ELECTRONIC SPHYGMOMANOMETER, automatic (Omron HBP-1320)

• ISO 81060-1, 2007, edition 1, (confirmed 2017) Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
• ISO 8160-3, 2022, Non-invasive sphygmomanometers — Part 3: Clinical investigation of continuous automated measurement type
• EN IEC 80601-2-30, 2019, edition 2, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
• ISO 81060-2, 2018, edition 3, +1:2020 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 1

• main unit with battery pack
• reusable cuff child
• reusable cuff adult medium
• reusable cuff adult large
• AC adapter
• Instruction manual

• Power source: AC adapter
• Input voltage range: AC 100 V to 240 V
• frequency: 50/60 Hz
• Output voltage range: DC 6V ±5%
• Rated Output Current: 0.5A
• OR battery pack (Nickel metal), rechargeable
• Pressure range: 0 to 300 mmHg
• Pressure accuracy: within +/- 3 mmHg
• NIBP measurement range:
• SYS = systolic blood pressure 60 to 250 mmHg
• DIA = diastolic blood pressure 40 to 200 mmHg
• Pulse rate 40 to 200 / min
• Pulse rate accuracy: within +/- 5%
• irregular pulse indicator
• LCD display with following parameters
• systolic pressure
• diastolic pressure
• pulse rate
• low battery
• current time and date
• 5 reusable GS cuffs with 1m tube and connector :
• child: SS: 12 to 18 cm
• small adult S: 17 to 22 cm (not in STD composition)
• medium adult M: 22 to 32 cm
• large adult L: 32 to 42 cm
• XL adult: 42 to 50 cm (not in STD composition)
• Inflation pressure settings 4 options:
• Auto
• 220 mmHg
• 250 mmHg
• 280 mmHg
• Protection against electric shock
• Type BF
• Operating conditions
• Temperature range: 5 to 40 °C (41 to 104 °F)
• Humidity range: 15 to 85% RH (not condensed)
• ​Weight:
• Main unit: Approx. 0,51 kg (not including accessories)
• AC adapter: Approx. 0,04 kg

Main unit: 130 x 175 x 120 mm
AC Adapter: 55 x 25 x 70 mm

Sales package dimensions:
149 x 142 x 178 mm
1,05 Kg

3 reusable cuffs‌ with 1m tube: child (SS), medium adults‌ (M) and large adult‌ (L)

• reusable GS cuffs for small adult (S) or XL adult‌ (XL)
• reusable cuffs with 4.5m tube are available on request
• single patient cuffs availabe in 4 sizes (child, small adult, medium adult, large adult)
• single patient connectors need to be ordered with the single patient cuffs, enabling to attach the s.p. cuffs to the tubing

Do not use the cuff or AC adapter to lift the unit, it can also cause the unit to malfunction.

Clinical testing has not been conducted on newborn infants and pregnant women. Do not use on newborn infants and pregnant women.

• 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)
• An SpO2 sensor 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.

The device requires no routine service other than cleaning, and visually checking the cuffs, tubing, etc.

Cleaning of the device

Can be cleaned and disinfected with a detergent/disinfectant for surfaces/non-invasive medical equipment. Prepare use-solution in concentration required. Always read the label and product information before use. Do not mix with other products. Make sure to wet the surfaces completely, use a wipe or towel, keep them wet for the whole exposure time.

Do not wipe the Power connector or allow it to become wet.

(Cf Introduction: Disinfection and sterilization in the field)

• Temperature range: -20 to 60 °C (-4 to 140 °F)
• Humidity range: 10 to 95% RH (not condensed)
• Atmospheric pressure: 500 to 1060 hPa