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Summary of Contents for Vapotherm 2000i
- Page 1 2000i Operating Instruction Manual...
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Page 2: Table Of Contents
About Vapotherm 2000i Product Description of oxygen greater than ambient air are utilized to treat symptoms and manifestations of hypoxia including: ™ Section 4 General 2000i Set up and instructions • Documented hypoxemia: decreased Pa0 in blood below normal range 4.1 Set Up – The 2000i Unit • Acute care in which hypoxemia is suspected 4.2... - Page 3 • Instructing the user in their responsibilities for operating the system • Do not operate if power cord is damaged. • Providing 1000 ml sterile water bags as needed • The device should not be turned on and left unattended. • Routine servicing of the system • Do not use the Vapotherm 2000i in or around water other than the water bag that feeds the system. • R emoving, replacing, and disposing of the disposable components (Vapor Transfer Cartridge, Vapotherm Spike Set -1 & Delivery Tube) every 30 days • Failure to utilize sterile water supply or clean gas supply may increase risk of bacterial contamination. • D isinfecting of the 2000i unit every thirty days following the procedure found in • The Vapotherm 2000i utilizes warmed water and can pose a risk for colonization of bacteria and Section 8.1 – 8.6 of the 2000i Operating Instruction Manual 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 2. The user/home care provider is responsible for the following: 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 • Change nasal cannulas when soiled or excessively wet from secretions. Dispose of properly.
- Page 4 Humidified gas flow is delivered through the center lumen. The outer lumens contain water which is flow from sterile water system. warmed via an internal heater and propelled through the system via an internal pump (See schematic, 3. If using an oxygen blender, mount the blender fig. 1). This maintains breathing gas temperature and minimizes condensation. The final patient interface above the Vapotherm 2000i on the IV pole. is a Vapotherm nasal cannula or approved interface configured to minimize resistance and heat loss. 4. Connect blender hoses into both air and NOTE: The water circuit and gas circuit of the Vapotherm 2000i do not come in contact with each other. oxygen wall connections. Air/Oxygen Respiratory gases are supplied to the Vapotherm™ 2000i from an external gas supply, typically through a 5. Plug Vapotherm power cord into a hospital Blender standard wall-mounted flow meter connected to the hospital medical gas supply. Gas flow rate is controlled wall power outlet. by the external flow meter or medical gas blender. There are no flow controls on the Vapotherm™ 2000i.
- Page 5 (Fig. 3). Make sure tubing is not kinked. each patient. 8 . Close hinged cover. If it does not close easily, check that cartridge If the VSS-1 is removed from the Vapotherm device for any reason the Vapotherm 2000i should be disinfected following the routine is pressed fully into place and that air tubes are not interfering disinfection procedure before being returned to service.
- Page 6 Always follow aseptic technique (including proper hand washing and avoiding direct hand contact with NOTES: connection points) when setting up the Vapotherm 2000i and Standard Precautions when placing on Pressing both the power and alarm mute buttons will set unit a patient.
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Page 7: Operations - General Guidelines
Section 5 Operation of The Vapotherm 2000i Section 6 Alarms, Trouble Shooting and Component Change-Outs ™ 5.7 Operations – General Guidelines 6.1 General 1. Check that water is properly circulating through the machine by making sure the Patient Delivery 1. Periodically check for alarm conditions. Tube is warm across the entire length. 2. Unit will shut down if there is no gas flow. However, flow will not be interrupted if unit 2. If good circulation cannot be confirmed, check that the water flow is not obstructed by air bubbles. shuts down or malfunctions for any other reason. 3. Take precautions to minimize cooling of the unheated cannula by trying to maintain contact with Unit will shut down if temperature safety limits are exceeded, or if water level is low for the patient’s skin and insulating the exposed portion of the cannula with bedding. more than 4 mins. However, unheated gas flow will continue. 4. Cartridge door should be closed during operation. NOTE: Should a malfunction occur, indicators on the front panel will light and an alarm will sound. -
Page 8: Component Change-Outs
Vapotherm 2000i. VSS-1 bubble trap or if a flow or replace cartridge, VSS-1 and delivery tube, The Patient Delivery Tube, VSS-1 and Vapor Transfer Cartridge water is visible in the tube below and follow set up instructions. -
Page 9: Removing From Patient And System Shut Down Section
Avoid disconnecting from power or gas sources while machine is WARNINGS: operating. Vapotherm should be disinfected after each patient or every 30 days on a single patient. Do not disinfect in Fig. 2 an open patient care area. Do not unplug from power source until display is blank. -
Page 10: Pre-Disinfection Cleaning And Decontamination
WARNING: The By-pass Tubing has been designed to optimize the Fig. 4 Tube B flow of solutions through the Vapotherm 2000i system. Failure to use NOTE: If the spike is inserted too the By-Pass Tubing supplied by Vapotherm , Inc. could lead to far into Bag B it will be difficult to ™... -
Page 11: Disinfect Gas And Water Circuits
12. The system is now ready for use or storage. accordance with all applicable regulations and institutional guidelines. CAUTION: Do not set the flowmeter above 35 lpm or start the drying process without the disinfecting 10. Wipe spike with an approved disinfectant wipe and firmly insert tube in place. This can cause damage to the pressure transducers in the Vapotherm 2000i system. into the spike port of a prepackaged sterile water bag. Confirm that water is flowing. WARNING: 11. Immediately start the Vapotherm 2000i in cleaning mode by... -
Page 12: Specifications
Dimensions: Height 11” (280 mm), width 5.5” (140 mm), depth 4.5” the date of sale by Vapotherm, Inc. If the product fails to perform in accordance with the product (114 mm) excluding IV pole clamp. specifications, Vapotherm, Inc. will repair, or replace, at its option, the defective materials or part. This Weight: Less than 6 lbs (2.7 kg) without water reservoir. warranty does not cover damage caused by accident, misuse, abuse, alteration and other defects not related to material or workmanship. Vapotherm spike set: Works with sterile water bags up to 2000 ml bag. VAPOTHERM, INC. DISCLAIMS ALL LIABILITY FOR ECONOMIC LOSS, LOSS OR PROFITS, OVERHEAD OR Circulating water volume <100 ml. (excluding Patient Patient Delivery Tube). CONSEQUENTIAL DAMAGES WHICH MAY BE CLAIMED TO ARISE FROM ANY SALE OR USE OF THIS Mounting: Rear mounted clamp fits standard IV pole or hanger. PRODUCT. THIS WARRANTY IS GIVEN IN LIEU OF ALL OTHER EXPRESS WARRANTIES. Power: (US) 115 V, 60 Hz, 250 VA (warm up), approximately 80 VA (continuous). -
Page 13: A Ppendix A - Disinfection Solution
WARNINGS: These disinfectant solutions are designed to be used to disinfect the Vapotherm 2000i machine without the cartridge in place. These disinfectant solutions ARE NOT approved to disinfect the cartridge. Failure to properly prepare the disinfection solution or circulate the disinfection solution throughout the machine for the appropriate hold time could result in inadequate disinfection. - Page 14 Vapotherm 2000i Operating Instruction Manual Vapotherm 2000i Operating Instruction Manual Appendix A – Disinfection Solutions Appendix B – Sample Disinfection Log (cont.) Dilution Instructions for preparing a 1% solution of Minncare and Control III ® ™ Disinfectant Vapotherm 2000i Hospital ID...
- Page 15 Supplied by Vapotherm, Inc. 198 Log Canoe Circle, Stevensville MD 21666 T: (001) 410.604.3977 F: (001) 410.604.3978 www.vtherm.com PN 8-300068-00 Rev. E bdc 8369...
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