Disinfecting......................................................
Calibrating........................................................................
Repairing and Maintenance......................................................
Warnings...........................................................................
Disposal...........................................................................
Warranty...........................................................................
Qualified certificate............................................................
Foreword
The Pulse Oximeter manual is intended to provide information for proper
operation and maintenance. General knowledge of monitoring and
understanding of the features and functions of the Pulse Oximeter
Monitor are prerequisites for proper use. Please read these instructions
carefully before using this equipment.
The manual describing the operating procedures should be followed
strictly. Failure to follow these instructions can cause measuring
abnormality, 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 Pulse Oximeter is a medical device, and can be used repeatedly.
1
Warning
Warnings are identified by the WARNING symbol shown above.
●
Explosion hazard. Do not use the PULSE OXIMETER in the presence
of flammable anesthetics mixed with air, or with oxygen, or nitrous
oxide.
●
Do not spray, pour, or spill any liquid on the PULSE OXIMETER, its
accessories, connectors, switches.
●
Reusable sensors must be moved to a new site at least every 4 hours.
Because individual skin condition affects the ability of the skin to
tolerate sensor placement, it may be necessary to change the sensor
site more frequently with some patients. If skin integrity changes,
move the sensor to another site.
●
At elevated ambient temperatures, patient skin could be severely
burned after prolonged sensor application at sites that are not well
perfused. To prevent this condition, be sure to check patient
application sites frequently. All listed sensors operate without risk of
exceeding 41℃ on the skin if the initial skin temperature does not
exceed 35℃.
●
Be aware that following removal of the sensor from the patient, it is
possible that environmental light may cause the monitor to continue
to display a waveform or data values but these data should not be
used as a basis for a clinical diagnosis.
●
Portable and mobile RF communications equipment can affect
MEDICAL ELECTRICAL EQUIPMENT.
● The waste of PULSE OXIMETER must not be disposed as unsorted
municipal waste and must be collected separately. Please contact an
authorized representative of the manufacturer for information
concerning the decommissioning of your equipment.
● Please refer to the correlative literature about the clinical restrictions
and caution.
● This device is not intended for treatment.
●
The LCD panel contains toxic chemicals. Do not ingest chemicals
from a broken LCD panel.
●
Do not modify this equipment without authorization of the
manufacturer.
Latex Content Statement
The PULSE OXIMETER and accessories are not made with natural rubber
latex in any location that may result in patient contact.
About This Manual
The PULSE OXIMETER is to be operated by qualified personnel only.
Before servicing this product, read the operator's manual carefully and a
thorough understanding of operation.
2
Section 1- Overview
Intended Use
The Pulse Oximeter is intended for continuous use or spot checking in
measuring and displaying functional arterial oxygen saturation (SpO
pulse rate and temperature of patients in hospitals, physician's office,
clinical settings and home care environment.
Target population: Adult, adolescent and child.
About the Pulse Oximeter
The device contains a dual light source (red LED and infrared red LED) and
a photo detector. Bone, tissue, pigmentation and venous vessels normally
absorb a constant amount of light over time. The arteriolar bed normally
pulsates and absorbs variable amounts of light during the pulsations. The
ratio of light absorbed is translated in an oxygen saturation measurement
(SpO ). Because a measurement of SpO is dependent on light from the
2 2
device, excessive ambient light can interfere with this measurement.
Identification of Front Panel, Left Panel Buttons and Symbols
Refer to the PULSE OXIMETER Operator's manual for a complete
description of all buttons, symbols, controls, displays and indicators.
6 7
4
1
9
2 3 5
Figure 1: PULSE OXIMETER Front Panel and Left Panel
1—Menu button/Power button 6—Waveform Display
7—Bar graph (The Pulse Amplitude
2—%SpO Display
2
Indicator)
3—Low Battery indicator 8—Screen turn switch
4—Temperature Display 9—Accessories Port Connector
5—Pulse Rate Display (bpm)
Equipment Symbols
Atmospheric
Caution Pressure
limitation
Non sterile Type BF (Body
Packaging Floating) Applied
Part
3
Refer to Instruction
manual/booklet
DO NOT THROW
AWAY
1 Intended for
2 multiple use
2
Humidity limitation
2
3 Protected against
3 vertically falling
3 IPX2 water drops when
3 enclosure tilted up
3 to 15°
4
Compliance with
6 WEEE Standard
6
CE Mark: conforms to essential requirements of the
7
Medical Device Directive 93/42/EEC.
7
0123 is Notified Body Number
7
8
Technical Specifications
8
Pulse Oximeter
8
9
SpO Range 70% to 100%
2
10
SpO Resolution 1%
2
11
90% to 100% range: ±2%;
12
70% to 89% range: ±3%
SpO Accuracy
14
2
<70%: unspecified; complies with EN
15
ISO80601-2-61：2011
15
Reminder Battery-low indicator
16
Method Dual wavelength LED
17
Pulse Rate Range 30 to 245 bpm
17
Pulse Rate Resolution 1 bpm
18
Pulse Accuracy ±3 bpm
19
LED Wavelengths Red: approximately 660nm; Infrared:
20
approximately 905nm
20
Optical output power Less than 15mW
20
Temperature
20
Note: The function of temperature measure works by the accessory of
21
temperature probe.
21
Range, Accuracy 77°to 113°F (25℃ to 45℃):±0.1℃
21
Display Resolution ±0.1℃
21
Power Supply Requirements
Note: The Oximeter does not include batteries.
Batteries 1.5V (AAA) alkaline batteryX2 (IEC Type
LR03)
Adaptable Range 2.6V～3.6V
Operating Current
Only SpO function
2
Less than 55mA
works
Only Temp function
Less than 40mA
works
SpO and Temp
2
function work Less than 60mA
together
4
Apply the accessory
Less than 55mA
of SpO probe
2
SpO , Pulse Rate, Pulse Waveform
2
Display Parameters Display, Bar Graph and Low Battery
Indicator
Data Update Period 8s
Reminder Response <2s
Time
SpO plethysmogram, 50Hz
2
pulse sound
Value of Pulse and 1Hz
SpO
2
Environment
Operating Temperature
environment humidity ≤80%
Temperature
Transportation and
humidity ≤80%
Storage environment
Hyperbaric Pressure
(Storage,
86kPa～106kPa
Transportation and
Operating)
Classification
Medical device ClassⅡa by EU Directive 93/42/EEC
Protection Against
IPX2
Liquids
Dimension and Weight: 31.5g (Not including batteries)
Weighting Size: 61*34*30.5mm
Compliance
Item Compliant with
Equipment Safety Standards: IEC 60601-1:2012,
classification EMC: IEC 60601-1-2:2014
Internally powered equipment (on
Type of protection
battery power)
Degree of protection Type BF Applied part
Mode of operation Continuous
Front panel and case
ISO15223-1
labeling
Pulse oximeter ISO 80601-2-61:2011
Temperature ISO 80601-2-56:2009
The surface material complies with ISO
Compatibility
10993-5:2009, ISO 10993-10:2010 and has no
harm or toxicity for the person in contact.
5
Product parts and accessories
The Pulse Oximeter is composed of instrument and accessories. The
accessories including adapter cable and Pulse Oximeter probe. Detail of
),
2
the instrument and accessories see figure 2 and figure 3.
1. Instrument
Display
Control
Screen
button
Battery cover
Accessories
Port Connector
Sling
Figure 2: instrument
2. Accessories（Separate Purchase）
2.1 Wrist strap adapter
Accessories
Port Connector
8 Figure 3-1: Wrist strap adapter
2.2 Probes
Connector
Cable
Applied part
Figure 3-2: Temperature probe (model
is W0024E by default, other
models are optional
accessories on paid.)
2.3 Adapter Cable
Cable
Yoke for connect with SpO
Figure 3-3: Adapter Cable
Principle of Measurement
The measurement of PULSE OXIMETER is uses a multi-functional
oxyhemoglobinometer to transmit some narrow spectrum light bands
through blood samples, and to measure attenuation of spectrum with
different wavelengths according to the characteristic that RHb, O
Met Hb and COHb absorb the light of different wavelength, thereby
6
determining O Hb saturation of different fractions. O
2
Temperature limit
called "fractional" O Hb saturation.
2
Environment-friendl
y use period
Batch Code
Present SpO oximeter transmits light of two wavelengths only, red light
2
and infrared, to differentiate HbO
contains two LEDs, and the other side contains a photoelectric detector.
Date of
SpO oximeter measures HbO
2
manufacture
plethysmograph when the pulse beats. The result is quite precise when
HbO saturatiion is between 70% to 100%.
2
Clinical Restrictions
No SpO Alarm
2
1) As the measure is taken on the basis of arteriole pulse, substantial
pulsating blood flow of the testee is required. For a testee with
weak pulse due to shock, low ambient/body temperature, major
bleeding, or use of vascular contracting drug, the SpO
will decrease. In this case, the measurement will be more sensitive
to interference.
2) For those with a substantial amount of staining dilution drug such as
monoxide hemoglobin (COHb), or methionine (MetHb) or
thiosalicylic hemoglobin, and some with icterus problem, the SpO
determination by this monitor may be inaccurate.
3) The drugs like dopamine, procaine, prilocaine, lidocaine and
butacaine may also be a major factor blamed for serious error of
SpO measure.
2
4) The SpO value serves only as a reference value for judgement of
2
anemic anoxia and toxic anoxia, some patients with serious anemia
may also report good SpO
Attentions
●
Keep the oximeter away from dust, vibration, corrosive substances,
explosive materials, high temperature and moisture.
●
If the oximeter gets wet, please stop using.
●
When it is carried from cold environment to warm and 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's Manual for instructions of
cleaning and disinfection.
● Do not have the oximeter immerged in liquid. When it needs
cleaning, please wipe its surface with disinfect solution by soft
material. Do not spray any liquid on the device directly.
●
When cleaning the device with water, the temperature should be
less than 60℃.
Unpacking and Inspection
Remove the instrument of PULSE OXIMETER from the shipping carton
and examine for signs of shipping damage. Please check all materials
against the packing list. Save the invoice, bill of lading and all packing
materials. These may be required if it is necessary to process a claim with
the carrier.
If anything is missing or damaged, please contact the Technical Service
Department.
You can contact by:
●
Phone: +86 755 61120085
●
Fax: +86 755 61120055
●
Email: user07@med-linket.com
Included in the package:
Description
PULSE OXIMETER (instrument)
PULSE OXIMETER Operator's Manual
Sling
Temperature probe(model W0024E by
default): Disposable Skin-surface
Temperature Probe, 0.9m.
Section 2- Operation
41°~104°(5℃~40℃),
Installation and Verification
14°~104°(-10℃~40℃),
●
Battery installation
Caution: The Pulse Oximeter does not operate with dead batteries and
can not be powered by external power source does not input outer
power. Install new batteries.
Install new batteries.
1. Unplug all accessories from the Pulse Oximeter, and press the menu
bar to access the Setting Interface, turn the PULSE OXIMETER off. See
table 1.
2. Pull the battery downward, toward the bottom of the PULSE
OXIMETER, and remove the battery access door. See Figure 4.
3. Insert two "AAA" size batteries, making sure the battery's positive and
negative poles are correctly oriented in the holder as shown in Figure
4.
4. Closing the battery rear cover.
Figure 4: Installing Batteries
WARNING: Explosion hazard. Do not use the PULSE OXIMETER in
the presence of flammable anesthetics mixed with air, with oxygen,
or nitrous oxide.
WARNING: To ensure accurate performance and prevent device failure,
do not expose the PULSE OXIMETER to extreme moisture such as rain.
●
Performance Verification
1. Performance Tests
The power-up performance test verifies that the PULSE OXIMETER is
ready for patient monitoring.
2. Power-On Self-Test
Applied
part Before using the PULSE OXIMETER, you must verify that the PULSE
OXIMETER is working properly and is safe to use. Proper working
conditions are verified each time when the PULSE OXIMETER is turned on
as described in the following procedure. The verification procedure (POST)
takes 2 to 3 seconds to complete.
Caution: If any indicator or display element does not light when the
PULSE OXIMETER is turned on, do not use the PULSE OXIMETER. Instead,
contact qualified service
representative, or MED-LINKET's Technical Services Department.
Note: Physiological conditions, medical procedures, or external agents
that may interfere with the PULSE OXIMETER's ability to detect and show
measurements, including dysfunctional hemoglobin, arterial dyes, low
perfusion, dark pigment, and externally applied coloring agents such as
nail polish, dye, or pigmented cream.
Note: The Pulse Oximeter automatically starts the Power-On Self-Test
(POST) to ensure that its internal circuits are functioning properly.
Procedure
1. Turn on the PULSE OXIMETER by pressing the Menu button.
2. After the device completes the Power-On Self-Test (POST), it will
directly switch to measure interface.
3. Long press the button to switch device interface of PULSE OXIMETER,
adjustment parameters. See table-1.
Connector
General Operation
The PULSE OXIMETER can be measure functional oxygen saturation
probe
2
in the blood by itself or plug an accessory of MED-LINKET SpO
probe into the instrument. To measure the body temperature by
apply a temperature probe of MED-LINK. See table-1.
●
Preparative for operating
1) Open up battery compartment cover carefully and then install two
"AAA" Alkaline batteries according to the (+/-) electrodes.
2) Press the "power switch" key for 1 second to activate the device.
Hb,
2 ●
SpO measure
2
Hb saturation is
2
from HbR. One side of the sensor
2
saturation in the blood by the light
2
waveform
2
2
measurement.
2
7
Qty
1 Piece
1 Piece
1 Piece
1 Piece
Battery rear cover
8
personnel, your local MED-LINKET
2
9