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