Suntech Medical One Piece Clinical Grade Blood Pressure Cuffs User Guide
- June 10, 2024
- SunTech Medical
Table of Contents
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
Size: | Color: | Range: |
---|---|---|
Infant | Orange | 8-13 cm |
Child | Green | 12-19 cm |
Small Adult | Royal Blue | 17-25 cm |
Small Adult Plus | Royal Blue | 18-29 cm |
Adult | Navy Blue | 23-33 cm |
Adult Long | Navy Blue | 23-33 cm |
Adult Plus | Navy Blue | 28-40 cm |
Large Adult | Burgundy | 31-40 cm |
Large Adult Long | Burgundy | 31-40 cm |
Large Adult Plus | Burgundy | 40-55 cm |
Thigh | Brown | 38-50 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. 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.
- 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.
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
- Use a fresh solution of STERIS® Prolystica® 2X Concentrate Neutral Detergent with warm tap water (50-60°C).
- 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.
- 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.
- Spray cuff with Quaternary Ammonium until soaked.
- Leave to soak for at least 10 minutes.
- 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
UKRP@ia-uk.com
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