Section 2
Warnings and Cautions
General Warnings
(cont.)
• The Vapotherm
®
2000i must be disinfected between each patient use and after 30 days of use on the
same patient.
• Gas flow delivered by this device is limited to 40 liters per minute. Maximum operational flow rate
should not be exceeded.
• Prior to use machine should be positioned and secured to a sturdy IV pole.
• The system includes several disposable elements that are labeled as single patient use only: do not
attempt to sterilize or reuse. Follow all local and federal regulations for disposal.
• Oxygen supports combustion; this device should not be used near or around open flames, oil, grease
or any flammables or anesthetics.
• Performance verification must be performed prior to use.
• Service on the device should be performed by qualified, certified service technicians ONLY.
• To prevent injury do not attempt to perform any service to the Vapotherm 2000i while a patient is
connected to the device.
• If the device is damaged or not working properly do not use. Contact Vapotherm or your authorized
Vapotherm representative.
• Do not operate if power cord is damaged.
• The device should not be turned on and left unattended.
• Do not use the Vapotherm 2000i in or around water other than the water bag that feeds the system.
• Failure to utilize sterile water supply or clean gas supply may increase risk of bacterial contamination.
• The Vapotherm 2000i utilizes warmed water and can pose a risk for colonization of bacteria and
patient infection if disinfection procedures are not followed.
• Gas flow is external to the Vapotherm, but the care giver should confirm the integrity of all respiratory
gases utilized to ensure they are free of contamination.
• Gas supply must be made of clean dry medical grade gas to prevent harm to the patient and prevent
damage to the Vapotherm 2000i.
• An oxygen analyzer with alarms must be used when the delivered concentration level is critical. The
Vapotherm 2000i does not provide oxygen concentration analysis capability.
• To reduce any potential transmission of contaminated water from the system, all assembly and/or
disassembly of the unit should take place outside the primary care areas.
• The 2000i is not a Continuous Positive Airway Device (CPAP). There are no controls to deliver or
monitor airway pressure. The 2000i humidifies breathing gases that are delivered externally through
standard air/oxygen blender and flowmeter. The 2000i should not be used to deliver pressure in a
closed system.
2.3
Cautions
• Verify that the power source is compatible with the electrical specifications shown on each component.
For proper grounding reliability, connect the 2000i power cord only to a properly marked hospital grade
receptacle. DO NOT USE EXTENSION CORDS. If any doubt exists as to the grounding connection, DO NOT
operate the device.
• Do not immerse the Vapotherm 2000i in water. Do not steam or gas sterilize the Vapotherm 2000i.
• Read and understand this manual prior to operating the system.
• The Vapotherm 2000i must be disinfected if the water circuit is opened up by removing or replacing a
component.
• Aseptic techniques (including proper hand washing and avoiding direct hand contact with connection
points) and Standard Precautions should always be followed when handling medical equipment.
• Standard Precautions should always be followed when coming in contact with patients.
Operating Instruction Manual
Page 4
Section 2
Warnings and Cautions
2.4
General Inspection
When unpacking the Vapotherm 2000i system , ensure that the unit is inspected for damage before use.
Report any damage or missing parts immediately to your authorized Vapotherm distributor.
When renting a Vapotherm 2000i, customers should require the rental service to provide a certification
that the machine has been disinfected before accepting delivery.
Section 3
About the Vapotherm 2000i and 2000h
The Vapotherm™ 2000h for home use consists of the combination of a 2000i unit and the “Home Care
Compressor Kit (Part number HCK200-M)”. The HCK-200 Kit consists of an HS-100 Stand, a 5060A
Room Air Compressor and Flowmeter assembly.
1. A Vapotherm authorized Durable Medical Equipment (DME) Supplier is responsible for the following:
Operating Instruction Manual
Page 5
2. The user/home care provider is responsible for the following:
• Assembling the 2000i unit and the kit components
•
Instructing the user in their responsibilities for operating the system
• Providing 1000 ml sterile water bags as needed
• Routine servicing of the system
• Removing, replacing, and disposing of the disposable components (Vapor Transfer Cartridge,
Vapotherm Spike Set -1 & Delivery Tube) every 30 days
• Disinfecting of the 2000i unit every thirty days following the procedure found in
Section 8.1 – 8.6 of the 2000i Operating Instruction Manual
• Change nasal cannulas when soiled or excessively wet from secretions. Dispose of properly.
•
Installing and replacing the sterile water bag
• Avoid liquid spills on the components
• Do not attempt any repairs. If you have any problems with your Vapotherm 2000i device
notify the DME provider immediately
Содержание 2000i
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