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Storz CALCUSPLIT - User Manual

Storz CALCUSPLIT
24 pages
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Instructions for use
CALCUSPLIT handpiece with lithotripsy solid
probes
en
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Summary

General Information

Read the Instructions for Use

Emphasizes the importance of following instructions to prevent injury or damage.

Read the Instructions for Use of Combinable Products

Highlights the need to read instructions for associated products to prevent injury.

Scope

Defines the products covered by this instruction manual.

Description of Warning Messages

Explains the meaning of different warning levels (WARNING, CAUTION, NOTICE).

Normal Use

Intended Purpose

Specifies the intended use of the CALCUSPLIT probe and handpiece.

Indications

Details the medical conditions for which the system is indicated.

Contraindications

Lists situations where the product should not be used.

Target User Populations

Identifies the qualified medical professionals who may use the device.

Patient Groups

States if there are any restrictions on patient groups for product use.

Safety

Serious Incidents

Defines serious incidents according to MDR and reporting requirements.

Correct Handling

Provides guidelines for proper handling and inspection to prevent injury.

Damaged Products

Advises against using damaged products due to potential injury risks.

Unsterile Product

Warns about the risk of infection from using non-sterile products.

Creutzfeldt-Jakob Disease

Addresses prion contamination risk and handling of products related to CNS contact.

Product Description

Product Overview

Illustrates and labels the main components of the CALCUSPLIT system.

Possible Combinations

Lists compatible endoscopes and components for use with the product.

Symbols on the Packaging

Explains the meaning of various symbols found on product packaging.

Ambient Conditions

States that there are no special transport or storage conditions.

Preparation

Unpacking the Product

Instructions for carefully removing and checking the product upon delivery.

Inspecting the Device

Details checks for contamination, damage, and correct assembly before use.

Assembling the Fabric Tube for Compressed Air Feed

Step-by-step guide to connect the fabric tube for compressed air supply.

Assembling the Damping Unit

Instructions on how to attach the damping unit to the lithotripsy solid probe.

Assembling the Lithotripsy Solid Probe

Detailed steps for assembling the lithotripsy solid probe with the handpiece.

Application

Functional Test

Procedure to check the system for leakage before each use.

Using the Product

Guidance on activating the product under visual contact and using compressed air.

Disassembly

Disassembling the Product

Instructions for safely removing the fabric tube and reversing assembly steps.

Maintenance, Servicing, Repairs, and Disposal

Repairing the Product

Specifies that repairs should only be done by authorized personnel or KARL STORZ.

Disposing of the Product

Outlines necessary measures for product disposal, including decontamination.

Accessories and Spare Parts

Accessories

Lists available accessories for the CALCUSPLIT handpiece and probes.

Spare Parts

Lists available spare parts, such as sealing rings and damping units.

Subsidiaries

Storz CALCUSPLIT Specifications

General IconGeneral
BrandStorz
ModelCALCUSPLIT
CategoryMedical Equipment
LanguageEnglish

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