Omron HBP-1320 User manual

PM-1795-01-06/2018
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33 2132 LR Hoofddorp The Netherlands
P.O. Box 2050 2130 GL Hoofddorp The Netherlands
Phone: [phone] fax [phone]
www.omron.healthcare.com
BANKERS JP Morgan Chase Bank NA ACC. NR.
413.90.366
IBAN GB04CHAS60924241390366 SWIFT CHASGB2L
CHAMBER OF COMMERCE NR. 342.10306
BTW/VAT NR. NL8132.86.281.B01
New Product Information Sheet
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Model (code): HBP-1320
(HBP-1320-E)

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Product description Automatic Upper Arm Blood Pressure Monitor
Product category: Electronic Sphygmomanometers
Model (code): HBP-1320 (HBP-1320-E)
LEGAL MANUFACTURER
OMRON HEALTHCARE Co., Ltd
53, Kunotsubo, Terado-cho, Muko, KYOTO,
617-0002 Japan
PRODUCION FACILITY
OMRON DALIAN Co., Ltd.
No. 3, Song Jiang Road,
Economic and Technical Development Zone,
Dalian 116600, China
EU REPRESENTATIVE
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp,
THE NETHERLANDS

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Included accessories / optional accessories
Included:
Product description Model Product code
Upper Arm Cuff GS CUFF2 L HX
A
-GCFL-PBE
Upper Arm Cuff GS CUFF2 M HX
A
-GCFM-PBE
A
C Adapte
r
A
C ADAPTER-E1600 60220H1040SW-E
AC Adapter UK AC ADAPTER-UK1600 60220H1040SW-UK
Optional:
Product description Model Product code
Upper Arm Cuff GS CUFF2 SS
(
1 m
)
HX
A
-GCFSS-PBE
Upper Arm Cuff GS CUFF2 S (1 m) HXA-GCFS-PBE
Upper Arm Cuff GS CUFF2 M
(
1 m
)
HX
A
-GCFM-PBE
Upper Arm Cuff GS CUFF2 L
(
1 m
)
HX
A
-GCFL-PBE
Upper Arm Cuff GS CUFF2 XL
(
1 m
)
HX
A
-GCFXL-PCE
Upper Arm Cuff GS CUFF2 SS (4.5 m) HXA-GCFSS-PCE
Upper Arm Cuff GS CUFF2 S (4.5 m) HXA-GCFS-PCE
Upper Arm Cuff GS CUFF2 M (4.5 m) HXA-GCFM-PCE
Upper Arm Cuff GS CUFF2 L (4.5 m) HXA-GCFL-PCE
Upper Arm Cuff GS CUFF2 XL (4.5 m) HXA-GCFXL-PCE
AC Adapter AC ADAPTER-E1600 60220H1040SW-E
AC Adapter UK AC ADAPTER-UK1600 60220H1040SW-UK
General description
OMRON’s HBP-1320 (HBP-1320-E) blood pressure monitor is a professional medical
device meant for measurement of blood pressure on the basis of the oscillometric
principle.
Packaging content
The manufacturer produces the HBP-1320 with the applicable accessories included,
necessary for the application of its intended purpose.
1. Main unit
2. GS CUFF2 L (HXA-GCFL-PBE) (32-42 cm)
3. GS CUFF2 M (HXA-GCFM-PBE) (22-32 cm)
4. AC Adapter [AC ADAPTER-E1600] (or [AC ADAPTER-UK1600])
5. Battery pack [HXA-BAT-2000]
6. Instruction manual
7. Guarantee card

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The complete set of the medical device is specified in the Instruction Manual in the
Technical Data section.
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).
Application field
This product is intended for use in in physicians’ offices, hospitals, clinics and other
medical facilities.
Intended user
This device is a digital monitor intended for use in measuring blood pressure and
pulse rate in adult patient population.
Indications for use
This device is a digital monitor intended for use in measuring blood pressure and
pulse rate in adult patient population.
Measurement Parameter
■ Non-Invasive Blood Pressure
■ Pulse rate
Features (Particularities)
The OMRON HBP-1320 is an affordable professional blood pressure unit that is
clinically proven accurate and provides fast, reliable results and is easy to use.
Key features
• 10 cuffs available in two sets of 5 sizes - (SS: 12 to 18 cm, S: 17 to 22 cm, M:
22 to 32 cm, L: 32 to 42 cm, XL: 42 to 50 cm) with shorter (1 m) or longer (4.5
m) tube attached. (12 to 50 cm arm circumference range)
• Designed to be used on a table

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• Motion stop function (When body movement is detected, the device stops
deflation for 5 seconds.)
• Irregular pulse Indicator - Helps identify changes in heart rate, rhythm, or pulse
which may be caused by heart disease or other serious health issues.
• Inflation Pressure Setting - 4 options: Auto, 220 mmHg, 250 mmHg, 280
mmHg
• Last reading display function
• Auto-Off
• Custom Rechargeable battery
• Large, easy-to-read backlight display
Description of operating principle
How it works
Blood pressure monitor HBP-1320 measures blood pressure using oscillometric
method. For detailed description of this method, consult the “Non-Invasive Blood
Pressure (NIBP) Measurement” chapter of the instruction manual.
How to use the device
Main steps:
1. Select the right sized cuff for the patient.
2. Wrap the cuff correctly on a bare arm or over thin clothing.
3. Select the mode of application (Manual Mode, Auscultation Mode)
4. Press start
5. Note the blood pressure and pulse rate in the patients’ documents
Review the Instruction Manual for the full details on the application of this product.
Technical data
Main unit
Product Cate
g
or
y
Electronic Sph
yg
momanometers
Product Description
A
utomatic Upper Arm Blood Pressure Monito
r
Model
(
code
)
HBP-1320
(
HBP-1320-E
)
Measurement Paramete
r
NIBP, PR
Dimension Main unit: 123 x 201 x 99 (mm)
4.84 x 7.91 x 3.90 (inch) (W x H x D)
AC adapter: 46 x 66 x 66.2 (mm)
1.81 x 2.60 x 2.61 (inch) (W x H x D)
Battery: 54 x 43.5 x 15.4 (mm)
2.13 x 1.71 x 0.61
(
inch
)
(
W x H x D
)

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Weight Main unit: Approx. 0.52 kg
(not including accessories and options)
AC adapter: Approx. 120 g
Batter
y
: Approx. 0.1 k
g
Displa
y
7 se
g
ment LCD
Protection Class
Class II (AC Adapter)
Internal powered equipment (when operating with
batter
y
onl
y)
De
g
ree of Protection T
y
pe BF
(
Applied part
)
: Cuff
Operation Mode Continuous operation
MDD Classification Class II a
Packaging contents Main unit, 2 Arm cuffs (M size/L size), AC Adapter,
Batter
y
pack, Instruction Manual, Guarantee card
Power supply
AC adapter Input voltage range: AC 100 V to 240 V
Frequency: 50/60 Hz
Output voltage range: DC 6 V ±5%
Rated output current: 1.6
A
Rechargeable battery Type: 3.6 V, 1900 mAh
Number of operation cycles when fully charged: 300
Measurement conditions
• New battery fully charged
• Ambient temperature of 23°C (73.4°F)
• Using M-size cuff
• SYS 120 / DIA 80 / PR 60 (Inflation setting: AUTO)
• One 5-minute cycle consisting of “cuff measurement
time + wait time”
Environmental Conditions
Operating Conditions Temperature range: 5 to 40°C (41 to 104°F)
Humidity range: 15 to 85%RH (not condensed)
A
tmospheric pressure: 700 to 1060hPa
Storage and transportation Temperature range: -20 to 60°C (-4 to 140°F)
Humidity range: 10 to 95%RH (not condensed)
A
tmospheric pressure: 500 to 1060hPa
Non-Invasive Blood Pressure (NIBP)
Measurement technolo
gy
Oscillometric
Measurement method D
y
namic Linear Deflation method
Pressure displa
y
ran
g
e 0 to 300 mmH
g
Pressure displa
y
accurac
y
Within ±3 mmH
g
NIBP measurement range SYS 60 to 250 mmHg
DIA 40 to 200 mmHg
Pulse rate 40 to 200 /min
NIBP accuracy* Maximum mean error within ±5 mmHg
Maximum standard deviation within 8 mmH
g

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Pulse rate accurac
y
Within ±5 % of readin
g
Reference Standard EN1060-1:1995+A2:2009
EN1060-3:1997+A2:2009
EN80601-2-30:2010+A1:2015
EN ISO 81060-2:2013
* Comparison with auscultation method performed by a trained professional.
DIA determined by the auscultation method is “K5”.
Materials used for main device
Item Material
Housin
g
A
BS
(
acr
y
lonitrile butadiene st
y
rene
)
Batter
y
Cove
r
A
BS
(
acr
y
lonitrile butadiene st
y
rene
)
Front Panel PC
(
pol
y
carbonate
)
Cuff N
y
lon / Pol
y
este
r
Tube PVC
(
pol
y
vin
y
l chloride
)
Packa
g
e Cardboard
Inst
r
uction Manual Pape
r
Materials used for accessories
Cuff
Item Material
Outside cloth N
y
lon / Pol
y
este
r
Inner cloth Pol
y
este
r
A
ir ba
g
Flexible urethane sheet
Velcro tape hook N
y
lon
Velcro tape loop N
y
lon
Sewin
g
cotton Pol
y
este
r
A
ir Tube PU
(
pol
y
urethane
)
A
ir plu
g
to device PVC
(
pol
y
vin
y
l chloride
)
A
ir plu
g
to cuff PVC
(
pol
y
vin
y
l chloride
)
AC Adapter
Item Material
Cable PVC
(
pol
y
vin
y
l chloride
)
A
dapter plu
g
Coppe
r
Housin
g
PPE
(
pol
y
phen
y
lenethe
r
)

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Title page of Instruction Manual

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Unfolded package design of main device and accessories
Main device:
Information in white square on package artwork

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Accessories:
AC ADAPTER-E1600 :
Packaging specifications from Explanation Diagram
List of Harmonized EN Standards
The above mentioned medical device belongs to Class IIa (MDD Annex IX Rule 10)
potential risk class. Applicable Directives & Standards:
Medical Device Directive (MDD) 93/42/EEC :
EN ISO 15223:1:2016
EN 1041:2008+A1:2013
EN 1060-1:1995+A2:2009
EN 1060-3 :1997+A2:2009
EN 60601-1:2006+A1:2013
Package Amount Approx. weight Approx. dimensions
W x D x H, mm
Main Unit 1 520
g
123 x 201 x 99 mm
Packa
g
e 1 1.63k
g
239 x 154 x 170 mm
Master Carton 5 8.93k
g
808 x 262 x 211 mm
EAN code 401567211129 5

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EN 60601-1-6:2010+A1 :2015
EN 80601-2-30:2010+A1 :2015
EN 62304:2006+A1:2015
EN 62366:2008+A1:2015
EN ISO 10993-1:2009/AC:2010
EN ISO 10993-5:2009
EN ISO 10993-10:2013
EN ISO 14971:2012
EN ISO 81060-2 :2014
EN ISO 13485 :2016
2011/65/EU Restriction of Hazardous Substances (RoHS) : EN 50581 :2012
Operation and care
Cleaning and disinfecting should be performed in accordance with your facility’s
infection control practice.
Cleaning of the device
Wipe with a cloth that has been moistened with isopropyl alcohol diluted to 50 v/v%,
or ethyl alcohol (disinfection alcohol) diluted to 80 v/v% or less and wrung out.
Do not wipe the DC jack or allow it to become wet.
Warnings
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.
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.
Storage/Setup
Warnings
• Install the unit in a location close to a power outlet where the AC adapter can be
easily disconnected. If the power cannot be quickly disconnected when an abnormal
condition occurs, an accident or fire may result.
• 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 OMRON retail dealer or distributor.
• 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.

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• 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.
• During measurement, make sure that no mobile phone or any other electrical
devices that emit electromagnetic fields is within 30 cm of this monitor. This may
result in incorrect operation of the monitor and/or cause an inaccurate reading.
Cautions
• 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 in a location with noise-emitting equipment such as a room with MRI, CT,
X-ray, or HF surgical equipment or an operating room. Noise from the equipment
may interfere with the operation of the unit.
Before use / during use
Warnings
• The unit complies with the EMC standard (EN60601-1-2). 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.

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• For the AC adapter connected to the unit, supplies, and optional devices, use only
the standard accessories or OMRON-specified products. This may damage and/or
may be hazardous to the device.
• 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 physicians’ office, hospitals, clinics and other medical
facilities.
• 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.
Cautions
• 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)
- The patient has a mastectomy
- 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.
• Do not wrap the cuff on an arm with an SpO2 sensor or other monitoring equipment
attached. The pulse may disappear when the cuff pressurizes, causing a temporary
loss of monitoring function.
Cleaning
Warnings
• 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.
Cautions
• 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.).

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• If using an antiseptic solution for cleaning, follow the instructions of the
manufacturer. This may damage on the surface of the device.
• Clean the unit regularly.
Maintenance and inspection
Warnings
• To use the unity safely and correctly, always inspect the unit when starting work.
• Unauthorized modification is prohibited by law. Do not attempt to disassemble or
modify the unit.
Rechargeable battery
Warnings
• 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 use the battery pack in any other device besides this unit. 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. Charge the battery once every 6 months. (Storage conditions for the
battery are a temperature of -20 to 30°C (-4 to 86°F) and a humidity of 65 ±20%.)
• Before use, always charge the battery.
• 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. If the battery does not connect well to the
unit, do not forcibly connect it.
• Do not connect the positive and negative terminals of the battery with a wire or
other metal object. Do not carry or store a battery with metal necklaces, hairpins, or
other metal objects.
• Use only the specified type of battery.
Caution
• Do not touch the positive and negative terminals of the battery pack with a wire or
other metal object. If battery fluid comes into contact with the skin or clothes,
immediately rinse with water.
Non-Invasive Blood Pressure (NIBP) measurement
Warnings
• If a cuff is used on some patients with an infection, treat the cuff as medical waste,
or disinfect before reuse. Otherwise, an infection may result.
• 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.

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• 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 an SpO2 sensor, IBP catheter, or other instrument is
attached.
- An upper arm with a shunt for hemodialysis
- An injured upper arm
• 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.
Cautions
• NIBP measurement should be performed on the upper arm.
• During NIBP measurement, 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:
- 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 OMRON GS CUFF2 can be used with this device. The use of any other cuff
may result in incorrect measurement.
Disposal
As there is a risk of environmental pollution, follow your applicable national and local
legal regulations regarding disposal or recycling of this equipment and batteries.
The main constituents of each part are listed in the table “Materials List”.
As there is a risk of infection, do not recycle patient attachments such as cuffs, but
dispose of them as instructed by your facility’s procedures and applicable regulations.

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Consult also the “Correct Disposal of This Product (Waste Electrical & Electronic
Equipment)” section of the Manual.
Transportation and storage conditions
Storage and transportation:
Temperature range: -20 to +60°C (-4 to 140°F)
Humidity range: 10 to 95%RH
Atmospheric pressure: 500 to 1060hPa
Warranty and lifetime
Warranty:
- blood pressure monitor: 3 years
- AC adapter: 1 years
- cuffs: this is considered a disposable item depending upon usage
Lifetime:
- blood pressure monitor: 5 years (only when appropriate inspection in performed)
- AC Adapter: 5 years
- tubes: no lifetime as these are considered disposable items
- cuffs: no lifetime as these are considered disposable items
Warranty term, lifetime and addresses of service centers are specified in the
warranty card inside the packaging of the HBP-1320.
Repair
If the unit has broken down, contact your OMRON retail dealer or distributor.
Servicing
The HBP-1320 must be maintained to ensure functionality and to secure the safety of
patients and operators.
Daily checks and maintenance should be performed by the operator.
In addition, qualified personnel are necessary to maintain the performance and the
safety, and to conduct periodic inspections. We recommend that the verification test
be performed at least once a year.
The device requires no routine service other than cleaning, and visually checking the
cuffs, tubing, etc.