Installation Manual

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Guidance and manufacturer’s declaration - electromagnetic emission
Guidance and manufacturer’s declaration -
electromagnetic emission for all
EQUIPMENT and SYSTEMS
Emissions test Compliance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class B
Harmonic
emissions
IEC 61000-3-2
N/A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
N/A
Electromagnetic
environment-guidance
Manufacturer:
Contec Medical Systems Co., Ltd.
No. 112 Qinhuang West Street,
Economic & Technical Development Zone,
Qinhuangdao, Hebei Province, China
Model No: CMS50D1A
ONE-YEAR PRODUCT LIMITED WARRANTY
• This product has a limited warranty against defects in
materials or workmanship for a period of one-year from the
date of purchase.
• This product is intended for personal use. Dr. Talbot’s does
not provide warranty of this product when used for commercial
use or any non-personal use or in any use not strictly in
conformity with use instructions provided herein.
• Dr. Talbot’s limits the duration and remedies of all implied
warranties, including without limitation the warranties of
merchantability and fitness for a particular purpose to the
duration of this express limited warranty. Some states do not
allow limitations on how long an implied warranty lasts, so the
above limitation may not apply to you.
• Dr. Talbot’s extends this limited warranty only to the
consumer who originally purchased the product. It does not
extend to any subsequent owner or other transferee of the
product.
• In the event of a malfunction or defect in materials or
workmanship during the in-warranty period, and after
analyzing the product, Dr. Talbot’s, at its discretion, may
replace or repair the product under warranty. Upon receipt of
the product and the proof of purchase with a valid date of
purchase, the defective part may be repaired or replaced and
returned to you free of charge. The warranty period is not
extended if we repair or replace the product. Please send
defective unit, proof of purchase with valid date of purchase,
and a description of the problem you have encountered to:
Dr. Talbot’s
Attn: Dr. Talbot’s Customer Care
3030 Aurora Avenue
Monroe, Louisiana 71201 U.S.A.
IMPORTANT: This warranty does not cover damage resulting
from accident, misuse or abuse, lack of reasonable care,
normal wear and tear, use not in strict conformity with use
provided with the product or loss of parts or subjecting the
product to any battery but the specified battery and type the
device requires. Further, no warranty extends to any problem
that is caused by conditions, malfunctions, or damage not
Disposal
Do not dispose of electrical appliances as unsorted municipal waste;
use separate collection facilities. Contact your local government for
information regarding the collection systems available. If electrical
appliances are disposed of in landfills or dumps, hazardous substances
can leak into the groundwater and get into the food chain, damaging
your health and well-being
.
Manufactured for:
Talbot’s Pharmaceuticals
Family Products, LLC.
Monroe, LA 71201
1-855-366-7755 (U.S.A. only)
www.drtalbots.com
Made in China
Form DTM
14920, 14921, 14922
© 2020 TPFP, LLC.
Dr. Talbot’s TM and
Dr. Talbot’s logo licensed
to TPFP, LLC. by
Admar International
All other TMs owned by
or licensed to TPFP, LLC.
May be covered by one or
more of the following
patents: 9474477B2
The following symbols may appear on the manual, packaging, or oximeter.
Explanation of Marks or Symbols (Cont.)
Symbol Description
This side up
Fragile; handle with care
Keep dry
Recyclable
Authorized Representative in the European Community
Non-ionizing electromagnetic radiation
Function Specification
Display Information Display Mode
TFT
TFT
TFT bar-graph display
Pulse Oxygen
Saturation (SpO )
Battery Requirement
Optical Sensor
Red light (wavelength is 660 nm)
Infrared (wavelength is 880 nm)
Range
Continuous bar graph display; the higher
display indicates the stronger pulse.
Pulse Rate (PR)
Pulse Intensity (bar-graph)
0% ~ 100% (the increment is 1%).
70% ~ 100%: ±2% (below 70% unspecified)
Measuring Range
Accuracy
30 bpm ~ 250 bpm (the increment is 1 bpm)
± 2 bpm or ±2% select larger
Measuring Range
Accuracy
6.1cm × 3.6cm × 3.2cm (2.4” × 1.4” × 1.25”)
About 57g (with batteries)
Dimensions
Weight
2x 1.5V (AAA size) alkaline batteries or rechargeable batteries
Two batteries can work continuously for 20 hours
TFT
Pulse Wave
SpO
Parameter Specification
Pulse Parameter Specification
Pulse Intensity
Battery Life
Dimensions and Weight
The Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The user of the Pulse Oximeter should
ensure that it is used in such an environment.
The Pulse Oximeter uses RF energy only
for its internal function, therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
The Pulse Oximeter is suitable for use in
all establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Guidance and manufacturer’s declaration - electromagnetic immunity
Guidance and manufacturer’s declaration -
electromagnetic immunity for all
EQUIPMENT and SYSTEMS
Immunity
test
IEC 60601
test level
Electrostatic
discharge
(ESD) IEC
61000-4-2
Power
frequency
(50Hz)
magnetic
field IEC
61000-4-8
±6KV contact
±8KV air
3 A/m
Compliance
level
±6KV contact
±8KV air
3 A/m
Electromagnetic
environment-guidance
The Pulse Oximeter is intended for use in the electromagnetic environment
specified below. The user of the Pulse Oximeter should ensure that it is
used in such an environment.
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment
Guidance and manufacturer’s declaration - electromagnetic immunity
Guidance and manufacturer’s declaration -
electromagnetic immunity for EQUIPMENT
and SYSTEMS that are not LIFE-SUPPORTING
Immunity
test
IEC 60601
test level
Radiated
RF
ICE
61000-
4-3
3V/m
80MHz
to 2.5GHz
Compliance
level
3V/m
Electromagnetic
environment-guidance
The Pulse Oximeter is intended for use in the electromagnetic environment
specified below. The user of the Pulse Oximeter should ensure that it is
used in such an environment.
NOTE 1: At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the
Pulse Oximeter is used exceeds the applicable RF compliance level
above, the Pulse Oximeter should be observed to verify normal
operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the Pulse Oximeter.
b. Over the frequency range 150KHz to 80MHz, field strengths should be
less than 3V/m.
Portable and mobile RF communication
equipment should be used no closer to
any part of the Pulse Oximeter,
including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
ecommended separation distance
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
a
should be
less than the compliance level in each
frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
E
d = P
3.5
80MHz to
800MHz
E
d = P
7
800MHz to
2.5GHz
Recommended separation distances between portable and mobile
RF communications equipment and the Pulse Oximeter
Recommended separation distances between
portable and mobile RF communications equipment
and the EQUIPMENT or SYSTEM for
EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
Separation distance according to frequency
of transmitter (m)
Rated maximum
output power of
transmitter (W)
The Pulse Oximeter is intended for use in the electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user
of the Pulse Oximeter can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Pulse Oximeter as
recommended below, according to the maximum output power of the
communications equipment.
For transmitters rated at a maximum output power not listed above, the
recommended separation distanced in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1: At
80MHz and 800MHz, the separation distance for the higher
frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
objects and people.
E
d = P
3.5
E
d = P
3.5
80MHz to
800MHz
150KHz to
80MHz
0.01
0.1
100
10
1
0.12
0.37
11.67
3.69
1.17
0.12
0.37
11.67
3.69
1.17
0.23
0.74
23.33
7.38
2.33
800MHz to
2.5GHz
E
d = P
7
resulting from defects in material or workmanship. It is suggested
that for your protection you return shipments of product by
insured mail, insurance prepaid. Damage occurring during
shipment is not covered by this warranty.
Note: No other warranty, written or oral is authorized by
Dr. Talbot’s.
This warranty gives you specific legal rights, and you may also
have other rights which vary from state to state. Some states
do not allow the exclusion or limitation of incidental or
consequential damages, so the above exclusion and
limitations may not apply to you. UNDER THIS LIMITED
WARRANTY, DR. TALBOT’S ASSUMES NO RESPONSIBILITY
FOR ANY SPECIAL, INCIDENTAL OR CONSEQUENTIAL
DAMAGES. OUR LIABILITY SHALL UNDER NO
CIRCUMSTANCES EXCEED THE ACTUAL AMOUNT PAID BY
YOU FOR THE DEFECTIVE PRODUCT.
Read enclosed instructions carefully.
WARNING: DR. TALBOT’S ADVISES USERS AGAINST
RELYING ON THE DEVICE AS THE SOLE BASIS FOR A
DECISION TO SEEK OR REFRAIN FROM SEEKING MEDICAL
ATTENTION, TREATMENT AND/OR PROFESSIONAL HELP.
DR. TALBOT’S HAS IDENTIFIED THAT THE RISK OF
DELAYING TREATMENT CAN HAVE SERIOUS
CONSEQUENCES FOR NEWBORNS (0-3 MONTHS), SMALL
CHILDREN (4-36 MONTHS) AND PATIENTS OF ANY AGE
THAT MAY NOT BE ABLE TO COMMUNICATE EFFECTIVELY
THE SYMPTOMS THEY MAY BE EXPERIENCING. IN THE
EVENT YOU ARE FEELING SICK, OR EXPERIENCING
SYMPTOMS OR FEEL AS THOUGH YOU ARE RUNNING A
FEVER, SEEK THE ATTENTION OF A MEDICAL CARE
PROFESSIONAL IMMEDIATELY.