PM35MN01-RR

Indications, Safety, and WarningsWarnings

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.

Patient monitoring via a network connected to the monitor is intended to supplement and not replace any part of the hospital’s device monitoring. Do not rely on remote patient monitoring as the sole source of patient data. To assure a timely response to changes in patient status, a clinician must be within the visual and/or audible range of the monitoring device. To provide medical intervention, a clinician must interact with the device at the bedside.

The monitor should not be used as an apnea monitor.

The monitor should be considered an early warning device. As a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory cooximeter to completely understand the patient’s condition.

To ensure patient safety, do not place the monitor in any position that might cause it to fall on the patient. If the monitor is mounted, ensure that it is securely mounted.

Carefully route patient cabling (SpO₂ sensor and sampling line) to reduce the possibility of patient entanglement or strangulation.

Do not lift the monitor by the SpO₂ sensor cable or sampling line, as they could disconnect from the monitor, causing the monitor to fall on the patient.

Do not obstruct the monitor so that the visual alarm indicators cannot be seen, or the audio alarm indicators cannot be heard.

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.

Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

All cables and tubing, including SpO₂sensors and CO₂ sampling lines, should be kept clear of the defibrillator and its electrodes, and should not run between, adjacent to, or overlapping the electrodes and the electrode wires, to reduce potential interference between the monitor and defibrillation equipment.

All SpO₂ sensors must be completely intact and undamaged, in order to enable use of a defibrillator with the monitor. Re-use of single-use accessories could pose a cross-contamination risk to the patient or damage the functioning of the monitor.

CO₂ readings, respiratory rate, pulse oximetry readings, and pulse signals can be affected by sensor application errors, certain ambient environmental conditions, including electromagnetic interference, and certain patient conditions.

The monitor is a prescription device and is to be operated by qualified healthcare personnel only.

No modification of this equipment is allowed.

If calibration does not take place as instructed in the relevant service manual, the monitor may be out of calibration. A monitor that is out of calibration may provide inaccurate results.

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

The device is not sterile. Do not autoclave or sterilize this device.

Do not transport damaged or defective lithium cells and batteries via air transport.

Charge the monitor fully before your first use of the monitor, by attaching the monitor to AC power with the removable battery installed. See chapter 3.2.5, "Battery and AC Connections Indicators" on page 72 of the instructions for use for more information.

The unit should always be operated with the removable battery installed in order to provide back-up power in the event of a momentary or temporary power outage.

The characteristics of a breath are calculated differently for the different patient types. Setting the correct patient type is therefore very important. Incorrect setting will result in inaccurate monitoring of the patient’s respiration and could lead to incorrect alarm limits or produce incorrect patient Integrated Pulmonary Index® (IPI) data.

Changing the institutional default settings might adversely affect the monitoring of patients. Changes to the institutional settings must only be made by authorized personnel.

Caution: Storage or transport of the monitor under environmental conditions beyond those mentioned in the specification will affect monitor performance and damage the monitor.

Note: Temperature sensors will turn the monitor off when it exceeds the permitted temperature.

Note: Dispose of calibration gases according to local regulations for disposal of gases.

Note: Any serious incident related to device use that may occur should be reported immediately to the manufacturer, the local authority, and any other regulators as required.

Devices connected to the monitor must be medical grade only. The accurate display of the following parameters is required in order to fill the essential performance of the monitor: carbon dioxide levels in expired breath (CO₂) when monitoring with capnography, and arterial oxygen saturation of blood (SpO₂) and pulse rate when monitoring with pulse oximetry. If the patient is being monitored with both functions, all of these parameters will be displayed. If the patient is being monitored with either or both functions, alarm volume is included in the monitor’s essential performance.

MRI scanning

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, the VitaLine™ H set infant/neonatal set, or any of the Microstream™ Advance neonatal-infant intubated CO₂ filter line extended duration products during magnetic resonance imaging (MRI) scanning. Using these products 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, EtCO₂monitoring can be implemented using the FilterLine™ XL or the MRI XL sampling line. See chapers 4.10.5 "Monitoring CO₂during MRI Scanning" on page 106 of the instructions for use.

Caution: Use of a CO₂sampling line with H in its name (indicating that it is for use in humidified environments) during MRI scanning may cause artefacts on the MRI image. The use of non-H sampling lines is advised. For a list of sampling lines, see chaper 8.1 "Microstream™ EtCO₂ Consumables" on page 263 of the instructions for use.

Alarms

Do not silence, pause, or decrease the volume of the audible alarm if patient safety may be compromised.

Do not pause or turn off the audible alarms until you verify that the patient is being monitored by other means, such as direct observation.

Do not decrease the volume of the audible alarm to a level that is less than the ambient sound level. Doing so might impede operator recognition of the audible alarm, which might lead to patient harm during an alarm situation.

Always respond immediately to a device alarm since the patient may not be monitored during certain technical/caution alarm conditions.

Before each use, verify that the alarm enabled/disabled status and the alarm limits are appropriate for the patient being monitored.

Do not set alarm limits to extreme values that render the monitoring system ineffective. Ensure alarm limits are appropriate for each patient.

Do not preset different or inappropriate alarm limits for the same or similar equipment in any single area since this may compromise patient safety.

Remote alarm generation is intended to supplement and not replace any part of the hospital’s device monitoring. Do not rely on remote alarms as the sole source of alarms. To assure a timely response to device alarms, a clinician must be within visual and/or audible range of the alarming device. To provide medical intervention, a clinician must interact with the device at the bedside.

Consider the following when setting delays on alarms that are being viewed with a remote alarm system: Connected devices report data to the application periodically, not continuously. Because of this, as well as delays caused by network bandwidth or hardware limitations or network loading, the true duration of any device alarm will be longer than the delay set in this screen for that alarm. Carefully consider these factors when choosing delay settings and use the shortest delay settings that are practical to reduce nuisance alarms, to avoid undue delay in response to events actually requiring direct clinical intervention.

Fire hazard

When using the monitor with anesthetics, nitrous oxide, or high concentrations of oxygen, connect the gas outlet to a scavenger system.

The monitor is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.

The sampling line may ignite in the presence of O₂ when directly exposed to laser, ESU devices, or high heat. When performing head and neck procedures involving laser, electrosurgical devices or high heat, use these devices with caution to prevent flammability of the sampling line or surrounding surgical drapes.

Recharge the removable battery pack only in the monitor or the external battery charger (reference 8.2 Available Accessories on page 270) to avoid possible heating, burning, or rupture of the battery pack.

The battery used in this device may present a risk of fire or chemical burn if mistreated. Do not disassemble, operate the monitor beyond its environmental specifications (reference 10.9 General Characteristics on page 286), or incinerate. Replace battery with Medtronic PN PM35BTY only. Use of another battery or a refurbished battery may present a risk of fire or explosion.

Replace the battery according to instructions. Dispose of the used battery promptly. Keep away from children. Do not open or short circuit the battery. Misuse may cause battery to ignite, explode, leak or get hot, causing personal injury. See chapers 1.2.5. "Electrical" in the instructions for use.

To protect against electric shock hazard, the monitor’s cover is to be removed only by qualified service personnel. There are no user-serviceable parts inside.

To ensure patient electrical isolation, connect only to other equipment with circuits that are electrically isolated.

Do not connect the monitor to a power supply other than that supplied with the monitor.

To avoid the risk of electric shock, the monitor must be connected only to a supply main with protective earth.

Connect the monitor only to a hospital grade receptacle. The plug must be inserted into a properly wired receptacle; if a properly wired receptacle is not available, a qualified electrician must install one in accordance with the governing electrical code. Do not use extension cords or adapters of any type. The power cord and plug must be intact and undamaged.

Do not connect to an electrical outlet controlled by a wall switch or a dimmer. Measure the monitor’s leakage current whenever an external device is connected to the serial port. Leakage current must not exceed 100 microamperes.

Protection of the monitor against the effects of the discharge of a cardiac defibrillator is dependent upon the use of appropriate SpO₂ cables and sensors listed in table 7 (Nellcor™ SpO₂ Sensor Models and Patient Sizes on page 124).

Any USB device (excluding a flash memory drive) or PC connected to the monitor must be running on a battery or an IEC 60601-1 compliant power supply (Clause 16, ME Systems), or a IEC 60601-1 compliant isolation transformer (Clause 16, ME systems).

All signal input and output (I/O) connectors are intended for connection of devices complying with Clause 16, ME Systems, of IEC 60601-1 only. Connecting additional devices to the monitor may increase chassis or patient leakage currents. To maintain operator and patient safety, consider the requirements of Clause 16, ME Systems, of IEC 60601-1. Measure the leakage currents to confirm that no electric shock hazard exists.

Electrical installation of the room or the building in which the monitor is to be used must comply with regulations specified by the country in which the equipment is to be used.

Keep the power cord, plug, and socket clear in case an urgent power supply disconnection is required (1.2.6. Electro magnetic Interference). This monitor has been tested and found to comply with the requirements for medical devices according to the standard IEC 60601-1-2. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio frequency (RF) transmitting equipment and other sources of electrical noise in healthcare environments (for example: cellular phones, mobile two–way radios, electrical appliances), it is possible that high levels of such interference due to proximity or strength of a source may result in disruption of performance of this device.

Operating high frequency electrosurgical equipment in the vicinity of the monitor can produce interference in the monitor and cause incorrect measurements. Do not use the monitor with nuclear spin tomography (MRT, NMR, NMT) as the function of the monitor may be disturbed.

EMI disruption can cause erratic readings, cessation of operation, or other incorrect functioning.

The monitoring system is intended for use by healthcare professionals only. It may cause radio interference or may disrupt the operation of nearby equipment. Mitigation for such disruption may require re-orienting or relocating the monitoring system or shielding the location.

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 this monitor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result (1.2.7. Connectivity).

Ensure the security of a Wi-Fi network before connecting the device to the network; connection to an unsecure network may endanger patient data. Access of unauthorized personnel through an unsecure network may result in patient risk.

Use the appropriate configuration information to ensure proper connectivity.

If there are changes to the network with which you are connecting the device, verify that changes are reflected in the device to ensure connectivity.

The Capnostream™ 35 monitor has been approved for use with the Vital Sync™ system. Use with hospital data systems other than the Vital Sync™ system is under the user’s responsibility.

Only use Medtronic-approved hardware or remote monitoring software for data port connectivity.

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