SunTech Medical 230725 Orbit-K Cuff with Microphone for Tango M2 Adult Size Instruction Manual

SunTech Medical
Orbit-K

Suntech Medical’s Clinical Grade Orbit-K Blood Pressure Cuffs

15223-1:2021
| To indicate that separate collection for waste electric and electronic equipment (WEEE) is required.| IEC 60417-6414

RANGES

It is important that the cuff is properly fitted to the patient’s arm, and that the microphone is placed over the brachial artery (on the inside of the arm between the bicep and tricep)! Improper cuff sizing and a misplaced microphone can lead to missed or poor readings and accuracy. Please refer to the Tango+ and Tango M2 User Manual for further information about this cuff that is used exclusively with the Tango Family Product Line.
POSSIBLE ADVERSE REACTIONS
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 petechiae) 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.

WARNINGS & CONTRAINDICATIONS
Federal (US) law restricts this device to sale by or on the order of a physician. After washing ensure the size indication on the bladder and cuff shell match. Make sure that the cuff hose is threaded through one of the hose openings in the cuff. Cuffs are intended for use with non-invasive blood pressure monitors only. Cuffs shall not be used in the proximity of an MRI device.
DO NOT apply the BP cuff to a limb being used for IV infusions as the cuff inflation can block the infusion, causing harm to the patient. 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.
A compressed or kinked connection hose may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient
DO NOT apply the BP cuff over a wound as this can cause further injury.
DO NOT apply the BP cuff to the arm on the side of a single mastectomy. In the case of double mastectomy use the side of the least dominant arm.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the user’s local competent authority.

INTENDED USE AND CLINICAL BENEFITS
The Orbit K Blood Pressure Cuff is intended to be used with the Tango (Tango, Tango+, Tango M2) line of automated Blood Pressure monitors for cardiac stress and exercise testing. The cuffs are to be prescribed and used only by licensed medical practitioners, doctors, or nurses. The clinical benefit of this cuff is designed to stay in place during use with a built-in microphone specifically for detecting the Korotkoff sounds of the patient. This cuff is designed to ensure consistent and accurate blood pressure measurements during cardiac stress and exercise testing.

APPLICATION
Check that the cuff is the correct size:

1. Fold the grey sleeve inside the blue cuff (away from the Velcro strip).
2. Wrap the cuff around the patient’s upper arm.
3. Make sure the INDEX (the end of the cuff) falls within the RANGE (printed inside the cuff).
4. If the INDEX falls outside the RANGE, select a new cuff size.

WARNING : Using an incorrect cuff size could result in erroneous and misleading BP measurements!
PROPER CUFF & MICROPHONE PLACEMENT

1. Locate the brachial artery, between the bicep and the tricep of the upper arm. The left arm is preferred.
2. Slide the cuff sleeve up the patient’s arm, with the “ARTERY” marker pointing down the arm.
3. There is a microphone located under the “ARTERY” marker. Make sure the microphone is placed on the inner portion of the arm, directly over the brachial artery between the edge of the cuff and the elbow.
4. Wrap the cuff around the arm and secure. Use the wrist straps to secure the cables to the patient’s wrist.
   NOTE: It is important that the cuff is properly fitted to the patient’s arm, and that the microphone is placed over the brachial artery in between the bicep and tricep on the inner portion of the upper arm.

CLEANING PROCESS:

1. Remove bladder & microphone.
2. Soak in warm water for 5 minutes to loosen the soil.
3. Rinse under running warm water (50-140°F or 10-60°C) for 1 minute. A soft bristle brush may be used to remove visible soil.
4. Fold up the cuff so that hook is attached to the loop with approximately ½” overlap and place in the washing machine.
5. Use a fresh solution of STERIS® Prolystica® 2X Concentrate Neutral Detergent.
6. Machine wash the shell in warm water (50-140°F or 10-60°C).
7. Remove shell from the washing machine and rinse and massage under warm water for 5 minutes to remove any residual detergent. Run rinse water over both sides of the cuff as well as directly into the inner portion where the bladder is placed.
8. Lay flat or line dry the shell.
9. The bladder & microphone needs to be inserted back into the cuff sleeve so the pneumatic hose portion of the bladder is outside the sleeve.

CAUTION: Do not machine wash bladder or microphone.
NOTE: The pneumatic hose connection should face downward when using the Orbit-K cuff on either the right or the left arm.
NOTE: Orbit-K cuff should be cleaned at the conclusion of each stress test.
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.

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

CUFF DISPOSAL
Do not return used cuffs. Used blood pressure cuffs may be contaminated medical waste and should be dealt with in accordance to your local regulations. The Orbit-K cuff contains a microphone/cable assembly which should be removed and disposed of separately as specified by the WEEE directive.
WARRANTY
SunTech Medical, Inc. provides to the original purchaser the following limited warranty from date of invoice.
Orbit-K Cuffs: 6 months
Accessories, i.e. patient cables, microphone,
disposables: 90 days
This limited warranty is void if the instrument has been damaged by accident, misuse, negligence, act of God or serviced by any person not authorized by SunTech Medical, Inc.
PRODUCT SERVICE LIFE
It is recommended that you replace the Orbit-K cuffs, microphones and patient cable annually to maintain measurement accuracy.

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
10-AUG-2021

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