Introduction; General Description; Safety Information - Vive DMD1001 User Manual

INTRODUCTION

General Description

Thank you for selecting VIVE™ upper arm Blood Pressure Monitor
(DMD1001). The monitor features blood pressure measurement, pulse
measurement, and result storage. The design provides you with two
years of reliable service.
Readings taken by the DMD1001 are equivalent to those obtained by
a trained observer using the cuff and stethoscope auscultation method.
This manual contains important safety and care information,
and provides step-by-step instructions for using the product.
Read the manual thoroughly before using the product.
Features:
2.4x1.6in Digital LCD display
Maximum 60 records per each user
3rd technology: Measuring during inflation
(Most up to date technology in the world)

Safety Information

The below signs might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Symbol for "THE OPERATION
GUIDE MUST BE READ"
Symbol for "MANUFACTURER"
Symbol for "SERIAL NUMBER"
Symbol for "DIRECT CURRENT"
Symbol for "MANUFACTURE
DATE"
2
Symbol for "TYPE BF APPLIED
PARTS"
Symbol for "ENVIRONMENT
PROTECTION - Waste electrical
products should not be disposed of
with household waste. Please recycle
where facilities exist. Check with your
local authority or retailer for recycling
advice"
CAUTION
This device is intended for adult use only.
This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for
use on extremities other than the arm or for functions other than obtaining a blood pressure measurement.
Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.
Do not begin or end medical treatment. Consult your physician for treatment or advice. If you are taking medication,
consult your physician to determine the most appropriate time to measure your blood pressure.
Never change a prescribed medication without consulting your physician.
If the cuff pressure exceeds 40kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when
pressure exceeds 40 kPa (300 mmHg), detach the cuff from the arm and press the START/STOP button to stop
inflation.
To avoid measurement errors, carefully read this manual before using the product.
The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture
with air of with oxygen or nitrous oxide.
The operator shall not touch output of batteries and the patient simultaneously.
To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal
or electrical fast transient/burst signal when using the AC adaptor.
The user must check that the equipment functions safely and see that it is in proper working condition before being
used.
Please use ACCESSORIES and detachable parts specified/ authorized by MANUFACTURE. Otherwise, it may
cause damage to the unit or danger to the user/ patients.
Manufacturer will make available on request circuit diagrams, component parts list, etc.
This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient's
arm and fingers will become anesthetic, swollen and even purple due to a lack of blood.
Please use the device under the environment which was provided in the user manual. Otherwise, the performance
and lifetime of the device will be impacted and reduced.
During using, the patient will contact with the cuff. The materials of the cuff have been tested and found to comply
with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential allergic reaction or
contact injury.
The device doesn't need to be calibrated in two years of reliable service.
Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.
When the device was used to measure patients who have common arrhythmias such as atrial or ventricular
premature beats or arterial fibrillation, the best result may occur deviation. Please consult your physician about the
result.
The device is contraindicated for any female subject who may be suspected of, or is pregnant. Besides provided
inaccurate readings, the effects of this device on the fetus are unknown.
When using this device, please pay attention to the following situation which may interrupt blood flow and influence
blood circulation of the patient, thus cause harmful injury to the patient: Too frequent and consecutive multiple
measurements; The application of the cuff and its pressurization on any arm where intravascular access or therapy,
or an arterio-venous (A-V) shunt, is present; Inflating the cuff on the arm on the side of a mastectomy.
Do not apply the cuff over a wound, otherwise it can cause further injury.
Do not inflate the cuff on the same limb which other monitoring ME EQUIPMENT is applied around simultaneously,
because this could cause temporary loss of function of those simultaneously-used monitoring ME EQUIPMENT.
Using it in case to result in prolonged impairment of the circulation of the blood of the PATIENT.
Don't kink the connection tube, otherwise, the cuff pressure may continuously increase which can prevent blood flow
and result in harmful injury to the PATIENT.
The device has been evaluated clinically used manual cuff/stethoscope auscultations the reference. Blood pressure
measurements determined with this device are equivalent to those obtained by a trained observer using the
cuff/stethoscope auscultatory method, within the limits prescribed
INTRODUCTION
3