Suntech Medical One Piece Clinical Grade Blood Pressure Cuffs User Guide

One Piece Clinical Grade Blood Pressure Cuffs
User Guide One Piece
Durable BP Cuff

One Piece Clinical Grade Blood Pressure Cuffs

Suntech Medical’s One Piece Clinical Grade Blood Pressure Cuffs

Symbol	Definitions	Standard/Source
	Index Line	Manufacturer
	Cuff index line must fall within range markings	Manufacturer
	Artery symbol and arrow should be placed over brachial or femoral artery	Manufacturer
	Not made with PVC	Manufacturer
	Not made with natural rubber latex	Manufacturer
	Product in compliance with (EU)2017/745 Medical Devices Regulation	EU Directive
	Symbol indicating arm circumference	Manufacturer
	Symbol indicating lot code of cuff	ISO 7000-2492
	Symbol indicating manufacturer	ISO 7000-3082
	Symbol indicating Caution	ISO 7000-0434A
	Warning message	ISO 7010-W001
	Device sale only by or on the order of a licensed practitioner	FDA
	Indicates keep dry	ISO 7000-0626
	Medical Device	Medical Device Regulations
	Indicates the temperature limits to which the medical device can be safely exposed	ISO 7000-0632
	Indicates the range of humidity to which the medical device  can be safely exposed	ISO 7000-2620
	Indicates the entity importing the medical device into the locale	ISO 15223-1:2021
	To identify the country of manufacture of products. The “CC” shall be replaced by the two-letter country code defined in ISO3166-1.	IEC 60417-6049
	Indicates the model number or type number of a product	IEC 60417-6050

RANGES / COLORS

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. Do not attach the cuff to a limb being used for IV infusions or any other intravascular access, therapy or an arteriovenous (A-V) shunt.
The cuff inflation can temporarily block blood flow, potentially causing harm to the patient.
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.
As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative small-bore connector, which can result in a hazardous situation causing harm to the patient. Special measures need be taken by the user to mitigate these reasonable foreseeable risks.
CAUTIONS
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
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.
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 accuracy of the reading.

1. Place open cuff around the inner portion of the upper arm (or thigh).
2. Align artery symbol ARTERY to the brachial (or femoral) artery.
3. 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.
4. Wrap the cuff snugly around the arm (or thigh).
   Promptly remove cuff from patient when monitoring is not in progress.

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the user’s local competent authority

CLEANING PROCESS

1. Use a fresh solution of STERIS® Prolystica® 2X Concentrate Neutral Detergent with warm tap water (50-60°C).
2. Immerse the cuff in the solution and hand wash and wipe the shell with a lint-free cloth for 1 minute per side to remove debris, ensuring liquid does not enter tube connector. A soft bristle brush may be used to remove visible soil.
3. Rinse sleeve with warm water until all cleaning solution is removed, pat dry, and line dry.

DISINFECTION PROCESS

NOTE: Before disinfecting, ensure that no liquid enters tubing by using a plug or taping off.

1. Spray cuff with Quaternary Ammonium until soaked.
2. Leave to soak for at least 10 minutes.
3. Rinse with distilled water, ensuring liquid does not enter tube connector, and line dry.

Disposal: Please dispose of cuff according to local regulations

ENVIRONMENTAL CONDITIONS

Operating Ranges: 0 – 50°C
Storage Ranges: -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. This limited warranty covers the no charge replacement of the cuff under normal wear and tear conditions when returned to the attention of Service Department at the address below depend-ing on location.
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 one of the addresses below.

INTENDED USE AND CLINICAL BENEFITS

The One Piece Durable Blood Pressure cuff Model # 222OPC is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure  parameters on pediatric and adult patients. The One Piece Durable BP cuff is a single bladder and shell construction use to support ease of cleaning.

International Associates Limited
Centrum House, 38 Queen Street, Glasgow,Lanarkshire, G1 3DX, UK
[email protected]

EMERGO Europe
Prinsessegracht 20 2514 AP The Hague
The Netherlands

82-0117-00-MO-RevL

www.SunTechMed.com
SunTech Medical, Inc.
507 Airport Blvd., Suite 117
Morrisville, NC 27560, USA
Tel: + 1.919.654.2300
1.800.421.8626
Fax: + 1.919.654.2301
04-AUG-2021

References

• Blood Pressure Clinical Monitoring and OEM NIBP - SunTech Medical
• 动态血压监测,多功能血压仪-顺泰医疗器械（深圳）有限公司。
• UK.COM
• Blood Pressure Clinical Monitoring and OEM NIBP - SunTech Medical