Creative PC-3000 Patient Monitor User Manual Part 1 V1.0 March 2014

User manual for Patient Monitor

Instructions to User Dear Users, Thank you very much for purchasing our product. Please read the following very carefully before using this equipment. Read these instructions carefully before using this monitor. These instructions describe the operating procedures to be followed strictly. Failure to follow these instructions can cause monitoring abnormality, equipment damage and personal injury. The manufacturer is NOT responsible for the safety, reliability and performance issues and any monitoring abnormality, personal injury and equipment damage due to user’s negligence of the operation instructions. The manufacturer’s warranty service does not cover such faults. 0 WARNING for PACEMAKER PATIENTS: Although the pacemaker pulse inhibition function is available in this device, the heart rate meter may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter ALARMS. Keep pacemaker patients under close surveillance. See this manual for disclosure of the pacemaker pulse rejection capability of this instrument. 0 If uncertain about the accuracy of any measurement, first check the patient’s vital signs by any alternative means, and then make sure the monitor is functioning properly. 0 The device should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory CO-oximeter to completely understand the patient's condition. 0 The monitor is not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide. 0 Monitoring a single person at a time. 0 The monitor is defibrillator proof. Verify that the accessories can function safely and normally and the monitor is grounded properly before conducting defibrillation. 0 Disconnect the monitor and sensors before MRI scanning. Use during MRI could cause burns or adversely affect the MRI image or the monitor’s accuracy. 0 If you have any doubt to the grounding layout and its performance, you must use the built-in battery to power the monitor. 0 All combinations of equipment must be in compliance with the standard IEC 60601-1. 0 Check SpO 2 probe application site periodically (every 30 minutes) to determine circulation, positioning and skin sensitivity. 0 The SpO 2 measurement of this monitor may not work for all testees. If stable readings cannot be obtained at any time, discontinue use. 0 Do not immerse the monitor or its accessories in liquid to clean. 0 Do not use accessories other than those provided/recommended by the -II-

User manual for Patient Monitor

manufacturer. 0 Each time the monitor is used, check the alarm limits to ensure that they are appropriate for the patient being monitored. 0 Do not silence the audible alarm if patient safety may be compromised. 0 The alarm limit value shall be within the measuring range, or it may disable the alarm system. Please refer to the related chapter for alarm limit range. 0 A HAZARD can exist if different alarm presets are used for the same or similar equipment in single area. 0 The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. 0 When taking the measure of a pediatric or neonates(less than 10 years old) blood pressure, do NOT operate in the adult mode. The high inflation pressure may cause lesion or even body putrescence. 0 The monitor is prohibited from applying to those who have severe hemorrhagic tendency or who are with sickle cell disease for they may develop partial bleeding when this monitor is used to take the blood pressure measurement. 0 DO NOT take blood pressure measurement from a limb receiving ongoing transfusion or intubations or skin lesion area, otherwise, damages may be caused to the limb. 0 Continuous use of SpO2 sensor may result in discomfort or pain, especially for those with microcirculatory problem. It is recommended that the sensor should NOT be applied to the same place for over two hours, change the measuring site periodically if necessary. 0 SpO2 measuring position must be examined more carefully for some special patient. Do NOT install the SpO2 sensor on the finger with edema or vulnerable tissue. 0 To prevent the risk of the short circuit and to ensure the ECG signal quality, the equipment must be properly grounded. 0 Although biocompatibility tests have been performed on all the applied parts, some exceptional allergic patients may still have anaphylaxis. Do NOT apply to those who have anaphylaxis. 0 All the connecting cables and rubber tubes of the applying parts should be kept away from the patient's cervix to prevent any possible suffocation of the patient. 0 All the parts of the monitor should NOT be replaced at will. If necessary, please use the components provided by the manufacturer or those that are of the same model and standards as the accessories along with the monitor which are provided by the same factory, otherwise, negative effects concerning safety and biocompatibility etc. may be caused. 0 DO NOT stare at the light of SpO2 sensor (infrared is invisible) when switch it on, for the infrared may do harm to the eye. 0 If the monitor falls off accidentally, please do NOT operate it before its safety and technical indexes have been tested minutely and positive testing results obtained. 0 The system might not meet its performance specifications if stored or used outside the manufacturer’s specified temperature and humidity ranges. -III-

User manual for Patient Monitor

0 Reuse, disassembly, cleaning, disinfecting the single patient use CO2 cannula kits and on-airway adapters may compromise functionality and system performance leading to a user or patient hazard. Performance is not guaranteed if an item labeled as single patient use is reused. 0 Electrical Shock Hazard: Always disconnect the CO2 Sensor before cleaning. Do NOT use if it appears to have been damaged. Refer servicing to qualified service personnel. 0 Electrical Shock Hazard:No user serviceable parts inside the CO2 Sensor. 0 After the life cycle of the Sidestream CO2 Sensor and its accessories has been met, disposal should be accomplished following national and/or local requirements. 0 Please peruse the relative content about the clinical restrictions and contraindication. 0 The accessories which can be used repeatedly should have a thorough cleanness before it is used to another patient. Please refer to the related chapter for maintenance method. 0 When disposing of the monitor and its accessories, the local law should be followed. 0 Substitution of a component different from that supplied might result in measurement error.

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User manual for Patient Monitor

Table of Contents Chapter 1

Overview... 1

1.1 Product Name... 1 1.2 Applications and Scope... 1 1.3 Operating Environment... 1 1.4 Impact on Environment and Resources... 1 1.5 Safety... 1 Chapter 2

Working Theories... 3

2.1 Overall Structure... 3 2.2 Composition... 3 2.3 Working Theories... 3 Chapter 3

Installation and Connection... 5

3.1 Installation... 5 3.1.1 Opening the Box and Check... 5 3.1.2 Connecting the AC Power Cable... 5 3.1.3 Starting the Monitor... 6 3.2 Connection... 6 3.2.1 ECG Cable/Lead Wires Connection... 6 3.2.2 Cuff Connection for Blood Pressure Measurement... 8 3.2.3 SpO2 Probe Connection... 11 3.2.4 CO2 Sensor Connection... 15 3.2.5 TEMP Probe Connection... 19 3.2.6 Loading Printing Paper... 19 Chapter 4

Alarm... 21

4.1 Alarm Description... 21 4.1.1 Alarm Condition... 21 4.1.2 Alarm Priority... 21 4.1.3 Alarm Modes... 22 4.1.4 Alarm Setting... 22 4.2 Alarm Technical Specifications... 22 Chapter 5

Technical Specifications... 24

5.1 ECG Monitoring... 24 5.2 RESP Monitoring... 25 5.3 TEMP Monitoring... 25 5.4 NIBP Monitoring... 25 5.5 SpO2 Monitoring... 26 5.6 Pulse Rate Monitoring... 26 5.7 CO2 Monitoring... 26 5.8 Data Recording... 27 5.9 Other Technical Specifications... 27 5.10 Classification... 27 5.11 Guidance and manufacturer’s declaration-Electromagnetic compatibility... 28 Chapter 6

Packaging and Accessories... 32 -V-

User manual for Patient Monitor

6.1 Packaging... 32 6.2 Accessories... 32 Chapter 7

Working Principles... 33

7.1 Introduction to ECG Measurement... 33 7.1.1 How to Obtain High Quality ECG and Accurate Heart Rate Value...33 7.1.2 Factors affecting ECG signal... 33 7.2 Introduction to Blood Pressure Measurement... 34 7.2.1 Blood Pressure Measuring Principle... 34 7.2.2 Factors affecting NIBP measuring... 35 7.2.3 Clinical Limitations... 36 7.3 Introduction to Oxygen Saturation Measurement... 36 7.3.1 SpO2 Measuring Principle... 36 7.3.2 SpO2 Measurement Restrictions (interference reason)... 37 7.4 Introduction to Respiration Measurement... 37 7.4.1 Respiration Measuring Principle... 37 7.4.2 Factors affecting respiration monitoring... 38 7.5 Introduction to Temperature Measurement... 38 7.6 Introduction to Capnograph Measurement... 38 7.6.1 CO2 Measuring Principle... 38 7.6.2 Mainstream vs. Sidestream Sampling... 38 Chapter 8

Troubleshooting... 40

8.1 No Display on the Screen... 40 8.2 Excessive ECG Signal Interference or too Thick Baseline... 40 8.3 No Blood Pressure and Pulse Oxygen Measures... 40 8.4 System Alarm... 40 Chapter 9

Maintenance...41

9.1 Service and Examination... 41 9.1.1 Daily Examination... 41 9.1.2 Routine Maintenance... 41 9.2 Battery Maintenance... 42 9.3 Cleaning and Disinfection of the Device... 42 9.4 Cleaning and Disinfection of Accessories... 43 9.5 Storage... 43 9.6 Transportation... 43 Chapter 10 Appendix... 44 10.1 Alarm Information... 44 10.2 Default Alarming Values and Setup Range... 45 10.3 Status/Error during NIBP Monitoring... 47 10.4 Status/Error during CO2 Monitoring... 48 10.5 Typical Pressures and CO2 Readings at Altitudes... 49 10.6 Accessories List... 49

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Chapter 1

Overview

1.1 Product Name Name:

Patient Monitor

1.2 Applications and Scope This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, end-tidal CO2 concentration, respiration rate, body temperature, and so on, it allows comprehensive analysis of patient’s physiological conditions. This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

1.3 Operating Environment 1. Ambient temperature range: 5°C~40°C Relative humidity: 30%~80% Atmospheric pressure: 70kPa ~106.0kPa Power Voltage: (100-240)VAC Power frequency: 50Hz/60Hz 2. This equipment should be situated in a place protected against direct sunlight, so as to prevent overheating inside the equipment. 3. The device should be stored and used within specified temperature, humidity and atmospheric pressure range, or it may cause damage to the device or inaccurate measurement result. 4．If the device gets wet by accident, the operator should NOT power it on directly until it has been air-dry enough to avoid any damage to it. 5、Do not use this equipment in an environment with toxic or inflammable gas. 6. This equipment should be placed on a stand or flat platforms, so as to prevent possible shock. 7. Do not use this equipment in combination with any equipment other than those expressly permitted in the manual. 8.

The monitor is defibrillator discharge proof and can be used with electrosurgical unit. But when the device is used together with defibrillator or electrosurgical equipment, the user (doctor or nurse) should keep the patient under close surveillance for his/her safety. Refer to the following function description for specific protective measures or notes.

9. Make sure that the equipotential grounding terminal is grounded correctly. 10. Do not use mobile phone nearby, so as to avoid strong radiant field interference.

1.4 Impact on Environment and Resources Low

1.5 Safety a)

This device conforms to IEC60601-1, electric safety classification: Class I, with Type BF and CF

User manual for Patient Monitor

applied parts. b)

This device can resist against the discharge of defibrillator and the interference of electrosurgical unit.

c)

This device can monitor the patients with pace-maker.

d)

DO NOT use this device while the patient is under MRI scanning.

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User manual for Patient Monitor

Chapter 2

Working Theories

2.1 Overall Structure The overall structure of the monitor is shown as Figure 2.1

Figure 2.1

2.2 Composition 1. The monitor consists of the main units and the corresponding functional components (ECG cables/lead wires, non-invasive blood pressure cuff, SpO2 probe, temperature transducer, accessories for invasive blood pressure and CO2 monitoring). 2. The patient monitor has multiple measurement channels including ECG/Heart Rate, NIBP, SpO2/Pulse Rate, Respiration Rate, Temperature, and CO2 Concentration. 3. The patient monitor has output ports including networking communication and the built-in printer. 4. Basic configuration includes the functions of ECG/Heart Rate, NIBP (systolic, diastolic, mean aterial pressure & pulse rate), SpO2/Pulse Rate, Respiration Rate, and Temperature.

2.3 Working Theories This Patient Monitor, which performs physiological parameter measurement through different modules, is a product with modular design. It consists of several modules: ECG/RESP/TEMP module, NIBP module, SpO2 module, CO2 module (optional), the mother board and other auxiliary boards. 1. The ECG/RESP/TEMP module detects the ECG signal through ECG cable/lead wires via electrodes, it also measures the respiration by use of the same ECG electrodes. The temperature is measured through the temperature probe. The heart rate and respiration rate are calculated from its signal waveform respectively. -3-

User manual for Patient Monitor

2. The SpO2 module detects the plethysmograph data via the SpO2 probe and calculates the pulse rate and oxygen saturation (SpO2) accordingly. 3. The NIBP module measures the blood pressures including systolic, diastolic, mean arterial pressure and pulse rate through the pneumatic system and cuff. The cuffs are designed for adult and pediatric patients respectively, and it can work in different modes to adapt different patient categories. 4. The CO2 module detects CO2 concentration through the sampling line (side stream) or within the airway (main stream), and calculate the respiration rate, end tidal CO2 concentration (EtCO2), and inspired CO2 concentration (InsCO2). 5. The mother board is the main controlling unit, which also connects to the interface board and key board. The interface board inter-connects the functional modules with the mother board.

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User manual for Patient Monitor

Chapter 3

Installation and Connection

3.1 Installation 3.1.1 Opening the Box and Check 1. Open the package, take out the monitor accessories from the box carefully and place it in a safe stable and easy to watch position. 2. Open the user manual to sort the accessories according to the packing list. ‹ Inspect the accessories for any mechanical damages ‹ Check all the exposed leads and inserted accessories ‹ Check whether any risk or abnormity exists in the device and its accessories before using the monitor. If any abnormity (such as broken cable or crack of the enclosure etc.) is found, stop using this device. ☞The user can customize the module configuration by choosing necessary modules to meet your own needs. Therefore, your monitor may not have all the monitoring functions and accessories. Please contact the local dealer or our company in case of any problems. We will offer the best solution for your satisfaction.

3.1.2 Connecting the AC Power Cable 1. When powered by AC mains power supply: ‹

Make sure that the AC power supply is (100-240)VAC, 50Hz/60Hz.

‹

Use the power cable provided by the manufacturer. Insert one end of it to the AC power input of the monitor and the other end to the three-pin outlet of the power source with protected-earth.

‹

To eliminate potential differences, the monitor has a separate connection to the equipotential grounding system. Connect one end of the provided ground cable to equipotential grounding port on the rear of the monitor, and connect the other end to one point of the equipotential grounding system. Caution: ensure that the monitor is grounded correctly.



After the supply mains has been interrupted when power switch remains in the “on” position and is restored after a period of time that is longer than 30 seconds, the monitor will run by the last settings when restarting the monitor.

 The monitor is applicable to connect to the public mains power network. 2. Built-in battery The following steps should be followed to install the battery: Step 1: open the battery cover; Step 2: pull out the battery cable and connect it to the battery pack; Step 3: push the battery pack into the battery compartment and lock it; Step 4: close the battery cover. ‹

Caution: it’s better to recharge the battery after it is used up, and the charging time should be 13~15 hours long.

‹ Battery life: Provided that a battery is new and fully charged, the minimal working time of the monitor with accessories connected is declared in the table below:

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User manual for Patient Monitor

Name

Battery life

Patient Monitor 120min ‹ NOTE: It will take 12-15 hours to charge battery from exhaust state to 90% charged. 

The provided battery of the monitor must be recharged after transportation or storage. So if the monitor is switched on without being connected to the AC power supply, it may not work properly due to insufficient battery power.

3.1.3 Starting the Monitor The system performs self-test and enters initial display after switch on the monitor, and the alarm rings to inform that the user can begin operating it. ‹

Check all the applicable functions to make sure that the monitor works normally.

‹

If the built-in battery is applied, please recharge it after using the monitor to ensure sufficient power storage. It will take at least 8 hours to charge battery from depletion to 90% charge.

0 Do not use the monitor to monitor the patient if there are indications of damage or reminders of error. Please contact the local dealer or our company. 0 Start the monitor again 1 minute later after it is switched off.

3.2 Connection 3.2.1 ECG Cable/Lead Wires Connection ECG measurement is to collect the ECG signal via the ECG electrodes. Electrode connects the patient and the lead wires and/or ECG cable. The lead wires and/or cable connect to the monitor. The locations of the electrodes are very important for obtaining accurate ECG signals. 1. Connect the cable to the connector marked with the “ECG" icon on the signal input panel. 2. Select electrodes to be used. Use only one type of electrode on the same patient to avoid variations in electrical resistance. For ECG monitoring, it is strongly recommended to use silver/silver chloride electrodes. When dissimilar metals are used for different electrodes, the electrodes may be subject to large offset potentials due to polarization. Using dissimilar metals may also increase recovery time after defibrillation. 3. Prepare the electrode sites according to the electrode manufacturer’s instructions. 4. Skin clean ¾

Clean and scrap skin to ensure low sensor impedance if necessary. Mild soap and Water is recommended as a skin cleanser. Note: If alcohol is used as cleanser, it is recommended to have 30-second dry time for a better connection.

¾

Scraping the skin gently with a dry wash cloth, gauze, for skin preparation is helpful to remove the non-conductive skin layer. The symbol indicates that the cable and accessories are designed to have special protection against electric shocks and is defibrillator-proof. The locations of the electrode are in the following Figure:

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User manual for Patient Monitor

Figure 3.5 Electrode Location Note: If any side-effect such as allergic or itchy reaction is found, remove the electrodes from the patients immediately. 5. After starting the monitor, if the electrodes become loose or disconnected during monitoring, the system will display “LEAD OFF” on the screen to alarm the operator.  It might not display ECG waveform when using ECG cable with 3 lead wires while the setting of “Cable” is set as “5” in the ECG parameter setup menu. The ECG cable with 5 leads wires should be used to measure ECG signal at this situation. 6. The ECG leads and their corresponding locations are as follows: Electrode connection 1

Electrode connection 2

(IEC Standard)

(AHA Standard) Electrode position on body surface

Color code

Label on lead wire connection

Color code

Label on lead wire connection

Red

R

White

RA

Right Arm: The intersection between the centerline of the right clavicle and Rib 2

Yellow

L

Black

LA

Left Arm: The intersection between the centerline of the left clavicle and Rib 2

Green

F

Red

LL

Left Leg: Left part of the upper abdomen

Black

N/RF

Green

RL

Right Leg: Right part of the upper abdomen

White

C

Brown

V

Any of the following location (C1-C6 or V1-V6) on chest

White/red

C1

Brown

V1

4th Intercostal (IC) space at right border of sternum

White/yellow

C2

Brown/yellow

V2

4th IC space at left border of sternum

White/green

C3

Brown/green

V3

Midway between V2 and V4

White/brown (blue)

C4

Brown/blue

V4

5th IC space on left midclavicular line

White/black

C5

Brown/red

V5

Left anterior axillary line at the horizontal level of V4

White/purple

C6

Brown/purple

V6

Left midaxillary line at the horizontal level of V4

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User manual for Patient Monitor

Safety Instructions for ECG Monitoring 0

Patient Monitor can only be equipped with ECG cable and/or lead wires provided by our company; using ECG cable and/or lead wires supplied by other companies may cause improper performance or poor protection while using defibrillator.

0

Using the same type of qualified and authorized electrodes which should be within its effective life on the same patient. If any side-effect such as allergic or stimulus skin is found, the measurement should be stopped at once. It is prohibited to apply the electrode to the patient with lesion and body putrescence.

0

To the patient with pacemaker, due to that this device has been designed to provide function of pacemaker pulse inhibition for heart beat identification, normally the pacemaker pulse is not counted in heart rate measurement and calculation, but when the pulse width of the pacemaker pulse is larger than 2ms, the pacemaker pulse inhibition may not be fully effective. In order to reduce this possibility, observe the ECG waveforms on the screen carefully and do NOT rely entirely on the heart rate display and alarm system of this monitor when monitoring this kind of patients. Keep pacemaker patient under close surveillance.

0

The improper connection with electrosurgical unit may not only cause burns, but also damage the monitor or arouse deviations of measurement. You can take some steps to avoid this situation, such as do NOT use small ECG electrodes, choosing the position which is far away from the estimated Hertzian waves route, using larger electrosurgical return electrodes and connecting them with the patient properly.



Electric parts of electrodes, leads and cable are forbidden to contact any other conductive parts (including ground).



Patient Monitor can resist against defibrillator and electrosurgical unit. Readings may be inaccurate for a short time after or during using defibrillator or electrosurgical unit.



Transient caused by cable circuitry blocks while monitoring may be similar to the real heartbeat waveform, as a result resistance heart rate alarm rings. If the electrodes and cable are located in proper places according to this manual’s instructions and the instructions for using electrode, the chance of this transient occurrence will be decreased.



ECG cable and/or lead wires may be damaged while using defibrillator. If the cable and/or lead wires are used again, please do the functional check firstly.



When the monitor is inoperable due to overload of ECG or saturation of any part of the amplifier, it will prompt “Lead off” to remind operator.



The user should ensure that no predictable hazard will be caused by the summation of leakage currents when several item of monitor are interconnected.

 When plugging or unplugging the ECG cable, be sure to hold the head of the connector and pull it out.

3.2.2 Cuff Connection for Blood Pressure Measurement 1. Connect the tube with cuff to the connector marked with “NIBP” icon on the signal input panel. 2. Unfold the cuff and wrap it around the patient’s upper arm. Requirements of the cuff: 1) Appropriate cuff should be selected according to the age and arm circumference of the subject. Its width should be 2/3 of the length of the upper arm. The inflatable part should be long enough to permit wrapping appropriately 80% of the limb. See the table below for the dimensions: Note: the appropriate cuff should be selected according to the age and arm circumference of the patient.

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User manual for Patient Monitor

Cuff Model

Arm Circumference

Cuff Width

Smallest Cuff

6cm～9.5cm

3cm

Small-sized Pediatric Cuff

6cm～11cm

4.5cm

Middle-sized Pediatric Cuff

10cm～19cm

8cm

Large-sized Pediatric Cuff

18cm～26cm

10.6cm

Adult Cuff

25cm～35cm

14cm

2) When putting on the cuff, unfold and wrap it around the upper arm evenly to appropriate tightness. 3) Remember to empty the residual air in the cuff before the measurement is commenced. 4) Locate the cuff in such a way that the artery mark “ brachial artery is observed.

” is at a location where the clearest pulsation of

5) The cuff should be tightened to a degree where insertion of one finger is allowed. 6) The lower end of the cuff should be 2cm above the elbow joint.

Figure 3.6 Cuff location The symbol indicates that the cable and accessories are designed to have special protection against electric shocks, and is defibrillator proof. ¾

Pressure Accuracy Verification Pressure Accuracy Verification is a function to inspect the accuracy of pressure measurement by the NIBP module inside the device. Technician or equipment manager should do pressure accuracy verification every half year or year in order to check if the pressure measurement still conforms to the requirement of product performance. If the deviation is beyond the declared specification, it is permitted to return it to factory for repair or calibration. Before verification, please connect the monitor to a precision pressure meter as the reference equipment like a mercury pressure meter

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User manual for Patient Monitor

Figure 3.7 Connection of Pressure Accuracy Verification Fixture Mode 1: Automatic inflation for the pressure accuracy verification At this mode, the monitor can activate the inflation, so the pressure will increase automatically until it exceeds the limit value specified in table A. This pressure limit value depends on the patient type selection as shown in table A: Adult

240mmHg

Pediatric

200mmHg

Neonate

120mmHg Table A

During the inflation, the Monitor will close the deflating valve, and the pressure value will be shown during the process. If there is no manual deflation operation, the pressure will persist until deflation by manual operation, so it is necessary to use a manual valve for doing adequate deflation in several steps to verify the pressure accuracy in the full scale of measurement range. Mode 2: Manual inflation for the pressure accuracy verification. At this mode, the pressure should be increased manually by a pumping balloon, and the verification can be done by applying different pressure value manually. If the increased pressure exceeds the given limit as shown in table B, the Monitor will deflate automatically because of over-pressure protection. Adult

300mmHg

Pediatric

240mmHg

Neonate

140mmHg

Table B  After the verification, do press the button again to return to normal working mode, then continue other operation, or the NIBP key will be invalid. 

¾

Pressure accuracy verification must be operated by technician or equipment manager. Doctor or nurse is not allowed to do the verification, it is very dangerous especially when the pressure cuff is still on patients.

Air Leakage Check -10-

User manual for Patient Monitor

In order to avoid significant error of blood pressure measurement or even no measurement result caused by air leakage in the pneumatic system including the cuff during measuring, it is recommended to check if there is leak in the pneumatic system as well. 

Please remove the cuff from patient while performing the leakage check.

Safety Instructions for NIBP Measurement 0 When taking the blood pressure measurement on a Pediatric or Neonate patient, do NOT operate in the Adult mode. The high inflation pressure may cause lesion or even body putrescence. Even though the monitor can identify the cuff type so it will stop inflation and indicate "wrong cuff" when taking the blood pressure measurement for a pediatric or neonate in the "adult" patient type setting. The user (doctor or nurse) should pay more attention to select the correct patient type. 0 It is recommended to take the blood pressure measurement manually. 0 NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or with sickle cell disease, or partial bleeding will appear. 0 Do NOT bind NIBP cuff on limbs with transfusion tube or intubations or skin lesion area, otherwise, damages may be caused to the limbs. 0 If the patient is moving or suffering tremble, hyperkinesia or arrhythmia, it may cause the inflation time of inflatable balloon endures longer, which may not only prolong the NIBP measurement time, but also result in the body wrapped by the cuff is troubled by purpura, hypoxemia and neuralgia because of the friction. 0 Before the measurement is carried out, select an appropriate monitoring mode depending on the patient type (adult, pediatric or neonate). 0 It is prohibited to wrap the cuff to a limb with skin lesion 0 DO NOT take blood pressure measurement from a limb receiving ongoing transfusion or intubations. Because it may damage the limb tissue around the intubation if the transfusion becomes slower or blocked during the cuff inflation. 0 The windpipe which connects the cuff and monitor should be straightway without any tangle.  When an adult subject is monitored, the machine may fail in giving the blood pressure measure if the pediatric mode is selected.  Prior to use of the cuff, empty the cuff until there is no residual air inside it to ensure accurate measurement.  Do NOT twist the cuff tube or put heavy things on it.  When unplugging the cuff, hold the head of the connector and pull it out.  The NIBP measurement will not be affected when the monitor is connected to the patient on whom the electrosurgical device such as defibrillator or electrosurgical knife with high frequency is being used.  The appearance of arrhythmia results in irregular heart beat which may affect the accuracy of NIBP measurement data. It is recommended to take the NIBP measurement again at this situation.  The Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard, Manual, electronic, or automated sphygmomanometers. The symbol indicates that the cable and accessories are designed to have special protection against electric shocks, and is defibrillator proof.

3.2.3 SpO2 Probe Connection Creative reusable SpO2 finger clip sensor is configured by default for general purpose. For further information, -11-

User manual for Patient Monitor

please contact your local representative. Creative reusable SpO2 finger clip sensor can be used with a compatible patient monitor (e.g. all models of Patient Monitors and PC-900A Vital Signs Monitor made by Creative) or pulse oximeters (e.g. PC-66B Handheld Pulse Oximeter made by Creative). The sensor is intended to be used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring for adult patients weighing greater than 40kg or pediatric patients weighing between 10~40kg. SpO2 probe is a kind of very delicate sensor. Please follow the steps and procedures in operating it. Failure to operate it correctly can cause damage to the SpO2 probe. Operation procedure: 1. Connect the SpO2 probe to the connector marked with “SpO2” icon on the signal input panel. When unplugging the probe, be sure to hold the head of the connector and pull it out. 2. Insert one finger (index finger is preferred, but middle or ring finger with proper nail length is possible as well) into the probe according to the finger mark on the probe, shown as below.

Figure 3.8A Demonstration of Adult/Pediatric SpO2 Finger Clip Sensor (A) With the upper and lower jaws open, place a finger evenly on the base of the clip. Push the finger tip against the stop so that it is over the sensor window. (B) Spread open the rear tabs of the sensor to provide even force over the length of the pads. (C) The sensor should be oriented in such a way that the cable is positioned along the top of the hand.

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User manual for Patient Monitor

Figure 3.8B Demonstration of Adult SpO2 Finger Rubber Sensor (A) Hold the sensor with its opening towards the patient’s finger, the sensor should be oriented in such a way that the sensor side with a finger tip sign is positioned on the top. (B) Insert the patient’s finger into the sensor until the fingernail tip rests against the stop at the end of the sensor. Adjust the finger to be placed evenly on the middle base of the sensor. Direct the cable along the top of the patient’s hand. Apply adhesive tape to secure the cable if necessary. When selecting a SpO2 probe or sensor, do consider the patient’s category, adequacy of perfusion, availability of probe site and anticipated monitoring duration. Use only SpO2 probes provided by our company with this monitor. Read the following table for SpO2 probe information. SpO2 Probe

Patient Category

Adult SpO2 Finger Clip Sensor (reusable)

Adult

Adult SpO2 Finger Rubber Sensor (reusable) Pediatric SpO2 Finger clip Sensor (reusable)

Pediatric

SpO2 Y-type sensor with wrapper (reusable)

Neonate

3. If the neonate SpO2 sensor is used, please follow figure to connect.

Sensor adapter: wrapper

Y type sensor

Figure 3.8C Neonate SpO2 sensor placement Some factors may affect the accuracy of saturation measurements. Such factors include: excessive patient motion, fingernail polish, use of intravascular dyes, excessive light, poorly perfused finger, extreme finger sizes or improper placement of the sensor. High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of a SpO2 sensor. -13-

User manual for Patient Monitor

To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material if necessary. Failure to take this action in high ambient light conditions may result in inaccurate measurements. If patient movement presents a problem, verify that the sensor is properly and securely applied; move the sensor to a less active site; use an adhesive sensor that tolerates some patient motion; or use a new sensor with fresh adhesive backing. For reusable sensors, follow the sensor directions for use, cleaning and reuse. For single-patient use sensors, use a new sensor for each patient. Caution: Do not disinfect any SpO2 sensor by irradiation, steaming, or ethylene oxide. Safety Introductions for SpO2 Monitoring 0 Continuous use of fingertip SpO2 sensor may result in discomfort or pain, especially for those patients with microcirculatory problem. It is recommended that the sensor should NOT be applied to the same site for over two hours, please inspect the monitoring site every 1~2 hours for skin integrity, and change the measuring site periodically if necessary. 0 SpO2 measuring site must be examined more carefully for some special patient. Do NOT place the SpO2 sensor on the finger with edema or fragile tissue. 0 Avoid placing the SpO2 sensor on the same extremity with an arterial catheter, blood pressure cuff, or intravascular infusion line, otherwise the blood flow could be interrupted by the cuff or the circulatory condition could make low blood perfusion so that would result in on pulse found or loss of pulse during SpO2 monitoring and further cause false alarm. 0 Do not apply tape to secure the sensor in place or to tape it shut; venous pulsation may lead to inaccurate oxygen saturation measurements.  For disposal SpO2 sensor, If the sterile packaging is damaged, do not use it any more.  Check the SpO2 sensor and cable before use. Do NOT use the damaged SpO2 sensor. Before each use, surface-clean sensor and cable with a soft gauze pad by saturating it with a solution such as 70% isopropyl alcohol. If low-level disinfection is required, use a 1:10 bleach solution. When the temperature of SpO2 sensor is abnormal, do not use it any more.  Please do not allow the cable to be twisted or bended.  Please do not use nail polisher or other cosmetic product on the nail.  The fingernail should be of normal length. 

The SpO2 sensor cannot be immerged into water, liquor or cleanser completely, because the sensor has no capability to resist the harmful ingress water. Carefully route cables to reduce the possibility of patient entanglement or strangulation. Do not use the sensor or other oximetry sensors during MRI scanning.

Our company offers a 6-month warranty against manufacturing defects for the SpO2 sensors mentioned above in its undamaged condition. If you have any question regarding any of SpO2 sensor instructions, please contact your local dealer.

3.2.4 CO2 Sensor Connection 3.2.4.1 Sidestream CO2 Sensor Connection -14-