Continuous patient monitoring

RespArray™ patient monitor

The RespArray™ patient monitor can help continuously monitor SpO₂, etCO₂, ECG, and temperature, measure NiBP, and connect wirelessly to EMR via HL7.

Ordering information

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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.

Features

Simplification: smart, connected, and intuitive

The RespArray™ patient monitor features simple connectivity and seamlessly integrates into workflow. You’ll have more time to focus on your patients.

Includes an HL7 interface, is WiFi-enabled, connects to your EMR and Vital Sync™ remote patient monitoring system — giving you more visibility, wherever you are
Features a large, intuitive touchscreen you can see from multiple angles and from a distance

96%
On average, medical-surgical registered nurses spend 96% of their shift away from the patient’s bedside.¹

Download EMR Connect information sheet (open in new window)

This is an image of the RespArray™ patient monitor being used by a medical professional.

Patient safety: manage risk — and alarms

Experience world-class Nellcor™ pulse oximetry and Microstream™ capnography technologies, designed to detect respiratory compromise early — and help reduce alarm fatigue.

See trends with near real-time monitoring so you can get to your patients sooner.
Patient monitor includes SpO₂ (Nellcor™ pulse oximetry) and EtCO₂ (Microstream™ capnography) proprietary algorithms, plus ECG, NiBP, and continuous and spot check (optional) temperature monitoring.

53%
The Smart Alarm for Respiratory Analysis™ (SARA) in Microstream™ technology reduces unnecessary nuisance alarms by 53%.²

View an image of a male patient lying in a hospital bed being monitored by a patient monitoring system.

Support: continuous monitoring, continuous support

Your dedicated white-glove service team is with you every step of the way. Customizable plans and service options are tailored to fit your needs.

Get optimal value with next-level support, education, and training that more effectively reduces adverse events and enables your team to deliver exceptional patient care.
Your Medtronic team includes tenured nursing professionals, respiratory therapists, informatics experts, and engineers. They have the background, experience, and knowledge to understand your challenges and optimally implement the monitor within your workflow.

$535K
Average amount that continuous monitoring of high-risk patients may help a median-sized hospital save annually^†,3

View solution delivery service brochure (open in new window)

This is an image of three healthcare professionals in a meeting.

Frequently asked questions

The RespArray™ patient monitor has the following algorithms: Integrated Pulmonary Index™ algorithm, Nellcor™ SatSeconds technology, Apnea-Sat Alert™ algorithm (A/hr and ODI), Smart Breath Detection (SBD) algorithm, and Smart Alarm for Respiratory Analysis algorithm. CCHD is also included for the IEC-certified monitor.

The RespArray™ patient monitor includes MEWS (Modified Early Warning Scores), NEWS (National Early Warning Score), NEWS2 (National Early Warning Score 2), and PEWS (Pediatric Early Warning Score). Please consult the instructions for use (IFU) to select the desired score system.

The RespArray™ patient monitor uses a single tube (single lumen) blood pressure (BP) hose and is set up to receive one tube bayonet for both reusable and disposable cuffs.

When the RespArray™ patient monitor is integrated and connected with the Vital Sync™ system, you can generate an “apneas per hour” patient report. Clinicians may want to review apneas for patients in their unit to better understand their condition, make assessments on supplemental oxygen needs, or sleep study evaluations. This report could also be useful if an “apneas per hour” assessment is required for patient discharge.

Monitors with V 01.05.00.17 or later are compatible with the Nellcor™ Analytics Tool software, enabling SpO₂ and pulse rate data to be exported into an overnight desaturation report.

The RespArray™ patient monitor provides a dedicated nurse call port which can be connected to a nurse call system. The nurse call interface type is a PS2 connector. To activate the nurse call function, please consult the IFU.

You can export patient trend data onto a USB drive. The monitor also supports HL7 protocol to output data to HIS (hospital information systems) like EMR for patient record keeping, or the Vital Sync™ system for remote patient monitoring. Please refer to the IFU for details on how to export and upload data from the RespArray™ patient monitor.

No. The RespArray™ patient monitor does not contain an additional internal coin-cell battery along with the replaceable battery that comes standard with the monitor. If the replaceable battery is removed while being powered by battery only (no AC power), the monitor will completely shut down.

Item number	Description	Units per box
RESPARRAYAHA01	RespArray™ patient monitor — AHA (American Heart Association) version	1
RESPARRAYKITAHA	RespArray™ patient monitor bundle	1

Resources

RespArray™ monitor specifications information sheet

RespArray™ Monitor Specifications (open in new window)

View this one page information sheet for the RespArray™ patient monitor.

PRODUCT PDF 726 KB

RespArray™ Monitor Buttonology (open in new window)

View a one-page quick-start guide for the RespArray™ patient monitor.

EDUCATION AND TRAINING PDF 805 KB

RespArray™ Cleaning Guide (open in new window)

View the guide for maintaining and caring for the RespArray™ patient monitor.

EDUCATION AND TRAINING PDF 601 KB

RespArray™ patient monitor noninvasive blood pressure (NIBP) tips information sheet

RespArray™ Patient Monitor NIBP Tips Information Sheet (open in new window)

This guide serves as a reference for taking noninvasive blood pressure (NIBP) measurements and common types of oscillometric measurements.

EDUCATION AND TRAINING PDF 561 KB

RespArray™ monitor ECG placement information sheet

RespArray™ Monitor ECG Placement (open in new window)

View this reference guide for 3- and 5-lead ECG placement and a normal sinus rhythm ECG waveform.

EDUCATION AND TRAINING PDF 636 KB

RespArray™ Monitor Normal Vital Signs Information Sheet (open in new window)

This card serves as a reference for normal adult and pediatric vital sign ranges.

EDUCATION AND TRAINING PDF 437 KB

An etCO2 monitor calibration and maintenance information sheet

Microstream™ patient monitors calibration guide (open in new window)

View capnography monitor calibration information.

EDUCATION AND TRAINING PDF 768 KB

Guide: RespArray™ Patient Monitor Profile Management (open in new window)

Guide: RespArray™ Patient Monitor Profile Management

PRODUCT PDF 490 KB

Guide: RespArray™ Waveform Navigator (open in new window)

Guide: RespArray™ patient monitor waveform navigator

PRODUCT PDF 1 MB

In-service videos

Select a module below to watch an interactive video.

This is the initial still image for module 1 of the RespArray™ monitor hybrid eLearning video series.

Module 1: Why the RespArray™ patient monitor?

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This is the initial still image for module 2 of the RespArray™ monitor hybrid eLearning video series.

Module 2: Overview of the RespArray™ patient monitor

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This is the initial still image for module 3 of the RespArray™ monitor hybrid eLearning video series.

Module 3: RespArray™ patient monitor interface

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Module 4: RespArray™ patient monitor parameters

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This is the initial still image for module 5 of the RespArray™ monitor hybrid eLearning video series.

Module 5: RespArray™ patient monitor workflow overview

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This is the initial still image for module 6 of the RespArray™ monitor hybrid eLearning video series.

Module 6: Alarms and troubleshooting

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Ordering information

U.S., Canada, ANZ, and Latin America

Item number	Description	Units per box
RESPARRAYAHA01	RespArray™ patient monitor — AHA (American Heart Association) version	1
RESPARRAYKITAHA	RespArray™ patient monitor bundle	1

Europe, Middle East, Africa

Item number	Description	Units per box
RESPARRAYIEC01	RespArray™ patient monitor — IEC (International Electrotechnical Commission) version	1

Germany

Item number	Description	Units per box
RESPARRAY-KIT-DE1	RespArray™ patient monitor	1

France

Item number	Description	Units per box
RESPARRAY-KIT-FR1	RespArray™ patient monitor	1

Italy

Item number	Description	Units per box
RESPARRAY-KIT-IT1	RespArray™ patient monitor	1

Netherlands

Item number	Description	Units per box
RESPARRAY-KIT-NL1	RespArray™ patient monitor	1

Spain

Item number	Description	Units per box
RESPARRAY-KIT-SP1	RespArray™ patient monitor	1

† This assumes a 20% respiratory depression reduction and an annual general care floor volume of 2,447 patients receiving opioids per median-sized hospital. 90% of surgical patients and 45% of medical patients on U.S. general care floors receive opioids. Continuous pulse oximetry and capnography device pricing assumptions used list pricing for the following: a Capnostream™ 35 portable respiratory monitor prorated over seven years; a Microstream™ capnography filter line, and a disposable Nellcor™ pulse oximetry sensor, resulting in $52.73 in device costs per continuously monitored patient stay on a medical surgical floor. For intermittent pulse oximetry monitoring, device pricing consisted of a multiparameter monitor prorated over seven years and a reusable pulse oximetry sensor, resulting in $0.68 in device costs per patient stay. Additional information on pricing and assumptions are available in the study publication.

Hendrich A, Chow M, Skierczynski B, Lu Z. A 36-hospital time and motion study: how do medical-surgical nurses spend their time? Perm J. 2008;12(3):25–34.
Hockman S, Glembot T, Niebel K. Comparison of capnography derived respiratory rate alarm frequency using the SARA algorithm versus an established non-adaptive respiratory rate alarm management algorithm in bariatric surgical patients. Respir Care. 2009;54(11):1582.
Khanna AK, Junquist CR, Buhre W, Soto R, Di Piazza F, Saager L, et al. Modeling the cost savings of continuous pulse oximetry and capnography monitoring of United States general care floor patients receiving opioids based on the PRODIGY trial. Adv Ther. 2021;38(7):3745–3759.

RespArray™ patient monitor

Features