DPM 3 Vital Signs Monitor Operator’s Manual
Revision History This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice. Revision number: 5.0 Release time: 2011-12 © Copyright 2008-2011 Mindray DS USA, Inc. All rights reserved. WARNING Federal Law (USA) restricts this device to sale by or on the order of a physician.
Intellectual Property Statement Mindray DS USA, Inc. (hereinafter called Mindray DS) owns the intellectual property rights to this product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the copyright and the patent rights of Mindray DS, nor the rights of others. Mindray DS intends to maintain the contents of this manual as confidential information.
Manufacturer’s Responsibility All information contained in this manual is believed to be correct. Mindray DS shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing or use of this manual.
Return Policy In the event that it becomes necessary to return a unit to Mindray DS, follow the instructions below. 1. Return authorization. Contact the Customer Service Department and obtain a Customer Service Authorization number. This number must appear on the outside of the shipping container. Returned shipments will not be accepted if the number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return. 2.
Preface Manual Purpose 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 question, please contact us. This manual is an integral part of the product.
FOR YOUR NOTES 2
Contents 1 Safety................................................................................................................................. 1-1 1.1 Safety Information .......................................................................................................... 1-1 1.1.1 Warnings............................................................................................................. 1-2 1.1.2 Cautions ....................................................................................
4.2.1 Common Setup................................................................................................... 4-2 4.2.2 Network Setup.................................................................................................... 4-3 4.2.3 Time Setup ......................................................................................................... 4-4 4.2.4 User Maintenance............................................................................................... 4-4 4.2.
7.1 Introduction..................................................................................................................... 7-1 7.2 Safety .............................................................................................................................. 7-2 7.3 Monitoring Procedure ..................................................................................................... 7-3 7.4 Measurement Limitations..........................................................................
A.6 SpO2 Specification ........................................................................................................ A-4 A.6.1 Mindray DS SpO2 Specification....................................................................... A-4 A.6.2 Masimo SpO2 Specification ............................................................................. A-5 A.6.3 Nellcor SpO2 Specification .............................................................................. A-6 A.7 NIBP Specification.................
1 Safety 1.1 Safety Information The safety statements presented in this chapter refer to the basic safety information that the operator shall pay attention to and abide by. There are additional safety statements in other chapters or sections, which may be the same as or similar to the followings, or specific to the operations. WARNING Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.
1.1.1 Warnings WARNING This monitor is not applicable for prolonged and continuous SpO2 monitoring, which may increase the risks of irritation and burns at the site of the sensor. This monitor is not applicable for prolonged and continuous temperature monitoring for more than 5 minutes. This monitor is intended for use by qualified clinical physicians or well-trained nurses in the specified places.
1.1.2 Cautions CAUTION To ensure patient safety, use only parts and accessories specified in this manual. Remove the battery from the monitor if it will not be used or not be connected to the power line for a long period. Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur.
1.1.3 Notes NOTES Put the equipment in a location where you can easily see the screen and access the operating controls. This monitor complies with the requirements of CISPR11 (EN55011) class A. The software was developed per IEC60601-1-4. The possibility of hazards arising from program errors is minimized. Put the monitor in a location where you can easily see the screen and access the operating controls. The instructions of this manual are based on the maximum configuration.
SET ALARMS NurseCall output DISPLAY RS-232 connector INTERVAL Date of manufacture European community representative Manufacturer RECORD Serial number Alarm Silenced Network connector Classified by Underwriters Laboratories Inc. with respect to electric shock, fire and mechanical hazards, only in accordance with UL 60601-1, CAN/CSA C22.2 NO.601-1, IEC 60601-1-1, IEC 60601-2-30, IEC 60601-2-49. The following definition of the WEEE label applies to EU member states only.
FOR YOUR NOTES 1-6
2 The Basics 2.1 Monitor Description 2.1.1 Intended Use This device is to monitor physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for transport. WARNING This device is to be operated by clinical physicians or appropriate medical staffs under the direction of physicians. The operator of the monitor must be well tranined.
2.1.3 Components This monitor is composed of a main unit, NIBP cuff, SpO2 sensor and TEMP probe. Note that some of the mentioned parts are optional and may not be found in your monitor. 2.1.4 Functions This monitor has the following functions and features: SpO2 measurement: pulse oxygen saturation (SpO2), pulse rate (PR), and SpO2 plethysmogram. NIBP measurement: systolic pressure (S), diastolic pressure (D), mean pressure (M), and pulse rate (PR). TEMP measurement: temperature (TEMP).
2.2 Appearance 2.2.
1. Alarm indicator The alarm indicator of this monitor is in compliance with the requirement of EN60825-1 A11 Class 1 for LED. The LED indicator varies its flash color and frequency to indicate different alarm levels. For details, refer to 5.2.1 Alarm Lamp. 2. SYS This LED displays the systolic pressure reading in the NIBP measurement. 3. DIA This LED displays the diastolic pressure reading in the NIBP measurement. At the right side of the NIBP reading, it is the NIBP unit: kPa or mmHg.
12. Battery indicator It indicates the status of the battery. For details, refer to 2.4 Battery. 13. AC power indicator ON: It indicates that the AC power is applied to the monitor; OFF: It indicates that the monitor is not applied to the monitor. 14. Patient type indicator It indicates the patient types: respectively adult, pediatric and neonate from left to right. 15.
23. OK Press this key to select the highlighted option. In the trend view, pressing this key pops up the REVIEW SETUP menu. 24. Down Press this key to move the cursor down. 25. INTERVAL Press this key to switch between the INTERVAL menu and the Normal screen.
2.2.2 Rear Panel 1 2 3 4 6 5 7 Figure 2-2 Rear Panel 1. TEMP probe sheath 2. TEMP probe connector 3. RS-232 connector:: used to connect the bar code scanner. 4. Nurse call connector: used to connect the monitor to the hospital’s nurse call system. 5. Network connector: used to connect the monitor to the CMS or PC. 6. Equipotential grounding connector: connects the equipotential grounding connectors of other devices. 7.
2.2.3 Recorder The recorder is on the left side of the monitor. See the following figure. Power indicator Paper outlet Recorder door Figure 2-3 Recorder For details about the recorder, refer to 6 Recording .
2.3 Display 1 2 3 Figure 2-4 Display This monitor adopts the LCD display. It is able to display the following three parts: 1. Patient information area This area displays patient ID, patient category and alarm status symbol. 2. PLETH wave/NIBP timing area This area displays the PLETH wave and/or NIBP timing. 3. Alarm information area On the left of this area is the technical alarm message or prompt message. If there are multiple messages, they will be displayed circularly.
2.4 Battery Rechargeable batteries can be used to supply power to the monitor where AC mains is unavailable or whenever the power supply is interrupted. The battery is charged automatically when the monitor is connected to AC mains till it is full. If the power supply is lost during monitoring, the monitor can run on internal battery. The battery indicator indicates the status of the battery. ON: The battery is being charged or the battery is fully charged.
2.4.1 Battery Maintenance 2.4.1.1 Conditioning a Battery A battery needs at least two conditioning cycles when it is used for the first time. A battery conditioning cycle is one uninterrupted charge of the battery, followed by an uninterrupted discharge of the battery. Batteries should be conditioned regularly to maintain their useful life. Condition a battery once when it is used or stored for two months, or when its run time becomes noticeably shorter. To condition a battery, follow this procedure: 1.
NOTE Life expectancy of a battery depends on how frequent and how long it is used. For a properly maintained and stored lead-acid or lithium ion battery, its life expectancy is about 2 or 3 years respectively. For more aggressive use models, life expectancy can be less. We recommend replacing lead acid batteries every 2 years and lithium ion batteries every 3 years. The operating time depends on the configuration and operation.
3 Installation and Maintenance 3.1 Installation WARNING The installation of the monitor must be carried out by personnel we authorize. The software copyright of the monitor is solely owned by our company. Any action to change, copy or exchange the software by any organization or person is regarded as copyright infringement and is not allowed. 3.1.1 Unpacking and Checking Before unpacking, examine the packing case carefully for signs of damage.
3.1.2 Environmental Requirements The operating environment of the monitor must meet the requirements specified in the section A.2 Environmental Specifications The environment where this monitor is to be used should be free from noise, vibration, dust, and corrosive or explosive and inflammable substances. For a cabinet mounted installation, allow sufficient room at the front and the rear of the cabinet for operation, maintenance and servicing.
3.1.5 Installation Method WARNING Equipments connected to this monitor must be certified according to the respective IEC standards (e.g. IEC 60950 for information technology equipment and IEC 60601-1 for medical electrical equipment). Furthermore all configurations shall comply with the valid version of IEC 60601-1-1. Any person who connects additional equipment to the signal input or signal output is responsible to ensure the system complies with the requirements of the valid version of IEC 60601-1-1.
3.1.5.2 Installing the battery The battery compartment is located at the bottom of the patient monitor. Follow the steps given below to install the battery. 1. Push the compartment door in the marked direction to open the door. 2. Flip the battery stopper to the left, as Figure 3-1 shows. 3. Follow the marked polarity to insert the battery into the compartment, as Figure 3-2 shows. 4. Push the battery to the bottom and flip the stopper back to the original position, as Figure 3-3 shows. 5.
Figure 3-3 NOTE Be sure to charge the battery after a long-term storage or when you find the battery energy is low. A low-energy battery may not provide enough power to start the patient monitor. To charge the battery, connect the AC power to the monitor. The battery will be charged regardless the monitor is on or off. 3.1.5.
3.1.5.5 Connecting the network cable The network connector of the monitor is a standard RJ45 connector. It connects the monitor with the specified central monitoring system, or with a PC for software upgrade and data export. To connect the monitor with CMS or PC, 1. Connect one end of the network cable to the network connector of the monitor. 2. Connect the other end of the network cable to the hub of the central monitoring system, or to the network connector of a PC.
3.1.6 Powering on the Monitor After installing the monitor, please power on it in the following procedure: 1. Before using the monitor, please carry out corresponding safety inspection in accordance with Section 3.2.1Inspection. 2. Press the Power Switch on the control panel. A beep will be heard. 3. The system starts self-test and the start-up screen will be displayed. 4. Several seconds later, the system finishes the self-test and displays the Normal screen. 5.
3.2.1 Inspection Make sure the qualified service personnel have implemented a complete inspection before putting the monitor into operation, after monitor servicing or system upgrading, or after the monitor has been used for 6-12 consecutive months. This is to ensure the normal operation of the system. Check that The environment and the power supply meet the specified requirements. The monitor surface is free from stains.
The exterior surfaces of the equipment may be cleaned with a clean and soft cloth, sponge or cotton ball, dampened with a non-erosive cleaning solution. Drying off excess cleaning solution before cleaning the equipment is recommended.
3.2.3 Disinfection WARNING Disinfection may cause damage to the equipment; therefore, when preparing to disinfect the equipment, consult your hospital’s infection controllers or professionals. The cleaning solutions above can only be used for general cleaning. If you use them to control infections, we shall assume no responsibility for the effectiveness. Disinfection may cause damage to the equipment.
4 Menus and Screens 4.1 Patient Information The figure shows the PATIENT INFORMATION menu. Figure 4-1 In the PATIENT INFORMATION menu, you can set: PATIENT ID: The system automatically creates a patient ID each time the monitor is turned on. You can also: Input a patient ID by scanning the bar code: In the event BARCODE POWER is switched on, you can scan the bar code information using a bar code scanner. The PATIENT INFORMATION menu pops up if the bar code is sucessfully identified.
NOTE The system automatically creates a patient ID each time the monitor is turned on. Select appropriate patient type each time a patient is admitted. If you need to change patient type after the patient has been admitted, switch off QUICK ADMIT; press and then change PATIENT TYPE in the pop-up PATIENT INFORMATION menu. If you need to admit a patient in the event both BARCODE POWER and QUICK ADMIT are set to OFF, switch either of them on.
In the following circumstance, the setting of ALARM VOL may be lower than the setting of MIN ALARM VOL. In this case, ALARM VOL is automatically adjusted according to MIN ALARM VOL. Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password; and then change MIN ALARM VOL in the pop-up menu.
4.2.3 Time Setup In the SYSTEM SETUP menu, select TIME SETUP. In the TIME SETUP menu, you can set the following items. 1. 2. DATE FORMAT: You can set DATE FORMAT to any of the following formats: YY-MM-DD MM-DD-YY DD-MM-YY System time: you can set the year, month, day, hour and minute respectively as required. 4.2.4 User Maintenance Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password.
4.2.5 Nurse Call Setup Select SYSTEM SETUP→MAINTAIN→NURSE CALL. You can set the following items in the pop-up menu: SIGNAL DURATION 1. CONTINUUM It indicates that the nurse call signal duration is the same with the alarm duration, namely, the nurse call signal lasts from the beginning of the alarm to the end of the alarm. 2. PULSE It indicates that the nurse call signal is a pulse signal whose duration is 1s.
WARNING Then nurse call settings shall not be changed by non-medical staff. 4.2.6 Version Select SYSTEM SETUP→MAINTAIN→VERSION, you can view information on the monitor’s hardware version and software version. 4.2.7 Configuration 4.2.7.1 Presetting Configuration If the monitor is turned off for less than 60 seconds, last configuration will be loaded automatically when it is restarted.
4.2.7.3 Resuming Default Configuration In actual applications, the operator may change some settings. However, these changes may not always be appropriate or correct, particularly for a newly admitted patient. The monitor has the function of loading factory configuration so that you can resume the factory default configuration as desired. You can also load the saved user configuration. 1. In the SYSTEM SETUP menu, select DEFAULT. 2. Select LOAD FACTORY CONFIG or LOAD USER CONFIG. 3.
4.4 Trend Screen The Trend screen displays systolic pressure (S), diastolic pressure (D) and mean pressure (M), SpO2, PR and TEMP, as shown in the figure below. Up to 1200 groups of data can be stored. The monitor stores trend data in either of the following modes: For SpO2 and TEMP values in monitor mode, the trend data is sampled value. The time interval of sampling is 30 seconds. Additionally, the last value obtained before the “SENSOR OFF” or “TEMP SENSOR OFF” alarm occurs will also be stored.
DELETE: By selecting DELETE, you can toggle between CURRENT ITEM, ITEMS OF CURRENT ID, or ITEMS OF ALL ID. Then select OK to respectively delete the current trend data, all trend data of current ID, or data of all ID. 4.5 Standby State 4.5.1 Entering the Standby State To enter the Standby state, press for less than 2 seconds and then select OK in the CONFIRM STANDBY STATE dialog box. 4.5.2 Exiting the Standby State In the Standby state, press any key on the front panel of the monitor.
4.6 Patient Review System Software The monitor can be configured with the optional patient review system software (hereafter called PrsView software ) to implement the following functions: Exporting data; Viewing exported data; Editing patient information; and Printing data. Refer to PrsView software instructions for installation and help information for detailed software instructions for use.
5 Alarms 5.1 Overview The monitor gives audible or visual alarms to indicate the medical staff when a vital sign of the patient appears abnormal, or mechanical or electrical problems occur to the monitor. WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area, e.g. an intensive care unit or cardiac operating room. NOTE For details about alarm setup of this monitor, please refer to 5.5 Setting Alarms. 5.1.
5.1.2 Alarm Levels By severity, the alarms of this monitor are divided into three priority levels: high level alarms, medium level alarms and low level alarms. 1. High level alarms The patient is in danger and requires emergency treatment, or A serious technical problem occurs to the monitor, such as an error in the NIBP module self-test. 2.
5.2.1 Alarm Lamp When an alarm occurs, the alarm lamp on the front panel of the monitor flashes in different color and frequency to match the alarm levels as follows: High level alarms: the lamp quickly flashes red. Medium level alarms: the lamp slowly flashes yellow. Low level alarms: the lamp turns yellow without flashing. 5.2.2 Audible Alarms The monitor uses different alarm tone patterns to indicate different alarm levels. High level alarm: “DO-DO-DO--DO-DO---DO-DO-DO--DO-DO”.
5.3 Alarm Status Apart from the aforementioned alarm indicators, the patient monitor still uses symbols to indicate the alarm status: You can set alarms to the following status as desired: Audio off: is displayed at the right side of patient information area and a prompt message “AUDIO ALARM OFF” appears at the right side of the alarm information area.
WARNING If alarm tones are switched off, the monitor does not give audible alarm signal even if new alarms occur. So take care when you switch off alarm tones. 5.3.2 Physiological Alarm Off If alarms related to a parameter are switched off, the monitor does not generate alarms even if the measured parameter values exceed the alarm limit. This status is called Alarms Off. To disable the alarms of a parameter, you need to open SET ALARMS menu .Take NIBP (Non-Invasive Blood Pressure) as an example. 1.
In the alarm paused status, All alarm indications are disabled when a new physiological alarm occurs. Alarm lamp flashing and alarm tone are disabled and only alarm message is displayed when a new technical alarm occurs. The monitor automatically exits the alarm paused status when the alarm pause time expires. You can also press to manually leave the larm paused status. 5.3.4 Alarm Silenced You can silence alarms by press and hold for more than 2 seconds.
5.4 Clearing Alarm Indications 1. Clearing alarm light flashing and alarm tones For some technical alarms, the alarm lamp flashing and alarm tones are cleared and the alarm messages change to prompt messages during and after the alarm paused period if is pressed for less than 2 seconds. If the technical alarm is triggered again after the monitor restores to the normal status, the monitor will give alarm indications as normal.
When any of the SpO2 or PR values exceeds the alarm limits, an alarm will be triggered. The ranges of SpO2 and PR limits are listed below: SpO2 module SpO2 PR Mindray DS SpO2 0 to 100％ 0 to 254 bpm Masimo SpO2 0 to 100％ 25 to 240 bpm Nellcor SpO2 0 to 100％ 20 to 250 bpm 5.6 SpO2 Sensor Off Alarm Select SYSTEM SETUP→MAINTAIN→USER MAINTAIN; enter required password and set SPO2 SENSOR OFF to HIGH, MED, LOW or OFF in the pop-up menu.
6 Recording 6.1 Overview A thermal recorder can be installed on the left side panel of the monitor to print: Real-time PLETH waveform. Currently displayed trend data. All trend data of the current patient. 6.2 Using the Recorder 6.2.1 Printing Real-time PLETH waveform 1. Press to enter the PLETH screen. 2. Press for less than 2 seconds to print the currently displayed PLETH waveform. 6.2.2 Printing Currently Displayed Trend Data 1. Enter the Trend screen. 2.
6.3 Loading Paper 1. Press the latch at the upper right of the recorder door to open the door. 2. Lift the roller lever located at the upper left of the recorder as shown in the following figure. 3. Install a new roll of paper into the compartment as shown below. The roller scrolls automatically to send the paper out of the compartment. 4. Push down the roller lever. 5. Close the recorder door. Paper roll Figure 6-1 Installing Recording Paper CAUTION Use only specified thermal paper.
6.4 Removing Paper Jam If the recorder works improperly or produces unusual sound, check whether there is a paper jam. If yes, remove it following this procedure: 1. Open the recorder door. 2. Take out the jammed paper and tear off the draped part. 3. Lift the lever on the upper left of the recorder. 4. Draw out the paper from the paper inlet. 5. Reload the paper and close the recorder door.
FOR YOUR NOTES 6-4
7 SpO Monitoring 2 This monitor can be equipped with any of the following SpO2 modules: Mindray DS SpO2 module Masimo SpO2 module Nellcor SpO2 module. A monitor, equipped with a Masimo or Nellcor SpO2 module, is marked by “Masimo SET” or “Nellcor” at the lower left corner of the front panel. The following pages respectively gives introduction to the above three SpO2 modules. Please read this chapter according to your monitor configuration before operation. 7.
7.2 Safety WARNING Use only SpO2 sensors specified in this manual. Follow the SpO2 sensor’s instructions for use and adhere to all warnings and cautions. When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a co-oximeter to completely understand the patient’s condition. Do not use SpO2 sensors during magnetic resonance imaging (MRI). Induced current could potentially cause burns.
NOTE Place the SpO2 sensor cable along the backside of patient’s hand. Make sure the fingernail is just opposite to the light emitted from the sensor. SpO2 waveform amplitude is not proportional to the pulse strength. SpO2 value is not proportional to the pulse rate. 7.3 Monitoring Procedure 1. Power on the monitor. 2. Remove colored nail polish from the application site. 3. Apply the sensor to the patient. 4.
7.5 Masimo Information The MASIMO SET® Product ® Masimo Patents This device is covered under one or more of the following U.S.A. patents: 5,758,644, 5,823,950, 6,011,986, 6,157,850, 6,263,222, 6,501,975, 7,469,157 and other applicable patents listed at www.masimo.com/patents.htm.
8 NIBP Monitoring 8.1 Overview The Non-invasive Blood Pressure (NIBP) module measures blood pressure using the oscillometric method. This monitor can be applied to adult, pediatric, and neonatal patients. Three modes of measurement are available: Manual: Pressing Auto: NIBP measurement is performed automatically at a preset interval. STAT: NIBP measurement is performed continually over a five minute period. starts an NIBP measurement manually.
8.2 Monitoring Procedure To perform NIBP measurement on a patient, follow the procedure below. 1. Power on the monitor. 2. Enter the PATIENT INFORMATION menu to select correct patient type. 3. Plug the air hose in the NIBP connector of the monitor. 4. Apply a cuff of proper size to the upper arm or the thigh of the patient. 5. Connect the cuff with the air hose. 6. Press to start the NIBP measurement. 8.2.1 Cuff Selection and Placement 1. Determine the patient’s limb circumference. 2.
5. Make sure that the cuff edge falls within the marked range. If it does not, use a larger or smaller cuff that will fit better. 6. The limb chosen for taking the NIBP measurement should be placed at the same level as the patient's heart. If this is not possible, use the following method to correct the measurement result: If the cuff is placed higher than the heart level, add 0.75 mmHg (0.10 kPa) to the measured result for each centimeter of difference.
3. To start a STAT NIBP measurement: Press to enter the INTERVAL menu and then select NIBP STAT to start a 5-minute continuous NIBP measurement. WARNING 4. Continuous non-invasive blood pressure measurements may cause purpura, ischemia and neuropathy in the limb with the cuff. Inspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth and sensitivity.
8.4 Setting Initial Cuff Inflation Pressure, NIBP Reset, Calibration and Test for Air Leakage 8.4.1 Setting Initial Cuff Inflation Pressure In SYSTEM SETUP menu, select MAINTAIN→NIBP TOOLS→Initial Cuff Inflation Pressure, and then you can set the initial cuff inflation pressure.
8.4.3 Calibrating NIBP In SYSTEM SETUP menu, select MAINTAIN→NIBP TOOLS→NIBP CALIBRATE to start NIBP calibration. Then the button NIBP CALIBRATE changes to STOP CALIBRATE. By selecting STOP CALIBRATE, you can stop the calibration. Follow this procedure to calibrate the cuff pressure with a calibrated reference manometer (or mercury manometer) with accuracy 1mmHg: 1. Disconnect the NIBP cuff from the monitor and replace it with a metal vessel with capacity 500±25ml. 2.
8.4.4 NIBP Leakage Test You can test the pump for air leakage by selecting SYSTEM SETUP→MAINTAIN→NIBP TOOLS→NIBP LEAK TEST. With the NIBP cuff connected, you can test the air way for leakage by selecting NIBP LEAK TEST. If the NIBP leakage test is passed, no prompt will be given; If it fails, error information will be displayed in the NIBP parameter area. To test air leakage, follow the procedure below: 1. Set the patient category to adult. 2.
FOR YOUR NOTES 8-8
9 TEMP Monitoring 9.1 Overview The SmarTemp™ TEMP module is intended for monitoring oral, axillary and rectal temperature of adult and pediatric patients and axillary temperature of neonatal patients. Be sure to set correct monitoring mode and position and to select appropriate temperature probe before taking measurement. TEMP TYPE can be set to PREDICT or MONITOR. The default TEMP TYPE is PREDICT.
9.2 Temperature Setup In the SYSTEM SETUP menu, select TEMP SETUP, you can adjust: TEMP TYPE: PREDICT or MONITOR. If MONTIOR is selected, The LED indicating measuring mode on the front panel illuminates. TEMP POSITION:: ORAL, AXILLARY or RECTAL. Corresponding indicating lamp on the front panel illuminates if a measurement site is selected. TEMP UNIT: ℃ or ℉. 9.3 Monitoring Procedure 9.3.
9.3.2 Oral Temperature Measurement Follow the procedure below to measure oral Temperature. 1. Make sure that the oral/axillary probe is connected to the probe connector and the indication lamp beside the temperature unit lights to indicate that TEMP module properly operates. 2. Select desired temperature type (the following procedure taking predict mode as an example) and set TEMP POSITION to ORAL. 3. Unplug the probe from the probe sheath and insert it into a cover in the probe cover box.
5. The monitor will give a beep as the temperature measurement is complete. The temperature reading is shown continuously. 6. Withdraw the probe from the patient’s armpit when accurate temperature reading is obtained. Press firmly the ejection button on the top of the probe to eject the probe cover. Return the probe into the sheath. Temperature reading displays when final temperature is reached. 9.3.4 Measuring Rectal Temperature 1.
9.3.5 Temperature Measurement in MONITOR Mode Temperature measurement can be taken in MONITOR mode. The monitor automatically enters the MONITOR mode in the following two cases: Accurate temperature is not reached in the PREDICT mode. Neither measurement is taken nor the probe is replaced in the probe sheath in 60s after the probe is withdrawn from the sheath.
9.5 Precautions WARNING Check the probe before taking temperature measurement. The prompt information “TEMP NO PROBE” will be presented and an auditory alarm will be triggered if the TEMP probe is disconnected from the probe connector. Check the disposable probe cover for damage before using. Never use any probe cover for temperature measurement in case of damage or contamination. Be careful to avoid damaging the TEMP probe. Replace the TEMP probe in the probe sheath if not in use.
10 Accessories WARNING Use specified accessories only. Accessories of other types may cause damage to the monitoror not meet the claimed specifications. Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy. Check the accessories and their packages for any sign of damage. Do not use them if any damage is detected. 10.
518B Reusable 512E 512F 512G 512H Adult, pediatric, neonate (Multi-sites) 518B-30-72107 512E-30-90390 Adult (Finger type) 512F-30-28263 512G-30-90607 Pediatric (Finger type) 512H-30-79061 For Masimo SpO2 Module Type Reusable Single patient use Model Applicable Patient Remark PN \ Adult (>30 kg) LNCS DCI 0600-00-0126 \ Pediatric (10 to 50 kg) LNCSDCIP 0600-00-0127 \ Adult (>30 kg) LNCS Adtx 0600-00-0121 \ Pediatric (10 to 50 kg) LNCS Pdtx 0600-00-0122 \ Infant (3 to 20 kg) LNC
10.2 NIBP Accessories Tubing Type Reusable Applicable Patient PN Adult, pediatric 509B-30-06259 Neonate 509B-30-06260 Cuff Type Model Limb Bladder Applicable Measurement Circumference Width PN Patient Site (cm) (cm \ Child Reusable 9.2 0683-15-0001-01 \ Small Adult Arm 18 to 26 12.2 0683-15-0002-01 \ Adult 25 to 35 15.1 0683-15-0003-01 \ Large adult 33 to 47 18.3 0683-15-0004-01 \ Adult 46 to 66 22.
10.3 TEMP Accessories Description Measurement Site PN oral/axillary 6006-30-39598 rectal 6006-30-39599 oral/axillary M09A-20-62062 rectal M09A-20-62062-51 Disposable probe cover (20 pcs) / M09A-20-62124 Disposable probe cover (200 pcs) / M09A-30-62126 Disposable probe cover (2000 pcs) / M09A-30-62128 TEMP probe Probe sheath 10.
A Product Specifications A.1 Safety Specifications Item Specification Class I; internally/externally powered equipment Type of protection against electrical shock When integrity of the external protection grounding or grounding cable is doubtable, the equipment must be powered by the internal power (battery).
A.3 Power Requirements Item Specification AC mains Input voltage 100 to 240V Input current 0.7 to 0.3A Frequency 50/60Hz Battery Number of batteries 1 Battery type Sealed lead-acid battery or lithium-ion battery Time to shutdown >5 min (after the first low-power alarm) Sealed lead-acid battery Nominal voltage 12VDC Battery capacity 2.
A.4 Hardware Specification Item Specification Size 177×240×170mm (width × height × depth)) Weight <3.5kg (battery included) LCD Type Monochrome FSTN Size 80.3×41.
A.5 Signal Output Item Specification Applicable standards Meet the requirements of EC60601-1 for short-circuit protection and leakage current Nurse call output Driving mode Driven by relay Electrical specification ≤60W, ≤2A, ≤36VDC, ≤25VAC Isolation voltage >1500VAC Working mode N/O or N/C (optional) Sound output Issues alarm tones (sound pressure 45 to 85 dB), key tones, pulse tones and audible temperature done prompt, supporting Pitch Tone and multiple volume levels.
Sensor type Totally neonates Data Arms 520N 122 (65 male & 57 female) 200 pairs 2.88% 518B 97 (51 male & 46 female) 200 pairs 2.38% This monitor with neonatal SpO2 sensors was also validated on adult subjects. Update period 1s Averaging time 7s PR Measurement range 20 to 254bpm Resolution 1bpm Accuracy ±3 bpm (in non-motion conditions) Update period 1s Averaging time 7s A.6.2 Masimo SpO2 Specification All SpO2 sensors for Masimo SpO2 Module specified in the section 10.
A.6.3 Nellcor SpO2 Specification Item SpO2 measurement range and accuracy Specification Sensor Range Accuracy* MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I, MAX-FAST 70% to 100% ±2% 0% to 69% Undefined OxiCliq A, OxiCliq N, OxiCliq P, OxiCliq I 70 %to 100% ±2.5% 0% to 69% Undefined D-YS, DS-100A, OXI-A/N, OXI-P/I 70 %to 100% ±3% 0% to 69% Undefined 70% to 100% ±3.
Resolution Over-pressure protection Default initial pressure 1mmHg Adult: 297±3 mmHg Pediatric: 240±3 mmHg Neonate: 147±3 mmHg Neonate: 67±5 mmHg PR Measurement range 40 to 240bpm Resolution 1bpm Accuracy ±3 bpm A.8 TEMP Specification Item Specification Displayed parameter TEMP Measurement range In MONITOR mode: 25 to 44 ºC (77 to 111.2 ºF) In PREDICT mode: 35 to 43 ºC (95 to 109.4 ºF) Resolution Accuracy Typical measurement time In MONITOR mode: 0.
FOR YOUR NOTES A-8
B EMC The device meets the requirements of IEC60601-1-2. NOTE Use of accessories, transducers, and cables other than those specified may result in increased emission and/or decreased electromagnetic immunity of the patient monitoring equipment. The device or its components should not be used adjacent to or stacked with other equipment. and if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used.
Guidance and Declaration - Electromagnetic Immunity The device is suitable for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity tests Electromagnetic environment - guidance IEC60601 test level Compliance level Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile.
Guidance and Declaration - Electromagnetic Immunity The device is suitable for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity tests IEC 60601 Test level Compliance level Electromagnetic environment — guidance Conduced RF IEC61000-4-6 3 Vrms 150k to 80MHz 3 Vrms Radiated RF IEC61000-4-3 3V/m 80M to 2.
Recommended Separation Distances between Portable and Mobile RF, Communications Equipment and This Equipment The equipment is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled.
C Alarm Messages and Prompt Information C.1 Physiological Alarm Messages Note: XX represents a parameter label, such as PR, SpO2, NIBP, etc.The “L” field indicates the alarm level. H means high, M means medium and L means low. Alarm message L Cause Action XX TOO HIGH M XX value exceeds the upper alarm limit. XX TOO LOW M XX value is lower than the lower alarm limit.. Make sure the alarm limits are appropriate for the patient, and check the patient’s condition.
C.2.1 General Alarm Messages of Parameter Modules Alarm message A B L Cause Action XX INIT ERR N Yes No H An error occurs to the XX module during initialization. Restart the monitor. If the problem persists, contact our service personnel for repair. Note: N stands for error code. XX COMM STOP No No H Failure in communication between XX module and the main board. XX COMM ERROR No No H Failure in communication between XX module and the main board.
NIBP COMM ERR Yes Yes H Communication between NIBP module and the host fails. Restart the monitor. If the problem still exists, contact our service personnel for repair. LOOSE CUFF No Yes L The NIBP cuff is not properly connected. AIR LEAK No Yes L Leak in the airway. CUFF TYPE ERR No Yes M PNEUMATIC LEAK No Yes L AIR PRESSURE ERROR No Yes L Check the patient’s condition and verify patient type. Replace with a appropriate cuff and connect it correctly.
C.2.3 Mindray DS SpO2 Module Alarm Messages Alarm message A B L Cause Action SPO2 SENSOR OFF No Yes * The sensor is disconnected from the patient or the monitor. Make sure that the sensor is placed at an appropriate position and the monitor is connected to cables correctly. SPO2 LOW PERFUSION No No L The pulse signal is too weak. Move the sensor to a site with better perfusion.
C.2.4 Masimo SpO2 Module Alarm Messages Alarm message A B L Cause Action SPO2 SENSOR OFF No Yes * The sensor is disconnected from the patient or the monitor. Make sure that the sensor is placed at an appropriate position and the monitor is connected to cables correctly. SPO2 PULSE SEARCH No No L The monitor is searching for the patient’s pulse signal. If the pulse reading is not displayed after 30 seconds, check if the sensor is properly connected to the patient.
SPO2 NO SENSOR No Yes L The sensor is disconnected from the patient or the monitor, or the sensor is not properly connected. Disconnect and reconnect the sensor as directed by the instructions. If the alarm remains, the sensor or the cable might have been damaged. SpO2 sensor is reversed. Disconnect and reconnect the sensor as directed by the instructions. Pay attention to the mark on the sensor. SPO2 WEAK SIGNAL No No L The pulse signals detected by the monitor are of poor quality.
C.2.5 Nellcor SpO2 Module Alarm Messages Alarm message A B L Cause Action SPO2 SENSOR OFF No Yes * The sensor is disconnected from the patient or the monitor. Make sure that the sensor is placed at an appropriate position and the monitor is connected to cables correctly. SPO2 NO SENSOR No Yes L The sensor is disconnected from the patient or the monitor, or the sensor is not connected properly. Disconnect and reconnect the sensor as directed by the instructions.
C.2.6 SmarTemp™ TEMP Module Alarm Messages Alarm message A B L Cause Action WARMUP TIMED OUT Yes Yes M TEMP probe initial temperature is too high. Cool the TEMP probe before taking measurement. WARMING RESISTOR ERR No No M The warming resistor in the TEMP probe fails. Replace the TEMP probe. TEMP PROBE MISPLACED Yes Yes M TEMP probe is not placed in the sheath or the probe sheath is not in place. 1. Check that the probe sheath is in place. 2.
Alarm message A B L Cause Action TEMP WRONG PROBE No No H A TEMP probe not supplied by our company is used. Replace with a TEMP probe we supply. TEMP COMM ERR No No H TEMP module is not available or TEMP module fails Check if a TEMP module is available. If yes, replace the TEMP module. C.2.7 Recorder Module Alarm Messages Alarm message A B L Cause Action RECORDER INIT ERR N Yes No M An error occurs during the recorder initialization.
Alarm message A B L Cause Action RECORDER PAPER JAM No No M The recorder has recorded data on paper for 30m long or more. Place the recorder correctly and try again. RECORDER COMM ERR Yes No M Error in recorder communication. TOO MANY REC TASKS No No M Too many alarm events occur at the same time. Clear recording tasks and restart the monitor. If the problem remains, contact our service personnel for repair. RECORDER PAPER W.P.
C.2.8 System Alarm Messages Alarm message A B L Cause Action REAL CLOCK NEED SET No No H The system time is incorrect. Reset the system time and then restart the monitor. REAL CLK NOT EXIST No No H There is no button battery, or the battery power is depleted. Install a button battery or replace with a new one. NET INIT ERR (G.) No No M NET INIT ERR (Ram) No No M Contact our service personnel for repair.
C.3 Prompt Messages Prompt message Cause Action SEARCH PULSE The SpO2 module is searching the pulse. Wait till the end of the search. SPO2 MOTION SpO2 sensor is moving. Eliminate sensor movement. SPO2 Alarm Disabled SpO2 alarm is switched off. Switch on SpO2 alarm. RECORDER BUSY The recorder is recording data. Wait till the end of the recording. Manual measure... The NIBP module is performing a manual measurement. Wait till the end of the measurement. Cont measuring...
TEMP Prediction Over TEMP predictive measurement is finished. Check TEMP reading. TEMP Measure Over TEMP monitoring is over Remove the TEMP probe from patient and insert it in the probe sheath. OUTPUTTING... Data are being output. None CONNECTING... The monitor is connecting to the PC software. None OUTPUT SUCCESS! Data output is finished. None Server not exist Sever is not installed. Install the server. AUDIO ALARM OFF The alarm volume is set to 0. Exit the audio alarm off status.
FOR YOUR NOTES C-14
D Factory Defaults This section lists the most important factory default settings. These settings are not user-adjustable. You can restore the factory default settings if necessary. Note: Column A indicates whether the item is affected by factory or user configuration. “√” represents that this item is affected by the configuration and user configuration will be loaded first when the monitor is restarted; if the user configuration is unavailable, factory configuration will be loaded.
D.2 System Setup System Setup A Factory Default Settings ALARM VOL √ 2 KEY VOL √ 0 PULSE VOL √ 0 LCD BRIGHT × 8 LCD CONTRAST × 6 NIBP UNIT √ mmHg TEMP TYPE × PREDICT TEMP POSITION × ORAL TEMP UNIT √ ℃ NET TYPE × CMS+ LOCAL NET NO. × 1 IP ADDRESS × 196.16.0.
D.
FOR YOUR NOTES D-4
E Symbols and Abbreviation E.
s second V volt VA volt ampere Ω ohm µA microampere µm micron µV microvolt W watt E.
E.
MRI magnetic resonance imaging N/A not applied NIBP noninvasive blood pressure ND NM —— NS oxyCRG Oxygen Cardio-respirogram P power PD photodetector PLETH plethysmogram PR pulse rate RAM random access memory Reg test NE2000 registers fail ROM read-only memory SpO2 arterial oxygen saturation from pulse oximetry S， SYS systolic pressure TEMP temperature VGA Video Graphic Array E-4
Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, New Jersey 07430 USA Tel:1.800.288.2121 Tel:1.201.995.8000 Fax:1.800.926.4275 www.mindray.com P/N: 046-000178-00(5.
