3
4
LIFE2000 VENTILATION SYSTEM INTRODUCTION
1
LIFE2000 VENTILATION SYSTEM INTRODUCTION
1
CAUTION:
• No user serviceable components are inside the device; do not attempt to repair any components inside
the device.
• Do not place the battery charger on wet surfaces or use in wet environments. Wet environments may
damage the battery charger and may cause electric shock.
• Use only the approved battery charger and cord set with the ventilation system. If an unauthorized battery
charger or cord set is used with the ventilation system the system may be damaged.
• The compressor's power supply must be certified to IEC 60601-1, IEC 60601-1-11, and be Class II and IP22.
• If using in Extended Range or Stand-Alone Configuration (wearable configurations), make sure the clip
is securely fastened to the belt and the ventilator. If the clip is not securely fastened to the belt or the
ventilator, the ventilator may fall and be damaged.
• If using in Extended Range or Stand-Alone Configuration (wearable configurations), secure the ventilator to
prevent it from falling or becoming damaged.
• A recommended 90-day replacement schedule for the Universal Circuit
®
Connector and the Breathe
Pillows Entrainment Interface.
• Do not use a Breathe Pillows Entrainment Interface or Universal Circuit
®
Connector that is cracked,
odorous, broken, or kinked. If a damaged interface is used, the patient may not receive adequate
respiratory therapy.
• 70% isopropyl alcohol may damage the touch screen. When cleaning external surfaces of the ventilation
system with 70% isopropyl alcohol, avoid contact with the touch screen.
• Keep in a clean environment to protect the equipment from ingress of dust, lint, and pests.
• Do not leave the ventilation system exposed to the sun or other sources of radiant heat, it may overheat.
• Do not allow children or pets to access the ventilation system; it may become damaged.
• The performance of the Life2000® Compressor has only been validated with the Life2000® Ventilator.
• Do not connect another device to the outlet fitting on the compressor when the ventilation system is in
Stationary Configuration.
• Do not connect the purge tube connector to the outlet fitting on the compressor while the ventilation
system is in Stationary Configuration and in use.
• Using the outlet fitting while the ventilation system is delivering therapy in Stationary Configuration might
decrease flow to the patient.
• The Life2000
®
Ventilation System provides high flows up to 40 LPM which may cause drying of the airway
passages. Alert the physician if the patient experiences air passageway drying.
• The ventilator settings might not be achieved when sourced by the Life2000® Compressor when used
at altitudes near or above 2500 feet, in high temperature, or in high humidity. If the ventilator settings
cannot be achieved the patient may not receive adequate respiratory therapy and you should switch to an
alternate means of ventilation.
• Follow local regulations and NFPA 55 in the handling and use of oxygen cylinders.
WARNING:
• For any accessories, read the label and accompanying document(s) before use.
• Use only approved accessories and replacement parts with the ventilation system. If unauthorized
accessories or replacement parts are used with the system, the ventilation system may be damaged and
performance may be degraded.
• Do not connect the ventilation system components or accessories to any other equipment that is not
described in this
Instructions for Use
.
• Adding attachments or other components and/or sub-assemblies to the ventilator breathing system can
cause an increase in expiratory resistance at the patient connection.
• Adding humidification or nebulization can increase the resistance of the breathing circuit. The operator of
the ventilation system needs to monitor the breathing system for increased resistance and blockage.
• Ventilator accuracy can be affected by the gas added by use of a nebulizer.
• To ensure accuracy of oxygen administration and to monitor for the presence of contamination (incorrect
gas connected), use an external oxygen monitor to verify the oxygen concentration in the delivered gas.
• To monitor minute volume, use an external exhaled volume monitor.
• Before beginning ventilation therapy in Stand-Alone Configuration, verify that there is an adequate supply
of source gas supply for the intended duration of the therapy. Otherwise, the patient may not receive
appropriate therapy.
• Use only a Life2000
®
source gas supply hose with the ventilation system. If an unauthorized source gas
supply hose is used with the ventilation system, the system may be damaged.
• Only use the ventilator with the compressor or approved medical grade compressed oxygen. Use with
non-approved sources of gas may cause the ventilator to malfunction and the patient may not receive
appropriate respiratory therapy.
• If using the ventilator with an alternate gas source in Stand-Alone Configuration, and the ventilator is not
used with a regulator capable of 41 PSI to 87 PSI (nominal 50 PSI) with greater than 40 LPM capability,
patients may not receive appropriate respiratory therapy.
• To prevent risk of cross-contamination, clean and disinfect the ventilation system before using it on a new
patient, and use a new Breathe Pillows Entrainment Interface or Universal Circuit
®
Connector. For the third-
party patient mask, refer to the user guide provided by the manufacturer. Replace the oxygen hose between
patients.
• Breathe interfaces are designed for single-patient use. To prevent risk of cross-contamination use a new
Breathe Pillows Entrainment Interface or Universal Circuit
®
Connector for each new patient. For third-party
masks or tubes, refer to the user guide provided by the manufacturer for replacement and/or cleaning and
disinfection instructions.
• Do not subject Breathe interfaces or source gas supply hoses to heat sterilization, hot water pasteurization,
autoclaving, radiation sterilization, ethylene oxide gas sterilization, or attempt to clean them in a dishwasher
or microwave oven. Doing any of these may damage the interfaces or hoses and impair gas delivery.
• If using the Breathe Pillows Entrainment Interface, properly secure the patient interface to the face and
route tubing around the ears to avoid strangulation.
• The interface, source gas supply hose, and power cords should be positioned to avoid restricting
movement, causing a tripping hazard, or posing a strangulation risk.
• Do not cover or block the compressor’s internal alarm buzzer with any object. Covering the buzzer may
make it difficult for a patient or caregiver to hear alarms, which may result in inadequate respiratory therapy.
• Do not cover the ventilator, touch screen, speaker, or backup alarm buzzer with tape or any other object.
Covering the ventilator or any of its parts might cause difficulty in hearing alarms and might affect ventilator
performance.
WARNING:
• Ensure that the alarm loudness is set above the loudness of your surroundings.
• If upgrading software from version 05.11.00 to 05.12.00 re-evaluate the ventilator settings if PEEP is applied.
• If upgrading a patient ventilator from ventilator REF MS-01-0100 to ventilator REF MS-01-0118 re-evaluate
ventilator settings if PEEP is applied.