RPAYQSKIEC01

Indications, Safety, and WarningsWarnings

Intended use: Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under “intended use.” Strictly observe all warning and precaution statements throughout these instructions for use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

Do not use any monitoring system, sensor, cable, connector, or screen that appears damaged. Remove any damaged equipment from service for inspection by a qualified service technician.

Explosion hazard: Do not use the device in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur.

Shock hazard: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Never adapt the three-prong plug from the monitor to fit a two-slot outlet.

Do not come into contact with the patient, table, or the monitor during defibrillation.

The simultaneous use of a cardiac pacemaker or other electrical stimulators may cause safety hazard.

Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason, make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

Extreme care must be exercised when applying medical electrical equipment. Many parts of the human/machine circuit are conductive, such as the patient, connectors, electrodes, transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the isolated patient input of the device. Such contact would bridge the patient’s isolation and cancel the protection provided by the isolated input. There must be no contact of the neutral electrode and ground.

Route all cables carefully to avoid possible entanglement, strangulation, or electrical interference.

Devices connecting with a monitor should be equipotential.

If the protective grounding (protective earth) system is doubtful, the monitor must be supplied by internal power only.

Do not rely exclusively on the auditory alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.

Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g., IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore, all configurations shall comply with the valid version of the standard IEC/EN 60601-1. Therefore, anybody who connects additional equipment to the signal input or output connector to configure a medical system must make sure that it complies with the requirements of the valid version of the system standard IEC/EN 60601-1. If in doubt, consult our technical service department or your local distributor.

The monitor is equipped with wireless AP/Wi-Fi to receive RF electromagnetic energy. Therefore, any other equipment complying with CISPR radiation requirements may also interfere with the wireless communication and make it interrupted.

Only patient cable and other accessories recommended by the manufacturer can be used. The performance and electric shock protection cannot be guaranteed, and the patient may be injured otherwise. Prior to use, check if the casing of a disposable or sterilized accessory is intact. Do not use it if its casing is damaged.

When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients.

If several items of medical equipment are interconnected, pay attention to the sum of the leakage currents; otherwise, it may cause shock hazard. Consult your service personnel.

Keep away from fire immediately when leakage or foul odor is detected.

Wireless LAN equipment contains an intentional RF radiator that has the potential of interfering with other medical equipment, including patient implanted devices. Be sure to perform the electromagnetic compatibility test before installation and any time new medical equipment is added to the wireless LAN coverage area.

Clinical decision making based on the output of the device is left to the discretion of the provider. The equipment should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. If uncertain about the accuracy of any measurement, first check the patient’s vital signs by alternate means, and then make sure the monitor is functioning correctly

This equipment is not intended for home use.

Do not perform service or maintenance on the device or any accessory while it is in use.

The appliance coupler or mains plug is used as an isolation means from supply mains. Position the monitor in a location where the operator can easily access the disconnection device.

Assembly of the monitor and modifications during actual service life shall be evaluated based on the requirements of IEC60601-1.

The monitors are not intended for use in an MRI environment.

Only batteries recommended by the manufacturer shall be used for the monitor.

Additional multiple socket-outlets or extension cords cannot be connected to the system.

Only items that have been specified as part of the system or specified as being compatible with the system can be connected to the system.

Connecting any accessory (such as external printer) or other device (such as the computer) to this monitor makes the monitor and connected devices a medical system. In that case, additional safety measures should be taken during installation of the system.

All the accessories connected to system must be installed outside the patient vicinity if they do not meet the requirement of IEC/EN 60601-1.

Portable and mobile RF communications equipment can affect medical electrical equipment.

Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the monitoring equipment.

The monitor should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the monitor shall be observed to verify normal operation in the configuration in which it will be used.

Do not touch accessible parts of medical or non-medical electrical equipment in the patient environment and the patient simultaneously. Such parts include a USB connector or other signal input/output connectors.

Shock hazard: Do not connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlet supplying the system.

Shock hazard: Do not connect electrical equipment supplied as a part of the system directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer.

Operation of equipment exceeding specified physiological signal, or the operational specification may cause inaccurate results.

The equipment can provide protective means to prevent the patient from being burned when used with HF surgical equipment. The equipment can protect against the effects of the discharge of a defibrillator. Use only accessories approved by the manufacturer.

When the monitor is used with HF surgical equipment, the transducer and the cables must be avoided from conductive connection to the HF equipment. This is to protect against burns to the patient.

Use only accessories specified by the manufacturer to protect the monitor from damage during defibrillation, use for accurate measurement information, and to protect against noise and other interference,

No modification of this equipment is allowed without authorization of the manufacturer.

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the monitor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

The monitor is suitable for use in the presence of electrosurgery. When the monitor is used with HF surgical equipment, the user (doctor or nurse) should be cautious about patient safety.

Make sure networking function is used in a secure network environment.

To avoid unacceptable risks, ensure that the monitor is supplied with a continuous power source during operation.

Do not touch the system components. Otherwise, patient injury may result.

Do not use oximetry sensors during magnetic resonance imaging (MRI) scanning. Conducted current could cause burns. The sensors may affect the MRI image, and the MRI unit may affect the accuracy of oximetry measurements.

Do not use the FilterLine™ H set infant/neonatal set or the VitaLine™ H set infant/neonatal set during magnetic resonance imaging (MRI) scanning. Using the FilterLine™ H set infant/neonatal set during MRI scanning could harm the patient.

During MRI scanning, the monitor must be placed outside the MRI suite. When the monitor is used outside the MRI suite, etCO₂ monitoring can be implemented using the FilterLine™ XL sampling line.

Precautions

The packaging is to be disposed of according to local or institutional regulations in order to avoid environmental contamination. Store the packaging out of reach of children.

The device and accessories are to be disposed of according to local regulations. Alternatively, it can be returned to the manufacturer for recycling or proper disposal.

Batteries are hazardous waste. Do not dispose of it together with household garbage. At the end of their life, hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, please contact your local municipal office or the establishment where you purchased the product.

Use of a carbon dioxide (CO₂) sampling line with H in its name (indicating that it is for use in humidified environments) during MRI scanning may cause artifacts on the MRI image. The use of non-H sampling lines is advised.

Some settings are password protected. Password should only be changed by authorized personnel. Contact the relevant personnel of the medical institution for a password to these features.

Ensure that the monitor is supplied with continuous electric power during operation from the main source power or batteries. Sudden power failure may cause failure to monitor parameters.

Electromagnetic Interference: Ensure that the environment in which the patient monitor is installed is not subject to any sources of strong electromagnetic interference, such as radio transmitters, mobile telephones, microwaves, etc.

Keep the environment clean. Avoid vibration. Keep it far away from corrosive medicine, dusty areas, high temperatures, and humid environments.

Do not use autoclave or gas to sterilize the monitor or any accessories.

The ingress protection of the monitor is IP22. Do not spray, pour, or spill any liquid on the monitor, its accessories, connectors, switches, or openings, since this may cause damage to the monitor. If liquid gets on or in the monitor, please contact the service personnel of the manufacturer.

To ensure patient safety, use only parts and accessories manufactured or recommended by the manufacturer.

Before connecting the monitor to the AC power, make sure the voltage and the power frequency are consistent with the requirements indicated on the device label.

Protect the device against mechanical damage resulting from falls, impacts, and vibration.

Do not touch the touch screen with a sharp object.

The device must be connected to the ground to avoid signal interference.

Poor contact might be caused by frequently plugging and unplugging the power cord. Check the power cord regularly and replace it as needed.

To protect eyes from damage, do not look directly into the barcode scanner’s light for long periods of time.

Additional notes

In case of a temporary power interruption, if the power is restored, monitoring will resume with all active settings unchanged.

Position the device in a location where the operator can easily see the screen and access the operating controls.

The monitor can only be used on one patient at a time.

Regular preventive maintenance should be carried out every two years. The purchasers are responsible for any requirements specific to their country.

When there is measurement beyond range, an invalid measurement or no measurement value, a “- -” will be displayed.

In normal use, the operator shall stand in front of the monitor.

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