Operating & Safety Instructions
8. Warning: (General) DO NOT use a Flowmeter if any damage has been detected (i.e. any cracks and/or
damage to any plastic components, loose fittings etc). It may cause possible injury when the unit becomes pressurised. Always carry out the test and inspection procedure before use. If a Flowmeter fails the test and inspection the unit will require servicing or repair. The Flowmeter should only be used with the flow tube in an upright position.
9. Technical Data
Specifications a) Single Flowmeter: working pressure: 400 kPa (58psi/4 bar) b) Twin Flowmeter: working pressure: 400 kPa (58psi/4 bar) Inlet Fittings All Single and Twin Flowmeters are available with either a BS Standard Probes or Nut type fitting (AFNOR & DIN fitting are also available). Calibration Range All Flowmeters are factory calibrated to ±10% of the full scale reading. a) Oxygen: 0 to 15 or 0 to 4 LPM b) Medical Air: 0 to15 or 0 to 4 LPM c) Nitrous Oxide: 0 to12 LPM d) Carbon Dioxide: 0 to 12 or 0 to 3 LPM Test Specification a) Required testing pressure: 400 kPa (58psi/4 bar) b) Calibration tolerance: ± 10% c) Leak test: permissible leak: None
Healthcare Equipment F1600 Series Pipeline Flowmeter Operating & Safety Instructions
10. Accessories and Replacement Parts a) b) c) d) e) f) g) h)
Product Code IS1106 IS1140 IS1174 SP554 H110 SP46 (White)/SP46B (Black) FM0001 (Female); FM0002 (Male) SKF6-O2; SKF6-AIR
Adult Oxygen Face Mask: Pediatric Oxygen Face Mask: Delivery Tube: Humidifier Adapter: Humidifier Bottle Assembly: Tubing Nipple: Air Safety Shield: Service Kit
Single Flowmeter with Probe
Note: All devices carry a 7 year warranty and are MR Conditional*.
Manufactured by: Oxylitre Limited Morton House Skerton Road Old Trafford Manchester M16 0WJ England *ASTM F2503-08
Tel: Fax: email:
Air Safety Shield
(0)161 872 6322 (0)161 848 7914 [email protected] 0473
Doc Ref: Issue No: Date: Page 3
Doc-OP-4101 2.8 16.5.13
1. Introduction The Oxylitre F1600 series (Pressure Compensated) Flowmeter has been designed specifically for medical use and conforms to the requirements of BS EN ISO 15002, BS EN ISO 14971, BS EN ISO 15001 and the 93/42/EEC European Medical Device Directive (Class IIa device). Products are available in either Single or in Twin Flowmeter configurations and for use with Oxygen, Nitrous Oxide, Heliox, Medical Air and Carbon Dioxide gases. The devices are constructed with a brass/chrome plated alloy body and with an easy to read ball type flow indicator tube calibrated in litres per minute. All units are MRI compatible.
2. Specifications Inlet Connection Flowmeter gas probe connectors comply with the BS & European Standards for the safety prevention of connecting an incorrect gas. Flowmeters that are fitted with 3/8 BSP nut connectors are specifically for the attachment to Oxylitre R1610 series Regulators. Outlet Connection The units are fitted with a universal sized tubing connector that will accept most types of delivery tube. Flowmeters are also available with a 9/16unf male Humidifier adapter for the attachment of a (female threaded) Humidifier Bottle Assembly. Filters The Flowmeter is fitted with an integral filter, which protects the device and the patient from receiving any foreign matter. Please Note: The filters are replaceable by qualified technicians only. Gas Supply The F1600 Series Flowmeter has been designed to operate from a gas supply of 400 kPa (4 bar/58 psi) of pressure. Accuracy The Flowmeters are factory calibrated to an accuracy of ± 10% of the full-scale reading at a temperature of 20ºC. The readings on the inner tubes have been calibrated with a pressure source 400 kPa (58 psi). GMDN Code: 37132 (Oxygen therapy flowmeter)
a. Connect the pressure Flowmeter into the appropriate gas outlet (identified on the product label) and ensure that the unit is securely locked into the outlet. b. With the Flowmeter fully shut off ensure that the Flowmeter Ball rests on the bottom of the inner tube without any movement. c. Turn the control knob anti-clockwise to increase the gas flow and until the Flowmeter Ball reaches the “Flush” indicator. Keep it at this point for approximately 2 seconds, this test ensures that the gas flow can be obtained. Turn the control knob clockwise and shut off the gas supply. d. Select the flow that will be required for patient therapy. Turn the control knob anticlockwise until the Flowmeter Ball reaches the selected gas flow rate. The calibrated markings are to be read at the centre of the ball. Ensure that the Flowmeter Ball does not fluctuate. e. Turn the control knob clockwise fully to shut off the gas flow.
5. Patient Therapy a. Ensure that the Flowmeter test and inspection procedure has been carried out in section 4 prior to use. b. Attach the therapy device (i.e.; tubing or humidifier bottle with mask etc) to the outlet fitting. c. Turn the control knob anti-clockwise until the selected gas flow rate is reading at the centre of the ball. d. During the patient administration periodically check the flow rate is reading the selected flow. Due to possible in line restrictions the gas the flow rate may require re-adjustment.
6. Fire and Explosion Safety Precautions DO NOT use any grease or oil within Oxygen filled environment, as these substances are combustible in the presence of Oxygen. DO NOT use an Oxygen/Nitrous Oxide Flowmeter within an environment where the gas may be exposed to any naked flames, sparks, cigarettes/cigars or any open electrical appliances. This precaution applies during and after a reasonable period of patient administration.
3. Flowmeter Set-up
Safety Warning: Before use, the Flowmeter must be inspected for any obvious damage such as cracks and broken parts. Ensure that the Flowmeter has been tested for any detectable leaks. Qualified servicing personnel only should perform this. NO leaks are permissible on the device. Before connecting the Flowmeter to a pressurised gas supply, ensure that the Flowmeter has been fully shut off. This is achieved by turning the control knob clockwise until it is shut off.
A Medical Flowmeter forms part of an essential support system. Flowmeters must be treated with care and be serviced on a regular basis, (i.e. preventative maintenance) to ensure the unit’s reliability and quality for the intended purpose. Clean outer surfaces with a propriety diluted mild non-alkaline disinfectant/detergent or wipe (always read and follow manufacturer’s instructions, especially noting material compatibility). It is important to note that the Polycarbonate used in the Flowmeter Tube Cover, Tubing Nipple and Control Knob is degraded by alkaline solutions, ammonia gas and it solutions, and amines. Inspection Recommended at least annually by a Service Engineer and consist of:
4. Flowmeter Inspection & Test Procedure (Before Patient Use) The following Flowmeter Inspection and test procedure must be carried out prior connection to a patient therapy device. Please complete the “Flowmeter Set Up” procedure in section “3”. Always read from the centre of the ball
Calibration Check Service/Repair Fully qualified technicians should only carry out servicing. A Major Service is recommended every 5 years. For service/repair enquiries and information, please contact our sales office. NEVER USE FAULTY EQUIPMENT. Preventative maintenance ensures safety for the patient and user.