Intended purpose of use: For physical examination, Diagnosis hypertension, Monitoring by measuring blood pressure.
Product description: Device used for the indirect (non-invasive) measurement of arterial blood pressure. The systolic and diastolic pressure is usually assessed by listening to Korotkoff sounds generated by arterial blood flow using a stethoscope simultaneously.
The sphygmomanometer is composed of cloth cuff containing an inflatable bag.
Connected via a tube to a flexible bulb with valve and integrated manometer needle gauge.
Material for cuff: durable nylon, non-deformable, washable at 30ºC.
Material for tube: rubber.
Very strong cuff with double velcro fastening, enabling it to be adjusted to fit tightly around the arm.
Cuff reinforced at both ends.
Dimensions of cuff: approx. 570 x 145mm.
The bag is inflated by means of a flexible bulb connected via a tube (length 60cm flexible and reliable quick connector). Rubber tubes to be detachable from other parts, allowing periodic cutting of decayed ends.
The quick connector can easily be connected to all types of inflation bulbs.
Rubber inflation bulb with integrated manometer needle gauge.
Glass and metal aneroid pressure gauge with needle.
Dial graduation: 0 to 300 mmHG.
Pressure gauge to allow reading of pressure to 2mmHg accuracy.
With pressure release valve.
Easily to grip bulb.
Warranty 2 years.
Instructions for use:
For the measurement of arterial blood pressure.
Operating conditions: Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%.
Packaging and labelling: as per regulations applied to the device.
One (1) sphygmomanometer (adult) in a box of case of bag with manufacturer's instruction for use in English, French and Spanish, spare parts and accessories (when applicable).
Symbols used according ISO 15223.
CE mark with Notified Number Body.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class Im device.
Safety & product Standards:
Must comply with following standards (as per the latest revision of standards):
ISO 14971:2007 Medical devices -- Application of risk management to medical devices.
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems.
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers.
ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type.
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing.
Environmental requirements:
ISO 14001.
Chemicals used shall not be "Carcinogenic, Mutagenic of Toxic to Reproduction, Persistent & Bio accumulative types".
Product description: Device used for the indirect (non-invasive) measurement of arterial blood pressure. The systolic and diastolic pressure is usually assessed by listening to Korotkoff sounds generated by arterial blood flow using a stethoscope simultaneously.
The sphygmomanometer is composed of cloth cuff containing an inflatable bag.
Connected via a tube to a flexible bulb with valve and integrated manometer needle gauge.
Material for cuff: durable nylon, non-deformable, washable at 30ºC.
Material for tube: rubber.
Very strong cuff with double velcro fastening, enabling it to be adjusted to fit tightly around the arm.
Cuff reinforced at both ends.
Dimensions of cuff: approx. 570 x 145mm.
The bag is inflated by means of a flexible bulb connected via a tube (length 60cm flexible and reliable quick connector). Rubber tubes to be detachable from other parts, allowing periodic cutting of decayed ends.
The quick connector can easily be connected to all types of inflation bulbs.
Rubber inflation bulb with integrated manometer needle gauge.
Glass and metal aneroid pressure gauge with needle.
Dial graduation: 0 to 300 mmHG.
Pressure gauge to allow reading of pressure to 2mmHg accuracy.
With pressure release valve.
Easily to grip bulb.
Warranty 2 years.
Instructions for use:
For the measurement of arterial blood pressure.
Operating conditions: Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%.
Packaging and labelling: as per regulations applied to the device.
One (1) sphygmomanometer (adult) in a box of case of bag with manufacturer's instruction for use in English, French and Spanish, spare parts and accessories (when applicable).
Symbols used according ISO 15223.
CE mark with Notified Number Body.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class Im device.
Safety & product Standards:
Must comply with following standards (as per the latest revision of standards):
ISO 14971:2007 Medical devices -- Application of risk management to medical devices.
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems.
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers.
ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type.
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing.
Environmental requirements:
ISO 14001.
Chemicals used shall not be "Carcinogenic, Mutagenic of Toxic to Reproduction, Persistent & Bio accumulative types".
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $8.54 |
