About this Manual P/N: 01.54.458316 MPN: 01.54.458316012 Release Date: July 2020 © Copyright EDAN INSTRUMENTS, INC. 2019-2020. All rights reserved. Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User‘s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable.
Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.
Table of Contents Chapter 1 Intended Use and Safety Guidance ................................................................................ 1 1.1 Intended Use/Indications for Use ........................................................................................... 1 1.2 Safety Guidance ..................................................................................................................... 1 1.3 Explanation of Symbols on the Monitor .......................................................
7.3 Save and Review .................................................................................................................. 28 Chapter 8 Networking ..................................................................................................................... 29 8.1 Cybersecurity Measures ....................................................................................................... 29 8.1.1 Personal Information Safety.................................................................
15.1 Internal Forehead TEMP Module....................................................................................... 56 15.1.1 Measuring Procedure .............................................................................................. 56 15.2 Quick TEMP with F3000 Module ...................................................................................... 57 15.2.1 Introduction ............................................................................................................. 57 15.2.
19.4.2 Disinfecting the Reusable Accessories.................................................................... 86 19.5 Cleaning and Disinfecting Other Accessories .................................................................... 87 19.6 After Reprocessing ............................................................................................................. 87 19.7 Storage and Transport ........................................................................................................
Vital Signs Monitor User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1.1 Intended Use/Indications for Use The device is intended to be used for measuring, storing, and reviewing of, and to generate prompts for, multiple physiological parameters of adults, pediatrics and neonates. The device is intended for use by trained healthcare professionals in hospital environments. Parameters include: NIBP, SpO2, PR (pulse rate), TEMP.
Vital Signs Monitor User Manual Intended Use and Safety Guidance WARNING 9 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.
Vital Signs Monitor User Manual Intended Use and Safety Guidance WARNING 19 The packaging is to be disposed of according to local or hospital‟s regulations; otherwise, it may cause environmental contamination. Place the packaging at the place which is inaccessible to children. 20 Do not service or maintain the monitor or any accessory which is in use with the patient. 21 The appliance coupler or mains plug is used as isolation means from supply mains.
Vital Signs Monitor User Manual Intended Use and Safety Guidance WARNING 32 SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlet supplying the system. 33 SHOCK HAZARD - Don't connect electrical equipment, which has been supplied as a part of the system, directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer.
Vital Signs Monitor User Manual 1 Intended Use and Safety Guidance CAUTION Electromagnetic Interference - Ensure that the environment in which the patient monitor is installed is not subject to any sources of strong electromagnetic interference, such as radio transmitters, mobile telephones, microwaves, etc. 2 Keep the environment clean. Avoid vibration. Keep it far away from corrosive medicine, dust area, high temperature and humid environment. 3 Do not immerse transducers in liquid.
Vital Signs Monitor User Manual Intended Use and Safety Guidance 7 When there's measurement beyond range, invalid measurement or no measurement value, it will display -?-. 8 In normal use, the operator shall stand in front of the monitor. 1.
Vital Signs Monitor User Manual 14 IPX1 Intended Use and Safety Guidance Ingress Protection IPX1 (Protected against vertically falling water drops) (Applicable to the Stand) 15 Ingress Protection: IP44 (protected against splashing water and solid foreign objects ≥ 1.0 mm diameter) (Applicable to the monitor) 16 Non-ionizing electromagnetic radiation 17 AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 18 Caution: Federal (U.S.
Vital Signs Monitor User Manual Intended Use and Safety Guidance 30 Chargeable battery 31 Battery check 32 Alternating current 33 Direct current 34 Data communication 35 Internal Forehead TEMP measurement window (Sensor area) 36 Barcode scanning window 37 TEMP measurement (button) 38 AA battery 39 Anode for Battery 40 Cathode for Battery NOTE: The user manual is printed in black and white.
Vital Signs Monitor User Manual Basic Operation Chapter 2 Basic Operation This user manual describes all features and options. Your monitor may not have all of them; they are not all available in all geographies. Your monitor is highly configurable. What you see on the screen, how the menus appear and so forth, depend on the way it has been tailored for your hospital and may not be exactly as shown here.
Vital Signs Monitor User Manual Basic Operation Protection Shell for Host WARNING To avoid infection, protection shell must not touch injured skin. 2.1.
Vital Signs Monitor User Manual Basic Operation Front and Rear Power-on/Prompt Indicator/Standby Indicator When starting up, the indicator flashes once in order of three colors; When prompt occurs, the indicator keeps lighting in blue. When Standby indicator is turned on, the indicator lights in blue in standby mode. 2 Charging Indicator Lighting in yellow means charging; Lighting in green means full charge; Flashing in yellow means low battery; Indicator off in charging process means charging fault.
Vital Signs Monitor User Manual Basic Operation Left side and Right side 1 Internal Forehead TEMP measurement window (Sensor area) 2 Barcode scanning window 3 Internal Forehead TEMP measurement button 1 2 3 Top and Bottom Top and Bottom 1 SpO2 port: for connecting the parameter sensor 2 NIBP port: for connecting the parameter sensor 3 Charging or communication port: Used to connect the Stand for charging or communication 2.1.
Vital Signs Monitor User Manual Basic Operation 3 AC power supply indicator On: AC power is connected; Off: AC power is not connected 4 Heat sink 5 AC power input: for connecting AC power cable Left, Right, Bottom Left, Right, Bottom Left, Right Plug-in interface Bottom Heat sink 2.1.
Vital Signs Monitor User Manual Basic Operation Indicator, from top to bottom: Working indicator of the Stand Keeps lighting in green: connected with monitor and will respond to host monitor; Flashes in green: disconnected with monitor; Off: in Off status; 3 AC Power indicator of the Stand Keeps lighting in green: connected with AC power; Off: disconnected with AC power; Battery Power indicator of the Stand Keeps lighting in green: battery full; Keeps lighting in yellow: in charging; Flashes i
Vital Signs Monitor User Manual Basic Operation Work mode Prompts Date&Time, Icons Patient Info. Quick Admit (barcode scanning icon) Parameters data (value&waveform) Custom parameters Filing time Operator Info.
Vital Signs Monitor User Manual Basic Operation Function icons In ward round mode New patient Start a new Ward Round Set network query condition Refresh patient based on the network query condition Import patient based on the network query Patients from network query In ward round mode or spot-checking mode Barcode scanning Confirm and save the operation Search Delete More operations. Click to show more operations. Click again to exit.
Vital Signs Monitor User Manual Basic Operation Other icons Patient type: ADU Patient type: PED Patient type: NEO For module with forehead TEMP Measuring forehead TEMP Measuring oral TEMP in ADU mode Measuring oral TEMP in PED mode Measuring axillary TEMP in ADU mode For device with F3000 TEMP Measuring axillary TEMP in PED mode Measuring rectal TEMP in ADU mode Measuring rectal TEMP in PED mode 2.3 Work Mode The monitor offers multiple work modes: Ward Round and Spot-checking.
Vital Signs Monitor User Manual Basic Operation 2.4 Operating State 2.4.1 Standby Mode The following way can be used to enter into standby mode. Automatic standby: click Menu > Auto Standby > choose 1 min, 2 min, 5 min, 10 min, 30 min, or Never. The default setting is 1 min. If there is no measurement, prompt and operation in specified time, the monitor will enter standby mode automatically. User can also turn on or off the Standby Indicator. In standby mode: 1.
Vital Signs Monitor User Manual Basic Operation 2.5 Settings for Initial Start-up At initial start-up, user should set language, system time and User Maintain password. NOTE: Please keep the User Maintain password properly. For password modification, please refer to the section User Login. 2.6 Changing Monitor Settings 2.6.1 Adjusting Screen Brightness and Device Volume Select Menu > Volume&Brightness > to adjust the Key Volume or Prompt Volume, and Brightness.
Vital Signs Monitor User Manual Installation Chapter 3 Installation NOTE: The monitor installations and settings must be configured by the authorized hospital personnel. 3.1 Initial Inspection Before unpacking, check the packaging and ensure that there are no signs of mishandling or damage. If the shipping cartons are damaged, contact the carrier for compensation and package them again. Open the package carefully and remove the monitor and accessories.
Vital Signs Monitor User Manual Installation NOTE: 1 Check all the functions of the monitor and make sure that the monitor is in good status. 2 If rechargeable batteries are provided, charge them after using the device every time, to ensure the electric power is enough. 3 After long-time continuous running, please restart the monitor to ensure the monitor‟s steady performance and long lifespan. 3.5 Connecting Sensor to Patient Connect all the necessary patient sensors between the monitor and the patient.
Vital Signs Monitor User Manual Operator Information Chapter 4 Operator Information 4.1 User Login Before measurement, user can login first to set the operator information and other user configurations. 1. User login: Select Menu > Operator or click the shortcut key > manually set First Name, Last Name and ID, or directly click the barcode scanning icon on the upper right area to get operator information to login. 2. Barcode setting for user: Refer to chapter Using the Barcode Scanner. 3.
Vital Signs Monitor User Manual Custom Parameters Chapter 5 Custom Parameters The device allows user to input custom parameters which can be saved, filed and uploaded as measurement data. 1. Set the attribute of the custom parameters Click Menu > Custom Param. to complete relevant settings, and the main interface will display the custom parameters correspondingly. The settings include: The master switch of custom parameters: Switch Custom Param.
Vital Signs Monitor User Manual Ward Round Mode Chapter 6 Ward Round Mode Ward Round mode is optimized for rapid multi-patient vitals capture and multiple patient data management (maximum 1000 patients). 6.1 Create New Patient To create new patient, you may: 1. Press Admit/Create New Patient hardkey on the front panel, or 2. Click Select Patient shortcut key 3. Scan patient barcode by clicking the barcode scanning icon > click icon , or in main interface.
Vital Signs Monitor User Manual Ward Round Mode 6.2 Editing Patient Information To edit the patient information after a patient has been admitted, click the patient information area in main interface to enter Patient Info window, and make the required changes on the popup interface. Click the icon to confirm the operation. If the monitor is powered off and restarted, the patient information will be restored by default, that is, the patient type is adult and the other information is blank. 6.
Vital Signs Monitor User Manual Ward Round Mode 6.5 Choose Patient for Measurement Choose the patient for measurement and the patient information will be displayed in the main interface. Click shortcut key to enter the window of Select Patient: All patients are displayed in list. The mini circle on right of patient shows measurement status by colour.
Vital Signs Monitor User Manual Spot-checking Mode Chapter 7 Spot-checking Mode Spot-checking mode is used for spot-checking measurement and multiple patient data management. 7.1 Create New Patient To create new patient, you may: 1. Press Admit/Create New Patient hardkey on the front panel, or 2. Click New Patient shortcut key 3. Scan patient barcode by clicking the barcode scanning icon , or in main interface.
Vital Signs Monitor User Manual Spot-checking Mode 7.2 Editing Patient Information To edit the patient information after a patient has been admitted, click the patient information area in main interface to enter Patient Info window, and make the required changes on the popup interface. Click the icon to confirm the operation. If the monitor is powered off and restarted, the patient information will be restored by default, that is, the patient type is adult and the other information is blank. 7.
Vital Signs Monitor User Manual Networking Chapter 8 Networking The device can be connected to the wireless network and can be connected to hospital systems (such as HIS) via the HL7 protocol. If the monitor is networked, a network icon displayed on the screen. is 8.1 Cybersecurity Measures 8.1.1 Personal Information Safety Protecting personal health information is a major component of security strategy.
Vital Signs Monitor User Manual Networking CAUTION 7 When the monitor is returned for maintenance, disposed of, or removed from the medical institution for other reasons, it is necessary to ensure that all patient data are removed from the monitor (Refer to Section Formatting the Internal Storage Device). 8 To avoid malicious tampering and theft of data transmitted by the network, it is recommended to switch on the encryption function.
Vital Signs Monitor User Manual Networking If TLS is enabled, click Import Certificate to upgrade the Certificate via USB flash drive. The self-signed certificate of manufacturer is provided by default. However, the certificate issued by Certificate Authority (CA) is recommended and self-signed certificate should be avoided. The certificate format is as follows: For CA certificate, the fixed name ‗ca.cer‘ is supported; For client certificate, the fixed name ‗client.
Vital Signs Monitor User Manual Networking Network Type to select e-link. The e-link key supports 6 digits at most, and the default is 123456. Active Connection means receiving the measurement data from external TEMP module. Before connection, in Menu > e-link > Paired Devices, up to 10 paired devices can be viewed. For the paired devices, user can modify Alias or view MAC address, etc. In the Available Devices, the available devices can be viewed, and user can select the desired device to connect. 6.
Vital Signs Monitor User Manual Networking Please refer to chapter Ward Round Mode for details. NOTE: If a conflict occurs when the monitor is connected to network, please modify the last number of monitor‟s Local IP/Net No. (in ward round mode or spot-checking mode).
Vital Signs Monitor User Manual Prompts Chapter 9 Prompts The monitor can give the character indication of monitoring process or other functions. And this character is called prompts. Prompt sound Indicator light Prompts area Mode is ―DO‖, which is triggered once every 8~10 The indicator lights in The message with icon blue. displays in prompts area. seconds.
Vital Signs Monitor User Manual Prompt Information Chapter 10 Prompt Information 10.1 Physiological Prompt Message Cause SpO2 No Pulse The signal of the measurement site is too weak due to insufficient blood supply and environmental factors, so the monitor can‘t detect the pulse signal. SpO2 Desat SpO2 measuring value is below the SpO2 Desat Limit. 10.2 Technical Prompt Message Cause Action Taken SpO2 Sensor Off SpO2 sensor may be disconnected from the patient measuring site.
Vital Signs Monitor User Manual Message Prompt Information Cause Action Taken NIBP Leak NIBP pump, valve, cuff or tube has a leakage. Check the connections and the wrapped cuff to see whether they are all prepared well. If failure persists, please notify biomedical engineer or manufacturer‘s service staff. NIBP Over Pressure Pressure has exceeded the specified upper safety limit.
Vital Signs Monitor User Manual Prompt Information Message Cause Action Taken NIBP Interference Signal noise is too large or pulse rate is not regular due to the patient movement. Make sure that the patient under monitoring is motionless. During leak testing, deflation is failed. Check the connections and the wrapped cuff to see whether they are all prepared well. If failure persists, please notify biomedical engineer or manufacturer‘s service staff.
Vital Signs Monitor User Manual Message Prompt Information Cause Action Taken Stop using measuring function of TEMP module; notify biomedical engineer or Manufacturer‘s service staff. TEMP Error P6 Unable to pre-heat probe tip. NOTE: Measure readings displayed on the screen are unreliable when the monitor indicates Temp Error P06. Temp COMM Fail TEMP module failure or communication failure. Stop using measuring function of TEMP module; notify biomedical engineer or Manufacturer‘s service staff.
Vital Signs Monitor User Manual Prompt Information Message Cause Action Taken Battery1 Charge Voltage Too High The charging voltage in battery of the monitor is too high Please replace the battery. Device Overheated The temperature monitor is too high. Turn off the monitor in time and restart it after cooling. Recorder Out Of Paper Recorder Out Of Paper Please install the paper. Recorder Needed The user presses the Record button when Recorder is not configured.
Vital Signs Monitor User Manual Prompt Information Message Cause Quick Predict Over Quick prediction measurement is completed.
Vital Signs Monitor User Manual User Interface Chapter 11 User Interface Changing some settings may have the risk, so only the authorized person can change them. After changing the settings, please notify the operator. 11.1 Selecting Display Parameters The user can select the display parameters based on the monitoring and measurement requirements. Click Menu > Module Switch to enable or disable the parameter module. Exit the menu and the screen will adjust the parameters automatically. 11.
Vital Signs Monitor User Manual Monitoring SpO2 Chapter 12 Monitoring SpO2 12.1 Overview SpO2 is used to measure arterial blood oxygen saturation, which is the percentage of oxyhemoglobin in the arterial blood. SpO2 parameter can also provide pulse rate (PR) and a plethysmogram wave (Pleth). 12.2 SpO2 Safety Information WARNING 1 Do not use the SpO2 sensors if the packaging or the sensor is damaged and return them to the vendor.
Vital Signs Monitor User Manual Monitoring SpO2 it can be used to demonstrate that a particular monitor reproduces a calibration curve that has been independently demonstrated to meet a particular accuracy. 5 If the surrounding temperature increases, the operator should pay attention to the site of poor perfusion, and increase the frequency of checking the skin and changing the measurement site to prevent burns.
Vital Signs Monitor User Manual Monitoring SpO2 Applying Neonatal Finger (or Toe) Wrap Sensors: When you perform the measurement, position the sensor over the hand or foot with optical components opposite each other. Hold the sensor, and insert stretched strap into slot, hold it there while threading end through latch. If strap is too long, thread it through second latch. Connect the sensor with the monitor (or with the extension cable if needed). 3.
Vital Signs Monitor User Manual Monitoring SpO2 incorrect sensor application high levels of ambient light sources, such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight failure to cover the sensor with opaque material in high levels of ambient light conditions dysfunctional hemoglobins low peripheral perfusion excessive or violent patient movement venous pulsations intravascular
Vital Signs Monitor User Manual Monitoring SpO2 limit patient movement, check the placement of the sensor, measure another site or replace the sensor. NOTE: 1 The SpO2 accuracy has been validated in controlled human studies against arterial blood sample reference measured with a CO-oximeter. SpO2 measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements.
Vital Signs Monitor User Manual Monitoring SpO2 12.8 Setting Pitch Tone If tone modulation is on, the PR sound lowers when the SpO2 level drops. In Menu > Module Switch, select Pitch Tone to toggle between On and Off. The lower SpO2 value is, the lower the frequency of Pitch tone is. 12.9 Setting Sensitivity The different sensitivity indicates different refresh frequency. High indicates the refresh frequency of SpO2 value is the most frequent.
Vital Signs Monitor User Manual Monitoring PR Chapter 13 Monitoring PR 13.1 Overview The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart in beats per minute (bpm). You can obtain a pulse from any measured SpO2 signal or NIBP measurement. 13.2 PR Source PR source can be from SpO2 or NIBP, and is not selectable. SpO2 is preferred source if PR from SpO2 is valid. If PR is on, and SpO2 & NIBP both are off, PR parameter area will display No source. 13.
Vital Signs Monitor User Manual Monitoring NIBP Chapter 14 Monitoring NIBP 14.1 Overview This monitor uses the oscillometric method for measuring NIBP. It can be used for adult, pediatric and neonatal patients. It is also intended for use with pregnant, including pre-eclamptic patients. Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure.
Vital Signs Monitor User Manual Monitoring NIBP WARNING 9 Measuring of blood pressure can temporarily cause malfunctioning of other medical monitoring devices on the same limb. 10 NIBP readings can be affected by the measurement site, the position of the patient, exercise, or the patient's physiologic conditions. 11 Continuous cuff pressure due to connection tubing kinking can block the blood flow, and may result in injury to the patient.
Vital Signs Monitor User Manual Monitoring NIBP Patients with rapid blood pressure changes. Patients with severe shock or hypothermia that reduces blood flow to the peripheries. Patients with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery. Patients on an edematous extremity. 14.4 Measurement Methods There are three methods of measuring NIBP: Manual - measurement on demand.
Vital Signs Monitor User Manual Monitoring NIBP Section NIBP accessories), and make sure that the symbol "Φ" is over the artery. Ensure that the middle of the cuff is at the level of the right atrium of the heart and the cuff is not wrapped too tightly around the limb. Excessive tightness may cause discoloration and eventual ischemia of the extremity. Cuff Usage 3. Check whether the patient type is appropriately selected. Clicking patient information area can change patient Type. 4.
Vital Signs Monitor User Manual Monitoring NIBP 14.5.1 Operation Prompts Slide NIBP parameter area left to select and set: 1. Manual Measuring Click 2. or press the button on the front panel to start measurement. Continuous measurement Click to start measurement. The continuous measurement will last 5 minutes with a fix interval of 5 seconds. 3. AVG measurement Click 4. , set the interval and times, and click Confirm to start measurement.
Vital Signs Monitor User Manual Monitoring NIBP 14.7 Calibrating NIBP NIBP is not user-calibrated. Cuff-pressure transducers must be verified and calibrated, if necessary, at least once every two years by a qualified service professional. See the Service Manual for details. 14.8 Leakage Test Leakage test is used to detect the air tightness of the NIBP pump, valve, and trachea. If not, the system will display NIBP leakage.
Vital Signs Monitor User Manual Monitoring NIBP 14.9 Setting Inflation Value To change the inflation value: 1. Select Menu > Module Switch > Inflation value; 2. Choose AUTO or other inflation values from the pull-down list. If other inflation values are chosen, the preset value by users will be adopted as the inflation value when measuring blood pressure. If AUTO is chosen, the default value will be adopted as the inflation value when measuring blood pressure. 14.
Vital Signs Monitor User Manual Monitoring TEMP Chapter 15 Monitoring TEMP Before measurement, please click Menu > Module Switch > select the Unit (℃ or℉) for TEMP measurement. 15.1 Internal Forehead TEMP Module The device with forehead TEMP module takes a temperature at forehead. 1 WARNING This thermometer converts the forehead temperature to display its „oral equivalent‟ (according to the result of the clinical evaluation to get the offset value).
Vital Signs Monitor User Manual Monitoring TEMP WARNING Clean the sensor and surrounding area after each use to ensure an accurate reading and avoid cross contamination. NOTE: 1 In daily use, please protect the sensor to avoid damage. 2 If there is any temperature difference between the places where the device is stored and where you are going to measure, patient and the device should stay in the same room for at least 30 minutes before measurement.
Vital Signs Monitor User Manual Monitoring TEMP WARNING 1 Do not use this device near flammable anesthetics. Not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide. 2 Do not use this thermometer without first installing a new probe cover. 3 4 Do not reuse the disposable probe covers. Use probe covers supplied by the manufacturer with this thermometer only. Use of any other probe cover will result in erroneous temperature readings.
Vital Signs Monitor User Manual Monitoring TEMP 2. Regular preventive maintenance should be carried out every two years. You are responsible for any requirements specific to your country. 3. The reference body site temperature is the same as the temperature of the measuring site. 4. The cumulative use time for the oral or rectal temperature probe in a single patient should be less than 24 hours. 15.2.2 Probe Covers —Applying & Removing 1.
Vital Signs Monitor User Manual Monitoring TEMP 6. To change probes, remove the isolation chamber as described previously. 7. Grasp the sides of the L-shaped connector piece with one hand and then using other hand pull backward on the latch holding the end of the L-shaped connector. 8. Once free of the latch, slide the L-shaped connector out of isolation chamber. 9. To replace, properly align the top of the L-shaped connector to the slot on the back of the isolation chamber. 10.
Vital Signs Monitor User Manual Monitoring TEMP 15.2.5 Measuring Procedure Oral and Axillary Temperature Taking 1. Make certain that the Blue isolation chamber /probe unit is attached. 2. Withdraw probe and apply a probe cover. The thermometer turns on automatically and a beep will be heard when the probe completes warm-up. 3.
Vital Signs Monitor User Manual Monitoring TEMP 8. If three short beeps are heard, it means the unit switched to Monitoring Mode for this temperature only. 9. Two beeps are sounded when measurement is complete and the final temperature is displayed. 10. Eject the used cover into a bio-waste container by pushing top button. Rectal Temperature Taking 1. Make certain that the Red isolation chamber/probe unit is attached. 2. Withdraw the probe and apply a probe cover.
Vital Signs Monitor User Manual Monitoring TEMP 2 Low Temp. Mode can be activated only when measure mode is PREDICT. 3 Make sure all settings of TEMP Setup are properly set up every time before you withdraw the probe from the probe well. If you modify the settings immediately a measurement is completed, the new settings will be effective for the next measurement. 15.3 Infrared TEMP with TAT Thermometer 15.3.
Vital Signs Monitor User Manual Monitoring TEMP CAUTION 7 Never drop or insert any object into any opening, unless stated in this manual. 8 If the thermometer is not used regularly, remove the battery to prevent possible damage due to chemical leakage. 9 Disposal of used TAT scanner must be performed in accordance with current medical practices or local regulations regarding disposal of infectious, biological medical waste.
Vital Signs Monitor User Manual Monitoring TEMP ■ Clicking: Each fast click indicates a rise to a higher temperature, similar to a radar detector. Slow clicking indicates that the thermometer is still scanning, but not finding any higher temperature. ■ To Retain or Lock Reading: The reading will remain on the LED display for 30 seconds after button is released. If measuring room temperature, the temperature will remain on the LED display for only 5 seconds.
Vital Signs Monitor User Manual Monitoring TEMP ■ Environmental Effects The temp scanner measures the temperature of the surrounding environment. For this measurement to be accurate, it needs to have become acclimated to the temperature of the room in which it is to be used. CAUTION Allow the temp scanner to acclimate for at least 30 minutes before use if it is taken from a cold room into a hot room, or vice versa.
Vital Signs Monitor User Manual Monitoring TEMP 4. Read Temp Release ON button. Remove from head. Read value on probe and monitor. 5. Return scanner back to cradle (or when not in use) Lay the temp scanner probe into the cradle‘s fingers (probe). Gently lay the temp scanner down into the bottom of the cradle. The temp scanner may be gently pushed into the cradle until the retaining clips are engaged around the body of the temp scanner.
Vital Signs Monitor User Manual Monitoring TEMP Measure straight across the forehead and not down the side of the face. At the mid-line, the temporal artery is about 2 mm below the surface, but can go deeply below the surface on the side of the face. Brush the hair aside if covering the area to be measured. The Measurement site must be exposed. How to Improve Accuracy of Adult Measurements Non-insulated forehead: Measure only the up-side on a patient in a lateral position.
Vital Signs Monitor User Manual Monitoring TEMP Measure exposed skin: Brush the hair and bangs aside if covering the area to be measured. If an abnormally high or low reading is obtained: Repeat the reading with the same Temp scanner; a correct reading will be reproducible. Repeat the reading with another Temp scanner. Two Temp scanners with the same reading will confirm the reading.
Vital Signs Monitor User Manual Monitoring TEMP Type of Abnormal Possible Cause Temperature Action Taken Complete diaphoresis includes diaphoresis of area behind the ear and suggests that the temperature is rapidly dropping. Measuring a completely Use an alternative method of diaphoretic patient. temperature measurement in these cases until the patient is dry and the temporal artery measurement can be repeated. Scan straight across forehead.
Vital Signs Monitor User Manual Monitoring TEMP F/C Switch 15.3.6 Replacing TAT TEMP Scanner‟s Battery When the TAT temp scanner battery fails to hold a charge it will need to be replaced or if the TAT temp scanner will not be used regularly, remove the battery to prevent possible damage due to chemical leakage. Follow this procedure to remove/replace the battery: 1 Insert a pointed object (e.g.
Vital Signs Monitor User Manual 9 Monitoring TEMP Gently push down on the compartment door until the door is fully seated into the temp scanner‘s recess. A click should be heard when the latch is engaged. NOTE Use only high quality alkaline batteries in the TAT temp scanner.
Vital Signs Monitor User Manual Recording Chapter 16 Recording A thermal dot matrix recorder is used for the monitor and can support many recording types and output patient information, measurement data, review data waveform and so forth. 1 2 3 4 1 Recording indicator ON: recorder is in normal working; OFF: the monitor is powered off.
Vital Signs Monitor User Manual Recording 16.2 Recorder Operations and Status Messages 16.2.1 Record Paper Requirement Only standard thermosensitive record paper can be used: otherwise the recorder may not function, the recording quality may be poor, and the thermosensitive printhead may be damaged. 16.2.2 Proper Operation ■ When the recorder is working, the record paper goes out steadily. Do not pull the paper outward with force: otherwise the recorder may be damaged.
Vital Signs Monitor User Manual Recording 3. Ensure proper position and tidy margin. 4. Pull about 2 cm of the paper out, and close the recorder casing. NOTE: Be careful when inserting papers. Avoid damaging the thermo-sensitive print head. Unless when inserting papers or shooting troubles, do not leave the recorder catch open. 16.2.5 Removing Paper Jam When the recorder functions or sounds improperly, you should open the recorder casing to check for a paper jam.
Vital Signs Monitor User Manual Date Store Chapter 17 Date Store 17.1 Data Store In ward round mode, storage data maximally contains the following information: Round record Patient information, parameters data (SpO2, Minimum 20000 sets in internal NIBP, TEMP measurement data and custom storage parameters data), storage time, etc. In spot-checking mode, storage data maximally contains the following information: In internal storage, Minimum 20000 sets of spot-checking data for multiple patients 17.
Vital Signs Monitor User Manual Using Battery Chapter 18 Using Battery This monitor can run on disposable AA battery or rechargeable Lithium-ion battery, which ensures its uninterrupted operation even when AC power supply is interrupted. The battery recharges whenever the monitor is connected to the Stand part. The Stand part can be used to charge the monitor only when Lithium-ion battery is used. It is forbidden to use the Stand to charge the monitor when AA battery is used.
Vital Signs Monitor User Manual Using Battery WARNING 14 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal condition is detected during use, charge, or storage. Keep it away from the monitor. 15 Do not use a battery with serious scratch or deformation. 16 When the monitor is running on battery power, do not replace the battery during monitoring patients; or the monitor will be powered off, which may result in patient injury.
Vital Signs Monitor User Manual Using Battery 1. Disconnect the patient from the monitor and stop all monitoring and measurement. 2. Switch the monitor power on and fully charge the battery. 3. Disconnect AC power and let the monitor run until there is no battery power left and the monitor shuts off. 4. The running time of the battery reflects the battery performance.
Vital Signs Monitor User Manual Using Battery WARNING Do not disassemble batteries, put them into fire or cause them to short circuit. They may ignite, explode or leak, causing personal injury. 18.7 Maintaining the Battery Batteries should be conditioned regularly to maintain their useful life. Remove the batteries from the monitor if they are not used for a longer period of time. Avoid charging the battery for a longer period of time.
Vital Signs Monitor User Manual Care and Cleaning Chapter 19 Care and Cleaning Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. EDAN Instruments has validated the cleaning and disinfection instructions included in this User Manual.
Vital Signs Monitor User Manual Care and Cleaning Do not allow liquid to enter the case. Never use abrasive material (such as steel wool or silver polish). Inspect the monitor and reusable accessories after they are cleaned and disinfected. CAUTION If you spill liquid on the equipment, battery, or accessories, or they are accidentally immersed in liquid, contact your service personnel or EDAN service engineer. 19.
Vital Signs Monitor User Manual Care and Cleaning water at least for 1 minute until no visible cleaning agent remains. 7. Dry the host, the protection shell and the charger stand in a ventilated and cool place. 8. If the host, the protection shell or the charger stand is not visually clean at the end of the cleaning steps, please repeat the cleaning steps through step 4 to step 7. 9. Inspect the host, the protection shell or the charger stand to ensure that there is no damage. 10.
Vital Signs Monitor User Manual Care and Cleaning 3. Wipe the surfaces of the sensor and cable using a soft cloth dampened with the cleaning solution until no visible contaminants remain. 4. Wipe the patient contact area of the sensor with the cotton swab dampened with the cleaning solution. until no visible contaminants remain 5. After cleaning, wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains. 6.
Vital Signs Monitor User Manual Care and Cleaning CAUTION 1 Do not use any disinfectant containing additional active ingredients other than those listed, such as disinfectant didecyl dimethyl ammonium bromide which contains quanternary ammonium salt.
Vital Signs Monitor User Manual Care and Cleaning 7. After disinfection, wipe off the disinfecting agent with a new sterile cloth dampened with sterile water. 8. Dry the host, the protection shell and the charger stand for at least 30 minutes in a ventilated and cool place. 9. Inspect the host, the protection shell or the charger stand to ensure that there is no damage. 10. Reassemble the protection shell to the host, and then reassemble the host with the protective shell to the charger stand. 19.
Vital Signs Monitor User Manual Care and Cleaning 19.4.2.3 Disinfecting the TEMP Sensor The intracavitary TEMP sensors should be reprocessed by high-level disinfection before and after use on each new patient. Cidex OPA is the validated agent for high level disinfection. Refer to the instructions of the disinfectant for the methods of disinfection. High level disinfection has been validated with a 12 minute soak. Rinse and dry according to the labeled instructions of Cidex OPA.
Vital Signs Monitor User Manual Care and Cleaning – Avoid recontamination and damage during transport All further information on storage and transport included in the accompanying documents must be observed.
Vital Signs Monitor User Manual Maintenance Chapter 20 Maintenance WARNING 1 Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. 2 If you discover a problem with any of the equipment, contact your service personnel, or your authorized supplier.
Vital Signs Monitor User Manual Maintenance 20.2 Maintenance Task and Test Schedule Maintenance shall be carried out at least once every two years, or as specified by local regulations. The following tasks are for EDAN-qualified service professionals only. Contact an EDAN-qualified service provider if your monitor needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it. Maintenance and Test Schedule Frequency Safety checks.
Vital Signs Monitor User Manual Warranty and Service Chapter 21 Warranty and Service 21.1 Warranty EDAN warrants that EDAN‘s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: a) damage caused by mishandling during shipping. b) subsequent damage caused by improper use or maintenance. c) damage caused by alteration or repair by anyone not authorized by EDAN.
Vital Signs Monitor User Manual Warranty and Service FCC Regulatory Conformance: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference. (2) This device must accept any interference received, including interference that may cause undesired operation. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
Vital Signs Monitor User Manual Accessories Chapter 22 Accessories You can order accessories from EDAN supplies at www.edan.com.cn or consult your local EDAN representative for details. WARNING 1 Never reuse disposable transducers, sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard. 2 Use only EDAN-approved accessories.
Vital Signs Monitor User Manual Accessories Part Number Accessories 01.57.471328 NIBP Cuff, Child E7, 16 cm-21.5 cm, reusable 01.57.471327 NIBP Cuff, Small child E6, 13 cm-17 cm, reusable 01.57.471326 NIBP Cuff, Infant E5, 10 cm-15 cm, reusable 01.57.471323 NIBP Cuff, Neonate, 10 cm-15 cm, reusable 01.57.471324 NIBP Cuff, Neonate, 6 cm-11 cm, reusable 01.57.471157 Single Patient Use NIBP Cuff, neonatal #1, 3 cm-6 cm, soft disposable 98-0400-99 01.57.
Vital Signs Monitor User Manual Accessories 22.4 Other Accessories Part Number Accessories 01.21.064397 Rechargeable Li-ion Battery Pack, ID1028, 1ICP6/47/40-2, 3.8 V, 2800 mAh 01.51.412666 Protection shell for monitor 01.13.036638 Power cable, European standard 01.13.037122 Power cable, American standard 01.57.78035 Recorder paper 02.04.101976 Rolling Stand Basket (in the bottom) 83.60.
Vital Signs Monitor User Manual Product Specification A Product Specification NOTE: The performance of the equipment with ☆ mark is determined to be essential performance. A.1 Classification Anti-electroshock type Class I equipment and internal powered equipment Anti-electroshock degree SpO2, NIBP: CF TAT TEMP, F3000 TEMP: BF Ingress Protection Monitor: IP44 (protected against splashing water and solid foreign objects ≥ 1.
Vital Signs Monitor User Manual Product Specification Size (CS-04 Charger Stand) (165±1) mm (L) × (113±1) mm (W) × (164±1) mm (H) Size (CS-05 Extended Stand) (165±1) mm (L) × (113±1) mm (W) × (164±1) mm (H) Weight (CS-04 Charger Stand) < 900 g Weight (CS-05 Extended Stand) < 2000 g (including recorder, not including TEMP module and accessories) A.2.
Vital Signs Monitor User Manual Product Specification Temperature +0 C to +40 C (32 ℉~104 ℉) Working The internal forehead TEMP: 10 C ~ +40 C (50 ℉~104 ℉) -20 C to +55 C (-4 ℉~131 ℉) Transport and Storage Humidity Working 15%RH ~ 95%RH (non-condensing) Transport and Storage 15%RH ~ 95%RH (non-condensing) Altitude Working 86 kPa ~ 106 kPa Transport and Storage 70 kPa ~ 106 kPa CS-04 Charger Stand Power Supply 100 V-240 V~, 50 Hz/60 Hz Current: 0.5 A-0.
Vital Signs Monitor User Manual Product Specification A.2.5 Battery Specification Battery of the monitor Number AA battery: 3 Lithium-ion battery: 1 Battery Type Disposable AA battery or rechargeable Lithium-ion battery Capacity AA battery: 3*1.5 V Lithium-ion battery: 3.
Vital Signs Monitor User Manual Product Specification A.
Vital Signs Monitor User Manual Product Specification Pre-inflation Pressure Adult Mode Default: 160 mmHg Range: mmHg Pediatric Mode Auto/80/100/120/140/150/160/180/200/220/240 Default: 140 mmHg Range: Auto/80/100/120/140/150/160/180/200 mmHg Neonatal Mode Default: 100 mmHg Range: Auto/60/70/80/100/120 mmHg A.
Vital Signs Monitor User Manual Product Specification A.5 PR Measuring range Accuracy Resolution 1 bpm PR (SpO2) EDAN 25 bpm to 300 bpm 2 bpm PR (NIBP) EDAN 40 bpm to 240 bpm ±3 bpm or 3.5%, whichever is 1 bpm greater A.6 TEMP Internal Forehead TEMP Measuring method Infrared measurement Measuring Mode Indirect measurement Measuring site Forehead ☆Measuring range 34 C ~ 43 C Unit C, ℉ Resolution 0.1 C ☆Accuracy 34 C ~ 35 C: 0.3 C 35 C ~ 43 C: 0.
Vital Signs Monitor User Manual insertion into measurement site) Product Specification (8~10) s (fever temps) Oral (Predictive Mode): (6~10) s Axillary: (8~12) s Rectal: (10~14) s Monitoring Mode (all sites): (60~120) s Measuring Mode Direct Mode /Adjusted Mode Transient Response Time ≤30 s monitoring mode Clinical Bias (-0.2 to -0.4 )C Limits of Agreement 0.49 Stability 0.
Vital Signs Monitor User Manual Product Specification EMI and RFI Protection Stainless steel enclosure on upper part inside of casing Storage Conditions -4 ℉ to 122 ℉ (-20 °C to 50 °C) Display Type and Size Large bright LED's Construction Method • • • • Warranty Lifetime Industrial duty impact resistant casing Chemically resistant casing and lens Hermetically sealed sensing system Stainless steel probe NOTE: 1 Automatically applied when temperature is within normal body temperature range, othe
Vital Signs Monitor User Manual Product Specification A.8 e-link Radio Technology BR, EDR, BLE Frequency Range 2402 MHz ~ 2480 MHz Modulation GFSK, π/4-DQPSK, 8-DPSK Output power <20 dBm Transmit rate Classic: 1 Mbps, 2 Mbps, 3 Mbps BLE: 1 Mbps Bandwidth Classic: 1 MHz BLE: 2 MHz A.9 USB Interface USB Interfaces 2, USB 2.
Vital Signs Monitor User Manual EMC Information B EMC Information - Guidance and Manufacture’s Declaration B.1 Electromagnetic Emissions Guidance and manufacture’s declaration – electromagnetic emission iM3s is intended for use in the electromagnetic environment specified below. The customer or the user of iM3s should assure that they are used in such an environment.
Vital Signs Monitor User Manual EMC Information 8 kV contact 8 kV contact 15 kV air 15 kV air 2 kV for power supply lines 2kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment. Surge 1 kV for line to line IEC/EN 61000-4-5 2 kV for line to ground 1 kV for line to line Mains power quality should be that of a typical commercial or hospital environment.
Vital Signs Monitor User Manual EMC Information B.3 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity iM3s is intended for use in the electromagnetic environment specified below. The customer or the user of iM3s should assure that they are used in such an environment.
Vital Signs Monitor User Manual EMC Information Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
Vital Signs Monitor User Manual 710 EMC Information 704-787 LTE Band 13, 17 Pulse modulation b) 217 Hz 0.2 0.3 9 800-960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation b) 18 Hz 2 0.3 28 1700-1990 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS Pulse modulation b) 217 Hz 2 0.3 28 2450 2400-2570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation b) 217 Hz 2 0.3 28 5240 5100-5800 WLAN 802.
Vital Signs Monitor User Manual Rated maximum output power of transmitter EMC Information Separation distance according to frequency of transmitter(m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz (W) d 1.2 P d 1.2 P d 2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.
Vital Signs Monitor User Manual Default Settings C Default Settings This appendix documents the most important default settings of your monitor as it is delivered from the factory. Note: If your monitor has been preconfigured according to your requirements, the settings at delivery will be different from the default settings listed here. C.
Vital Signs Monitor User Manual Default Settings C.3 SpO2 Default Settings SpO2 Settings Pitch Tone On Sensitivity Medium Sweep 6.25 mm/s SpO2 Desat 80% C.4 PR Default Settings PR Settings PR Source SpO2 Pulse Volume Medium C.5 NIBP Default Settings NIBP Settings ADU PED NEO Inflation value 160 140 100 Unit mmHg Interval (Average) 1 minute Measurement times (Average) 3 C.
Vital Signs Monitor User Manual Abbreviations D Abbreviations Abbr English Full Name/Description AC Alternating current Adu Adult Art Arterial BP Blood pressure BTPS Body temperature and pressure, saturated CI Cardiac index CISPR International Special Committee on Radio Interference COHb Carboxyhemoglobin DC Direct current Dia Diastolic DoS Denial of Service DDoS Distributed Denial of Service EEC European Economic Community EMC Electromagnetic compatibility EMI Electromagnet
Vital Signs Monitor User Manual Abbreviations Abbr English Full Name/Description MRI Magnetic resonance imaging N/A Not applied Neo Neonate NIBP Non-invasive blood pressure O2 Oxygen OxyCRG Oxygen cardio-respirogram Ped Pediatric Pleth Plethysmogram PR Pulse rate PVC Premature ventricular complex R Right RA Right arm RAP Right atrial pressure RHb Reduced hemoglobin RL Right leg RR Respiration Rate Sev Sevoflurane SYS Systolic pressure SpO2 Pulse Oxygen Saturation TB
