zewa UAM-950 User manual

CAUTION CAUTION
* Warning: This device is not AP/APG equipment. Do not use the device where flammable
anesthetic are present, or in environments mixture wi h air of with oxygen or nitrous oxide.
* The device contains sensitive electronic components.To avoid measurement errors, avoid taking
blood pressure measurements near a strong electromagne ic field radiated interference signal
or electrical fast transient/burst signal.
* Wireless communication equipment, such as wireless home network devices, mobile phones,
cordless telephones and their base stations, walkie-talkies may cause interference that may
affect he accuracy of measurements. A minimum distance of 1 foot (30 cm) should be kept from
such devices during a measurement.
* You can use this device to take your own measurement, no third-party operator is required.
* Please use the device under the environment which is provided in the user manual. O herwise,
the performance and lifetime of the device will be impacted and reduced.
* The device may require up to 30 minutes to warm up / cool down from the minimum / maximum
storage temperature before it is ready for use.
* Warning: Excessive cuff tube lengths could cause strangulation if you don't manage them
properly.
* Warning: Do not touch output of the batteries/adapter and the user simultaneously.
* Adapter is specified as a part of ME EQUIPMENT.
* Warning: The power cord is considered the disconnect device for isolating this equipment from
supply mains. Do not position the equipment so that it is difficult to reach or disconnect.
* The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient
environment.
* Warning: Do not use this device if you are allergic to polyester, nylon, or plastic.
* Warning: Only use accessories approved by manufacturer. Using unapproved accessories
might cause damage to the unit and injure users.
* Warning: If you experience discomfort during a measurement, such as pain in the arm or other
complaints, press the Power button immediately to release the air from the cuff.
* No calibration is required within two years of reliable service.
* Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out by
authorized service centers.
* At he request of authorized service personnel, circuit diagrams, component part lists,
descriptions, and calibration procedures will be made available by the manufacturer or
distributor.
* It is recommended that he performance should be checked after repair, maintenance, and
every two years of use, by retesting the requirements in limits of the error of the cuff pressure
indication and air leakage (testing at least at 50 mmHg and 200 mmHg).
* Warning: Do not use the device while under maintenance, or being serviced.
* Store your device, cuff and adapter in a clean and dry place, protect it against extreme moisture,
heat, lint, dust and direct sunlight. Never place any heavy objects on it.
* Make sure the rubber tube of the cuff is not squeezed, stretched, or kinked during storage.
* Warning: Keep the device, cuff, and batteries away from children as they may pose a risk of
choking or strangulation if used improperly.
* Clean both device and cuff with a soft, dry cloth. If necessary use a dampened cloth and natural
detergent. Do not use alcohol, benzene, or other harsh chemicals.
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and storage
state. The typical service life is 10000 times.
* Dispose of accessories, detachable parts, and the device according to the local guidelines.
* This device is intended for indoor, home use.
* This device is not intended for public use.
* This device is portable, but it is not intended for use during patient transport.
* This device is not suitable for continuous monitoring during medical emergencies or operations.
* This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is
not intended for use on extremities other than the arm, or for any purpose other than obtaining a
blood pressure measurement.
* This device is for adults. Do not use this device on neonates or infants. Do not use it on children
unless otherwise instructed by a medical professional.
* Do not use on the women in pregnant, including pre-eclamptic, patients.
* The device is not suitable for use on patients with implanted, electrical devices, such as cardiac
pacemakers, defibrillators.
* The effectiveness of this device has not been established for use:
-on users with common arrhythmias such as atrial or ventricular premature beats or atrial
fibrillation,
-on users with peripheral arterial disease,
-on users undergoing intravascular therapy, or with arteriovenous (AV) shunt.
Consult a medical professional before use.
* Do not use this device for diagnosis or treatment of any health problem or disease. Contact your
physician if you have or suspect any medical problem. Do not change your medications without
the advice of your physician or health care professional.
* If you are taking medica ion, consult your physician to determine the proper time to measure
your blood pressure.
* This device may be used only for the intended use described in this manual, the manufacturer
shall have no liability for any incidental, consequential, or special damages caused by misuse or
abuse.
* Report any unexpected operation or events to the manufacturer.
* Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.
* Warning: Do not kink, fold, stretch, compress, or otherwise deform the tube during measuring, as
the cuff pressure might continuously increase, which could prevent blood flow and result injury.
* Warning: Taking blood pressure measurements too frequently could disrupt blood circulation and
cause injuries.
*Warning: Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site
frequently for irritation.
* Warning: Do not place the cuff on the arm of a person whose arteries or veins are undergoing
medical treatment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V)
shunt, which could disrupt blood circulation and cause injuries.
* Do not place the cuff on the arm on the same side of a mastectomy (especially when lymph
nodes have been removed). it is recommended to take measurements on the unaffected side.
* Do not wrap the cuff on the same arm to which another monitoring device is applied. One or both
devices could temporarily stop functioning if you try to use them at the same time.
* Please check that the operation of the device do not result in prolonged impairment of patient
blood circulation.
* Warning: On the rare occasion of a fault causing the cuff to remain fully inflated during
measurement, loosen and remove the cuff immediately. Prolonged high pressure applied to the
arm (cuff pressure >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) might
lead to bruising and discolored skin.
* Warning: Do not use this device with high-frequency (HF) surgical equipment at the same time.
INTRODUCTIONINTRODUCTION
45

22 23
EMC GUIDANCEFCC STATEMENT
EMC Guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Warning: Don’t be near the active HF surgical equipment and the RF shielded room of an ME
system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and he
other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the equipment UAM-950, including cables specified by the manufacturer. Otherwise, degrada-
tion of the performance of this equipment could result.
Technical description：
1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFOR-
MANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity.
Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
RF emissions
CISPR 11
RF emissions
CISPR 11
Group 1
Class B
Class A
Comply
Compliance
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Emissions test
FCC Statement
This device complies with Part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
Caution: The user is cautioned that changes or modifications not expressly
approved by the party responsible for compliance could void the user's
authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used
in accordance with the instructions, may cause harmful interference to
radio communications. However, there is no guarantee that interference
will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more of
the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for
an uncontrolled environment. This transmitter must not be co-located or
operating in conjunction with any other antenna or transmitter.
Contains FCC ID: XMR2020BG95M2

24 25
EMC GUIDANCE
Table 3
3850.3 27
Service Modulation
380-3901 8
450430-470 2 0.3 28
710704-787
745
780
0 2 0.3 9
810
870
930
800-960 2 0.3 28
2 0.3 28
2 0.3 28
0 2 0.3 9
1720
1845
1970
1700-
1990
24502400-
2570
5240
5500
5785
5100-
5800
Guidance and manufacturer’s declaration - electromagnetic Immunity
Test
Frequency
(MHz)
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communicati-
ons
equipment)
Band
(MHz)
Distance
(m)
IEC
60601-1-2
Test Level
(V/m)
TETRA
400
Pulse
modulation
18 Hz
GMRS 460,
FRS 460
FM ± 5k Hz
deviation
1kHz sine
LTE Band
13,
17
Pulse
modulation
217 Hz
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation
18 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3, 4,25;
UMTS
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11
b/g/n, RFID
2450, LTE
Band 7
Pulse
modulation
217 Hz
WLAN
802.11
a/n
Pulse
modulation
217 Hz
Compliance
level
(V/m)
27
28
9
28
Maximum
Power
(W)
28
9
28
Table 2
Guidance and manufacturer’s declaration – electromagnetic Immunity
Immunity Test
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±1 kV ±2 kV,100 kHz repetition
frequency
For AC power port:
Power supply lines: ±2 kV
±1 kV (Line to ±0.5 kV line)
±0 5 kV ±1 kV ±2 kV (Line to ground)
±2 kV Signal line (LAN line)
For AC power port:
Line to lines: ±1 kV
30 A/m
50 Hz / 60 Hz
30 A/m
50 Hz / 60 Hz
NOTE U T is the a.c. mains voltage prior to application of the test level.
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Power frequency
magnetic field
IEC 61000-4-8
Voltage dips, short
interrup ions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
IEC 60601-1-2
Test level
For AC power port:
0% for 0,5 cycle, 0°for 1 cycle
70% for 25 cycles;
Single phase: 0% for 250 cycle
0%, 70%, 0% of UT
Conduced RF
IEC61000-4-6
0,15 MHz – 80 MHz 3 V
ISM and amateur radio bands between
0,15 MHz and 80 MHz 6 V
For AC power port:
3 Vrms
6 Vrms (in ISM and amateur radio
bands) 80% AM at 1 KHz
10 V/m
80 MHz – 2,7 GHz
80% AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80% AM at 1 kHz
Radiated RF
IEC61000-4-3
EMC GUIDANCE

Limited 2 Year Warranty
Zewa provides a 2 year limited warranty on this product to be free from
defects in material and workmanship only under normal use. This warranty
extends only to the original owner.
For warranty claims, please return the product together with satisfactory
proof of purchase such as a sales receipt. Be sure to include your return
address, phone number and a brief description of the problem and mail it to:
Zewa Inc.
Attn: Service Department
12960 Commerce Lakes Drive Suite 29
Ft. Myers, Florida 33913
Include a check for return shipping and insurance. Contact Zewa (US and
Canada only) at 1-888-993-3592 for appropriate shipping and insurance
costs.
In lieu of return of the product, Zewa offers a free of charge warranty repair
service on all defective subassemblies, provided the product fails to perform
due to faulty workmanship or faulty materials. Defects on the product due to
normal wear and tear, misuse, abuse, improper handling whether negligent
or intentional, failure to follow instructions or alterations and repairs of the
product other than by an authorized Zewa Service location will void this
warranty.
All other repair services not covered under this warranty will be charged to
the customer.
Zewa will either repair or replace any parts necessary ( at its option) to
correct defects in the materials or workmanship. Any replacement parts or
product may be new or refurbished.
The above warranty is complete and exclusive. Except as stated above,
Zewa makes no express or implied warranties or representations, including,
but not limited to the accuracy or completeness or information delivered to
you, or warranties of fitness for a particular purpose, intended use,
merchantability, non-infringement, or any implied warranties arising out of a
course of performance, dealing, or trade usage and we specifically disclaim
such warranties. In no event will Zewa be liable for indirect, exemplary,
incidental, special or consequential punitive or similar damages, including
without limitation, any damages resulting from loss of use, loss of business,
loss of revenue, loss of profits, or arising in connection with this warranty or
your purchase or attempt to purchase products, or of any other obligations,
even if we have been advised of the possibility of such damages. Further,
the aggregate liability (whether claims arise in contract, tort, personal injury,
product liability or otherwise) of Zewa ( and its officers, directors,
employees, agents, representatives and affiliates), and your sole and
exclusive remedy, arising with respect to or in connection with this warranty,
shall not exceed the aggregate of our invoiced purchase price with respect
to any products as to which there is a dispute. The foregoing limitation of
liability shall apply regardless of the cause of action under which such
damages are sought, whether in contract, in tort or otherwise.
This warranty gives you specific legal rights, and you may have other rights,
which vary from state to state. For this warranty to be effective the enclosed
registration card must be completed and returned to us within 15 days from
the date of purchase. This warranty registration is also available online at
www.zewa.com. Any failure to return the registration card to Zewa timely
will constitute a complete bar to any claim by you with respect to such
product. Any failure to make a timely claim with respect to the cuff will also
bar your claim. Unauthorized returns will be returned to you at your
expense and need not be accepted by Zewa.
For any questions regarding this warranty, please contact us at
www.zewa.com.
WARRANTY WARRANTY
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