HERSILL OXYMO User Manual
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HERSILL OXYMO User Manual

Demand oxygen delivery system and respiratory monitor
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Demand Oxygen Delivery System and
Respiratory Monitor
User Manual
www.hersill.com
0051
Manual Ref.: 9550601 Rev.: 1.6
Jan 2016

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  • Page 1 Demand Oxygen Delivery System and Respiratory Monitor User Manual www.hersill.com 0051 Manual Ref.: 9550601 Rev.: 1.6 Jan 2016...
  • Page 2 Manual Ref.: 9550601 Rev.: 1.6 Jan 2016...
  • Page 3 User Manual English...

  • Page 4: Table Of Contents

    CONTENTS INTENDED USE ....................4 SAFETY INFORMATION .................. 5 2.1. MEANING OF SYMBOLS ....................5 2.2. SAFETY INFORMATION ....................5 TECHNICAL SPECIFICATIONS............... 8 SCHEME OF THE DEVICE................9 INNOVATIVE FEATURES ................12 5.1. SMART FLOW ......................... 12 5.2. SMART ASSIST ......................13 5.3.
  • Page 5 9.2. LOW PRESSURE OXYGEN PIPELINE (HOSPITAL) ............46 9.3. LIQUID OXYGEN ......................47 10. CONTINUOUS FLOW ADAPTER ..............47 11. SOFTWARE OXYMO-SW ................48 12. SPARE PARTS AND ACCESSORIES ............49 13. TROUBLESHOOTING ..................50 14. MAINTENANCE, STORAGE AND REMOVAL ..........53 14.1.

  • Page 6: Intended Use

    NTENDED USE OXYMO is a portable electronic demand oxygen delivery device. These devices are also called oxygen conservers or savers. It provides a small amount of oxygen (bolus) when the patient begins the inspiration, with physiological effect similar to a continuous flow (equivalent flow).

  • Page 7: Safety Information

    AFETY INFORMATION 2.1. MEANING OF SYMBOLS Urgent notice on hazardous situation which, if not WARNING corrected, could result in serious injury or death. Important notice on hazardous situation which, if not CAUTION corrected, could result in minor or moderate patient injury or device damage.
  • Page 8 Federal (USA) law restricts this device to sale by or on the order of a physician. • The oxygen supplied by OXYMO should not be considered as a vital treatment. •...
  • Page 9 • Periodically check the tank pressure (on the gauge), to ensure it is sufficiently filled (it is advisable to always have a spare bottle). • Do not immerse the unit. • Do not subject the device to temperatures above 50 ° C or below -10 °...

  • Page 10: Technical Specifications

    • 5 V DC adapter Autonomy 80 hours (typical use, with batteries NiMH) USB port Communications ® Software OXYMO-SW for Windows Operation -10 ºC to + 50 ºC temperature Store temperature -40 ºC to + 70 ºC In regular use as patient compliance monitor: until 1...

  • Page 11: Scheme Of The Device

    CHEME OF THE DEVICE 1. O input connector 12. Push “OK” button 2. O output connector 13. Keyboard locked 3. ON/OFF 14. Detection of inspiration 4. Minus 15. Breathing frequency (breaths per 5. Plus minute) 6. To confirm (OK) 16. Battery level 7.
  • Page 12 21. Spiral hose 22. Nasal cannula 23. Continuous flow adapter (3 L/min) 24. Regulator OXYMO P-15 Micro (with O connection DISS) 25. Cylinder regulator P-300 (with O auxiliary output DISS) (*) *(Consult different types of cylinder connections available).
  • Page 13 26. Oxygen cylinder 27. AC/DC adapter 28. USB cable 29. O2 pipeline regulator OXYMO P-15 (**) ** (Consult different types of connections available)

  • Page 14: Innovative Features

    20 to 30 BPM, the system will increase the equivalent flow by 50% (5% per 1 BPM above 20). If the flow of oxygen prescribed for the patient was 2 L/min Equiv., and rising from 20 to 30 BPM, OXYMO would provide a bolus corresponding to 3 L/min Equiv.

  • Page 15: Smart Assist

    NOTE This functionality can be enabled or disabled. OXYMO is factory supplied with the Smart Flow deactivated. 5.2. SMART ASSIST If the nasal cannula is not well placed, its holes are too small or the patient breathes through the mouth, any device of pulsed oxygen therapy...

  • Page 16: Smart Supervision

    Working as Oxygen Conserver or as Respiratory Monitor (See Chapter 6.8), OXYMO stores the respiratory rate, the hours of daily use and the events* for about 1 year. This allows to check therapeutic compliance. Moreover, on the last day of use each patient's breath is recorded.
  • Page 17 Safety Flow during disconnection/apnea alarms. Being this feature enabled, during a disconnection/apnea alarm OXYMO will supply oxygen, by a pulsed mode, reaching a rate of 2 L / min, until the alarm is deactivated or the device is switch off.

  • Page 18: Operation Instructions

    Insert batteries (back door of the device) and/or connect de AC/DC adapter Turn-on the device (On button). During the boot sequence the display will blink three times and the buzzer will beep. CAUTION Does not turn on OXYMO with nasal cannula connected to the patient.
  • Page 19 (you can see on the screen the symbol To switch off the device: Press the button ON / OFF. Confirm by pressing OK. CAUTION Do not connect the OXYMO device to any other regulator than the OXYMO P-15 MICRO.
  • Page 20 OXYMO P-15 regulator. Follow steps 3 to 8 described in the previous section. For use of OXYMO in a pipeline oxygen supply, this CAUTION last must have a pressure ranging between 2.8 to 7...

  • Page 21: Connection To A Liquid O2 Tank (Lox)

    6.3. CONNECTION TO A LIQUID O2 TANK (LOX) OXYMO can be operated with a tank of liquid oxygen (LOX) as long as it meets the following requirements: Oxygen outlet pressure of 1.5 ± 0,15 bar. Oxygen flow rate higher than 6 L/min.

  • Page 22: Switch On And Placement Of The Nasal Cannula

    ON/OFF. During the starting test (3 seconds) all the symbols on the screen blink together with an acoustic signal. After the test, OXYMO is ready to operate in Conserver Mode. During the starting test (3 seconds) it is possible to delete the memory (See Chapter 6.6) or to access...

  • Page 23: Switch Off

    6.5. SWITCH OFF The unit is switched off by pushing the key ON/OFF. To switch off the unit, the order must be confirmed by pushing OK before 5 seconds (during that time the symbol OK blinks in the display). If in 5 seconds the OK key is not pushed, the unit continues operative.

  • Page 24: Keyboard Locking

    Silence alarm and OK keys (the symbol of a padlock disappears). After unlocking, the keyboard can be used in a normal way. NOTE This device can also be locked from the PC software OXYMO-SW. In this case the device can´t be unlocked from the keyboard.

  • Page 25: Configuration

    6.8. CONFIGURATION The simplest way to configure the unit is using a PC and the software OXYMO-SW, via USB (See Chapter ). Anyway it is also possible to configure the unit directly using the keyboard, following these instructions After switching on the unit (See Chapter ) all the symbols on screen blink for the 3 seconds.
  • Page 26 To change from one function to another, just press Plus and Minus. Once selected the function wished to configure, press OK. From whichever function, it is possible to come back to main menu of Configuration Mode by pressing ON/OFF. Likewise, getting out of the main menu of Configuration Mode only requires pressing ON/OFF.

  • Page 27: Clock Settings

    6.8.1. Clock Settings Once inside Configuration Mode (S), the first available function will be that for date/time settings. On screen the letters CL (Clock) will be shown. Clock settings menu is entered by pressing OK key. Letter S change for y (year) indicating that year can be selected.
  • Page 28 Automatically, it will go to select hour (H), minutes (n), and seconds (S). Pressing OK key after each setting. In the example it has been selected the time 21:02:07. After selecting the seconds, press OK to confirm date and time. If you press ON / OFF, it returns to the main menu.

  • Page 29: Smart Flow Configuration

    6.8.2. Smart Flow configuration The second option available in the Configuration Mode (S) is the activation Smart Flow (SF). This system increases the oxygen equivalent flow with increasing respiratory rate. Pressing the OK key and the Plus or Minus keys can be activated (y from yes) or deactivated (n from no).
  • Page 30 If Smart Flow is activated, it is required to set up two additional parameters: the first to be presented on the screen is the basal respiratory frequency (the respiratory frequency having the patient at rest) (bF). Pressing the OK button changes the letter S to F (Frequency) and you can modify the value.
  • Page 31 5%. You can see a practical example on page 13. To change the value, use the Plus or Minus keys. Once configured, you must confirm by pressing OK. NOTE OXYMO never provides a bolus greater than an equivalent flow of 7.5L/min.

  • Page 32: Smart Assist Configuration

    6.8.3. Smart Assist configuration The next available option within the Configuration Mode (S) is activation of the Smart Assist system (SA). Pressing the OK key and the Plus or Minus keys can be activated (y) or deactivated (n). In the example, SA is activated (y). Once activated or deactivated, confirm with OK.

  • Page 33: Setting The Time At Which The Alarm Of Disconnection Or Apnea Should Be Activated

    6.8.4. Setting the time at which the alarm of disconnection or apnea should be activated The next available option within the Configuration Mode (S) is setting the time at which the alarm of disconnection or apnea should be activated (At). Pressing the OK key, the letter t and below the programmed time in seconds are displayed.

  • Page 34: Configuration Of Safety Flow For Disconnection Or Apnea

    (S) is the activation of a security flow for apnea (AF). Being this option activated, during an alarm for apnea OXYMO supplies pulses of oxygen, reaching a flow of 2 L/min, until the alarm is deactivated or the device switched off. If the alarm is silenced (by the keyboard), but inspirations still not detected, the security flow is not interrupted.

  • Page 35: Configuration Of Automated Power-Off

    Mode (S) is Auto power-Off (AO). Being this function activated, when an alarm for apnea or disconnection is not activated in 5 minutes, OXYMO interprets it is not dealing with an apnea but a disconnection (patient has taken off the nasal cannula forgetting to switch off the unit).

  • Page 36: Operating Modes

    It does not release oxygen nor require be connected to the oxygen supply. User get access to this mode by the software OXYMO-SW or by the keyboard, taking the equivalent flow to zero (0) To change to Conserver Mode simply increase the equivalent flow pressing the Plus button.

  • Page 37: Setting The Equivalent Flow

    CAUTION The equivalence between bolus and continuous flow is approximate. It is recommended to adjust the equivalent flow required by each patient monitoring their pulsioximetry. 6.9.3. Setting the equivalent flow Equiv It can be adjusted within 0,5 and 7,5 L/min To increase or decrease the oxygen flow, press Plus or Minus buttons.

  • Page 38: Setting The Trigger

    NOTE Taking the equivalent flow to 0 L/min, OXYMO only performs monitor tasks (Respiratory Monitor Mode). It does not release oxygen nor require be connected to the oxygen supply. 6.9.4. Setting the trigger During regular operation, the screen shows the...
  • Page 39 To go out of the trigger adjustment menu, it must be pressed Trigger button once more. After 10 seconds of inactivity, the unit goes out the trigger adjustment menu automatically. NOTE Keeping the trigger button pressed it will be visible on the screen the current trigger level instead of the equivalent flow, even with the keypad locked...

  • Page 40: Alarms

    LARMS OXYMO includes systems for detection of the main events that affect the regular operation of device or the regular behaviour of patient. To avoid risks, as soon as one of these events is detected, an alarm will be activated.

  • Page 41: Low Battery Alarm

    7.1. LOW BATTERY ALARM OXYMO allows different power modes. When the unit is battery-powered, a symbol will appear on the lower left-side corner of screen, indicating battery level. This symbol is composed of 3 bars that show an approximate level of charge.

  • Page 42: Low Opressure Supply Alarm

    Disconnected from unit. Out of coanas. • Clogged or folded. • Too long (> 2 metres). • CAUTION . The cannula whose intranasal orifices are too small may not register properly inspiratory vacuum and no activate the trigger. HERSILL advise flare-tipped cannula.

  • Page 43: Power Supply

    With a power supply (AC 100-240 V, 45/65 Hz) connecting the power adapter to the power connector of OXYMO (See Chapter If battery powered, OXYMO is a totally portable unit. With a couple of rechargeable NiMH batteries the operating time is 80 hours on average.

  • Page 44: Rechargeable Batteries Feeding

    8.1. RECHARGEABLE BATTERIES FEEDING OXYMO includes an internal system for recharging NiMH technology batteries. To recharge them only connect the power adapter to the power connector of OXYMO (See Chapter ). They will be recharged whether the unit is switched on or off. Before using the unit, batteries shall be fully charged;...

  • Page 45: Change Batteries

    Though not used, batteries get discharged slowly. If discharged, their capacity for recharging is reduced. Recharge every 3 months, though not used. OXYMO charge batteries in a progressive way and by cycles (quick, slow and maintenance charging). This way NiMH batteries life and their capacity are extended.

  • Page 46: Power Supply Feeding

    8.3. POWER SUPPLY FEEDING OXYMO can operate when connected directly to the power supply (100- 240V , 45/65 Hz), using the provided power adapter (See Chapter Depending whether or not batteries are installed, and if they are or not rechargeable, 2 operating modes are available from the power supply: If unit provided with rechargeable batteries, they will automatically be recharged.

  • Page 47: Oxygen Source

    P-300 and the OXYMO P-15 MICRO regulator (See Chapter Once both regulators are connected to an oxygen cylinder, connect directly the spiral hose to the outlet of the OXYMO P-15 MICRO regulator and to the oxygen inlet connector of OXYMO. NOTE...

  • Page 48: Low Pressure Oxygen Pipeline (Hospital)

    9.2. LOW PRESSURE OXYGEN PIPELINE (HOSPITAL) OXYMO can be operated with piped low pressure oxygen as long as it meets the following requirements: Pressure within the piped oxygen supply system ranging between 2.8 to 7 bars. Capacity to supply higher flow rates than 100 L/min.

  • Page 49: Liquid Oxygen

    9.3. LIQUID OXYGEN OXYMO can be operated with a tank of liquid oxygen (LOX) as long as it meets the following requirements: Oxygen outlet pressure of 1.5 ± 0,15 bar. Oxygen flow rate higher than 6 L/min. A hose barbed outlet that allows to connect a tube of 5 mm inner diameter.

  • Page 50: Software Oxymo-Sw

    11. S OFTWARE OXYMO OXYMO can communicate through its mini-USB port to a computer PC which ® has installed OXYMO-SW for Windows OXYMO-SW allows: To configure or change settings To erase the memory To download the stored data To perform a graphical and statistical analysis of data downloaded If the keyboard is not blocked, 1 and 2 can also be made from the keyboard.

  • Page 51: Spare Parts And Accessories

    12. S PARE PARTS AND ACCESSORIES OXYMO P-15 MICRO Ref.: 4550609 Regulator Ref.: 4550617 (DIN) Ref.: 4550614 (NF) OXYMO P-15 Ref.: 4550613 (BS) Regulator Ref.: 4550611 (AGA) * Consult for further options Ref.: 5501041 (DIN) Ref.: 5501011 (NF) P-300 P40 DISS Ref.: 5501021 (BS)

  • Page 52: Troubleshooting

    Connect the adapter to the network supply Disconnect the nasal cannula and The unit won’t turn the spiral hose from OXYMO and on ( See Chapter connect the adapter for a continuous flow instead. 2. The unit is This way, a continuous oxygen...
  • Page 53 (See Chapter 7.3) of the patient (See Chapter Do not use a nasal cannula more than 2 meters long Replace OXYMO for the 3 L/min continuous flow accessory...
  • Page 54 Chapter 7.2) 4. The oxygen the oxygen flow. If not possible, outlet connector in call the technical service or your OXYMO is clogged oxygen provider Disconnect the power supply (battery, mains or USB) for more 1. Power failure than 30 seconds.

  • Page 55: Maintenance, Storage And Removal

    14. M AINTENANCE STORAGE AND REMOVAL 14.1. MAINTENANCE It is recommended maintenance by qualified and/or authorized personnel at least every 5 years, just apart from checking if any operating problem is detected. Check the cylinder pressure periodically (manometer) to make sure it is with enough charge.

  • Page 56: Warranty

    15. W ARRANTY HERSILL guarantees the buyer this device is free from defects in components and manpower for a period of 2 YEARS from date of acquisition. The warranty does not cover damage in the device due to improper use,...

  • Page 57: Quality Standards

    16. Q UALITY STANDARDS OXYMO meets quality standards EN 60601-1-1, EN 60601-1-2, EN 60601-1- 6, EN 62366, EN 60601-1-11, EN 62304, EN 60601-1-8, ISO 10524-4, ISO 15001, ISO 14971, EN 1041, ISO 15223 16.1. ELECTROMAGNETIC STANDARDS Guidance and manufacturer's declaration – Electromagnetic emissions The Product is intended for use in the electromagnetic environment described below.
  • Page 58 Guidance and manufacturer's declaration – Electromagnetic immunity The Product is intended for use in the electromagnetic environment described below. The customer or the user of the Product should assure that it is used in such an environment. IEC 60601 Test Immunity Tests Compliance Level Electromagnetic Environment - Guidance...
  • Page 59 Guidance and manufacturer's declaration – Electromagnetic immunity for not life support equipment The Product is intended for use in an electromagnetic environment described below. The customer or user of the Product should assure that it is used in such an environment. IEC 60601 Test Electromagnetic Environment - Immunity Tests...
  • Page 60 Recommended separation distances between portable and mobile RF communications equipment and the not life support equipment. The Product is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the Product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Product as recommended below, according to the maximum output power of the communications equipment.
  • Page 61 NOTES...
  • Page 62 NOTES...
  • Page 63 HERSILL reserves the right to modify its device and user guides without prior notification. ® OXYMO is a registered trademark of HERSILL S.L. ® Windows is a registered trademark of Microsoft Corporation. Manufacturer: HERSILL, S.L. – Puerto de Navacerrada 3, 28935, Móstoles, Madrid, Spain...
  • Page 64 www.hersill.com...

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