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General| Brand | Stryker |
|---|---|
| Model | FLUID SAFE |
| Category | Medical Equipment |
| Language | English |
Indicates a hazard that may result in death or serious injury if not avoided.
Indicates a hazard that could result in death or serious injury if not avoided.
Provides additional important information or helpful tips for the user.
Device usage regulations under U.S. federal law, requiring physician supervision.
Manufacturer disclaims liability for damages from misuse or non-compliance.
Only authorized technicians may perform repairs, adjustments, or alterations.
Device must be used strictly according to its intended purpose and manual.
Proper care, maintenance, and decontamination procedures for safe operation.
Proper disposal procedures for electrical and electronic equipment.
Identifies potential dangers and risks associated with device operation.
Groups various safety warnings and precautions for device operation.
Device use for uterine distension in hysteroscopic procedures and specific indications.
Situations where hysteroscopy is contraindicated and device's technical limits.
How the device measures and regulates fluid pressure during operation.
Critical risks associated with the device's operation and use.
Risks like air embolisms, balancing errors, and fluid management.
Checking for damage and preparing the device for installation and operation.
Proper electrical connection, including grounding and socket requirements.
Precautions and guidelines for operating the device with electromagnetic fields.
Recommended safety distances for wireless devices to avoid RF interference.
Step-by-step instructions for assembling the fluid management system components.
Familiarization with control and display elements on the pump unit.
Identification of connection ports and elements on the rear of the pump and display units.
Detailed steps for correctly installing the fluid management system's tube set.
Steps to safely turn on the device and its initialization process.
Instructions for starting, stopping, and managing pump operation and settings.
Understanding deficit, inflow volume, and deficit bar graph displays.
How to access and configure device parameters through the user menu.
Procedures for using and equipping the weighing unit for fluid measurement.
Steps for safely turning off the device and placing it in standby mode.
Steps to prepare the device and accessories for performing function tests.
Detailed procedures for testing pump, balancing, and instrument detection functions.
Final steps to conclude the function test and prepare the device for use.
Regular inspection and tightening of mechanical parts for stability.
Safe methods for cleaning the device surface with disinfectants.
Procedures for cleaning and disinfecting reusable tube set components.
Instructions for sterilizing reusable tube sets via autoclave or gas.
Requirements for regular device testing by qualified personnel.
Recommended intervals and responsibilities for device servicing.
Step-by-step guide for safely replacing a defective fuse.
Visual inspection and electrical safety testing of the device.
Checking displays, keys, and overall device performance.
Verifying the functionality of the pressure chamber, sensors, and measuring system.
Testing individual pressure sensors and the weighing unit's functionality.
A logbook for recording test results, comments, and signatures.
Details Stryker Endoscopy's product warranty terms, conditions, and limitations.
Instructions for requesting service or initiating claims for the product.
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