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The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for: 3 & 5 Lead ECG monitoring: 12 Lead ECG recording with interpretation: real-time arrhythmia detection / alarming: QT measurement / alarming and ST measurements / alarming; impedance pneumography; non-invasive blood pressure (NIBP); end-tidal CO2 (ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), methaemoglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) The monitor is intended to be used as a stand-alone monitor or as a telemedicine system measurements. (transmitting patient data to other medical professionals located elsewhere). The device is indicated for adults, paediatrics and neonates. The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz Small Parts / Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. These optional accessories are to be used in accordance with their Indications for Use.

The Tempus Pro is a multi-parameter vital signs monitoring system designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3 & 5 lead ECG recording, real-time arrhythmia detection & alarming, QT interval measurement & alarming, ST segment & alarming, impedance respiration, pulse oximetry (including Masimo Rainbow® co-oximetry measurements i.e. SpOC, SpHb, SpMet, SpCO, PVI and Pl), non-invasive blood pressure, sidestream capnometry, contact temperature, invasive pressure, and user configurable alarms. Third-party video laryngoscopes and ultrasound probes may also be connected to the device. In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a telemedicine software system expected to be based in a facility far from the user e.g. a response centre facility. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic position by an integrated GPS receiver, and voice via a wired or wireless headset. This submission is to notify the FDA of our intent to market the Tempus Pro modified by the addition of an optional thermal printer, which enables the user of a Tempus Pro to print medical records on-demand. Additionally, compatible external devices may also print medical records on the Tempus Pro's optional thermal printer when paired to the Tempus Pro via a secure 1-to-1 data link called Tempus Data Link (TDL).

The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 & 5 Lead ECG monitoring and 12 Lead ECG recording, impedance pneumography, non-invasive blood pressure (NIBP), end-tidal CO2 (ETCO2) and respiration rate, pulse oximetry (SpO2), contact temperature and invasive pressure. The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere). The device is indicated for adults, paediatrics and neonates. The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz Small Parts / Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. These optional accessories are to be used in accordance with their Indications For Use.

The Tempus Pro is a multi-parameter vital signs monitor designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3&5 lead ECG monitoring, 12 lead ECG recording, pulse oximetry, non-invasive blood pressure, sidestream capnometry, contact temperature, impedance respiration, invasive pressure and user configurable alarms. In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a software system (called i2i) expected to be based in a facility far from the user e.q. a response centre facility. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic position by an integrated GPS receiver and voice via a wired or wireless headset.

The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 & 5 Lead ECG monitoring and 12 Lead ECG recording with interpretation, impedance pneumography, non-invasive blood pressure (NIBP), endtidal CO2 (ETCO2), respiration rate, pulse oximetry (SpO2), contact temperature, invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), metheglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) measurements. The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere). The device is indicated for adults, pediatrics and neonates.

The Tempus Pro is a multi-parameter vital signs monitor designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3&5 lead ECG monitoring, 12 lead ECG recording, pulse oximetry, non-invasive blood pressure, sidestream capnometry, contact temperature, impedance respiration, invasive pressure and user configurable alarms. In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a software system (called i2i) expected to be based in a facility far from the user e.g. a response centre facility. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic position by an integrated GP\$ receiver and voice via a wired or wireless headset.

The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 & 5 Lead ECG monitoring and 12 Lead ECG recording, impedance pneumography, noninvasive blood pressure (NIBP), end-tidal CO2 (ETCO2) and respiration rate, pulse oximetry (SpO2), contact temperature and invasive pressure. The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere). The device is indicated for adults, paediatrics and neonates.

The Tempus Pro is a multi-parameter vital signs monitor designed for use in prehospital care and remote clinical locations by trained healthcare professionals. It provides 3 & 5 Lead ECG monitoring and 12 Lead ECG recording, impedance pneumography, non-invasive blood pressure (NIBP), end-tidal CO2 (ETCO2) and respiration rate, pulse oximely (SpO2), contact temperature and invasive pressure .. In addition, it provides the ability to transmit all vital signs data via wired Ethernet or wireless WiFi connections to a software system (called i2i) expected to be based in a facility far from the user e.g. a response centre facility. In addition to sending all vital signs, the system can also capture and transmit other data including still or moving pictures via an integrated camera, geographic position by an integrated GPS receiver and voice via a wired or wireless headset.

Tempus IC is intended to aid with the diagnosis of a person presenting as unwell or sick when they are in a location remote from immediate medical assistance. The device allows the User to take vital signs data from a patient and to transmit that data to medical professionals located at the response centre elsewhere. Typical examples are remote land, sea or air locations. Tempus IC is intended primarily to be used by medically unqualified people who have received basic training in the use of the device. Medical expertise is provided through communication with the Response Centre which would be staffed by physicians who would advise the operator on the nature of the medical incident. Tempus IC is intended to be used where a physician or other medically trained staff may or may not be present but where remote physician support is required. Tempus IC measures non-invasive blood pressure, SpO2, pulse rate, respiration rate and ETCO2, 12 Lead ECG, tympanic temperature (via a wireless external module) and blood glucose (via a wireless external module). Tempus IC is suitable for use on adults or children (over 10 years old and over 20kg in weight).

The TempusIC™ is an advanced multi-parameter vital signs monitor designed for use in remote locations by trained non-expert users. It provides a wide range of features in a highly robust package, including integrated voice link and video camera. The device remains unchanged from its previous/existing clearance with the exception that the device is now capable of receiving (wirelessly over a Bluetooth™ link) both tympanic temperature readings from a tympanic thermometer (cleared under K101264) and blood glucose data from the Entra Health Systems MyGlucoHealth glucometer (cleared under K081703), Voice and data connections are made automatically via existing satellite or terrestrial communications systems. The TempusIC™ is used in conjunction with TempusNET™ software, which provides a system for receiving real-time voice and vital signs data. The system enables users to receive voice, vital signs data, and still video pictures from TempusICTM devices located anywhere in the world. The TempusNET™ system can be used by commercial response centre service providers or by individuals or organisations wishing to provide their own internal service. It also provides a synchronised user interface, and remote control of the TempusIC™. TempusNET™ also supports a full patient records database.

The Tempus IC Professional is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal CO2 (ETCO2), pulse oximetry (SpO2) and tympanic temperature. The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere). The ECG Harness.of the Tempus IC Professional is suitable for use on adults or children (over 10 years old and over 20kg in weight).

The Tempus IC Professional is a multi-parameter vital signs monitor designed for use in prehospital care and remote clinical locations by trained healthcare professionals e.g. nurse. EMT, paramedic, physician, army corpsman etc. It provides 3 lead ECG monitoring, 12 lead ECG recording, pulse Oximetry, non-invasive blood pressure, sidestream Capnometry, a tympanic thermometer and user configurable alarms. In addition, it provides the ability to transmit all vital signs data via wired or wireless Ethernet connections to a software system (called i2i) expected to be based in a facility far from the user e.g. a response centre facility. In addition to sending all vital signs, the system can also send pictures via an integrated camera, geographic position by an integrated GPS receiver and voice via a wired or wireless headset. The device is intended to be used primarily as a standalone monitor for traditional monitoring applications. It is expected that its real-time telemedicine capabilities will be used in a minority of applications. When its telemedicine features are used it is intended that this will be for the purpose of obtaining support in the diagnosis and treatment decisions for the patient e.g. where the patient is in a remote country and the user's organisation needs to make an extraction or repatriation decision. It is expected that the ability to transmit data in real-time will be performed in remote locations typically using satellite or terrestrial communications systems.

Tempus IC is intended to aid with the diagnosis of a person presenting as unwell or sick when they are in a location remote from immediate medical assistance. The device allows the User to take vital signs data from a patient and to transmit that data to medical professionals located at the response centre elsewhere. Typical examples are remote land, sea or air locations. Tempus IC is intended primarily to be used by medically unqualified people who have received basic training in the use of the device. Medical expertise is provided through communication with the Response Centre which would be staffed by physicians who would advise the operator on the nature of the medical incident. Tempus IC is intended to be used where a physician or other medically trained staff may or may not be present but where remote physician support is required. Tempus IC is suitable for use on adults or children (over 10 years old and over 20kg in weight).

The TempusIC™ is an advanced multi-parameter vital signs monitor designed for use in remote locations by trained non-expert users. It provides a wide range of features in a highly robust package, including integrated voice link and video camera. Voice and data connections are made automatically via existing satellite or terrestrial communications systems. The TempusIC™ is used in conjunction with TempusNET™ software, which provides a system for receiving real-time voice and vital signs data. The system enables users to receive voice, vital signs data, and still video pictures from TempusICTM devices located anywhere in the world. The TempusNET™ system can be used by commercial response centre service providers or by individuals or organisations wishing to provide their own internal service. It also provides a synchronised user interface, and remote control of the TempusIC™ TempusNET™ also supports a full patient records database.

The Tempus 2000 Patient Monitor System is intended to be used when a medical situation rises at a location remote from readily available medical expertise. Situations demanding use af the Tempus 2000 Patient Monitor System can occur at remote land locations on private yachts while sailing at considerable distances from land, and during flight on commercial /private iets as well as in other situations. The Tempus 2000 Patient Monitor is intended to be used by trained non-experts upon people rne rompac Lowell. It is designed with the most ease of use for the operator so that it can be prooming as alliably, with minimum training and with little or no support from medical staff. This allows the Tempus 2000 Patient Monitor to be used as either a stand-alone monitor or also connected to the Tempus Monitoring Station. In the latter mode, the Tempus 2000 Patient Monitor connects to a sister device, called the Tempus Monitoring Station, allowing the recorded data to be viewed, stored and manipulated by trained medical staff. The Tempus Monitoring Station is a normal, commercial grade PC which is dedicated to running the software that enables it to communicate with the Tempus 2000 Patient Monitor. The Tempus Monitoring Station is installed at a Response Centre (typically an emergency room within a hospital) and is operated by experts from the hospital staff. The operator at the Response Centre is able to receive voice calls and data on the patient's condition for assessment and consequently advise on an appropriate course of action. Such action may include advice on treatments to stabilize the condition, or instructions to return to land or divert from the planned journey, if the patient is at sea or in the air. The Tempus 2000 Patient Monitor is a patient monitor intended to be used in remote locations where medical staff may not be present. The device is intended to be applied to the patient by a trained operator who is not a medical rric device is intended to be applied to allow the operator to make any clinical decision for treatment or diagnosis. The device permits the operator to take measurements from a patient, troutinon. of aller transmission or transmit medical information to a Response Centre at the time of recording, where trained staff can make clinical assessments based on the information transmitted and advise the operator on the nature of the medical incident. A trained information transmitted annous 2000 Patient Monitor as a standalone diagnostic device. The Tempus 2000 Patient Monitor is suitable for use on adults or children (over 10 years old and over 20kg in weight).

The Tempus 2000 Patient Monitor is a portable, multi-parameter patient monitor. The unit is housed in a plastic enclosure and comprises a large colour screen, a rechargeable battery and a wrist-mounted keypad which incorporates a digital camera. The device can measure a patient's ECG (Electro Cardio Graph) using a 12-lead harness, noninvasive blood pressure, temperature (infra-red tympanic), respiration rate, end-tidal exhaled CO2, pulse rate and Sp02 (blood oxygen saturation). The device collects the patient's physiological data and displays the data in numeric and graphical form to the operator and, remotely, to a Response Centre. The operator interfaces with the device via 8 control buttons (with an additional button on the thermometer, a battery power level button and an on/off button on the front panel) and by graphical help-screens that are displayed in a logical sequence for ease of use. The graphical holp or splayed for all operations including operating the main medical functions, no port one are acking the unit and clearing basic errors that can be expected when using the system e.g. blood pressure hose occlusions or telecoms connection errors. The device is fitted with a colour, digital video-stills camera for transmitting images of the patient to the Response Centre. The Tempus 2000 Patient Monitor is designed to connect only to a PC which is configured with the Tempus Monitoring Station software.