Instructions for Use Part 1 urogold100

Transcription

1 Instructions for Use Part 1 urogold100 Revision H,

2 Instructions for Use OW100, urogold100 Copyright 2017 MTS Medical UG All rights reserved for patents or trademark registration. No part of this document may be distributed or reproduced, utilized or imparted to a third party without the prior written permission of MTS. Nonobservance will result in liability for damages. Technical features are subject to change without notice. Manufacturer MTS Medical UG Robert-Bosch-Str. 18 DE Konstanz, Germany Tel.: Fax: Internet: Revision History Revision A December 6, 2012 Initial Revision POP561 Revision B March 3, 2014 POP440 Revision C May 07, 2014 POP678 Revision D July 16, 2015 POP762 Revision E Sept. 16, 2015 POP779 Revision F April 01, 2016 POP820 Revision G January 11, 2017 POP847 Revision H POP859

3 Content Content General notes Introduction The urogold Diagnosis Indications Contraindications Treatment abortion Treatment Preparation for treatment Treatment Safety instructions Adverse effects Failure during treatment Release of shock waves Preparation for urological treatment Shock wave treatment for urological indications Treatment parameter Peyronie s disease (Induratio penis plastica) Erectile dysfunction Chronic pelvic pain (CPPS) / Chronic prostatitis End of treatment for urological indications Chapter 4-12 see Part 2 of Instruction of Use (MTS_OW100_IFU_Part2) General Notes Safety Description Operation Technical Data The various applicators Setting into operation Maintenance and troubleshooting Transport mts_ow100_ifu_part1-urogold100_e_h 3

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5 1 General notes The Instruction for Use has two different parts. Part 1: Indications, contraindications and application of the device Part 2: Operating instruction, Safety instruction and technical data 1.1 Introduction This Part 1 of the Instruction for Use informs you about indications and contraindications and about application protocol of the device. Please read carefully Part 2 of the Instruction for Use before treatment! 1.2 The urogold100 The urogold100 is a transportable device for therapeutic shock wave treatment. It is comfortable in handling and operating. In Part 2 of this Instruction for Use we use the name OW100 instead of urogold100 2 Diagnosis 2.1 Indications The urogold100 is in combination with the applicators OE050, OE035 and OP155 an appropriate shock wave treatment device for the following indications. Urological indications: Shock wave therapy for the treatment of penis dysfunction such as Peyronie's disease - IPP (Induratio penis plastica) erectile dysfunction - ED chronic pelvic pain (CPP) / chronic prostatitis mts_ow100_ifu_part1-urogold100_e_h 5

6 Usage of the different applicators: MTS advices for urological indications the following applicators: Peyronie's disease - IPP (Induratio penis plastica) (applicator OE050 or OE035) erectile dysfunction - ED (applicator OP155) chronic pelvic pain (CPP) / chronic prostatitis (applicator OP155) 2.2 Contraindications Do not use the urogold100 in patients with pacemakers or implantable defibrillators. Do not use the urogold100 in patients who are using devices which are sensitive to electromagnetic radiation. Do not use the urogold100 for the treatment of vertebrae, skull bones and ribs. Do not use the urogold100 for the treatment of patients with tumours. Do not use the urogold100 for the treatment of patients with severe coagulation disorders. Do not use the urogold100 for extracorporeal shock wave lithotripsy. Do not direct the shock waves on large nerves. Do not direct the shock waves on large vessels. Do not direct the shock waves on airfilled internal organs (especially lungs). Do not use the urogold100 for the treatment of patients younger than 18 years or of patients with open epiphyseal plates. 2.3 Treatment abortion If a patient experiences cardiac arrhythmia during treatment or a kind of uneasy feeling, shock wave delivery should be terminated. 6 mts_ow100_ifu_part1-urogold100_e_h

7 3 Treatment This chapter informs you about the miscellaneous treatment options for different indications. 3.1 Preparation for treatment 1. Clean and disinfect the device and the applicator acc. to Part 2, Chapter 11.2 / Connect the footswitch (Part 2, Chapter 10.7). 3. Establish power supply (Part 2, Chapter ). 4. Switch on the device (Part 2, Chapter 7.6). 5. Fill the applicator (Part 2, Chapter 7.8.2). 6. Adjust the appropriate treatment parameter (Part 2, Chapter 7.8). 7. Select in Interval a preset of shot counts (Part 2, Chapter 7.8.6). 3.2 Treatment Safety instructions Pay attention to the following treatment instructions: Do not direct the shock wave treatment on airfilled internal organs (especially lungs). Do not direct the shock wave treatment on esophagus. Do not direct the shock wave treatment on large vessels. Do not direct the shock wave treatment on the ears. Do not direct the shock wave treatment on large nerves. Do not direct the shock wave treatment on the head. Protect always patients and medical personnel, with appropriate noise protection measures, e.g. provide ear protectors. Danger of Infection! Always clean and disinfect the device, before any therapy procedure is initiated and after a therapy procedure is terminated. Any inorganic and non inflammable disinfectant may be used for this purpose (for example KleenAseptic : follow the respective instructions). Do not spray the disinfectant directly to the device. Use a sponge or a cloth. mts_ow100_ifu_part1-urogold100_e_h 7

8 Noise Protection Measures! The release of shock waves produces noise. To protect patients and medical personnel, take appropriate noise protection measures, e.g. provide ear protectors. CAUTION Cleaning agent Use only inorganic and non inflammable disinfectant. Do not use abrasive. Follow the instructions of the manufacturer of the used disinfectant. 3.3 Adverse effects Adverse effects! Potential adverse effects associated with shock wave treatments include those listed below: Transient moderate increase in pain Redness and swelling Hematoma and petechial hemorrhage Headaches and fainting during extracorporeal shock wave treatments Short-term hypaesthesia Nausea during therapy Tingling during therapy 3.4 Failure during treatment If there are any troubles with the urogold100 or the applicator during treatment, shut down the device inclusive connected applicator and ensure against restarting. 3.5 Release of shock waves Execution: Make sure, that an applicator is connected and filled. Pay attention to the safety instructions! It is important, that the chapter s medical safety (Part 2, Chapter 5), Safety (Part 2, Chapter 5.9) and medical indications (Chapter 2.1) and contraindications (Chapter 2.2) are been read and understood. 8 mts_ow100_ifu_part1-urogold100_e_h

9 Noise Protection Measures! The release of shock waves produces noise. To protect patients and medical personnel, take appropriate noise protection measures, e.g. provide ear protectors. Release of shock waves by footswitch: Press the footswitch. As long as the footswitch is pressed, shock waves will be released. The display shows the number of released shock waves. Release of shock waves by applicator release button: Press the button (2) at the applicator. As long as the button is pressed, shock waves will be released. Short pressing releases single shock waves. Pressing twice releases the under Interval preset number of shock waves. To stop the under Interval preset shock waves press the button shortly. The display shows the number of released shock waves. Indication und contraindication! Read and follow chapters 2.1 Indication and 2.2 Contraindication! Air bubbles! Air bubbles in the applicator scatter and absorb shock waves. This can lead to uncontrolled propagation of shock waves, ineffective treatment and increases risk of side effects. Therefore remove air bubbles from the applicator carefully Preparation for urological treatment 1. Direction and penetration depth of the treatment area must be located by ultrasound, palpation or anatomical knowledge. 2. Mark the region for coupling (as located in step 1) on the skin of the patient. 3. Make sure that skin is cleaned from any fat and hair in the coupling area. 4. Make sure, that the patient is prepared for the treatment and the water membrane and applicator housing are cleaned and disinfected. Clean and disinfect with customary, inorganic and non flammable disinfectants. 5. Place the device close to the patient and check, if there is enough space to move the applicator over the mts_ow100_ifu_part1-urogold100_e_h 9

10 treatment area. The patient can either sit or lay down for treatment. 6. Adjust the necessary treatment parameter (Chapter 3.7). 7. Make sure, that the applicator is filled. 8. Press the RESET-key field on the touch screen. Danger of infection! The applicator must never get in direct contact with skin injuries or abscesses. Otherwise infectious material can contaminate the water membrane the applicator or the water membrane can contaminate the wound. Use always disposal neoprene gloves. 3.6 Shock wave treatment for urological indications Indication und contraindication! Follow exactly chapter 2.1 Indications and 2.2 Contraindications 1. Adjust the penetration depth via regulation of the coupling pressure. 2. Apply ultrasound gel onto the water membrane of the applicator. 3. Select appropriate values for energy and frequency. 4. Bring the applicator in contact with the skin of the patient and release shock waves. Avoid air bubbles in the scope of shock waves! The degree of tissue damage or hematomas is dependent on the applied total energy and the energy density. The water membrane of the applicator should have very good contact to the skin of the patient, to avoid energy loss and the development of hematomas. Make sure, that there are no air bubbles inside the water membrane, especially in cases, when the applicator is used in upward direction. Use always ultrasound gel and make sure, that there are no air bubbles between water membrane and skin. 10 mts_ow100_ifu_part1-urogold100_e_h

11 3.7 Treatment parameter The applicator should be moved across the treatment area including the bordering area which has been marked. Good clinical results can be accomplished through the following treatment protocol: Peyronie s disease (Induratio penis plastica) It is recommended in this process to apply 700 to 900 shock waves onto each affected area of the penis shaft where the plaques are located. The applicator OE050 or OE035 must be used with an energy level of approx mj/ mm 2. The treatment can be repeated every one to two weeks for up to a number of 6 treatments in total. If needed, the treatment can be resumed after a 4 week period Erectile dysfunction It is recommended to apply approximately 1500 pulses to the manually stretched penis to the distal, mid and proximal penile shaft and to the left and right crura of the penile shaft (approximately 300 pulses per treated region). The applicator OP155 must be used with an energy level of approx. 0.1 mj/ mm 2. The treatment can be repeated every one to two weeks for up to a number of 6 treatments in total. If needed, the treatment can be resumed after a 4 week period Chronic pelvic pain (CPPS) / Chronic prostatitis Prior to treatment, prostate cancer should be excluded clinically and/or serologically and/or image guided (Ultrasound or MRI). It is recommended to apply about shock waves directly to the perineal area (from anus to scrotum) directed to the prostate or in which the pain has been localized. The applicator OP155 must be used with an energy level of approx mj/ mm 2. The treatment can be repeated weekly for up to a number of 6 treatments in total. If needed, the treatment can be resumed after a 4 week period. Treatment parameter! Energy, trigger frequency and number of shock waves have to be applied according to the current literature about shock wave treatments. Any feedback of the patient has to be considered. It is advised, to start a treatment with low energy and trigger frequency. In continuation of the treatment the settings should be increased to the necessary values. mts_ow100_ifu_part1-urogold100_e_h 11

12 3.8 End of treatment for urological indications 1. Clean the skin from ultrasound gel. 2. Clean and disinfect the water membrane of the applicator and the applicator housing. Any inorganic and not flammable disinfectant can be used. 12 mts_ow100_ifu_part1-urogold100_e_h

13 Chapter 4-12 see Part 2 of Instruction of Use (MTS_OW100_IFU_Part2) 4 General Notes 5 Safety 6 Description 7 Operation 8 Technical Data 9 The various applicators 10 Setting into operation 11 Maintenance and troubleshooting 12 Transport mts_ow100_ifu_part1-urogold100_e_h 13