RVS-100 User Manual Rev A July 2017

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RVS-100 Vital Signs Monitor User Manual 0124

This manual contains exclusive information protected by copyright laws and we reserve its copyright. Without written approval of manufacturer no parts of this manual shall be photocopied, Xeroxed or translated into other languages. The contents contained in this manual are subject to amendments without notification. Manufacturer‘s Responsibility Only under the following circumstances the manufacturer will be responsible for the safety, reliability and performance of the instrument: •

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All the installation, expansion, readjustment, renovation or repairs are only meant to be conducted by personnel certified by the manufacturer. The storage condition, operation condition and electrical status of the instrument conform to the product specification. The instrument is used in accordance with the user’s manual.

that generates a voltage based on changes in temperature, and these voltages are recorded by the temperature circuitry. The RVS100 is a portable device, approximately 350 x 245 x 115 mm in size and weighs approximately 3006 g without battery. A color touch screen allows the user to stop/start a BP measurement, save a set of measurements to memory, control patient alarm functions, print measurements, and return to the home screen. The touch screen can also be used to select many different device options. The backlit LCD display shows the user device status and measurement information. A set of multi-color LED’s on the corner of the front enclosure alert users to visual alarms. The device uses a microprocessor with software, which is not accessible to the user. The unit is powered by a single rechargeable lithium-ion battery at the bottom of the device. Four USB-A port connections can be used to connect optional barcode scanner or Wi-Fi dongle. An optional internal thermal printer is available. There is also RJ45 Ethernet port for network connectivity and an RJ11 jack for nurse call connectivity. Note: For purposes of this manual, the Riester RVS-100 may be referred to as “the Riester RVS-100”, “the RVS-100,” “the device” or “the monitor”.

About this manual This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any questions, please contact us. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed. The manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practice and terminology as required for monitoring patients. All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your product. Conventions: • Bold Italic text is used in this manual to quote the referenced chapter or sections. • [ ] are used to enclose screen texts. • > is used to indicate operational procedures. Signs in this manual: Warning: Indicates a potential hazard or unsafe practice that, if not avoided, will result in death or serious injury. Caution: Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage. Note: Provides application tips or other useful information to ensure that you get the most from your product. Welcome to the Riester RVS-100 Thank you for choosing the Riester RVS-100 for accurate monitoring of vital signs. The Riester RVS-100 is designed to be simple and efficient to use and the RVS-100 features: automatic patient monitoring modes averaging of multiple BP readings user-programmable monitoring intervals audible and visual patient alarms connection to EMR system Riester RVS-100 Description and Operation The Riester RVS-100 vital signs monitor can perform automatic blood pressure, pulse oximetry and body temperature measurements for clinical professionals. For measuring blood pressure, a blood pressure cuff is placed around the patient’s non-dominant upper arm. The cuff is inflated automatically and blood pressure is measured by the oscillometric method-which senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of the frequency of the pressure waves enables heart rate to also be measured. The pulse oximetry function non-invasively measures the patient’s percent oxygen saturation of arterial hemoglobin using principles of plethysmography via a SpO2 sensor placed on the patient’s finger. Temperature can be measured using an oral/axillary/rectal temperature probe containing a thermistor

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Contents 39 1. General Introduction 39 1.1 Intended Use 39 1.2 Restrictions for use 40 1.3 Configurations 40 1.4 Main Unit 40 1.4.1 Front View 40 1.4.2 Side View 40 1.4.3 Rear View 41 1.4.4 Bottom View 41 1.5 Equipment Symbols 41 1.6 Packaging Symbols 41 2. Safety 41 2.1 Safety Information 42 2.2 General Safety 42 2.3 Important Notes for Safety 43 2.4 Safe Operation Conditions 43 3. Operations 43 3.1 Unpacking and Checking Contents 43 3.2 Getting Started 43 3.3 Connect Accessories 43 3.4 Shutting off the Monitor 43 3.5 Operation Profiles 44 3.6 Using Menus 44 3.7 Clinician Management 45 3.8 General Setup 45 3.8.2 DEMO Modes 45 3.8.3 General Device Options 45 3.8.4 Data Options 45 3.8.5 Network Settings 45 3.8.6 Service settings 46 3.8.7 Other settings 46 4. Patient Management 46 4.1 Adding a Patient 46 4.2 Patient manage 47 5. Patient Monitoring 47 5.1 NIBP Measurement 49 5.2 SpO2 measurement 51 5.3 PR Measurement 51 5.4 Temperature Measurement 52 5.5 Nurse Call 52 6. Alarms 52 6.1 Alarm Categories 53 6.2 Alarm Levels 53 6.3 Alarm Indicators 54 6.4 Alarm Icons 52 6.5 Setting Alarm Volume 52 6.6 Alarm Parameters 54 6.7 Pausing Alarms 54 6.8 Acknowledging Alarms 54 6.9 Alarm Reset 54 6.10 Alarm Volume off and on 55 6.11 Resetting Alarm Limit 55 6.12 Alarm History 55 7.Reviewing 55 7.1 Reviewing patient measurements 55 7.2 Deletingpatient data 55 7.3 Print patient data 55 8. Battery 55 8.1 Introduction 55 8.2 Installing a Battery 56 8.3 Optimizing Battery Performance 56 8.4 Checking Battery Performance 56 8.5 Disposing of Batteries 56 9. Maintenance and Cleaning 56 9.1 Introduction 56 9.2 Cleaning the Monitor 56 9.3 Cleaning and Disinfection of Accessories 9.4 Maintenance and replacement of the accessories 56 57 10. Accessories 58 10.1 SpO2 59 10.2 NIBP 59 10.3 Temp 59 10.4 Miscellaneous 60 Appendix A Product Specifications 60 A.1 Safety Specifications 60 A.2 Environmental Specifications 60 A.3 Physical Specifications 60 A.4 Power Specifications 61 A.5 Hardware Specifications

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A.6 Measurement Specifications Appendix B :Factory Defaults B.1 Date /Time B.2 Alarm B.3 Display B.4 Others B.5 SpO2 B.6 NIBP B.7 Temp Appendix C : Guidance and Manufacturer’s Declaration of EMC Appendix D Troubleshooting Appendix E Applicable Standards

63 67 67 67 67 67 67 67 68 68 71 73

1. General Introduction 1.1 Intended Use The RVS-100 vital signs monitor is intended to be used for monitoring, displaying, reviewing, storing and sending alarms regarding multiple physiological patient parameters, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (Temp). The RVS-100 vital signs monitor is intended to be used in outpatient departments, emergency treatment rooms, and low-acuity areas of hospitals, community clinics, private clinics and other medical institutions. It is not intended for helicopter transport, hospital ambulance or home use. Warning: The monitor is intended for use only by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operations on it. 1.2 Restrictions for use • Do not use the monitor and the SpO2 sensor during magnetic resonance imaging (MRI). Induced current could cause burns. • Operating high frequency electrosurgical equipment in the vicinity of the monitor may produce interference and cause incorrect measurements. • The following factors may influence the accuracy of SPO2 measurements: ◊ Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material); ◊ Electromagnetic interference, such as from an MRI device; ◊ Excessive patient movement; ◊ Intravascular dyes such as indocyanine green or methylene blue; ◊ Significant levels of dysfunctional hemoglobins (such as carboxyhemoglobin or methemoglobin); ◊ Incorrect sensor application or use; ◊ Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter or intravascular line; ◊ Low perfusion; ◊ Electrosurgical units. • Do not use the SpO2 sensor on the same limb being used for NIBP measurement. This may result in inaccurate SpO2 reading due to blocked blood flow during cuff inflation. • Do not measure SpO2 on a finger painted with nail polish. This may result in unreliable measurements. • Do not measure NIBP on patients with sickle-cell disease or any condition in which skin damage has occurred or is expected. • Use clinical judgment to decide whether to perform frequent Auto BP measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff. • Use clinical judgment to decide whether to perform Auto BP measurement on patients with thrombasthemia. • Do not use the NIBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation.

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NIBP Measurement Limitations: Accurate NIBP measurements cannot be taken when the heart rate is extremely low (less than 40 bpm) or extremely high (greater than 240 bpm) or if the patient is on a heartlung machine. Accurate measurement also cannot be taken when the following conditions exist: ◊ excessive and continuous patient movement such as shivering or convulsions; ◊ difficulty detecting a regular arterial pressure pulse; ◊ cardiac arrhythmias; ◊ rapid blood pressure changes; ◊ severe shock or hypothermia that reduces blood flow to the peripheries; ◊ an edematous extremity. MRI may lead to vessel damage;

1) Grounding terminal 2) Nurse call connector 3) AC power connector (input) 4) DC power connector (output) 5) USB socket x 2 6) Ethernet LAN Network connector Caution: Devices connected to this monitor must meet the requirements of the applicable IEC standards (e.g. IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical electrical equipment). The system configuration must meet the requirements of the IEC 60601-1 medical electrical systems standard. Any personnel who connect devices to this monitor‘s signal input/output port is responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1. If you have any questions, please contact Riester. If it is not evident from the equipment specifications whether a particular device combination is hazardous--for example, due to summation of leakage currents-please consult the manufacturers or an expert in the field to ensure the necessary safety of patients and proper function of all connected devices.

1.3 Configurations The monitor consists of main unit, NIBP cuff, SpO2 sensor, Temperature sensor (optional) and printer (optional). It can connect to the optional RVS-200 Wall Diagnostic Station through DC output. The connection details are provided the corresponding manual for the RVS-200 Wall Diagnostic Station. 1.4 Main Unit 1.4.1 Front View Left side:

Fig.1-1 1) Physiological alarm visual indicator LED’s. When a physiological alarm occurs, this lamp will light up as defined below: • High level alarm: the lamp quickly flashes red. • Medium level alarm: the lamp slowly flashes yellow. • Low level alarm: the lamp lights yellow without flashing. 2) LCD Touchscreen 3) SpO2 connector 4) NIBP connector 5) USB connector x 2 6) Power button • Press this button to turn on the monitor after AC power is connected or the battery is installed. • Press and hold for 3 seconds to turn the monitor off. 7) Battery charging indicator LED • On: When the battery is being charged. • Off: When the battery is fully charged or there is no battery in monitor. 8) Power indicator LED. Status of the LED is specified as follows: • Green: When the AC mains connected. • Orange: When the AC mains not connected and monitor is powered by battery. • Off: When the AC mains not connected. 9) Well for Temp Probe Cover box (20pcs) 10) Covidien Filac 3000 temp probe

Fig.1-3 1) Integrated Thermal Printer 1.4.3 Rear View

Fig.1-4 1) Speaker 1.4.4 Bottom View

1.4.2 Side View Right side:

1. Battery compartment

1. Battery compartment Fig.1-5

Fig.1-2

Caution: Clean the battery contacts regularly to ensure optimal electrical contact. Before cleaning, power down the unit and disconnect it from A/C power. To clean the contacts, rub with a cotton swab dampened (not dripping wet) with isopropyl alcohol.

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1.5 Equipment Symbols

1.6 Packaging symbols

Symbol

Symbol Note Fragile. Handle with care.

This Side Up.

Keep dry. Stacking layer limit, where ‘n’ represents the maximum permissible number of layers. (N = 6).

2. Safety 2.1 Safety Information Warning: • Before putting the system into operation, verify that the RVS-100 and RVS-200 and accessories are in correct working order and operating condition. • Do not use device if any electrical connections become damaged, bent, or misaligned. • To avoid explosion hazard, do not use the monitor in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. • Do not open the monitor housings; electric shock hazard may exist. All servicing must be performed by personnel authorized by the manufacturer only. • When using the monitor with electrosurgical units (ESU), make sure the patient is safe. And the ESU must not contact with patient cable. • Do not come into contact with the patient during defibrillation. Otherwise serious injury or death could result. • Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off may result in a hazard to the patient. Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring. • The physiological data and alarm messages displayed on the monitor are for reference only and cannot be directly used for diagnostic interpretation. • To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to avoid risk of entanglement or strangulation by patient or personnel. • To avoid risk of electric shock, this equipment must only be connected to a grounded power supply. • No modification of this equipment is allowed. Do not modify this equipment without authorization of the manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment. • There will be significant risks of reciprocal interference when the device is used in specific investigations or treatments. • The device’s connector (including USB, network and so on) can only be connected to the matched accessories and network server. The misuse of them may cause damage to the device. • Operating high frequency electrosurgical equipment in the vicinity of the monitor may produce interference and cause incorrect measurements.

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•

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Caution: To ensure patient safety, use only parts and accessories specified in this manual. At the end of its service life, the monitor, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the monitor, please contact the manufacturer. Magnetic and electrical fields are capable of interfering with the proper performance of the monitor. For this re-

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ason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. Before connecting the monitor to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the monitor’s label or in this manual. Always install or carry the monitor properly to avoid damage caused by drop, impact, strong vibration or other mechanical force. Note: Put the monitor in a location where you can easily see the screen and access the operating controls. Keep this manual in the vicinity of the monitor so that it can be obtained conveniently when needed. The software was developed in compliance with IEC 62304. The possibility of hazards arising from software errors is minimized. This manual describes all features and options. Your monitor may not have all of them.

2.2 General Safety Warning: This monitor is neither a therapeutic instrument nor a device that can be used at home. 1. Safety precautions for installation • Connect the power cord to a properly grounded socket. Only connect device to A/C power sockets designated for use by medical equipment. • Avoid putting the monitor in a location where it easily shakes or wobbles. • Enough space shall be left around the monitor so as to guarantee normal ventilation. • Make sure the ambient temperature and humidity are stable and avoid the occurrence of condensation in the operation process of the monitor. Warning: Never install the monitor in an environment where flammable anesthetic gas is present. 2. Monitor conforms to the safety requirements of IEC 606011. This monitor is protected against defibrillation effects. 3. Notes on symbols related to safety Type CF applied part, defibrillation protected. The unit displaying this symbol contains an F-Type isolated (floating) applied part providing a high degree of protection against shock, and is defibrillator-proof. The type CF applied parts provide a higher degree of protection against electric shock than that provided by type BF applied parts. Attention! Please refer to the documents accompanying this monitor, such as the instruction manual. 4. When a defibrillator is applied on a patient, the monitor may have some disruption in its display of waveforms. Warning: When conducting defibrillation, do not come into contact with the patient, the bed or the monitor. Otherwise serious injury or death could result. 5. To guarantee the safe operation of the monitor, the monitor is provided with various replaceable parts, accessories and consumables. Please use the products provided or designated by the manufacturer. 6. Safety and accuracy are assured only by the device and accessories provided or designated by the manufacturer. If the monitor is connected to other undesignated electrical equipment or devices, safety hazards and/or excessive leakage current may occur. 7. To guarantee the normal and safe operation of the monitor, a preventive check and maintenance should be conducted of the monitor and its parts every 6-12 months (including performance and safety check) to verify that the instrument can be operated safely, properly, and accurately. Caution: The monitor does not contain any user-serviceable parts. The repair of the instrument must be conducted by technical personnel authorized by the manufacturer.

2.3 Important Notes for Safety • Patient Number The monitor can only be applied to one patient at one time. • Interference Do not use a mobile phone in the vicinity of the monitor. High level of electromagnetic radiation emitted from such devices may result in strong interference with the monitor performance. • Protection against ingress of liquid To avoid electric shock or device malfunction, liquids must not be allowed to enter the device. If liquids have entered the device, take it out of service and have it checked by a service technician before it is used again. • Accuracy If the accuracy of any value displayed on the monitor or printed on a printout paper is questionable, determine the patient’s vital signs by alternative means. Verify that the equipment is working correctly. • Alarm Do not rely exclusively on the audible 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 and correct operation of monitor. The functions of the alarm system for monitoring the patient must be verified at regular intervals. • Before Use Before putting the system into operation, please visually inspect all connecting cables for signs of damage. Damaged cables and connectors must be replaced immediately. Before using the system, the operator must verify that it is in correct working order and operating condition. Periodically, and whenever the integrity of the product is in doubt, test all functions. • Cables Route all cables away from patient’s throat to avoid possible strangulation. • Disposal of package When disposing of the packaging material, please observe the applicable waste control regulations and keep it out of children’s reach. • Explosion hazard Do not use this equipment in the presence of flammable anesthetics, vapors or liquids. • Leakage current test When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients. • Battery The device is equipped with a battery. The battery discharges even when the device is not in use. Store the device with a fully charged battery and take out the battery, so that the service life of the battery will not be shortened. • Disposal of accessories and device Disposable accessories are intended for single use only. They should not be reused as performance could degrade or contamination could occur. The service life of this monitor is 5 years. At the end of its service life, the monitor, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have questions concerning disposal of products, please contact manufacturer or its representatives. • EMC 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. Also, keep mobile phones or other telecommunication equipment away from the monitor. • Instruction for use For continuous safe use of the monitor, it is necessary that listed instructions are followed. However, instructions listed in this manual can in no way can supersede established medical practices concerning patient care. • Loss of data Should the monitor at any time temporarily lose patient data, close patient observation or alternative monitoring devices should be used until monitor function is restored. If the monitor does not automatically resume operation within 60s, restart the monitor using the power switch. Once monitoring is restored, you should verify correct monitoring state and alarm function.

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• Intended for use in conjunction with other medical devices The monitor can be used together with high-frequency electrosurgical units and defibrillators. • IT-NETWORK Connection to IT-NETWORKS including other equipment could result in previously unidentified risks to patients, operators or third parties. The responsible organization operating the device should identify, analyse, evaluate and control these risks. Changes to the IT-NETWORK could introduce new risks that require additional analysis Changes to the IT-NETWORK include: - Changes In Network Configuration - Connection Of Additional Items - Disconnection Of Items - Update Of Equipment - Upgrade Of Equipment

2.

the visual alarm LED’s will illuminate in sequence from red, to yellow, to cyan, and then turn off, after that the device will produce a sound and the Riester logo will also appear on the display. After the Riester logo disappears, the monitor will enter the main interface. After a successful power up, the device will produce a sound. Warning: If the startup characteristics are different from the description above, the monitor could be damaged. Caution: The monitor does not have a mains power switch. The monitor is disconnected from A/C power only by unplugging the power cable from the A/C power source. If device accessories are placed near the heart, connect the monitor’s equipotential grounding system. Connect a green/yellow equipotential grounding cable to the terminal labeled with the symbol :

2.4 Safe Operation Conditions

Methods of sterilization or disinfection recommended by the manufacturer Electromagnetic interference Electrosurgical interference damage Diathermy instruments influence Defibrillation shocks

Sterilization: not applicable Disinfection: Refer to Maintenance and Cleaning Chapter

Not in proximity with mobile phones No damage Displayed values and prints may be disturbed or erroneous during diathermy The monitor specifications fulfill the requirements of IEC 60601-1, IEC 60601-2-49

3. Operations 3.1 Unpacking and Checking Contents 1. Unpacking Before unpacking the unit, examine the packing box carefully for signs of damage. If any damage is detected, contact the carrier. 2. Remove the device and accessories carefully. 3. Keep all the packaging materials for future use in transportation or storage. 4. Check the monitor and accessories according to the packing list. Check to see if the parts have any mechanical damage. In case of damaged items, please contact Rudolf Riester or a Rudolf Riester Authorized Service Center.

Warning: The plug is used to break the power supply, it should not be placed in place bad for operation. 3.3 Connect Accessories 1. Decide which parameter should be monitored or measured. 2. Connect required cables or sensors to the monitor. 3. Connect appropriate cables or sensors to the patient. 4. Ensure the installation of cables or sensors is correct. 5. Ensure that device settings are correct. 6. Review instructions in Chapter 5 and start monitoring on a patient. 3.4 Shutting off the Monitor There are two ways to shut off the monitor: 1. Press and hold the power switch for more than 1 second. A message box will appear asking for verification that power down is desired. Press ‘Ok’ to power down the device. 2. Press the power switch and hold it for 5 seconds to turn off the monitor without additional prompts. 3.5 Operation Profiles The device has three Operation Profiles for different clinical applications: Monitor Profile: This profile is designed for monitoring patients over time, and includes physiological and technical alarms. Here is an example of the home screen in Monitor Profile:

Warning: Keep packing materials out of the reach of children. Dispose of the packing materials according to applicable local waste control regulations. Warning: The monitor might be damaged during storage and transport. Never use a damaged device or apply a damaged accessory to the patient. Caution: Always place the monitor on a horizontal and stable supporting surface. Avoid putting the monitor in a location where it easily shakes or wobbles. Enough space should be left around the monitor to guarantee normal ventilation. Warning: Always use the monitor within the conditions specified in Appendix A; otherwise, the technical specifications mentioned in this manual will not be met and could lead to damaged equipment, inaccurate readings and other unexpected results. 3.2 Getting Started 3.2.1 Powering the Monitor 1. Plug the included power cord into the A/C receptacle on the monitor. Ensure that it is fully seated in the socket. 2. Plug the power cord into A/C power source. When using a battery for the first time, the battery must be charged following the instructions given in Chapter 8: Battery. 3.2.2 Monitor Startup 1. After pressing the power switch, the monitor will begin an automatic self-diagnostic and start-up. During this process,

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Spot Check Profile: This profile is designed for taking a single set of vital signs measurements on a patient. Patient information can be entered and managed, and while technical alarms are still available, physiological alarms are disabled. Here is an example of the home screen in Spot Check profile:

Triage profile: This profile is designed for rapidly taking vital signs measurements on many patients. Patient information is disabled, in addition to physiological alarms. Here is an example of the home screen in Triage profile:

8.

If you want to change the work mode, you can select [SETTINGS] > [Profile]to select the work mode you want. 3.6 Using Menus The main Home Screen can clearly display the basic patient information, time and date, physiological parameters, clinician information, and alarm information:

measurement information. ALARM: Used to adjust alarm limits for each parameter, change alarm volume settings, and review historical alarms. NOTE: This tab does not appear in either Spot Check profile or Triage profile. e) SETTINGS: Used to adjust special settings for each vital sign parameter, enter and manage clinician information, and manage general device settings. General device settings include Date/Time, and selection of Operation Profile. Advanced settings are also accessed from the SETTINGS tab and include language settings, nurse call settings, and data / network setup and maintenance. NOTE: A password is required to access Advanced settings. Shortcut Icons: Used to perform specific functions on the device. d)

a)

: Help key;

b)

: Alarm pause key;

c)

: Shortcut key to reset the alarm;

d)

: Shortcut key to print ;

e)

: Shortcut key to start/stop NIBP measurement;

f)

: Shortcut key to standby mode;

NOTE: In standby mode, the patient is not being monitored, but the monitor is still powered on. If no parameter is being measured, you can press the to enter the standby mode. A warning pops up, select [Yes] to enter the standby mode. Click any area of the screen to exit standby mode. If no parameter is being measured for 5 minutes, the monitor will turn to standby mode automatically. g) 9.

1.

2.

3.

4.

5.

6. 7.

Clinician Information: Displays the clinician’s Full Name, Department, and ID. Press anywhere in this area to open the Clinician Settings. Clinician Settings can also be accessed from the Settings tab: [SETTING] > [Clinician] System Time and Date and Network status: Displays the current system time and date. Press anywhere in this area to open the Device Settings window where time and date can be set. Time and Date Settings can also be accessed from the Settings tab: [SETTING] > [Device] > [Time]. Network settings please refer to chapter 3.8.5 Battery Status: Displays the current charge status of the battery and whether or not the unit is connected to A/C power. See Chapter 9 for more details. Device Alarm Message Bar: Entire area displays alarm messages when physiological and technical alarms are activated. If more than one alarm occurs, the highest level alarm will be displayed. Alarm settings can be changed by pressing the alarm areas in each measurement display window, or from the Alarm tab: [ALARM] Measurement Display Area: Displays information about each vital sign parameter, including measurement values, and upper and lower alarm limits. Pressing on a measurement value will enlarge the information for that parameter. Pressing on the measurement again will shrink it. Pressing on an alarm limit box will open the Alarm Setting window for that parameter, where the alarm limits can be adjusted. This window can also be accessed from the Alarm tab: [ALARM] > [NIBP]/ [PR] / [SpO2] / [Temp] Patient Information: Displays patient information such as Name, Location, and ID. Menu Tabs: Used to access and navigate through the device Menu. a) MEASURE: The MEASURE tab is the default Home screen used to display vital sign parameter information. b) PATIENT: Used to enter, modify, and select patient information, review the patient list, and transmit patient information. NOTE: This tab does not appear in Triage Profile. c) REVIEW: Used to quickly review historical patient

: Shortcut key to the home screen ; Save button: Press to save the current measurement data for the current patient.

3.7 Clinician Management To enter information for a clinician: 1. Select [SETTING] > [Clinician] to set the clinician [ID], [First name], [Last name], [Department]

2.

Select [SETTINGS] > [ADVANCED] > [DATA] > [Clinician Set] to choose the clinician information as follows that can be displayed :[Clinician ID], [Clinician name], [Clinician Icon] Note: * means this item must be input related information, or the settings will not be effective.

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3.8 General Setup 3.8.1 Language settings

1.

2.

Select [SETTINGS] > [ADVANCED] > [GENERAL] > [DEMO] to select demo type. There are three demo modes to choose from: Monitor profile demo, Spot check profile demo, or Triage profile demo. Select [Start]to begin the demo.

3.8.4 General Device Options

1. 2.

Select [SETTINGS] > [ADVANCED] > [Language] to access the language list. Select the desired Language and press [OK] save the language setting.

3.8.2 Setting the Date and Time Setting the current time: 1. Select [SETTINGS] > [DEVICE] > [Settings] > [Time]. 2. Set [Year], [Month], [Day], [Hour], [Minute] to the desired value. 3. Select [OK] to save settings.

1. 2. 3.

Select [SETTINGS] > [ADVANCED] > [GENERAL] > [OPTIONAL]to view the list of options available. Choose the desired options. Select [OK] to save settings.

3.8.5 Data Options

Setting the date/time format: 1. Select [SETTINGS] > [ADVANCED] > [GENERAL] > [DATE/ TIME] 2. Set the [Date Format] to yyyy-mm-dd, mm-dd-yyyy or ddmm-yyyy; 3. Set the [Time Zone] to be GMT, GMT+1, GMT+2, GMT+3, etc.

1.

2.

Select [SETTINGS] > [ADVANCED] > [DATA] to choose whether or not the full name or abbreviation is displayed for both the Patient and the Clinician. You can also choose to automatically send clinical information to the EMR when saving manually, and whether or not to delete the displayed readings after the data is sent to the EMR successfully. Select [OK] to save settings

3.8.6 Network Settings

3.8.3 DEMO Modes

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4. Patient Management 4.1 Adding a Patient To add a patient, 1. Select [PATIENT] > [Add]. The patient information window will pop up. 2. Enter or select the patient information: Patient ID: The system can automatically produce an ID for the patient. The ID can also be manually entered. First Name: Enter the patient’s first name. Last Name: Enter the patient’s last name (family name). Age: Enter the patient’s birthday. Gender: Choose [Male] or [Female]. Patient Type: Choose the patient category, either [Adult], [Pediatric] or [Neonate]. Select [OK] to add the new patient.

1. 2.

3.

Select [SETTINGS] > [ADVANCED] > [NETWORK] to set the network to be [Wired Network] or the [Wireless Network]. Select [SETTINGS] > [ADVANCED] > [NETWORK]> [IHE Setting], in this interface set the network server to be [PCD Server] / [PDQ Server]. Select [OK] to save settings.

3.8.7 Service settings

1.

Select [SETTINGS] > [ADVANCED] > [SERVICE] to reset factory default settings (not recommended), import and export the configure files by USB, or import configuration settings from a USB drive. In the [SERVICE] menu, you can also see the device logs and other information about the device.

3.8.8 Other settings

Caution: The patient type determines which measurement algorithms, safety limits, and alarm limits the device will use during operation. Caution: The number of patients who can be entered depends on the device’s storage space. 4.2 Patient manage When the patient is added, the patient information will automatically populate the patient interface (see the following picture):

You can conduct any of the following operations: Select [View All]: Can view the last 1 day, last 7 days, or all the patients. Even you can choose the keyword search to find the exact one you need. Select [Delete]: Select one or more pieces of patient information to delete it. Select [Modify]: Select one piece of patient information to modify it [except the patient ID]. Caution: Do not attempt to delete or modify that patient that is currently being monitored. Select [Select]: Select one piece of patient information. The system automatically will go to the home screen. Monitoring of the selected patient will begin immediately. Select [Discharge]: Discharges the current patient. Select [Print]: Prints the patient information and measurement data about the selected one; Select [Last page]: Checks the patient information of the last page; Select [Next page]: Checks the patient information of the next page;

1. 2.

Select [SETTINGS] > [ADVANCED] > [PARAM] > [OTHERS] to set the [Height Unit] and the [Weight Unit]. Select [OK] to save settings.

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5. Patient Monitoring 5.1 NIBP Measurement The monitor uses the oscillometric method for measuring NIBP. It is applicable for adult, pediatric and neonatal patients. It is not applicable for pregnant or pre-eclamptic patients. The oscillometric method indirectly estimates the systolic and diastolic pressures within the blood vessels by measuring pressure change within the blood pressure cuff. The device senses pressure waves in the artery when occluded by pressure in the cuff and calculates the average pressure. NIBP measurement is suitable for use during electrosurgery and during the discharge of a cardiac defibrillator according to IEC 80601-2-30. A physician must determine the clinical significance of the NIBP measurement. 5.1.1 Safety Information Warnings: • Check the patient category before monitoring. Incorrect settings may result in some risk for patient safety. For example, higher alarm-level settings for adults are not suitable for pediatric and neonatal patients. • Do not measure NIBP on patients with sickle-cell disease or any condition in which skin damage has occurred or is expected. • Use clinical judgment to decide whether to perform frequent Auto BP measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff. • Use clinical judgment to decide whether to perform Auto BP measurement on patients with thrombasthemia. • Do not use the NIBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation. • If you doubt the NIBP measurements, check the patient’s vital signs using another device, and then check the monitor. • The NIBP measurement function must be calibrated regularly for safe use. • The performance of the automated sphygmomanometer can be affected by extremes of temperature, humidity and altitude. • Avoid compression or restriction of the connection tubing, or the measurement result will be wrong, which may mislead the doctor to make wrong diagnosis, patient may be hurt. • When patients cannot take care of themselves, there must be an operator standing by during auto mode measurement. • The environmental or operational factors which can affect the performance of the NIBP module and its BP reading : ◊ Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing. ◊ The bladder of the cuff is not folded or twisted. ◊ A wrong cuff size, and a folded or twisted bladder, can cause inaccurate measurements ◊ Do not wrap the cuff too tightly around the limb. • Continuously high cuff pressure due to compressed or bent tubing, may have the effect of blood flow interference and may result in harmful injury to the patient. • Do not use the cuff over a wound, as this can cause further injury. • A pressurized cuff can temporarily cause loss of function of simultaneously used monitoring equipment on the same limb. • Do not use the NIBP cuff on the arm of a mastectomy patient, we suggest measuring blood pressure on their legs. • Pressurization of the cuff can temporarily cause loss of function of simultaneously used monitoring ME EQUIPMENT on the same limb. • The application of the cuff and its pressurization on any limb where intravascular access, therapy, or an arteriovenous(A-V) shunt is present, temporary interference to blood flow and could result in injury to the patient. • Check the operation of the automated sphygmomanometer regularly to make sure that it does not result in prolonged impairment of the circulation of the blood of the patient.

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5.1.2 NIBP Measurement Limitations Accurate NIBP measurements cannot be taken when the heart rate is extremely low (less than 40 bpm) or extremely high (greater than 240 bpm) or if the patient is on a heart-lung machine. Accurate measurement also cannot be taken when the following conditions exist: • excessive and continuous patient movement such as shivering or convulsions; • difficulty detecting a regular arterial pressure pulse; • cardiac arrhythmias; • rapid blood pressure changes; • severe shock or hypothermia that reduces blood flow to the peripheries; • an edematous extremity. 5.1.3 NIBP Measurement Modes There are four modes of measuring NIBP: • Manual: a single measurement on demand. • Auto: continuous repeated measurements with a set interval. • STAT: rapid series of measurements over a five-minute period. For use only on supervised patients. • Averaging: a set number of measurements taken and averaged.

5.1.4 NIBP Monitoring Procedure Preparing to Measure NIBP 1. Encourage the patient to be still and quiet. 2. Check the patient category. If you want to change the patient category, select to enter the [Patient Info] menu. Select the desired patient category. 3. Select the appropriate cuff according to patient size. • Check the limb circumference of the patient. (Use the upper arm or thigh.) • Select the appropriate cuff. (The applicable limb circumference for the cuff is marked on the cuff). The width of the cuff should be about 40% of the limb circumference (50% for neonates), or 2/3 of the upper arm’s length. The inflatable part of the cuff should be long enough to encircle 50% to 80% of the limb. Note: • BP measurement accuracy depends on a properly fitted cuff. • The following steps should be taken to obtain accurate routine resting blood pressure measurements for the condition of hypertension , including: 1) Comfortably seated 2) Legs uncrossed 3) Feet flat on the floor 4) Back and arm supported 5) Middle of the cuff at the level of the right atrium of the heart. 6) The patient should relax as much as possible and not talk during the measurement procedure. 7) 5 min should elapse before the first reading is taken; 8) The operator is suggested standing on the right side of the monitor in normal use. 4. 5.

6.

Confirm the cuff has been entirely deflated. Connect one end of the BP cable to the cuff air tube and the other end to the monitor’s NIBP connector. Gently push the tip of the BP cable over each socket to click the cable securely in place. Wrap the cuff snugly around the upper arm or thigh of the patient. On the arm, the bottom of the cuff should be approximately 1 inch above the elbow joint. Ensure the Artery Marker

“²” on the cuff is positioned above artery and that there are no knots in the BP cable. When wrapped around the patient’s arm, the Cuff Index Line should fall within the Range Markers printed on the cuff. If not, select another cuff size. The monitor is designed for use with standard neonatal, pediatric and adult cuffs (including arm and thigh cuffs). Note: The cuff should be at heart level to avoid measurement errors. If you cannot position the cuff on a limb at heart level, you may need to make manual adjustments to measurements as follows: •

•

If the limb/cuff position is higher than heart level, the BP reading will be lower. Add 0.75mmHg (0.1kPa) to the measurement result for each centimeter of distance between the limb/ cuff and the heart. If the limb/cuff position is lower than heart level, the BP reading will be higher. Subtract 0.75mmHg (0.1kPa) for each centimeter of distance between the limb/cuff and the heart.

1. Systolic blood pressure 2. Diastolic blood pressure 3. Mean arterial blood pressure 4. Upper alarm limits 5. Lower alarm limits 6. Alarm switch 7. Pressure unit 8. Measurement mode 9. Patient type

Starting/Stopping Measuring Press on the device display to start NIBP measurement. Press

Note: In Triage profile, click the patient type area (see the above picture area 9) in order to change the patient type. In monitor and spot check Profile, the patient type is just displayed in this area.

again to stop measurement.

Auto Measurement 1. Select [SETTING] > [NIBP Mode] > [Long-Term Automatic] to start an automatic measurement cycle. 2. Select [Minute] to set the duration of time you want to automatically measure BP. Select a time period from [5 min] to [240 min] . 3. Select to begin the cycle. Warning: Prolonged NIBP measurement in Auto Measurement mode can be associated with purpura, ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the extremities of the limb frequently for normal color, warmth and sensitivity. If any abnormality is observed, stop NIBP measurement immediately. STAT Measurement 1. Select [SETTING] > [NIBP Mode] > [STAT]to start a quick measurement cycle. BP measurements will be taken for about 5 minutes. 2. Select to begin the cycle.

Note: STAT measurement mode will return to manual mode when one STAT measurement is finished. Averaging Mode 1. Select [SETTING] > [NIBP Mode] > [Averaging] to start an averaging mode measurement cycle. 2. To include the first measurement in the average, check the box beside “Include the first measurement in averaging calculation.” If you do not wish to include the first measurement in the average, and the box is checked, touch the check box to uncheck it. 3. Select the total number of measurements to be taken and averaged. Select between 2 and 5 measurements. 4. Select the number of minutes before the first measurement begins. Select between 0 minutes and 5 minutes. If you select 0, measurement will begin immediately after you begin the cycle by touching . If you select 1, measurement will begin 1 minute after you touch , etc. 5. Select the number of seconds between each discreet measurement. Select an interval between 15 seconds and 120 seconds. 6. Select OK to apply your settings and then select to begin the cycle. Warning: Operator is in continual attendance during the series of measurements. 5.1.5 NIBP Display There is no waveform displayed for NIBP measurement. NIBP readings are displayed in the BP section of the measurement display. The following figure shows the NIBP display screen. The display on your monitor may look slightly different.

5.1.6 Setting NIBP You can setup the NIBP measurement information as follows: 1. Select [SETTING] > [ADVANCED] > [PARAMETERS] > [NIBP] > [Default patient type] to choose the patient category. Choose either [Adult], [Pediatric] or [Neonate]. 2. Select [SETTING] > [ADVANCED] > [PARAMETERS] > [NIBP] to set the [Unit] to [mmHg] or [kPa]. Note: This setup is only available in Triage profile.

5.1.7 NIBP Calibration EU countries except Germany: Legal regulations for monitoring instruments apply to all EU countries except Germany. Countries outside the EU: For any countries where no legal regulations exist for monitoring instruments, it is recommended to examine the accuracy of measuring instruments in 2-year intervals. If you need to do NIBP maintenance, please contact professional service personnel. Calibration tools: 3 way connector, pipe, pressure ball, metal container (500±25 ml), standard manometer (already calibrated, precision over 1 mmHg) 1. Connect monitor, manometer, pressure ball and metal container as follows.

2. 3.

4.

Reading of manometer should be 0 before deflation, if not, cut the connection until it returns to zero. 3. Select [Main Menu] - [Settings] – [Advanced] - input password > [Factory] – input password [Factory] > [NIBP Calibration]. Select e.g. 250 mmHg as calibration level. Push [Start] button. Manually pump up standard manometer to 250 mm Hg. Consult pressure level shown on device. Deviation +-can’t be over 3 mmHg. If correct, push [Set] button to confirm pressure calibration level.

48

certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG-based arrhythmia analysis. Caution: If it is necessary to clip the SpO2 device to the patient, always clip the cable, not the sensor itself. Never use force to pull the sensor cable.

5.1.8 Manometer Test When the NIBP value measured is inaccurate, you can select [SETTINGS] > [ADVANCED] input password > [Factory], after enter the correct password to go to [Factory] to select the following tests: Manometer test , air leakage test ,over press test, NIBP Calibration. After the selection, you can actually conduct these tests.

•

•

•

• •

Note: Only qualified clinical professionals or specified personnel of the manufacturer can perform the above operation. 5.2 SpO2 measurement 5.2.1 Introduction The measurement of oxygen saturation of arterial blood (also known as pulse oxygen saturation, or SpO2) adopts the principles of light spectra and volume tracing. The LED emits lights with two specific wavelengths, which are selectively absorbed by oxygenated hemoglobin and deoxyhemoglobin. The optical receptor measures the changes in the light intensity after the light passes the capillary network and estimates the ratio of oxygenated hemoglobin and the total hemoglobin.

5.2.3 SpO2 Monitoring Procedure 1. Selecting SpO2 Sensor: Select a SpO2 sensor that is appropriate for the patient category, weight and application site. 2. Connecting SpO2 Sensor: Plug the SpO2 sensor cable into the SpO2 connector on the device. (See device diagram in Chapter 1.4.) 3. Applying SpO2 Sensor: Clean the application site, remove any colored nail polish, and apply the sensor to the patient. Typically, the sensor should be used on the index, middle or ring finger. The fingernail should face the side with the red light.

•

• • Wavelengths of the light emitted by the pulse oximeter probe are nominally 660nm for red LED and 940nm for infrared LED.

Note: During SpO2 measurement, a pleth wave will show in the SpO2 display area. This wave does not equal the intensity of the PR signal. The production divergence and drive current of LED influence the range of the peak wavelength of the emitted light by the oxygen probe. The monitor does not provide an automatic self-examination alarm signal. The operator must use a SpO2 simulator for self-test of the device. Functional test cannot be used to assess the accuracy of the monitor. When the displayed SpO2 or pulse rate value is potentially incorrect, the system will show a “?” in the value position.

•

Warnings: Do not use the SpO2 sensor on the same limb being used for NIBP measurement. This may result in inaccurate SpO2 reading due to blocked blood flow during cuff inflation. Do not measureSpO2 on a finger painted with nail polish. This may result in unreliable measurements. When using a finger sensor, make sure the fingernail faces the red light. If “Weak Signal” is indicated, check the patient’s condition and move the probe to another position to try to obtain a better signal.

5.2.2 Safety Information 5.2.4 SpO2 Display •

•

•

•

•

•

•

• •

•

49

Warnings: Only use SpO2 sensors specified in this manual. Follow the SpO2 sensor’s instructions for use and adhere to all warnings and cautions. When using Covidien Nellcor SpO2 sensors/cables, please use the enclosed Covidien Nellcor SpO2 sensors/cables instruction manuals. When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s conditions. Do not use the monitor and the SpO2 sensor during magnetic resonance imaging (MRI). Induced current could cause burns. Prolonged continuous monitoring may increase the risk of unexpected changes in skin characteristics, such as irritation, reddening, blistering or burns. Inspect the sensor site every two hours and move the sensor if the skin quality changes. For neonates, or patients with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently. Check the SpO2 sensor and its package for any sign of damage before use. Do not use the sensor if any damage is detected. Contact the manufacturer. Use only SpO2 sensors and extension cables approved for use with this monitor. Do not use damaged sensors or cables. Incompatible or damaged sensors or cables could pose patient burn risk. Do not soak the sensor in water. Avoid contact with moisture to prevent damage. When disposing of any SpO2 probes, please observe all local, state, and federal regulations that relate to the disposal of this product or similar products. Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect

SpO2 unit

Upper alarm

%SpO2 value

limit Lower alarm limit





Pleth waveform

5.2.5 Setting SpO2 1. Select [SETTING] > [ADVANCED] > [PARAMETERS] > [SPO2] > [Default response] to choose the response to be[Normal: 16 seconds] or [Fast : 4 seconds]. 2. Select [SETTING] > [ADVANCED] > [PARAMETERS] > [SPO2] > [Sweep speed] to setup the speed to be [6.25mm/s] or [25 mm/s]. 5.2.6 SpO2 Measurement Limitations If you doubt the SpO2 measurements, check the patient and move the probe to a different finger. The following factors may influence the accuracy of measurements: • Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material); • Electromagnetic interference, such as from an MRI device; • Excessive patient movement; • Intravascular dyes such as indocyanine green or methylene blue; • Significant levels of dysfunctional hemoglobins (such ascarboxyhemoglobin or methemoglobin); • Incorrect sensor application or use;

•

Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter or intravascular line; • Low perfusion; • Electrosurgical units. The monitor can be used during defibrillation, but the readings may be inaccurate for a short time.

5.2.7 Riester / Biolight SpO2 Sensors and Extension cables a) Sensors Model: 15-100-0013, 15-100-0015 Intended use: Intended use of the non-invasive pulse oximeter probe is during continuous non-invasive arterial oxygen or hemoglobin saturation measurement or during pulse rate monitoring. The probes may be used in co-ordination with a variety of other equipment of the noninvasive pulse oximeter. Contraindications: The probe may be used on the same location for a maximum of 4 hours, provided the location is inspected routinely to ensure skin integrity and correct positioning. Because individual skin condition affects the ability of the skin to tolerate probe placement, it may be necessary to change the probe location more frequently with some patients. Instruction: a) Select a suitable location for the probe. The patient’s index finger is the preferred location, alternative recommended locations are middle or ring finger. b) As shown on figure 2 , place the index finger over the sensor window into the probe with the fingertip against the stop. The probe should be positioned with the cable showing above the finger and hand.

Note: If the probe doesn’t track the pulse reliably, it may be positioned incorrectly. It is possible that the diameter of the finger might be too thick, too thin, or deeply pigmented. Otherwise it might also be too deeply coloured (for example, as a result of externally applied coloring such as nail polish, dye, or pigmented cream) to permit appropriated light transmission . . If any of these situations occurs, reposition the probe or choose an alternate probe to be used at a different location. Warning: The operator or user is responsible for checking compatibility of monitor, probe and cable before use. Otherwise, incompatible components can result in patient injury or inferior performance. Failure to apply the probe properly may cause incorrect measurements. Using in the presence of bright light may result in inaccurate measurements. In such cases, cover the probe location with an opaque material. Intravascular dyes or externally applied coloring such as nail polish, dye, or pigmented cream, may lead to inaccurate measurements. Heavily moving fingers of active patients affect and/or may compromise the performance of the probe. The use of the probe is not recommended for such patients. Do not use any tape to secure positioning of the probe or on any fingers directly. Strong venous pulsations may result in inaccurate saturation measurements. As with other medical devices likewise, do carefully position cables in order to reduce possible patient entanglement or strangulation. Do not use the probe during MRI scanning. Conducted current may cause burns. The probe may as well affect the MRI image, , and the MRI unit may affect the accuracy of oximeter measurement. Do not assess the probe’s accuracy only by testing it on a oximetry simulation device. Do not do NIBP measurement or use other instruments on the same arm as the SpO2 probe. Interruption of flow of blood by an NIBP cuff or special circulatory condition of the patient may result in no pulse found or a loss of pulse. Do not reprocess or modify the probes. Performance or accuracy of probes may otherwise be affected. . Do not disassemble or repair probes, as it may result in product damage of operator injury. Such wrongdoings will be regarded as

severe product misuse and a breach of warranty and thus result in a complete loss of all warranty claims thereafter. Disposal of the pulse oximeter probe and extension cable shall comply with laws of the local government. Please contact your local government authorities regarding such relative local rules. . Specifications: Peak wavelength: Red 660-666nm, IR 895-920nm Maximum optical output power: 2mW Measurement Range: SpO2 0% ~ 100% Arms: 70% ~ 100% SpO2: ±2% 0 ~ 69% SpO2: unspecified Notes: The accuracy can be reached only in normal working conditions. Required working conditions: Range of temperature: 10°C ~ 40°C Relative humidity: 30% ~ 75% Required transport and storage conditions: Range of temperature: -40°C ~ +70°C Relative humidity: ȱ 93% Cleaning and disinfection: Use a clean, soft cloth to wipe the probe with 70% isopropyl alcohol. Do not use undiluted bleach (5%~5.25% sodium hypochlorite) or any cleaning solution other than those recommended here because permanent damage to the probe may occur. Clean and disinfect the probe after use. Saturate a clean, soft cloth with 70% isopropyl alcohol. Wring out excess isopropyl alcohol and wipe all surfaces of the probe and cable. Dry all surfaces of the probe and cable with a clean, soft cloth. Caution: Do not sterilize by irradiation, steam, or ethylene oxide. These sterilization methods may damage the probe. b) Extension cables 1. Introduction Description of function The SpO2 extension cable is a type of cable connecting the pulse oximeter sensor cable with the SpO2 main board thus prolonging the signal transmission distance. . 2. Required working and storage conditions: Range of working temperature 1°C ~ +40°C Range of storage temperature -20°C ~ +60°C (inside box), -20°C ~ +50°C (outside of box) Humidity: 30% – 75% c) Transportation The packaged product may be transported by any means of transport. However, during transport collision, severe vibrations or any exposure to severe weather conditions such as rain, snow, flooding, etc. must be avoided by any means. Storing goods in any kind of open-air warehouse may severely damage the product and may lead to loss of performance. d) Storage The product shall be stored in a dry and ventilated environment, free of any acid, alkali or other corrosive gases. The temperature and humidity conditions in such warehouse shall be within -20°C +60°C, and in between of 30% -70% relative humidity. e) Cleaning and disinfection Please use the following materials for cleaning and disinfection: green soap, green soap (USP) or non-alcoholic hand soap; • 2% Glutaraldehyde solution (such as Cidex) • 10% Aqueous sodium hypochlorite solution (Bleach). f) Life requirements If the product is used in normal environment conditions, correctly operated, cleaned and disinfected, the working life is minimum two years. Maximum shelf life: 4 years g) Using Steps: 1) Check the product in order to make sure it is not damaged. 2) Clean the product. 3) Connect the 12P plug to the appropriate connector on the instrument.

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4) Connect the DB9P plug to the corresponding SpO2 probe socket 5) Start the test. 6) After the detection, take down SpO2 probe, and then remove the SpO2 extension cable. 7) Clean and dry thoroughly after use.

• •

•

•

Warning: This product is intended to be used by the physician only our under the instructions of a physician. Avoid using on imaging equipment such as magnetic resonance imaging equipment (MRI) and electronic computer tomography (CT). In order to avoid damage to the cable code sensor, hold the plug of the medical signal specific cable in our hand when disconnecting. Incorrect connection will cause the device data display to be discontinued or not displayed.

5.2.8 Nellcor Information

This is the trademark of Covidien plc.

5.3 PR Measurement 5.3.1 PR display

temperature in the mouth (oral), the anus (rectal) and the armpit (axillary) and thus aids the detection, diagnosis and monitoring of vital body functions. 5.4.1 Introduction This monitor is equipped with fast temperature measurement capability. Fast temperature measurement uses a pre-heating mode to reach the patient’s body temperature rapidly. It then converts the temperature into electrical signals, which are processed by the monitor and quickly displayed as measurements. Information about body temperature It is a common misconception that 37 °C is the ’normal’ body temperature. It is actually the case that 37 °C is the average body temperature. Normal body temperature are in a range that varies with age, gender and measuring point. Furthermore, body temperature fluctuates over the course of the day. It is usually lower in the morning, higher in the afternoon and goes down a little again in the evening. Other factors that affect body temperature include the patient‘s particular activity, metabolic rate or medications taken. The normal body temperature also tends to drop with increasing age. Normal temperatures are listed in the following table according to the age of the patient and measuring point. Temperatures measured at different parts of the body, even if they are measured at the same time, must not be directly compared with one another as body temperature differs between measuring points. !$%'(% !&(%" $#"'&

#%! #) '!$%'(%& #%" '# $'"'   )%&  *   *  *    *    *   *  *    *  *   *   *    *  *   *  *    *

%  #(' %' '(! %!$'

 )%& *   *  *    *  *   *   *    *  *   *  *    *  *   *   *    *  *   *   *    *

 )%&  *   *   *    *  *   *  *    * *   *   *    *  *   *  *    * *   *  *    *

 )%& *   *   *    * *   *   *    *  *   *   *    * *   *  *    * *   *   *    *

5.4.2 Temperature Monitoring Procedure 1. Select the appropriate measurement sites. Choose between Oral 2. 5.3.2 Selecting PR Source Select [SETTING] > [ADVANCED] > [PARAMETERS] > [PR] > [Source] SpO2 or NIBP. 5.4 Temperature Measurement Contraindications: a) There is a possible danger of inflammation of gases if the instrument is operated in the presence of inflammatory mixtures or mixtures of pharmaceuticals and air or oxygen or laughing gas! b) Never attempt to take the instrument apart! c) Unplug the instrument before cleaning or when disinfecting. d) RVS-100 thermometer probe and probe cover are designed for use with this thermometer. e) Do not use this thermometer without first installing a new RVS100 thermometer probe cover. f) Use only RVS-100 thermometer probe covers with this device. g) Use of any other probe cover will result in erroneous temperature readings. h) The device and probe covers are non-sterile. Do not use on abraded tissue. i) To limit cross contamination, only use blue devices for taking oral and axillary temperatures. j) Use red devices only for rectal temperatures. k) Thoroughly dry all electrical contacts on both probe and thermometer after washing or device may fail to function properly. l) For re-calibration, service or integrity checks refer to a qualified biomedical technician or return to manufacturer. m) Do not open unit. No user-serviceable parts inside. Opening device may affect calibration and voids warranty. n) Disposal of used probe covers must be performed in accordance with current medical practices or local regulations regarding disposal of infectious, biological medical waste. o) Cleaning frequency and practices must be consistent with institutional policy for cleaning of non-sterile devices. p) Device to be used by trained personnel. Intended use / Indications for use The RVS-100 thermometer module is used for measuring body

51

, Axillary

or Rectal

.

Select the measurement mode. Choose between quick , Cold, or Monitor . For Oral site measurement, only Quick or Cold modes are available. For Axillary or Rectal site measurement, all three modes are available.

•

•

•

Note: Quick mode is suitable for patients whose body temperature is expected to be in the normal range of between 96.8 degrees F to 100.4 degrees F(36 degrees C to 38 degrees C). Cold Preheat mode is suitable for patients whose temperature is expected to be lower than normal (i.e., 91.4 degrees F, or 33 degrees C), such as those coming out of surgery. Monitor mode is suitable for continuous temperature monitoring. The minimum measuring time of this mode is recommend to be 60s.

3.

Remove the temp probe rapidly from the probe well on the front of the monitor. This temp probe symbol will begin flashing as a reminder to apply a probe cover.

4.

Place the disposable probe cover and position the probe on the patient (see guidance below on proper positioning). The temperature timer symbol will flash while the measurement is completed.

5.

If using Direct mode, real-time measurement data will appear on the screen continuously. When the measurement is completed, this probe symbol will flash as a reminder to eject the used disposable probe cover. Eject the probe cover and insert the probe back into the probe well. Warnings: a.) Never make a body temperature measurement without new probe covers. Body temperature measurement without probe covers can give incorrect readings. To avoid infection always use a new probe cover. b.) Probe To avoid infection use only the blue probe for taking oral and axillary temperatures. The red probe must only be used for taking rectal temperatures.

Proper Temperature Probe Positioning Oral Temperature Taking • Insert the probe tip under the tongue on one side or the other. Ask the patient to close their mouth. Hold the probe in place until there is a long beep and the temperature reading is displayed.

•

For any countries where no legal regulations exist for monitoring instruments, it is recommended to examine the accuracy of measuring instruments in 2-year intervals If the temperature exceeds the measurement range, the alarm will be activated. Check whether the temperature probe is placed on the patient’s appropriate site. Damaged or outdated probes should be repaired or replaced immediately.

5.5 Nurse Call The Nurse Call function will send a signal to the nurse call system when a patient’s vital signs exceed a pre-set alarm limit. To activate this function, the monitor must be connected to the hospital’s nurse call system. Please use the provided the nurse-call connection cable. The Nurse Call function will only operate under these concurrent conditions: • The Nurse Call function is active; • An alarm condition is occurring; and • Alarms have not been paused or silenced.

Axillary Temperature Taking With the patient’s arm uplifted, place the probe tip into the patient’s armpit, directly on the skin. Ask the patient to lower their arm and hold still. Hold the probe perpendicular to the arm until there is a long beep and the temperature reading is displayed.

To set up Nurse Call: 1. Select [SETTINGS] > [ADVANCED] > [GENERAL] > [OPTIONAL] and then [Enable Nurse Call] 2. Select [SETTINGS] > [ADVANCED] > [GENERAL] > [ALARM] > [Nurse Call threshold] to set the alarm level at which the nurse will be called (i.e., low, middle or high). 3. Select [SETTINGS] > [ADVANCED] > [GENERAL] > [ALARM] > [Nurse Call relay type] to set the relay type to be [Normally close] or [Normally open]. 4. Select[SETTINGS] > [ADVANCED] > [GENERAL] > [ALARM] > [Nurse Call trigger mode] to set the trigger mode to be [continual] or [1s pause]. Warning: The Nurse Call function should not be used as the primary means of patient monitoring. The care team should evaluate alarms in combination with observations of the patient’s symptoms and overall physiological condition.

Rectal Temperature Taking Apply lubricant to the probe cover and insert it gently into the patient’s rectum only one-half inch to three-fourth inch (12 mm to 19 mm) for adults or one-fourth to one-half inch (6 mm to 13 mm) for children. Hold the probe still until there is a long beep and the temperature reading displays. Caution: If the monitor cannot take the temperature in quick temp mode, it will automatically change modes and output the results. The temperature measurement site and mode can only be changed when the probe is stored in its holding receptacle on the monitor. These settings cannot be changed when the probe is out. 5.4.3 Temperature Display 5.4.3 Temperature Display Temp value er. e

Probe Cover indicator

Measurement site Upper alarm limit

Temp unit of measure

Lower alarm limit

Alternate Temp value

Mode

5.4.4 Temperature Settings 1. Select [SETTING] > [ADVANCED] > [PARAMETERS] > [Temp] to enter the temperature setup menu. 2. Set [Unit] to [Celsius] or [Fahrenheit]. The selected measurement unit will be effective during the next measurement. 5.4.5 Safety Information • EU countries except Germany: Legal regulations for monitoring instruments apply to all EU countries except Germany. • Countries outside the EU:

6. Alarms Alarms are prompts given by the monitor for medical personnel through visual, audible and other means when either a vital sign appears to be abnormal or a technical problem occurs. Note: • The monitor generates all audible and visual alarms through a speaker, LED lights and the display. When the monitor powers on, the alarm LEDs will light once and the speaker will beep, which indicates that the alarm system is working properly. • Alarm settings are saved in real time, and then stored in the memory of the device. After a loss of power, the last stored settings will be shown after restarting the monitor. Warning: Do not set the alarm limits to extreme values that can render the alarm system useless. Vital signs alarm limits are pre-set by the manufacturer, but be sure to choose clinically appropriate limits for the patient. Only when the selected patient type is different from the last one, the alarm limits will return to factory defaults. 6.1 Alarm Categories The monitor’s alarms can be classified into three categories: physiologic alarms, technical alarms and prompt messages. Physiologic alarms: Physiologic alarms are triggered by a monitored parameter value (i.e., the DIA blood pressure value) that violates set alarm limits. Physiologic alarm messages are displayed in the physiologic alarm area. Technical alarms: Technical alarms are triggered by a device malfunction due to improper operation or system problems. The problems may result in system abnormal operation. Technical alarm messages are displayed in the technical alarm area. Prompt messages: As a matter of fact, prompt messages are not alarm messages. Apart from the physiological and technical alarm messages, the monitor will show some message to indicate the system status.

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6.2 Alarm Levels The monitor’s physiologic alarms are classified into three categories according to the severity of the alarm issue. High level alarms: Indicate that the patient is in a life-threatening situation and an emergency treatment is necessary. This is the highest level alarm. Medium level alarms: Indicate that the patient’s vital signs appear abnormal and an immediate treatment is required.

6.3.1 Alarm Tones The device will make the following sounds for different level alarms:

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Low level alarms: Indicate that the patient’s vital signs appear abnormal and an immediate treatment may be required. The monitor’s technical alarms are classified into three categories: high level, medium level and low level. Technical alarm levels are predefined at the factory and can’t be changed by users. The alarm levels are as follows:

Physiological alarm

Alarm level

SpO2 lower alarm limit exceeded

High

NIBP SYS high /low

Medium

.9F?= !P;==<=<

(GO

NIBP DIA high /low

Medium

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(GO

NIBP MAP high /low

Medium

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PR high /low

Medium

SpO2 high /low

High

TEMP high /low

Low

Search timeout

High

6.3 Alarm Indicators When an alarm occurs, the monitor will indicate it through the following means: Alarm tone: According to the alarm level, alarm sounds of different tones will emit from the speaker. Alarm Light: According to the alarm level, the alarm LED light on the monitor will flash in a different color and speed. Alarm message: Alarm messages will be displayed on the screen. Caution: The exact nature of the alarm depends on the specific alarm level.

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6.3.2 Alarm Lamp The device has two alarm lamps; one flashes as red/yellow, and the other flashes as cyan. When a physiologic alarm occurs, the alarm levels are indicated in the following visual ways:

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When a technical alarm occurs, the alarm levels are indicated in following visual ways:

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6.6.2 Setting Alarm Limits 1. Go to [Settings] > [Profile] and select [Monitor] to make sure the device is in this profile. This profile must be selected in order to access alarms settings and set alarm limits. 2. From the main measurement display, press anywhere in the Alarm Settings Area to access alarm limit settings. You can then set the upper and lower alarm limits. 3. The alarm limits can also be set up by selecting [Alarm] on the main measurement display and then selecting the tab for the alarm limits you wish to set (i.e., alarm limits for NIBP, PR, etc.).

K $R AFL=JN9DK

Caution: When multiple alarms of different levels occur at the same time, the monitor will issue visual and audible alarm indicators for the highest-level issues. If both the low level technical alarm and the low level physiologic alarm occur simultaneously, both of the two corresponding LED lights will be lit, one continuous yellow and the other continuous cyan. 6.3.3 Alarm Messages The system uses different background colors to distinguish alarm level messages. The background color for different alarm message levels is as follows: High level alarms: red Medium level alarms: yellow Low level alarms: yellow (Physiologic alarm), cyan (technical alarm) The number of * will indicate the relative alarm level in the message area as follows: High level alarms: *** Medium level alarms: ** Low level alarms: *. Caution: If several alarms occur, the highest-level alarm message will be displayed first. The latest alarm message will display first when the alarm level of two alarm messages is the same. You can manually change the displayed message in the alarm area to see other alarm messages.

Warning: Medical personnel should set alarm limits based on industry protocols, the clinical environment and their clinical experience. Before monitoring, please confirm whether alarm settings are suitable for the monitored patient. 6.7 Pausing Alarms Press the button

on the front panel of monitor to temporarily

suspend all alarm indicators. The icon

will appear in the status

area; press the button again to exit alarm pause status, the icon will disappear. When you pause alarms, the following will occur: • All the physiological alarms will be closed. • Only alarm messages in the technical alarm area will still be displayed. The light and volume of the technical alarm will be closed. • A 30-second countdown for the alarm pause period will appear in top right in a red bar across the top of the screen. After the alarm pause time has elapsed, the monitor will automatically cancel the alarm pause and return to normal status. If alarm conditions remain active, alarms will be active. To manually cancel the alarm pause at any time, select

.

6.8 Acknowledging Alarms

The alarm is active.

By selecting on the front panel of the monitor; you can acknowledge active physiological and technical alarms one by one. After you perform this action, the following occurs: • Visual alarms are open, but audible alarms are shut off. • “Acknowledged” will appear in front of the acknowledged physiologic alarm message. • Other remaining physiological and technical alarms will remain. If a new technical or physiological alarm occurs, the acknowledged alarms will not be influenced, and the system will produce audible alarms according to the level of the new alarms.

The alarm sound is off.

6.9 Alarm Reset

The alarm is paused

Press the button on the front panel of the monitor, you can reset all active physiological and technical alarms: • The auditory alarms are all shut off. • The visual alarm signals for any existing alarm conditions will continue as long as those alarm conditions exist. • Technical alarms about lead-off/sensor-off will be deleted. • After resetting the alarms, if a new technical alarm or physiological alarm occurs, the monitor will enable the audible alarms once again.

6.4 Alarm Icons The alarm is off.

6.5 Setting Alarm Volume 1. Select [Alarm] > [General]. 2. Select [Alarm Volume] and choose a desired value from [Low], [Medium], [High]; 3. At the same time, you can select [SETTINGS] > [ADANCED] > [General] > [Alarm] to set the Minimum Alarm Volume to be [Low], [Medium], [High]. Warning: Ensure that alarm volume is always higher than ambient noise which may occur. • If not, it may impede operator recognition of actual alarm and evtl. put patient in danger. 6.6 Alarm Parameters All alarm limits are adjustable. When the physical measurement value exceeds the alarm limit value, the alarm will be triggered. •

6.6.1 Alarm Switches To turn alarm limits on or off, select [SETTINGS] > [ADVANCED]> [PARAMETERS] > [Alarm limits status] and then choose the measurement type (i.e., NIBP, PR, SpO2 or Temp). To set the alarm to be [Alarm limits on] or [Alarm limits off]. When you select [Alarm limits off], the symbol will display in the status bar of the related parameter.

6.10 Alarm Volume off and on Only when the following setting steps are performed, function of the alarm volume off or on can be achieved. Select [SETTINGS] > [ADVANCED], input the correct password to enter the alarm control interface. In this interface, select [Allow control alarm audio]. Then go back to the main interface, select: [ALARM] to choose [Alarm audio on ] or [Alarm audio off].

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