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Storz MASTERPULS ONE User Manual

Storz MASTERPULS ONE
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29511.0002
OPERATING MANUAL
MASTERPULS
®
ONE
DS.#####
Part No. 27800
Published: 12.2020
Original language: German
29511

Questions and Answers:

Storz MASTERPULS ONE Specifications

General IconGeneral
Treatment ModesContinuous
DisplayTouchscreen
Power Supply100 - 240 V, 50/60 Hz
Tank CapacityNot applicable
HeatingNot applicable
TechnologyRadial Shockwave Therapy
ApplicatorsVarious applicators available, depending on treatment area

Summary

General Safety Information

Intended Use and Operational Safety

User must possess technical proficiency and knowledge of the operating manual.

Protection Against Electrical Hazards

Information on protecting against electrical hazards during device operation.

Protection Against Noise

Recommendation for wearing ear protection due to potential noise exposure.

Safety During Patient Treatment

General notes and precautions for patient safety during treatment.

Warning Against Damage to Equipment and the Device

Warnings against device damage from incorrect operation, EMC, and setup.

Electromagnetic Compatibility

Guidelines and precautions regarding electromagnetic interference.

Setup and Operation

Instructions for proper device setup and operational considerations.

Storage and Transport

Guidelines for correct storage and transport to prevent device damage.

Disposal

Guidelines for disposing of the product according to national regulations.

Principles

Physical Principles

Explains the kinetic energy conversion into sound energy for pressure waves.

Indications

Lists approved uses for pain in musculoskeletal system and aesthetic treatments.

Contraindications

Specifies cases where MASTERPULS® ONE is not permitted, e.g., pregnancy.

Side Effects

Details potential side effects like swelling, redness, pain after treatment.

Preconditions for Operation

Outlines requirements for operating personnel and necessary training.

System Description

Control Device with Handpiece

Details the components of the control device and handpiece with diagrams.

Scope of Supply

Lists the standard items included in the MASTERPULS® ONE package.

Unpacking the Device

Instructions for safely removing the device and accessories from packaging.

Before Start-up: Removing the Transport Base Plate

Step-by-step guide to detach the device from its transport base plate.

Before Transport: Attaching the Transport Base Plate

Instructions for securing the device to the transport base plate for transport.

Installation Instructions

Guides for installing the device, including handpiece assembly.

Handpiece Components

Identifies and illustrates the individual parts of the handpiece.

Assembling the Handpiece

Provides instructions for assembling the handpiece components correctly.

Connecting the Electrical Power Supply

Details how to connect the device to the mains power supply.

Connecting Handpiece

Instructions for connecting the handpiece hose to the device.

Compatibility

Lists compatible handpieces for the MASTERPULS® ONE.

Operation

Switching On and Off

How to power the control device on and off using the mains switch.

Setting the Intensity

Guide to adjusting the treatment intensity levels and their corresponding frequencies.

Resetting the Counter Reading

Instructions on how to reset the pulse counter display to zero.

Reading Out Device Data

How to retrieve operating hours, total pulses, and software version.

Start-up

Steps for preparing the device and initiating treatment.

Treatment

Safety information and initial steps before starting patient treatment.

Cleaning, Maintenance, and Overhaul

Cleaning and Overhaul

General instructions for regular cleaning to ensure hygiene and operation.

Ventilation Slits

Instruction to keep the ventilation slits clean for proper device function.

Cleaning the Handpiece

Procedures for thorough cleaning and disinfection of the handpiece after sessions.

Replacing the Pulse Transmitter

Step-by-step guide on how to replace the pulse transmitter.

Cleaning the Handpiece

Detailed steps for cleaning the handpiece and its components.

Cleaning and Disinfecting the Pulse Transmitter

Instructions for cleaning and disinfecting pulse transmitter parts.

Overhaul of the Handpiece

Procedure for overhauling the handpiece, including parts and steps.

Mains Fuse Replacement

Guide on how to replace the mains fuse in the device.

Maintenance

Information on preventive maintenance and service options.

Disposal

Guidelines for disposing of the product according to national regulations.

Repair

Information on authorized repair personnel and original parts.

Service Life

Details on the expected service life of the device and its components.

Trouble Shooting

Accessories

Technical Specifications and Conformity

Technical Specifications

Lists detailed technical data for the MASTERPULS® ONE device.

Type Plates

Explains the different type plates found on the device.

Conformity with Directives

States conformity with the Medical Device Directive (MDD) 93/42/EEC.

Conformity with Standards

Lists applicable standards the device complies with, e.g., EN/IEC 60601-1.

EMC Guidelines and Manufacturer's Declaration

Details EMC guidelines and the manufacturer's declaration on emissions.

Certificates

Presents the EC Declaration of Conformity for the device.

Symbols and Labels

Explains the meaning of various symbols and labels on the device.

Warranty and Service

Warranty for the Control Device

Details the warranty period and conditions for the control device.

Service

Information on how to contact a certified dealer for service inquiries.

System Book

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