SunTech Medical Soft Disposable Single Patient Use Blood Pressure Cuff Instructions
Suntech Medical’s Disposable Clinical Grade Blood Pressure Cuffs
Index Line
Cuff index line must fall within range markings
Artery symbol and arrow should be placed over brachial or femoral artery
Not made with natural rubber latex
Product in compliance with Council Directive 93/42/EEC Medical Devices Directive
Symbol indicating arm circumference
Symbol indicating lot code of cuff
Symbol indicating Caution
Symbol indicating manufacturer
Indicates device sale only by or on the order of a licensed practitioner
Indicates keep dry
Medical Device
Single Patient Multi-Use
RANGES / COLORS
Size: Color: Range:
Infant Orange -13 cm
Child Green 12-19 cm
Child Long Green 12-19 cm
Sm Adult Turquoise 17-25 cm
Sm Adult Long Turquoise 17-25 cm
Sm Adult Plus Turquoise 18-29 cm
Adult Navy Blue 23-33 cm
Adult Long Navy Blue 23-33 cm
Adult Plus Navy Blue 28-40 cm
Lg Adult Burgundy 31-40 cm
Lg Adult Long Burgundy 31-40 cm
Lg Adult Plus Burgundy 40-55 cm
Thigh Brown 38-50 cm
Neonatal:
Size: Color: Range:
- Orange 3-6 cm
- Turquoise 4-8 cm
- Green 6-11 cm
- Navy Blue 7-13 cm
- Burgundy 8-15 cm
WARNINGS
Pressurization of the cuff can temporarily cause loss of function if simultaneously used with monitoring equipment on the same limb.
The cuff should not be placed on the patient’s arm on the side of a mastectomy. In the case of a double mastectomy use the side of the least dominant arm.
If luer lock connectors are used in the construction of tubing, there is a possibility to connect the cuff to intravenous fluids, allowing air to be pumped into a blood vessel, potentially causing serious injury.
Following the application of the BP cuff, petechia formation (a minute reddish or purplish spot containing blood that appears in the skin) or Rumpel-Leede phenomenon (multiple petechia) on the arm, which may lead to idiopathic-thrombocytopenia (spontaneous persistent decrease in the number of platelets, associated with
hemorrhagic conditions) or phlebitis (inflammation of a vein) may be observed.
Do not attach the cuff to a limb being used for IV infusions or any other intravascular access, therapy or an arterio-venous (A-V) shunt. The cuff inflation can temporarily block blood flow, potentially causing harm to the patient.
CAUTIONS
Do not use cuff if there are any signs of damage. Failure to do so could affect measurement accuracy
Minimize limb movement during the measurement.
Federal (US) law restricts this device to sale by or on the order of a licensed healthcare practitioner
The cuff should not be applied over a wound as this can cause further injury
Avoid contact with the cuff, other than that of the patient’s limb, while measurement is in progress.
A compressed or kinked connection hose may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient
Using an incorrect cuff size could result in erroneous and misleading BP measurement results
APPLICATION
Follow the application instructions for use to ensure the correct size cuff for the patient. Failure to do so will adversely affect the accura- cy of the reading.
- Place open cuff around the inner portion of the upper arm (or thigh).
- Align artery symbol ARTERY to the brachial (or femoral) artery.
- Use the RANGE indicator with the INDEX line to check that the limb falls within the specified range of that cuff. If it does not, select a cuff that better accommodates the limb circumference.
- Wrap the cuff snugly around the arm (or thigh).
Promptly remove cuff from patient when monitoring is not in progress.
Disposal: Please dispose of cuff according to local regulations.
ENVIRONMENTAL CONDITIONS
Operating Ranges Temp: 0 – 50°C RH: 15 – 95% non-condensing
Storage Ranges Temp: -20 – 65°C RH: 15 – 95% non-condensing
WARRANTY
SunTech Medical warrants our blood pressure cuff products to be free from defects in material and workmanship 24 months from the. original date of purchase. The warranty shall only cover out-of-box failures, as this is a Single Use product. It is not intended for repeat- ed use.
Contact the Service Department at either of these locations to receive a Return Material Authorization number before sending any product. Cuffs should be returned to the attention of the appropriate Service Department at of the addresses below..
DISPOSABLE CUFF INTENDED USE STATEMENT
The Disposable Blood Pressure cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.
