PERFORM Operating Document Omnisound 3000C Pro Series Ultrasound Rich Mar CM4 Ultrasound/Stimulation Combination Unit PC-POD-AT-003-v04 Revision History Version Reason for Revision Date 04 Cyclical Revision no changes made May 1, 2018 Summary The content of this PERFORM Operating Document (POD) provides guidelines for the use and maintenance schedule of the Omnisound 3000C Pro Series Ultrasound located in the treatment area of the Athletic Therapy Clinic and the Rich Mar Winner CM 4 Series 1030 Multi-therapy combination (ultrasound/stimulation) unit. The operating guidelines for the ultrasound portion are contained in this POD. PC-POD-AT-003-v04 Printed copies are not controlled. Page 1 of 5
Table of Contents 1. DEFINITION OF TERMS --------------------------------------------------------- 3 2. INTRODUCTION --------------------------------------------------------------- 3 3. INSTALLATION INSTRUCTIONS ------------------------------------------- 4 4. MAINTENANCE SCHEDULE ------------------------------------------------- 4 5. CONTRAINDICATIONS & WARNINGS ----------------------------------- 5 6. TRAINING REQUIREMENTS -------------------------------------------------- 5 APPENDIX I: POD TRAINING RECORD FORM PC-POD-AT-003-v04 Printed copies are not controlled. Page 2 of 5
1. Definition of Terms PERFORM operating document (POD) Protocol Users Supervisor Instructor Internship Student Modality Operating documents that are specific to an instrument or technique. Methods that are developed by users on specific instruments/equipment Person using space or equipment at the PERFORM Centre that has received adequate technical and safety training. Knowledgeable person regarding all or an aspect of a project or program and is familiar with PERFORM's best practices that is responsible for ensuring that junior users conduct their activities in a safe manner and within scope of the project. Person that has attained an adequate level of certification and expertise which qualifies them to supervise and teach students. A current student or recent graduate that is undergoing supervised practical training supervised by PERFORM employees. A method of application of or employment of any therapeutic agent, especially a physical agent that involves the physical treatment of a disorder 2. Introduction The Athletic Therapy Clinic has two Omnisound 3000C Pro Series Ultrasound machines and one Rich Mar CM 4 Combination Unit located within the treatment area of the Athletic Therapy Clinic. The Omnisound 3000C units were manufactured by Accelerated Care Plus and distributed by Medelco Inc. The Rich Mar CM 4 Combination Unit is manufactured and distributed by Rich Mar. This POD is designed to outline the use, maintenance schedule and training needs for the Omnisound 3000C Pro Series Ultrasound and the Rich Mar CM 4 Combination Unit. This POD only covers the use within the Athletic Therapy Clinic and within the Scope of Practice for Athletic Therapists. PC-POD-AT-003-v04 Printed copies are not controlled. Page 3 of 5
3. Installation Instructions No specialty set up is required for the ultrasound machines. The Omnisound 3000 C Pro Series were assembled as per the user manual instructions and received a Certificate of Calibration on November 2, 2010 signed and approved by Patrick Parker, Vice President of Biomedical Services and Quality Assurance. The maintenance and training requirements are identical for both of these machines. The Rich Mar CM4 did not require any specific set up. 4. Maintenance Schedule 4.1. Regular external cleaning and daily housekeeping practices are used to keep the equipment clean and free of contaminants. The machine should be cleaned daily with germicidal wipes and allowed to air dry. 4.2. The ultrasound transducers should be cleaned with germicidal wipes after each use. 4.3. In the case where body substance isolation is required during the use of this unit universal precautions must be taken. Gloves, masks, gowns along with transducer covers and barrier films must be used. After a usage of this type, all surfaces and parts must be thoroughly cleaned with germicidal wipes and allowed to dry once dry they are cleaned a second time in the same manner. After the second cleaning the machine can be used again as usual. 4.4. A list of step by step instructions for the above can be found in the user manuals provided by the manufacturers. PC-POD-AT-003-v04 Printed copies are not controlled. Page 4 of 5
5. Contraindications & Warnings 5.1. Should not be used on patients with cardiac demand pacemakers 5.2. Should not be applied over the carotid sinus nerves, over the neck and mouth, applied transthoracically or transcerebrally, over swollen, infected or inflamed areas, phlebitis or cancerous lesions or in those with sensory nerve damage. 5.3. Should not be applied over a growth plate area in children under 18. 5.4. Cautions should be taken during pregnancy, in patients with suspected or diagnosed epilepsy or following surgical procedures when muscle contraction may disrupt the healing process. 5.5. Skin irritation and burns beneath the electrodes have been reported with long term application of stimulators. The ultrasound will be used in the Athletic Therapy Clinic for treatments that reside under the Scope of Practice for Athletic Therapy. 6. Training Requirements The internship students from Concordia s Department of Exercise Science have completed a required course in modalities as well as a teaching lab in the subject. All modalities used in the clinic are covered in both of these semester long sessions. Internship students using this modality must have taken the modalities course offered in the Department of Exercise Science and have attended the orientation session at the start of their internship semester where these particular ultrasound systems are reviewed. PC-POD-AT-003-v04 Printed copies are not controlled. Page 5 of 5
APPENDIX I POD Training Record Form PC-POD-AT-003-v04 Printed copies are not controlled. APPENDIX I
POD Title Omnisound 3000C Pro Series Ultrasound Rich Mar CM4 Ultrasound/Stimulation Combination Unit POD Code Ownership Document type Area POD Number Version PC POD AT 003 04 Training Record Full Name Institution Contact (email or phone number) Signature Sign here Date POD Training Record