Omron HBP-1100 User manual

Thank you for purchasing this OMRON Professional Blood
Pressure Monitor.
Please completely read this Instruction Manual before using the
monitor for the first time.
Read this manual to ensure the safe and accurate use of the
monitor.
Professional Blood Pressure Monitor
HBP-1100
Instruction Manual
XXXXXXX-X A
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Exemptions
OMRON will not bear any responsibilities on the following matters.
1. When a problem or damage occurs caused by the maintenance and/
or repair conducted by a person other than OMRON or the dealer
specified by OMRON
2. The problem or damage of OMRON product caused by the product of
other manufacturer not delivered by OMRON
3. The problem and damage caused by the maintenance and/or repair
using the repair parts not specified by OMRON
4. The problem and damage caused by the results not observing the
Notes on Safety or the operational method mentioned in this
Instruction Manual
5. Under the circumstances not within the operating conditions of this
unit including the power source or the setting environment mentioned
in this Instruction Manual
6. The problem and damage caused by the result(s) of remodeling or
improper repair of this product
7. The problem and damage caused by act of god such as fire,
earthquake, flood, or lightning
1. The contents of this Instruction Manual may be changed without prior
notice.
2. We have thoroughly reviewed the contents of this Instruction Manual.
However, if an inadequate description or error is found, please let us
know.
3. It is prohibited to copy a part of or the entire Instruction Manual without
getting OMRON’s permission. Unless this Instruction Manual is used
by an individual (company), it cannot be used without getting
OMRON’s permission from the standpoint of the Copyright Law.
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Table of Contents
Introduction
Intended Use ................................................................................2
Features of the Product ................................................................2
Notes on Safety............................................................................3
Using the Unit
Components of the Product..........................................................10
Features / Functions of Unit .........................................................11
Installing the Batteries ..................................................................13
Connecting the AC Adapter..........................................................13
Cuff Selection and Connection .....................................................14
Applying the Cuff to the Patient ....................................................15
Zero indicator function ..................................................................17
Non-Invasive Blood Pressure (NIBP) Measurement
Measurement in normal mode......................................................18
Measurement in auscultation mode..............................................20
Stopping the Measurement ..........................................................21
Non-Invasive Pressure Measurement Principles..........................22
Maintenance
Maintenance Inspection and Safety Management .......................23
Device Maintenance .....................................................................23
Accessory Care ............................................................................23
Managing Supplies .......................................................................23
Check before Use.........................................................................24
Checking pressure accuracy ........................................................25
Troubleshooting............................................................................26
List of Error Codes .......................................................................29
Disposal........................................................................................31
Specifications
Specifications ...............................................................................32
Manufacturer's Declaration...........................................................36
Optional Accessories
Optional Medical Accessories ......................................................40
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Introduction
Intended Use
Medical Purpose
The device is a digital monitor intended for use in measuring blood
pressure and pulse rate in adult and pediatric patient population with arm
circumference ranging from 12 cm to 50 cm (from 5 inches to 20 inches).
Intended User
This device should be used by a medical professional.
Patient Population
This device is intended for use on adults and children of age 3-years and
older.
Environment
The instrument is designed for use in physicians' offices, hospitals, clinics
and other medical facilities.
Measurement Parameter
■ Non-Invasive Blood Pressure
■ Pulse rate
Precautions for Use
Warnings and cautions described in the instruction manual should be observed
at all times.
Features of the Product
The blood pressure accuracy of the HBP-1100 is clinically proven. Easy to
use, the HBP-1100 is intended for use by medical professionals.
■
Zero indicator function (page 14): Before each measurement, this device
indicates that "zero calibration" was successful.
■ Auscultation mode
■ 5 cuffs available - (XL: 42 to 50 cm, L: 32 to 42 cm, M: 22 to 32 cm, S: 17
to 22 cm, SS: 12 to 18 cm)
■ This device and cuff can be cleaned with a soft cloth moistened with
alcohol.
■ Compact, can be stored in a drawer
■ Motion stop function: When body movement is detected, this device
stops deflation for 5 seconds.
■ Irregular pulse icon: Helps identify changes in heart rate, rhythm, and
pulse that may be caused by heart disease or other serious health
problems.
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Notes on Safety
The warning signs and symbol examples indicated below are intended to
ensure safe use of the product and prevent damage and injury to you and
others. The signs and symbols are explained below.
Setup
Warning
• Do not use the cuff or AC adapter to lift the unit, it can also cause the unit
to malfunction.
• If the unit has broken down, contact your local OMRON representative.
• Do not use in combination with a hyperbaric oxygen therapy device, or in
an environment where combustible gas may be generated.
• Do not use in combination with magnetic resonance imaging (MRI)
equipment. If MRI is to be performed, remove cuff connected to the unit
from the patient.
• Do not use with a defibrillator.
• Do not install the unit in the following locations:
- Locations subject to vibration such as ambulances and emergency
helicopters.
- A location where there is gas or flame.
- A location where there is water or steam.
- A location where chemicals are stored.
• Do not use at extremely high temperature, high humidity, or high altitude.
Use only within the required ambient conditions.
• Do not subject the unit to intense shock.
• Do not place heavy objects on the AC adapter cable, or allow the unit to
sit on the cord.
• Clinical testing has not been conducted on newborn infants and pregnant
women. Do not use on newborn infants and pregnant women.
• Do not plug in or unplug the AC adapter with wet hands.
Safety Symbols used in this Instruction Manual
Warning Indicates the matters in which death or severe bodily
damage may arise as a result of incorrect handling.
Caution Indicates the matters in which bodily harm or material
damage may arise as a result of incorrect handling.
General Information
Note:
Indicates general information to keep in mind when using the unit and
other useful information.
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Caution
• Do not install the unit in the following locations:
- Locations with dust, salt, or sulfur.
- Locations directly exposed to sunlight for extended periods of time (in
particular, do not leave in direct sunlight or near a source of ultraviolet
light for extended periods, as ultraviolet light will cause deterioration of
the LCD).
- Locations subject to vibration or shock.
- Near heaters.
• Do not use the unit near large equipment that uses a switching relay for
power ON/OFF.
Before use / during use
Warning
• The unit complies with the EMC standard (IEC60601-1-2). As such, it
can be used simultaneously with multiple medical instruments. However,
if instruments that generate noise such as an electric scalpel or a
microwave therapy device are near the unit, check the operation of the
unit during and after use of these instruments.
• If an error occurs or a measurement result is questionable, check the
vital signs of the patient by auscultation or palpation. Avoid relying solely
on the measurement results of the unit when judging the patient's
condition.
• Only trained healthcare providers should use this device. Do not allow
patients to operate this device.
• Properly connect the connectors and AC adapter cable.
• Do not place objects or liquids on top of this unit.
• Check the following before using the unit:
- Make sure the AC adapter cable is not damaged (wires are not
exposed or broken), and the connections are firm.
• For the AC adapter connected to the unit, supplies, and optional devices,
use only the standard accessories or OMRON-specified products.
• Do not use in a location with moisture, or a location where water may
splash on the unit.
This unit is intended for use in a physician's office.
• Do not use the unit if it emits smoke, an abnormal odor, or abnormal
noise.
• Do not bring cellular telephones or transceivers into the room where the
unit is installed or being used.
• Do not connect multiple monitors to the same patient.
• Do not connect the unit to a power outlet that is controlled by a wall
switch.
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Caution
• Before using the unit, verify that none of the following apply to the
patient:
- Poor peripheral circulation, noticeably low blood pressure, or low body
temperature (there will be low blood flow to the measurement position)
- The patient uses an artificial heart and lung (there will be no pulse)
-AnSpO
2sensor and the cuff are attached to the same arm
- The patient has an aneurysm
- The patient has frequent arrhythmia
- Body motions such as convulsions, arterial pulsations, or trembling
(cardiac massage in progress, minute continuous vibrations,
rheumatism, etc.)
• Before use, visually inspect the unit to make sure there are no
deformations due to falling, and that there is no dirt or moisture on the
unit.
• When the unit has not been used for an extended period of time, always
verify that it operates normally and safely before use.
• Do not use in a location where the unit may easily fall. In the event that
the unit falls, verify that it operates normally and safely.
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Cleaning
Warning
• When cleaning the unit, turn off the power and disconnect the AC
adapter from the unit.
• After cleaning the unit, make sure it is completely dry before connecting
to a power outlet.
• Do not spray, pour, or spill liquids into or onto the unit, accessories,
connectors, buttons, or openings in the housing.
Caution
• Do not use thinner, benzene, or other solvents to clean the unit.
• Do not sterilize by autoclave or gas sterilization (EOG, formaldehyde gas,
high-concentration ozone, etc.).
• If using an antiseptic solution for cleaning, follow the instructions of the
manufacturer.
• Clean the unit regularly.
Maintenance and inspection
Warning
• To use the unity safely and correctly, always inspect the unit when start-
ing work.
• Unauthorized modification is prohibited by law. Do not attempt to disas-
semble or modify the unit.
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Dry cell battery
Warning
• If battery fluid comes in contact with the eye, immediately flush with
copious amounts of water. Do not rub. Seek medical attention
immediately.
• Do not throw into flame, disassemble, or heat.
• Always disconnect the AC adapter from the unit before removing or
installing a battery.
• If the unit will not be used for a month or longer, remove the battery from
the unit and store.
• Do not attempt to disassemble or modify the battery.
• Do not apply pressure to and deform the battery. Do not throw, pound,
drop, bend, or hit the battery.
• The battery has positive/negative polarity. Do not insert batteries with
their polarities reversed.
• Do not connect the positive and negative terminals of the battery with a
wire or other metal object.
• Do not use the AC adapter and battery at the same time.
Caution
• If battery fluid comes in contact with skin or clothing, rinse immediately
with water.
• Do not use new and old batteries together, or use different types of
batteries together.
Non-Invasive Blood Pressure (NIBP) measurement
Warning
• If a cuff is used on a patient with an infection, treat the cuff as medical
waste, or sterilize before reuse.
• If frequently performing NIBP measurement using a cuff over an extended
period of time, periodically check the patient's circulation. In addition,
wrap the cuff as indicated in the cautionary points in this manual.
• Do not connect the NIBP cuff or cuff joint to a luer lock adapter.
• Do not bend cuff tube during inflation and deflation, particularly after a
change of body position.
• Do not wrap the cuff on the following parts:
- An upper arm on which intravenous drip or a blood transfusion is being
performed.
- An upper arm on which SpO2sensor, IBP catheter, or other instrument
is attached.
- An upper arm with a shunt for hemodialysis
• If measuring blood pressure with the cuff wrapped on the arm on the side
of the body where a mastectomy was performed, check the patient's
condition.
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Caution
• NIBP measurement should be performed on the upper arm.
• During NIBP, stop excessive body movement by the patient and
minimize trembling.
• If a doctor has indicated that the patient has hemorrhagic diathesis or
hypercoagulability, check the condition of the arm after measurement.
• Use the appropriate cuff size to ensure correct measurements. If too
large a cuff is used, the measured blood pressure value tends to be
lower than the actual blood pressure. If too small a cuff is used, the
measured blood pressure value tends to be higher.
• Before and during measurement, verify that none of the following apply
to the patient:
- An inappropriate cuff size is used.
- The part where the cuff is wrapped is at a different height than the
heart.
(A difference of 10 cm (4 inches) in height may cause a variation in the
blood pressure value of up to 7 or 8 mmHg.)
- Body movement or conversing during measurement.
- Cuff wrapped over thick clothing.
- Pressure on the arm due to a rolled up sleeve.
• In the case of a cuff for adults, the cuff should be wrapped to a tightness
that allows two fingers to be inserted in between the cuff and the arm.
• The accuracy of a flashing measurement value that is out of the
measurement range cannot be guaranteed. Always check the patient's
condition before deciding what steps to take.
• Do not use the cuff if it is damaged or has holes.
• Only an OMRON GS CUFF can be used with this device. The use of any
other cuff may result in incorrect measurement.
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