AII5000F Inhalation Antalgic System User s Manual Series No. :SP-Y53564 Version :A1 Date of Review:2012-04-29
To Users: Welcome to Blendox AII5000F Inhalation Antalgic System (hereafter referred to as Blendox). The specifications and the operating procedures described in this user s manual (hereafter referred to as Manual) are specifically for use with Blendox. This manual, including directions, labels, and safety notices, must be followed during inspection, installation, operation and maintenance. To ensure safety of both patients and operators, all users of Blendox must carefully read the Manual, and follow all instructions described within. Statement of the Manufacturer: 1) Blendox must be installed and operated by qualified personnel only. The unit can be maintained, adjusted, and rebuilt by persons only authorized by the manufacturer. 2) Blendox must be installed to meet the applicable local construction codes. 3) Blendox must be installed to meet requirements specified in Manual to ensure proper operation. Declaration: This manual is protected by copy right and contains intellectual property. It is unlawful to copy the content of the manual, in part or in whole, without the manufacturer s prior approval. The manufacturer reserves the right to update or change the content of Manual without notice. 1
Table of Contents 1. Safety Guide 3 2. Overview 5 3. Installation 7 4. General Description 11 5. Operational Instruction 12 6. Maintenance 14 7. Trouble Shooting 15 8. Specifications 16 9. Warranty Statement 18 2
1. Safety Guide 1.1 Terminology Words in bold specify risk levels to make you aware of potential harm during Blendox use. Definitions Danger and patient. Warning patient. : Information that operators must know to avoid serious injury of both operator : Information that operators must know to avoid injury of both operator and Caution : Information that operators must know to avoid possible device damage. Note: The following safety guide can help to minimize possible injury while using Blendox. 1.2 Safety Guide 1.2.1. Blendox should be operated by qualified personnel only. 1.2.2. Blendox mixes oxygen and nitrous oxide gases; then, the mixed gas is delivered to the patient by autonomous respiration, to inhibit pain. Inhalation of the mixed gas of nitrous oxide and oxygen is a simple, safe, efficient way of pain relief. Danger Blendox cannot be used for mixing gases other than nitrous oxide and oxygen. Warning Blendox should be installed in a non-flammable environment. Warning Only qualified professionals should disassemble Blendox. Any unauthorized repair, alteration or misuse of Blendox will void warranty. Warning Blendox blends high-pressure gases, oxygen and nitrous oxide. Keep Blendox clean and strictly avoid contact with grease and other dangerous lubricants. Warning Keep Blendox away from direct heat-sources. Warning Before using Blendox, obtain detailed medical history. The medical treatment with Blendox shall follow the guidance by local medical professional associations. Caution To ensure safety of patient, please use Manufacturer s recommended parts and accessories. Caution Do not use thermal conducting and electrical conducting respiratory tube. 3
Caution Blendox and all moving parts should be safely mounted. Caution All connections to Blendox should be clean and dry to avoid malfunction. Caution Operator should check the gauges of gases to make sure they are in the correct position before starting to use Blendox. Caution Gases discharged from Blendox will not pollute environment, but the room must be well ventilated; otherwise, the combustible gas can cause fire. Caution Double check all connections to ensure there are no leaks before Blendox goes into service. Caution Gases are used in the ambient temperature of 15 and above. Caution To ensure Blendox safety and long-term operation, please follow the instructions in the Manual. However, this manual cannot be a substitute for the established medical practice to treat patients. Caution Periodically service Blendox. Caution Place the packaging material of Blendox where children cannot reach or dispose in accordance with relevant environmental regulations. cycle. Caution Blendox parts should be disposed of when they reach the end of their useful life Note: The above mentioned is the basic safety requirements, and refer to subsequent chapters for more detailed and specific safety requirements. Note: The level of importance of above mentioned safety requirements are arranged in random order. As well, the detailed safety requirements in subsequent chapters are as important as those in this chapter. 4
2. Overview 2.1. Intended Application Blendox delivers a mixed gas of 50% oxygen and 50% nitrous oxide to patient by autonomous respiration to inhibit pain. Inhalation of mixed nitrous oxide and oxygen is a simple, safe, efficient way to provide pain relief during minimal trauma treatment, and childbirth. 2.2. Principle of Operation Blendox blends medical oxygen and medical nitrous oxide by connecting to a gas source from medical grade outlets on the wall to the corresponding inlets. The gases flow through the stainless steel passages independently into the oxygen and Nitrous Oxide modules; then blended through the blending module. The blending module is pre-adjusted and locked to deliver 50% oxygen and 50% nitrous oxide, with a mixing accuracy of ±5%, or in a range of 47.5% to 52.5%. The mixed gas is then delivered to the patient through a high pressure hose to a demand valve (DVR) controlled by patient demand breaths. 2.3. Components List Blendox consists of gas inlets with on/off switches, nitrous oxide / oxygen blending module, flow ratio control module, high pressure hose, demand valve (DVR), mask, and wall mount brackets. 5
3. Installation 3.1. Installation of Bracket Bracket Wall Mounting Hole Self-tapping Screw Limited Screw 3.1.1 Check all items, including Blendox unit and accessories, with packing list when opening the package. 3.1.2 Install the bracket as per wall structure and configuration. 3.2 Installation of Main Body Switch N2O Inlet Mixed Gas Outlet Switch O2 Inlet O-Ring 6 Connect to Bracket
3.2.1 Before installing the main body of Blendox, check the 3 pressure gauges of N2O, O2, and mixed gas to make sure that the gauge needle indicators are on the position of 0 and check the two gas inlet switches to make sure that they are factory preset on the position of Off. 3.2.2 As shown above. Mount Blendox unit onto the bracket by inserting the connector into the mounting hole on the bracket. Make sure that the O-ring is in its position. It is normal if there is a feeling of resistance when loading the unit onto the bracket. 3.2..3 After mounting Blendox onto the bracket, swing the unit to desired position; then, tighten the limit screws with a mid-sized screwdriver to fix the unit in position. See the picture below for the installed Blendox. 3.3 Connecting of Pipeline 3.3.1 Before connecting the pipeline, set the two gas inlet switches to the Off position. Follow the procedure, 1) connect hoses to the Blendox gas inlets; 2) connect hoses to the gas sources. 3.3.2 As shown below, there are 3 hose fittings in the lower part of Blendox with different thread specification up to the international standard. The connector on the left, with thread spec. 3/4-16UNF, is the Nitrous Oxide INLET. The connector on the right, with thread spec. 9/16-18UNF, is the Oxygen INLET (oxygen gas inlet). The front connector, with thread spec. 5/8-18UNF, is Mixture Outlet (mixed gas delivery). Outlet Mixed Gas Inlet N2O Inlet O2 7
3.3.3 Connecting the nitrous oxide hose. The supplied blue hose is for nitrous oxide gas. The blue hose is connected to the left connector labeled N2O INLET, gently tightened with a wrench. 3.3.4 Connecting the oxygen hose. The supplied white hose is for oxygen gas. The white hose is connected to the right connector labeled O2 INLET, gently tightened with a wrench. 3.3.5 Connecting the mixed gas hose. The supplied grid-pattern transparent hose is for mixed gas. The transparent hose is connected to the middle connector labeled MIXTURE OUTLET, by hand tightening the patterned nut. After connecting the hoses, please read Chapter 4 General Description for more details. 3.3.6 The other end of grid-patterned transparent hose is connected to a demand valve by hand tightening the patterned nut. Then, rest the demand valve on the rack on left side of Blendox, as shown below. 3.3.7 The blue Nitrous Oxide hose and the white Oxygen hose are connected to the Nitrous Oxide and oxygen outlet on wall. The pressure of a central supplied gas source is 50±10% PSI, or in the range between 45~55 PSI. 3.3.8 After all hoses are properly connected; turn on the switches at gas inlet following the procedure, 3.3.8.1 Push any one of two switches up to the ON position, the corresponding pressure gauge will point to the position around 50 PSI, depending on the pressure of the gas source. Meanwhile, the alarm will be on which is normal. 3.3.8.2 Push the other gas switch up to the ON position, the corresponding pressure gauge will be pointing to the position around 50 PSI, depending on the pressure of the gas source. The alarm will stop automatically. 3.3.8.3 All three pressure gauges will point to the position around 50 PSI, depending on the pressure of the gas source. 3.3.9 After switching on both gases connected to the Blendox unit, three pressure gauges will steadily point to the position of 50 PSI. Push and release the emergency force delivery button at the back of demand valve twice, with the pin attached, as shown in the pictures below. If the gauge needle indicator of the mixed gas gauge is fluctuating, it means that Blendox is ready to use. 8
Pin for pressure release Push to release pressure 3.3.10 After installation and when system not in use, turn off the switches at gas inlets, following the turn off procedure. 3.3.10.1 Pull any one of two switches down to the OFF position, the corresponding pressure gauge will point to the position of 0 PSI. The alarm will be on which is normal. 3.3.10.2 Pull the other gas switch down to the OFF position, the corresponding pressure gauge will point to the position 0 PSI. The alarm will be off automatically. 3.3.10.3 The pressure on mixed gas gauge will stay 50 PSI. Press the emergent force delivery button at the back of demand (refer the images in 3.3.9.) to release the pressure in the system and to let the pointer of mixed gas gauge back to 0. 9
4. General Description Demand Valve Resuscitator (DVR) with Mask Pressure Gauge Mixed Gas Alarm Rack For DVR Pressure Gauge N2O Pressure Gauge O2 O2 Inlet ON/OFF Switch N2O Inlet ON/OFF Switch Demand Valve Resuscitator (DVR) Mask 4.1 Features and Specifications 4.1.1 The required gas sources pressure and Blendox s working pressure of the two gases, nitrous oxide and oxygen is 50±10% (45-55) PSI. This number displayed on the pressure gauges of the two gases shall be in this range. 4.1.2 The mixed gas pressure gauge indicates the pressure of mixed gas in the system. When source gases are connected, the pressure indicated on mixed gas gauge shall be the same as displayed on the gauges of nitrous oxide and oxygen. During inhalation, the gas needle indicator of the mixed gas gauge will be moving up and down in a range between 45 PSI and 55 PSI, which is normal and indicates that the gas is being inhaled by patient. 10
4.1.3 Blendox has an audible alarm device to give a warning when (1) central gas supply system fails to supply any one of the two gases; (2) pressure difference of the two gases is equal to or more than 30 PSI. When the gas supply source is back to normal, the alarm will be automatically turned off. The alarm will not work if the unit is not connected to a gas source. 4.1.4 Blendox is a fixed oxygen/nitrous oxide proportion antalgic system with factory presets fixed on 50% oxygen and 50% nitrous oxide. The accuracy is ±5%, or in a range between 47.5% and 52.5%. 4.1.5 The output flow is not less than 120 LPM. 4.2 Demand Valve Feature and Specifications 4.2.1 The demand valve pressure switch is spontaneously triggered to deliver the mixed gas once patient is breathing. 4.2.2 The triggering pressure of a demand valve is 6 mm water column and its peak delivery volume is up to 120 LPM. 11
5. Operational Instruction 5.1 Turning on Blendox 5.1.1 Make sure the pressure of the source gases is 50±10% PSI or in the range between 45 PSI and 55 PSI. 5.1.2 Push any one of two switches at source gas inlet up to the ON position, the corresponding pressure gauge needle indicator will point to the position around 50 PSI, depending on the pressure of the gas source. The alarm will be on which is normal. 5.1.3 Push the other gas switch up to the ON position, the corresponding pressure gauge needle indicator will point to the position around 50 PSI, depending on the pressure of the gas source. The alarm will be off automatically. 5.1.4 All three pressure gauges will steadily point to the position around 50 PSI. The machine is ready to operate. 5.2 During Operation 5.2.1 During inhalation, the gauge needle indicator of the mixed gas gauge will be moving up and down in a range between 45 PSI and 55PSI. This indicates that the gas is being inhaled by patient. Warning If the alarm is on during patient inhalation, (1) remove the mask from patient immediately, (2) switch off the source gases following the procedure specified in 5.4. 5.3 After using Blendox 5.3.1 In order to extend the life time of Blendox, it is suggested to turn off the switches at the gas inlets, if the machine is not in use. 5.3.2 Follow the source gas switch off procedure 5.3.3.1 Pull any one of two switches down to the OFF position, the corresponding pressure gauge indicator will point to the position of 0 PSI. The alarm will be on which is normal. 5.3.3.2 Pull the other gas switch down to the OFF position, the corresponding pressure gauge indicator will point to the position 0 PSI. The alarm will be off automatically. 5.3.3.3 The pressure on mixed gas gauge will stay on 50 PSI. Press the emergent force delivery button at the back of demand (refer the images in 3.3.9.) to release the pressure in the system and to let the needle gauge indicator of the mixed gas gauge back to 0. 12
6. Maintenance 6.1. Detachable Parts White high pressure oxygen hose, blue high pressure Nitrous Oxide hose, grid-patterned high pressure gas mixture hose, demand valve and mask 6.2. Main body of Blendox To clean the Blendox, use a soft cloth dipped in warm soapy water to wipe the surface of Blendox; then wipe with a dry cloth. Avoid liquid from running into the main body of Blendox. Do not sanitize the main body of Blendox under high pressure and high temperature condition. Do not sanitize the main body by soaking in any kind of liquid. Do not spill any liquid on the unit; do not let liquid flow into connectors on the unit. Parts needed to be sanitized should be in a temperature not exceeding 160 C (275 F). If the unit is damaged or dysfunctional, stop using the Blendox and contact maintenance professionals. 6.3. Maintenance Cycles Every 2 years. Inspection and maintenance must be performed by the persons certified by Manufacturer in the facilities certified by Manufacturer. 6.4. Warranty and Technical Support 6.4.1 Blendox has been tested and calibrated in the factory. Manufacturer provides 1 year warranty for main body and 6 months warranty for accessories. If the unit fails to function, only authorized personnel should conduct repair work. 6.4.2 Once the Blendox unit is opened or repaired by Non-authorized person, the warranty will be invalid. 6.4.3 The following conditions are not covered by the warranty: Damages and risks caused by improper operation; Damages caused by improper connection with other equipment or gas outlets; Damages caused by misuse; Damages caused by use by non-authorized personnel, maintenance and repair by non-authorized repair professional. Damages caused by replacing parts from sources not recognized by manufacturer. Serial number removed or not visible Note: Please keep the original packaging so that it can be used if ever required to be sent back to manufacturer or local service centre for servicing, repair, and/or replacement. 6.4.4 Customer Service For technical service and support, please call your local dealer. 13
6.5. Demand Valve DVR Maintenance DVR Main Body Diaphragm Patient Valve Scavenging Adaptor 6.5.1 Maintenance Cycle 6.5.1.1 The demand valve should be serviced at least every 6 months 6.5.1.2 The service work includes 1) checking flow rate and other specifications specified in 8.3; 2) checking the parts, such as diaphragm, patient valve, and scavenging adaptor if in good condition; 3) cleaning the surface of the main body. 6.5.2 Routine Cleaning Warning The demand valve should be cleaned and disinfected after each use to avoid cross infection. Warning Before service or cleaning the demand valve, the gas sources should be disconnected, following the procedure specified in 3.3.10, and the residual gas and pressure in the demand valve should be released, following the procedure specified in 3.3.10.3. Detergents, disinfectants, and sterilization method. 1) All parts cleaned with mild soap solution; 2) disinfectants includes acetaldehyde, ethanol, quaternionicamino-group compound etc.; 3) sterilization method, with soft detergents, steam at 121.3, for 15-30 minutes or at 134 for silicon parts. 6.5.3 Cleaning Procedure 6.5.3.1 Disconnect the gas source following the procedures in 3.3.10. 6.5.3.2 Release the gas residual and pressure following the procedure in 3.3.10.3 6.5.3.3 Disconnect the mask 14
6.5.3.4 Remove the scavenging adaptor 6.5.3.5 Carefully, counter-clockwisely unscrew patient valve out of the demand valve, to ensure the diaphragm does not drop off; 6.5.3.6 Completely clean all parts with detergent; then dip the parts in disinfectant. Sterilize the mask for every use while the other parts periodically by following the method specified in 6.5.2; 6.5.3.7 The demand valve main body can be wiped over with soft cloth and mild soap solution; 6.5.3.8 Completely dry all parts 6.5.3.9 Re-assemble the demand valve and test it. Note: If any of the procedures for cleaning, disinfecting and/or sterilization specified in this manual conflict with local medical professional associations' regulations or guidelines, local regulations or guidelines should be followed. 15
7. Trouble Shooting Malfunctions Diagnosis Solutions No mixed gas flow from mask Inefficient gas flow from mask 1. Gas inlet switches are on OFF position 2. No pressure at the point of mixed gas outlet 3. No pressure at mixing unit 1. Abnormal pressure at mixed gas outlet 2. Demand valve lost its required sensitivity Continuous alarm 1. Pressure difference of two inlet gases 2. Fail of balance valve Gauges abnormal fluctuation 1. Unstable gas supply 2. Broken gas gauges 1. Check source gas gauges to make sure if it is 50±10% PSI 2. Check mixed gas gauge to make sure if is 50±10 PSI 3. Check the pressure at connector of mixed gas by loosening the nut at the mixed gas connector. If there is no pressure or no gas blowing out, send machine to local dealer. 1. Adjust the source gas pressure to the required value 2. Replace demand valve 1. Check the pressure of gases at inlet to make sure they are 50±10% PSI 2. Send the machine to local dealer 1. Check gas source and repair 2. Replace gauges by local dealer or a certified technician Leaking at gas inlet 1. Loose nut at connection 2. Gas inlet switches not set to the full ON or OFF position 3. Failure of gas inlet switch 1. Tighten the nut 2. Fully engage ON or OFF position 3. Replace the switch by local dealer or a certified technician 16
8. Specifications Product Name Model Number Blendox Inhalation Antalgic System AII5000F 8.1. Safety Type Type of Device: Non electrical powered Industry Standard Applied: ISO 11195 Risk Classification: Class II 8.2 Working Environment Working temperature: 15 ~ 40 Transportation temperature: -5 ~ 40 Relative humidity: 80% Atmospheric pressure: 96 ~ 106kPa Oxygen source pressure 50±10% PSI Nitrous oxide source pressure 50±10% PSI Mixed gas pressure 50±10% PSI 8.3 Performance A. Respiratory parameters: Flow volume: independently control by the patient Flow rate: not less than 120 LPM Pressure limit: 0-60cm H2O (through demand valve) Demand Flow Triggering pressure: 90 lpm @ < -5 cm H2O Fresh gas compensation: automatic compensation flow volume The proportion of oxygen: 50% fixed, accuracy ± 5%. (47.5%~52.5%) The proportion of Nitrous Oxide 50% fixed, accuracy ± 5%. (47.5%~52.5%) B. Inhalation mode: Spontaneous breathing pattern Accessories: Mask (optional sizes: large, medium, small) 8.4 Waste gas discharge A scavenger hose (optional) connected between scavenging adaptor and scavenging outlet 8.5 Physical parameters: Environmental Requirements Ambient temperature: 15 ~ 40 Relative Humidity: 80% 17
Atmospheric pressure: Outline dimensions of main body: Weight: 96kPa ~ 104kPa 230mm (W) x260mm (high) x110mm (D) 3.4 kg Working Temperature Avoid moisture Layer of stack Up Fragile 15~ 40 18
9. Warranty Statement THIS WARRANTY IS GIVEN IN PLACE OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE. Under no circumstances shall Manufacturer be liable for incidental or consequential damages as those terms are defined in the uniform commercial code. Manufacturer warrants that each product or part shall be free from defects in workmanship and materials, under normal use and with appropriate maintenance, for one (1) year from the date of delivery to customer unless otherwise specified in writing. All rubber and plastic parts and accessories are warranted under the same conditions for a period of ninety (90) days from date of purchase. The main components are warranted under the same conditions for a period of 1 year from the date of purchase. Please check manual for the detailed warranty services. No statement or claim about the product by any employee, agent, representative, or dealer of Manufacturer shall constitute a warranty by Manufacturer or give to rise any liability or obligation of Manufacturer. Manufacturer shall not be liable for any damage, injury or loss arising out of the use of the product, whether as a result of a defect in the product or otherwise, if, prior to such damage, injury or loss, the product was (1) damaged or misused; (2) repaired, altered or modified by persons other than Manufacturer; (3) not installed in strict compliance with applicable codes and ordinances; or (4) not installed by an authorized Manufacturer dealer. Manufacturer obligation for breach of this warranty, or for negligence or otherwise, shall be strictly and exclusively limited to the repair or replacement of the product or part. This warranty shall be void on any product on which the serial number has been altered, defaced or removed. ORDERS All orders are to be made through authorized Manufacturer distributors. All billing will be done through said distributors. Direct orders will be handled through the authorized local dealer as determined by Manufacturer. RETURNS & EXCHANGE No returns or exchange will be accepted unless authorized in writing by Manufacturer Instrument Division, and accompanied by a properly completed return goods authorization. All returns are subject to a re-stocking and possible rework charges to be determined by Manufacturers Instrument Division. 19
Policies subject to change without notice. Manufacturer Ambulanc (Shenzhen) Tech. Co., Ltd. Address: East 3/F, Block A Nan Yuan Ind. Park, Xinyuan Rd.,NanShan District, Shenzhen, China, 518052 Tel: +86-755-26072212, Fax: +86-755-33975117 Email: manager@ambu-lanc.com Canadian Exclusive Dealer Westone Medical Products Inc. Address: 29781 Fraser Hwy, Abbotsford, BC, Canada V4X 1V2 Tel: 1 (604) 636-1836, Fax 1(604) 909-1678 20