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User Manual
Pulson 100

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Summary of Contents for Gymna Pulson 100

  • Page 1 User Manual Pulson 100...
  • Page 2 Pulson 100 © 2007, GymnaUniphy N.V. All rights reserved. Nothing from this publication may be copied, stored in an automated data file, or made public, in any form or in any way, be it electronically, mechanically, by photocopying, recordings or in any other...
  • Page 3 Pulson 100 User Manual Pulson 100 Device for ultrasound therapy Manufacturer GymnaUniphy N.V. Main office Pasweg 6A B-3740 BILZEN Telephone +(32) (0)89-510.510 +(32) (0)89-510.511 E-mail info@gymna-uniphy.com Website www.gymna-uniphy.com Version 1.0 September 2007...
  • Page 4 Pulson 100 Abbreviations Electromagnetic Compatibility Electrostatic Discharge Hospital Antiseptic Concentrate Ultrasound Symbols on the equipment Read the manual Manufacturer Symbols in the manual Warning or important information.
  • Page 5: Table Of Contents

    Pulson 100 TABLE OF CONTENTS SAFETY .................... 5 ..............5 URPOSE ........... 5 AFETY INSTRUCTIONS ........... 7 EDICAL EVICES IRECTIVE ..............7 IABILITY INSTALLATION ................9 ..............9 ECEIPT ..........9 LACING AND CONNECTION ........9 ERFORMING THE FUNCTIONAL TEST ..........
  • Page 6 Pulson 100 ......... 28 NVIRONMENTAL CONDITIONS ..........28 RANSPORT AND STORAGE ..........29 TANDARD ACCESSORIES ..........30 PTIONAL ACCESSORIES APPENDICES ................. 31 ............31 DIRECTIVE ........35 ECHNICAL SAFETY INSPECTION ..............37 ISPOSAL REFERENCE ................... 39 Function overview ............. 39 ...............
  • Page 7: Safety

    Pulson 100 AFETY Purpose The Pulson 100 is intended solely for medical applications. You can use the Pulson 100 for ultrasound therapy. The device is suited for continuous use. Safety instructions 1.2.1 General • Only qualified people who are trained in the application of the therapies may use the appliance.
  • Page 8 Pulson 100 1.2.2 Electrical safety • Only use the equipment in an area with facilities that meet the applicable legal regulations. • Connect the equipment to an outlet with a protective earth terminal. The outlet must meet the locally applicable requirements for medical areas.
  • Page 9: Medical Devices Directive

    Pulson 100 Medical Devices Directive The device complies with the essential requirements of the Medical Device Directive of the European Committee (93/42/EEC) as most recently changed. Liability The manufacturer cannot be held liable for injury to the therapist, the patient or third parties, or for damage to or by the equipment used, if for example: •...
  • Page 10 Pulson 100...
  • Page 11: Installation

    Pulson 100 NSTALLATION Receipt 1. Check whether the equipment has been damaged during transport. 2. Check whether the accessories are intact and complete. See §7.5 and §7.6. • Inform your supplier of any damage or defects by no later than within 3 working days after receipt.
  • Page 12 Pulson 100...
  • Page 13: Description Of The Equipment

    Pulson 100 ESCRIPTION OF THE EQUIPMENT Pulson 100 and standard accessories 1. Pulson 100. See §3.2. 3. Contact gel 2. Power cord 4. US head...
  • Page 14: Components Of The Pulson 100

    Pulson 100 Components of the Pulson 100 9 10 11 1. Display. See §3.3. 7. Connector for US head 2. Decrease the selected 8. Indication: Floating patient parameter circuit 3. Increase the selected 9. On/off switch parameter 10. Connection to mains supply 4.
  • Page 15: Display

    Pulson 100 Display 1. Treatment mode 7. Timer value 2. Program number/System 8. Ultrasound frequency settings number 9. Ultrasound output indication 3. System settings mode 10. Type of US head 4. Intensity symbol 11. Ultrasound output power 5. Treatment time symbol 12.
  • Page 16: Parameter Symbols

    Pulson 100 Parameter symbols Intensity Output power Duty cycle Ultrasound frequency...
  • Page 17: Operation

    • Intensity 0.1 W/cm2 • Duty cycle: 100% The type of US head will be detected automatically by the Pulson 100. If no US head is connected, the symbols are displayed alternating. The Ultrasound frequency is fixed at 1 MHz.
  • Page 18: Performing Ultrasound Therapy

    The treatment can not be started. 1. Plug the connector of the US head into the connector the Pulson 100. 2. Select the desired program number. For the US head placement see §9.1.2. for the number in the placing diagrams.
  • Page 19: Read Out Values

    Pulson 100 Read out values 1. Remaining treatment time. 2. Ultrasound frequency. 3. Ultrasound output symbol. 4. Output power. Remaining treatment time (mm:ss) Counts down during treatment Ultrasound frequency Fixed value: 1 MHz. Ultrasound output symbol • wave animation: good US contact.
  • Page 20: System Settings

    Pulson 100 System settings • Press and hold for 3 seconds to enter or leave the system settings menu. • Press to confirm the value and to select the next system setting. 4.5.1 01: Stop time if bad US 1. Press to switch the parameter ON or OFF.
  • Page 21 Pulson 100 4.5.4 04: SW code The software-version is displayed.
  • Page 22 Pulson 100...
  • Page 23: Inspections And Maintenance

    5.1.1 US head test Test the US head if its conduction is bad. The conduction is bad if the Ultrasound indication blinks during treatment and the Pulson 100 generates a ‘bad contact’ sound. 1. Switch on the Pulson100. 2. Place the US head in a bowl with water.
  • Page 24: Maintenance

    Pulson 100 Inspection points The technical safety inspection contains the following tests: 1. Test 1: General: Visual inspection and check on the operating functions 2. Test 2: Ultrasound therapy 3. Test 3: Electrical safety inspection: measurement of the earth leakage current and patient leakage current according to DIN/VDE 0751-1 ed.
  • Page 25: Malfunctions, Service And Guarantee

    Pulson 100 ALFUNCTIONS SERVICE AND GUARANTEE Malfunctions Component Problem Solution Pulson 100 Equipment cannot be See §6.1.1. switched on Equipment does not react to See §6.1.3. commands or a fault report appears 6.1.1 Equipment cannot be switched on 1. Check if the mains voltage has failed.
  • Page 26: Service

    Pulson 100 Service • Only a technician authorised by GymnaUniphy N.V. may open the equipment or the accessories to perform repairs. The equipment does not contain any components that may be replaced by the user. • If possible, open the screen with the system settings before you contact the technical service department.
  • Page 27: Technical Life Time

    Pulson 100 This guarantee does not apply to the repair of defects that are caused: • by incorrect use of the equipment, • by an incorrect interpretation or not accurately following these user instructions, • by carelessness or misuse, •...
  • Page 28 Pulson 100...
  • Page 29: Technical Information

    Pulson 100 ECHNICAL INFORMATION General Dimensions Pulson 100 (w x h x d) 266 x 275 x 100 mm Weight Pulson 100 3,1 kg Weight including accessories4,15 kg Mains voltage 100 - 240 VAC, 50/60 Hz Maximum power, in operation...
  • Page 30: Environmental Conditions

    Pulson 100 7.2.3 US heads US head, model 104 Acoustic operating frequency Output power Effective intensity of output voltage W/cm Effective Radiating Area (ERA) Beam Non-uniform Ratio (BNR) Maximum intensity of beam 10,2 W/cm Beam type Collimated US head, model 101...
  • Page 31: Standard Accessories

    Pulson 100 Standard accessories Quantity Description Art. no. US head, 1 MHz - ERA 4 cm incl. 332.310 holder Contact gel, 500 ml 100.016 Power cord 100.689 331.991 331.969 331.958 User manual 331.947 332.013 332.002 331.980 US placing diagrams 117.277 1 This power cord has a CEE 7/7 type plug.
  • Page 32: Optional Accessories

    Pulson 100 Optional accessories Quantity Description Art. no. US head, 1 MHz - ERA 1 cm , incl. 332.321 holder Contact gel, can 5 l 100.019 Pump for can, 5 l 100.020 Article numbers can change in the course of time. Check the article numbers in the most recent catalogue or ask your dealer.
  • Page 33: Appendices

    If you use the Pulson 100 in the vicinity of other equipment, you must check that the Pulson 100 is functioning normally. The following paragraphs contain information about the EMC properties of the equipment.
  • Page 34 Pulson 100 Guidance and manufacturer’s declaration - electromagnetic immunity The 100-series devices are intended for use in the electromagnetic environment specified below. The customer or the user of a 100-series device should assure that it is used in such an environment.
  • Page 35 Pulson 100 Guidance and manufacturer’s declaration - electromagnetic immunity The 100-series devices are intended for use in the electromagnetic environment specified below. The customer or the user of a 100-series device should assure that it is used in such an environment.
  • Page 36 Pulson 100 Recommended separation distances between portable and mobile RF communications equipment and the 100-series device The 100-series device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of...
  • Page 37: Technical Safety Inspection

    Pulson 100 Technical safety inspection Pulson 100 with serial number..... is / is not in good working order Inspection performed by: Owner: Location: Name: Name: Date: Initials: Initials: 1 Cross out what does not apply. If a specific test does not apply to this equipment, place a mark in the NA (not applicable) column.
  • Page 38 Pulson 100 8.2.2 Test 2: Ultrasound Yes No Connect the treatment head and place it in an ultrasound measurement device. Select continuous (duty cycle 100%), 2 W/cm The measured value is within ±20% of the output power value in the display.
  • Page 39: Disposal

    Pulson 100 Disposal Take account of the following environmental aspects when disposing of the equipment and the accessories: • The basic device and the cables fall under small chemical waste (electrical and electronic equipment waste). These components contain lead, tin, copper, iron, various other metals and various plastics, etc.
  • Page 40 Pulson 100...
  • Page 41: Reference

    Pulson 100 EFERENCE Function overview 9.1.1 System settings Press for 3 seconds Timer On/Off during bad contact Frequency tuning HW code SW code 9.1.2 Indication list The head placement numbers refer to the numbers in the placing diagrams. Indication Program number US head placement...
  • Page 42: Literature

    Pulson 100 9.1.3 Contra indication Ultrasound therapy Specific relative for continuous General ultrasound High fever Infections Severe cardiovascular problems Acute inflammations Psychological problems Thrombosis, thrombophlebitis Cancer with tumor metastasis Varices Generalised tuberculosis Increased risk to haemorrhage Pacemaker Specific relative for pulsing...
  • Page 43: Index

    Pulson 100 INDEX Malfunctions 23 Abbreviations 2 Medical Devices Directive 7 Accessories 29 optional 30 Parameter settings 15 standard 29 Parameter symbols ultrasound therapy 14 Cleaning 22 Placing 9 Connection 9 Prevention of explosion 6 Contra indication 40 Purpose 5...
  • Page 44 Pulson 100...
  • Page 45 Pasweg 6A B-3740 Bilzen Tel.: (+32) (0) 89/510.510 Fax: (+32) (0) 89/510.511 www.gymna-uniphy.com E-mail: info@gymna-uniphy.com Your dealer:...

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