CPAP SLEEP APNEA DEVICE

Transcription

1 SLEEP APNEA DEVICE User Manual

2 TABLE OF CONTENT 1 INTRODUCTION What is the SleepAs CPAP? Intended Use Contraindications About this Manual SAFETY INFORMATION General User Precautions Electrical Safety Environmental Conditions Usage of Patient Circuit Usage of Filters Cleaning and Maintenance Adverse Patient Symptoms Usage of the Humidifier Usage of Oxygen PRODUCT DESCRIPTION Main Parts (Components) The SleepAs CPAP Front Panel SleepAs CPAP Top Panel SleepAs CPAP s Rear Panel SETTINGS OF THE SLEEPAS CPAP Settings Adjustable and Applicable Parameters

3 5 USING THE SLEEPAS CPAP Checking the SleepAs CPAP before Use Switching the SleepAs CPAP On and Off Using the Menu Transferring Data between the SleepAs CPAP and PC Using the Integrated Humidifier Using with an External Battery and Lighter Cord PREPARING THE SLEEPAS CPAP FOR USE Installing the SleepAs CPAP Placing the SleepAs CPAP Connecting the SleepAs CPAP to the Power Source Connecting the Patient Circuit MAINTENANCE Cleaning the SleepAs CPAP and Replacing the Filters Cleaning and Replacing the Patient Air Filter Regular Maintenance Control Service and Repair Storage Disposal

4 1 INTRODUCTION WARNING! SleepAs CPAP must be used: For the intended treatment in accordance with this manual and with the instructions given by the responsible clinical personnel. In accordance with the operating conditions specified in this manual. In original and unmodified shape and only with accessories specified or approved by Foras Medical. Every other use may lead to risk of personal injury! WARNING! Do not use the SleepAs CPAP for any kind of life support treatment. WARNING! Read this manual thoroughly so that you completely understand how the SleepAs CPAP is operated and maintained before taking it into use, to ensure correct usage, maximum performance and serviceability. To verify the full performance and operating accordance with set values of SleepAs CPAP make the calibration and make the maintenance and settings of device according to the calibration value at least once a year. If the power plug is removed or power is cut off while device running device will give audible alarm. Authorized person or dealers can access to Settings menu with the password they have. CAUTION! Foras Medical reserves the right to make changes to this product without any prior notification. 4

5 1.1 What is the SleepAs CPAP? SleepAs CPAP is a respiratory apparatus that provides non-invasive continuous positive airway pressure for the treatment of sleep apnea. 1.2 Intended Use SleepAs CPAP is intended for non-invasive use. SleepAs CPAP only be used by patients with spontaneous breathing. The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea in adults (who weigh more than 30 kg). SleepAs CPAP can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It must always be prescribed by a licensed physician. SleepAs CPAP is intended to be operated by trained users and qualified personnel. The SleepAs CPAP is not intended for life support or life-sustaining applications or for transport of critical care patients. 1.3 Contraindications Therapy with the SleepAs CPAP should not be prescribed when the following specific diseases or conditions are present: Bullous lung disease Pathologically low blood pressure Severe cardiac arrhythmias Coronary artery disease Unstable angina pectoris Decompensated cardiac failure or hypotension, particularly if associated with intravascular volume depletion Recent thoracic surgery Pneumothorax Pneumomediastinum Massive epistaxis or previous history of massive epistaxis (risk of recurrence) Pneumoencephalus, recent trauma or surgery that may have produced cranio-nasopharyngeal fistula Cerebral spinal fluid (CSF) leaks Acute or unstable respiratory failure or insufficiency Caution should be used when prescribing CPAP therapy for susceptible patients, such as patients with abnormalities of the cribriform plate, or prior history of head trauma 5

6 The use of CPAP therapy may be temporarily contraindicated if the patient exhibits signs of a sinus or middle ear infection. 1.4 About this Manual Always read this manual before setting up and using the SleepAs CPAP or performing maintenance on the SleepAs CPAP, to ensure correct usage, maximum performance and serviceability. Foras Medical reserves the right to make changes to the contents of this manual without any prior notification. This manual is primarily intended for care providers, clinical personnel, physicians and others who require a working knowledge of the SleepAs CPAP system. The manual comprises detailed information on the settings and functions of the SleepAs CPAP to be handled by trained health care personnel only. ICONS In this manual, icons are used to highlight specific information. The meaning of each icon is explained in the table below. Read This manual thoroughly before connecting the CPAP to the patient. Class II Equipment; double insulation Caution USB Port Boby Floating (IEC Type BF, Isolated Applied Part) Read Disposal for information about recycling and disposal. Manufacturer CE Marking applies in accordance with the directive MDD 93/42/EEC Keep Dry Storage Temperature 6

7 2 SAFETY INFORMATION 2.1 General User Precautions. The SleepAs CPAP should not be used for any kind of life support treatment.. The SleepAs CPAP shall only be used by patients with spontaneous breathing.. If the patient is admitted to a hospital or is prescribed any other form of medical treatment, always inform the medical staff that the patient is on ventilation treatment.. The SleepAs CPAP must only be used: -For the intended treatment in accordance with this manual and with the instructions given by the responsible clinical personnel, - In accordance with the operating conditions specified in this manual, - In original and only with accessories specified or approved by Foras Medical.. Do not use SleepAs CPAP in the event of suspected damage to the device, unexplainable or sudden pressure, performance or sound changes during operation, or if the delivered air from the SleepAs CPAP is abnormally hot or emits an odor. Contact your Foras representative for an inspection.. The SleepAs CPAP therapy settings must be always based on medical advice and must be carried out by authorized personnel only.. Always perform the procedures Checking the SleepAs CPAP before use. Inadequate use of device or accessories may cause loss of treatment or decreased performance.. Clinical personnel and the patient must read the manual thoroughly and understand the use of the SleepAs CPAP before setting up and using the SleepAs CPAP.. Handle the SleepAs CPAP with care.. Do not use the SleepAs CPAP while in a bag. 2.2 Electrical Safety. Do not operate the SleepAs CPAP if it has a damage power cord, power supply or casing.. The SleepAs CPAP may not work properly if any part has been dropped, damaged or submerged in water.. To avoid electrical shock, disconnect the electrical supply to the SleepAs CPAP before cleaning. Do not immerse the SleepAs CPAP into any fluids.. When handling the heating unit, always turn off and disconnect the SleepAs CPAP from any power source.. If an external battery is used it must be disconnected when the SleepAs CPAP is switched off. Otherwise the battery will discharge.. The device power supply works in AC V, 50-60Hz and provides device DC 24V 3A. 7

8 2.3 Environmental Conditions. Do not use the SleepAs CPAP in any toxic environment.. Do not use the SleepAs CPAP in environments where there are explosive gases or other flammable anesthetic agents are present.. The performance of the SleepAs CPAP may deteriorate at: -ambient temperatures below 41 F (5 C) and above 104 F (40 C) -ambient relative humidity below 10% RH (relative humidity) and above 95% RH -atmosphere pressure below 700 mbar and above 1060 mbar.. Do not use the SleepAs CPAP while positioned in a warm place, such as direct sunlight.. Device sound level at 10 cm H2O is less than 28 db(a).. The device complies with the EMC requirements of standards. Necessary measures should be taken in order to assure that field levels exceeding 10 V/m are avoided, since this may impair the safety and performance of the SleepAs CPAP. Measures should include but not be limited to: - normal precautions with regard to relative humidity and conductive characteristics of clothing in order to minimize the build-up of electrostatic charges. -avoiding use of radio emitting devices closer than 1 m to the SleepAs CPAP. Radio emitting devices are for example cellular or cordless telephones, microwave ovens and highfrequency surgery apparatus.. SleepAs CPAP, any accessories and all replaced parts must be disposed of in accordance with the local environmental regulations.. The performance of the SleepAs CPAP and treatment of the patient may deteriorate if the operation conditions in Technical Specifications are not fulfilled. Do not use the SleepAs CPAP immediately after storage or transport outside the recommended operating conditions. 2.4 Usage of Patient Circuit. Only use the SleepAs CPAP with a mask and a patient tube recommended by Foras Medical and authorized health care professional.. Do not breathe in the connected patient circuit unless the SleepAs CPAP is turned on and operating properly.. Do not use patient hoses or tubes made of electrically conductive or static material.. Always use a new mask and a patient tube when use of the SleepAs CPAP by a new patient is applicable.. Patient connected parts and filter must be replaced regularly to ensure correct and effective function of the SleepAs CPAP. All replaced parts must be disposed of according to local environmental regulations regarding the disposal of used equipment and parts.. If the patient is using a full face mask (covering mouth and nose) the mask must be equipped with a safety entrainment valve. 8

9 . Make sure that ventilation hole or ventilation valve connections on the mask are never blocked or obstructed. These ports are used for ventilating the mask in order to prevent re-breathing of exhaled air. Rebreathing of exhaled gases for longer than a few minutes can, in some circumstances, lead to suffocation.. At low CPAP pressures, the air flow through the ventilation holes in the mask or adjacent ventilation valve may be inadequate to clear all exhaled gases from the mask. Some re-breathing may occur. 2.5 Usage of Filters. Always use the SleepAs CPAP with a patient air inlet filter installed. Only use filters that are specified in this manual.. Replace or clean the filters regularly to ensure correct and effective function of the SleepAs CPAP, especially when changing patient. Failure to replace or clean a dirty filter may cause the SleepAs CPAP to operate at higher temperatures than intended.. When operating the SleepAs CPAP, make sure that the air inlet and the filter is not obstructed or occluded. 2.6 Cleaning and Maintenance. The SleepAs CPAP shall be cleaned and maintained in accordance with this manual.. Do not attempt to autoclave or sterilize the SleepAs CPAP.. The SleepAs CPAP shall be subjected to maintenance, service and control and any applicable upgrades, in accordance with Foras Medical service instructions.. The SleepAs CPAP should only be repaired or modified in accordance with Foras Medical service manuals, technical bulletins, and any special service instructions, by service technicians authorized by Foras Medical.. Do not under any circumstances attempt to service or repair the SleepAs CPAP yourself. If you do so, the manufacturer will no longer be responsible for the performance and safety of the SleepAs CPAP. It will also no longer be valid warranty. 2.7 Adverse Patient Symptoms If the patient experiences any of the following symptoms while using the SleepAs CPAP, a physician or responsible clinician shall be contacted immediately:. Bloated feeling from excessive swallowing of air while awake. Air continually leaking from the mouth while sleeping. Dryness of air passages or nose. Ear pain, runny nose or sinus discomfort. Day time sleepiness. Disorientation (Loss of ability to adapt to the environment), memory lapse, decline in the ability to remember. Mood change or irritability. Skin sensitivity. Morning headache 9

10 2.8 Usage of the Humidifier. The Humidifier and the SleepAs CPAP are intended for non-invasive use.. When the Humidifier is installed, SleepAs CPAP must be located below the patient to prevent personal injury from accidental spillage.. If a room humidifier is used, place it at least 2 meters away from the SleepAs CPAP.. Periodically check for moisture in the patient circuit. When present, remove the moisture. Before attempting to dry the circuit, disconnect it from the SleepAs CPAP to ensure no water back-flow into the SleepAs CPAP. The frequency at which these checks must be performed will depend on the patient s own condition and condition of the device used.. If the condensation in the patient circuit is excessive, the use of a heated humidifier may require the installation of a water trap in the circuit. The water trap prevents any condensed water in the patient circuit from running into the patient airways and causing personal injury.. Water in the humidifier must be drained during transportation. 2.9 Usage of Oxygen. The presence of oxygen can speed up combustion of inflammable materials.. If oxygen has been prescribed, connect the oxygen supply tube to the appropriate oxygen port of the nasal mask or breathing system connector.. At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure delivered, patient s breathing pattern, mask selection, and leak rate.. When oxygen is used with the SleepAs CPAP, the oxygen flow must be turned off when the SleepAs CPAP is not operating. If the SleepAs CPAP is not in operation and the oxygen flow is left on, oxygen delivered into the patient tubing may accumulate within the SleepAs CPAP enclosure. Oxygen accumulated in the SleepAs CPAP enclosure will create a risk of fire.. Ventilate the room adequately.. Do not smoke in a room where oxygen is being used.. Naked light bulbs and other sources of ignition must be kept a minimum of 2 meters away from the oxygen cylinder or any part of the patient circuit.. Do not use aerosols or solvents close to the oxygen supply, even when the oxygen supply is shut off. 10

11 3 PRODUCT DESCRIPTION 3.1 Main Parts (Components) The SleepAs CPAP system contains the following components Component Function 1 Carrying Bag To protect SleepAs CPAP 2 User Manual Product and usage information 3 Mask 4 Patient Tube 5 Power Supply 6 AC Power Cord 7 Filter (grey: washable) Inlet Air Filtration 8 SleepAs CPAP Main Unit 3.2 The SleepAs CPAP Front Panel SleepAs CPAP is used by control via touch screen. MENU I Figure 1 Language Options can be changed by touching flag icons. To start the therapy, touch the ON button (see figure 2); to see other options, touch the MENU button (see figure 3). When the ON button is touched, the device will start working and working screen indicated below will appear. To stop the device or to reach the settings, touch the back button at the left bottom corner of the screen. 11

12 1 WORKING SCREEN Figure 2 1. Pressure Barograph 6. Ramp Time (min.) 2. Minimum Pressure 7. Micro SD Memory Card Indicator 3. Maximum Pressure 8. Back/Stop Button 4. Set Pressure Value 5. Humidifier Value MENU II Figure 3 To make Pressure and calibration settings touch the SETUP Button. (Authorized person or dealers can access to this menu with the password) and reach the MENU III. ** Password: 4213 By touching INFO button; device version, operation time, device serial number and contact information can be seen. Humidifier settings should be set by considering the environmental conditions by touching HUMID button. Please use plus and minus buttons to set. 0 means the humidifier is off. Ramp time setting should be set by touching RAMP button. Please use plus and minus buttons to set. SMART BREATH setting is used to make the exhalation of the patient more comfortable. Please set level 1 or level 2 according to the patient conditions. 12

13 DEVICE SETUP menu is used to set the date/time, screen brightness and screen backlight time. MENU III Figure 4 PRESSURE button should be touched to set the working pressure between 3-20 cmh2o according to the physician prescription and advices. Please use plus and minus buttons to set. CAL Calibration settings should be only entered by authorized technical services. 3.3 SleepAs CPAP Top Panel Rotatable air outlet on the Humidifier. 3.4 SleepAs CPAP s Rear Panel Humidifier 7. DC voltage information 2. Water pouring hole and plug of Humidifier 8. Data matrix 3. Humidifier release latch 9. Model info 4. Micro SD port 10. Barcode number 5. USB port 11. Air inlet filter 6. DC 24V input 12. Serial number 13

14 4 SETTINGS OF THE SLEEPAS CPAP 4.1 Settings The configuration of the SleepAs CPAP therapy settings must always be prescribed by a licensed physician and carried out by an authorized health care professional. Always document the set values before the patient returns home. Authorized person or dealers can access to Settings menu with the password they have! ON; Running Button MENU; Top menu of the following menu SETUP(Pressure); Pressure and Calibration Setting INFO; Device serial number, operating time and company information HUMID; Humidifier Setting SMART BREATH: Exhalation flexibility setting RAMP; Ramp Time Setting DEVICE SETUP; Setting of Screen Brightness and Date-Time The Ramp Function The ramp function provides a pressure increase from the ramp start pressure to the set CPAP pressure during a set time. Setting range: 0 to 60 min. Resolution: 5 min. During the ramp time the algorithm calculations are disabled. Humidifier The humidifier function is adjustable to provide additional humidity to the patient air. The humidifier function can be set between 0-14 levels. Usage of Micro SD Card Micro SD card should be up to 8 GB capacity and must be inserted while the notched side facing up and inserted and removed after the main electricity connection is off. If the green SD icon is on the screen, it means memory card is inserted. The card storage device usage information for about 5 years and details can be displayed with SleepAs Software. Device does not storage information during Micro SD card is not inserted. 4.2 Adjustable and Applicable Parameters Set Pressure Ramp Time Humidifier Backlight Time 3 to 20 cmh2o 0 to 60 min. Resolution: 5 min 0 to 14 (0 is off) Screen Brightness 10%- 100% 30s.- 5 min. (Off: backlight is always on.) 14

15 5 USING THE SLEEPAS CPAP 5.1 Checking the SleepAs CPAP before Use Always make the following checks before using the SleepAs CPAP: 1. Connect a cleaned or a new patient circuit to the SleepAs CPAP. 2. Connect the SleepAs CPAP to the AC supply. 3. Check the patient settings. 4. Operate the SleepAs CPAP by pressing the Start button on the front panel on screen. Ensure that the SleepAs CPAP is running. 5. Put on the mask and adjust its fit. 6. Ensure that the settings are adjusted as prescribed. The SleepAs CPAP is ready for use. 7. SleepAs CPAP operates with touch screen system. Processes are doing by touching and holding on the screen for 3 seconds. 5.2 Switching the SleepAs CPAP On and Off 1. Make sure the power supply is connected. 2. Device is operated by touching the green ON button. While SleepAs CPAP is running, device stops by touching the blue Back button and then red OFF button. 5.3 Using the Menu See Page Transferring Data between the SleepAs CPAP and PC In order to view and present patient data correctly, the Foras Sleep Software must be installed on the PC. Transferring data is performed in accordance with software usage instructions. 5.5 Using the Integrated Humidifier The Humidifier is intended to humidify the patient air. Due to integrate with the device, using without humidifier is not possible. If necessary to use without humidifier, set of humidifier must be adjust to 0 Caution! To avoid overflow of water and water spillage on device, water pouring process should be performed while the plug is taken off. The water that poured through this hole appoint the upper water limit in humidifier and also if the humidifier fitted according to instructions it prevent the spillage water into the device during the overturning situations. Close the plug securely after the water pouring. Release and Lock of Humidifier; In order to release humidifier chamber from the device pull the chamber backwards from the top or holding holes while holding the latch. You can fit the chamber again by pushing to the slot. You should hear the clicks of the latch. If you do not hear this voice this mean the humidifier is not properly fit. Provide lifting up the latch by pressing or push the humidifier forwards sharply. 15

16 Setting the Humidifier Setting of the humidifier may varied depends on the ambient temperature, set pressure and air flow. The patient can determine the most optimum setting and for this a temperature value must selected to avoid accumulate excessive water in tube. Humidifier temperature can rise to a maximum of 80 degrees. Do not touch the heater when the chamber is not attached. 5.6 Using with an External Battery and Lighter Cord Only use the SleepAs CPAP with external battery recommended by the manufacturer. Should be used with lighter cord that provided by manufacturer, otherwise the device and the patient may have problems. 6 PREPARING THE SLEEPAS CPAP FOR USE 6.1 Installing the SleepAs CPAP When using the SleepAs CPAP for the first time, follow the instructions below: 1 Check that all main components and ordered accessories have been delivered (refer to the packing note or the invoice, if available). 2 Ensure that the equipment is in good condition. 3 Check that the mandatory grey patient air filter is installed. 6.2 Placing the SleepAs CPAP 1 Place the SleepAs CPAP on a solid and flat surface on facing the patient. The SleepAs CPAP should be placed lower than the patient in order to prevent the device from falling on the patient, as well as preventing condensed water to reach the patient. 2 Make sure that nothing can block the patient air inlet at the rear side of the SleepAs CPAP. 6.3 Connecting the SleepAs CPAP to the Power Source 1 Plug the power cord into the power inlet of the SleepAs CPAP. 2 Connect the power cord into the power supply. 3 Connect the power cord to the power source. Do not use connecting cable. 6.4 Connecting the Patient Circuit 1 Connect the patient tube to the air outlet. 2 Connect the other end of the patient tube to the mask. Make sure the leakage port is available. 16

17 Mask Leakage Flow The leakage from the mask should be at least 12 L/min at 4 cmh2o, to preventer-breathing of exhaled air. The recommended mask leakage is L/min at 10 cmh2o pressure. This leakage may be achieved by:. small holes in the mask. an adjoining ventilation valve In order to achieve an applicable leakage Foras Medical CPAP Mask is recommended.. Leak compensation is included in the device so that the device compensates the pressure loss due to air leakage. 7 MAINTENANCE 7.1 Cleaning the SleepAs CPAP and Replacing the Filters Patient connected parts and filter must be cleaned and replaced regularly to ensure correct function of the SleepAs CPAP. All replaced parts must be disposed of and recycled in accordance with the local environmental regulations regarding the disposal of used equipment and waste. To avoid electrical shock, disconnect the electrical supply to the SleepAs CPAP before cleaning. Do not immerse the SleepAs CPAP into any fluids.. Always be careful when cleaning to ensure that you do not damage any equipment.. Fluid must not be allowed to enter into the SleepAs CPAP. Main Unit 1 Switch off the SleepAs CPAP and disconnect the power supply. 2 Remove the patient circuits. 3 Detach the humidifier. 4 Disconnect all cables. 5 Clean the outside of the SleepAs CPAP using a lint-free cloth and a mild detergent solution. 6 Reconnect cables and the patient circuit. Make sure all parts are dry before the SleepAs CPAP is put into operation. Humidifier The humidifier of SleepAs should be cleaned regularly. The humidifier can be released from the device by pushing to backwards of device while holding the latch Upper lid of humidifier detached and under silicone gasket is removed; Put the hot water in humidifier chamber up to the upper water limit against the lime and the residue consisting in the SleepAs water chamber. 17

18 Add water to 15g citric acid. After waiting 30 minutes, clear by hand wash or without detergent in the dishwasher in maximum 70 C. Use after thoroughly dried. Reassemble the humidifier placing the gasket and cover. Replace the humidifier in case of damage. Patient Circuit The patient circuit should always be cleaned in accordance with the manufacturer s instructions. Always replace the patient circuit with a new one when the SleepAs CPAP is to be used by a new patient. All parts that come into contact with the respiration gas must be cleaned as follows: 1 Place the dismantled parts in hot water containing washing-up liquid. 2 Remove fouling with a brush. 3 Rinse parts thoroughly under running hot water. 4 Shake water out of all parts. 5 Dry the parts completely. 6 Store in dust-free location. The patient circuit should be replaced regularly in accordance with the manufacturer s instructions. Check the patient circuit for damage regularly. In case of damage, replace the circuit. 7.2 Cleaning and Replacing the Patient Air Filter The patient air filter is located on the rear side of the SleepAs CPAP. Washable Filter (grey) Replace the washable filter at least once a year. Wash the filter at least once a week. 1 Wash the filter using warm water and a mild detergent. 2 Rinse thoroughly. 3 Dry the filter by squeezing it out in a towel. Do not wring the filter. 7.3 Regular Maintenance Control The SleepAs CPAP should not require any regular maintenance inspections if it is used and maintained in accordance with the instructions in this manual. Do not use the device and contact your responsible care provider for an inspection of the device in the event of:. Unexpected patient symptoms during treatment.. Unexplainable or sudden pressure, performance or sound changes during operation.. Suspected damage to the device or power supply. 18

19 7.4 Service and Repair The service and repair of the SleepAs CPAP must only be carried out by authorized service personnel in accordance with Foras Medical service instructions. Service inspections must always be carried out after any repair of the device. Authorized service workshops can order the SleepAs CPAP Service Manual that contains all technical documentation required for the maintenance and service of the SleepAs CPAP. The values given of SleepAs CPAP must be verified at least once a year by performing the necessary calibration and testing. Blower motor that used in the device needs to be replaced at hours. This time may be shortened in case of the filter is not clean and not replacement on time and also extremely dirty and dusty using environment. The battery, located in the device that used as source of energy of clock and alarm should be checked after every maintenance and repair. The battery must be replaced if the device gives not any alarm in case of power failure or in case of the clock is not operating normally. Batteries should be replaced at least once a year. 7.5 Storage Before storage of the SleepAs breathing devices empty, clean and dry the humidifier and keep in the original box in a convenient location to storage conditions without sun. The storage condition of the device is -20 C to 50 C. 7.6 Disposal The SleepAs CPAP, all accessories and all replaced parts must be disposed of and recycled in accordance with the local environmental regulations regarding the disposal of used equipment and waste. 19

20 Foras Bilg. Elekt. Medikal San. Tic. Ltd. Şti Ostim Mahallesi 1466.Sokak No: 28 Yenimahalle ANKARA Made in TURKEY / info@foras.com.tr / sales@foras.com.tr Tel: Fax: Rev: 04 Version