PC-900 User Manual Ver 1.0 Oct 2013

User Manual for Vital Signs Monitor

This Manual is written and compiled in accordance with the IEC 60601-1（Medical electrical equipment Part1: General requirements for safety）and MDD 93/42/EEC. It complies with both international and enterprise standards and is also approved by State Technological Supervision Bureau. The Manual is written for the current PC-900 Vital Signs Monitor. The Manual describes, in accordance with the Vital Signs Monitor’s features and requirements, main structure, functions, specifications, correct methods for transportation, installation, usage, operation, repair, maintenance and storage, etc. as well as the safety procedures to protect both the user and equipment. Refer to the respective chapters for details. The Manual is published in English and Creative has the ultimate right to explain the Manual. No part of this manual may be photocopied, reproduced or translated into another language without the prior written consent. Creative reserves the right to improve and amend it any time without prior notice. Amendments will however be published in a new edition of this manual. Version of This Manual: Ver 1.0 October 30, 2013 All rights reserved. Marks in the Manual:

 Warning: must be followed to avoid endangering the operator and the patient.  Attention: must be followed to avoid causing damage to the monitor. ☞ Note: some important information and tips about operations and application.

3502-2530006

Instructions to User Dear Users, 1

User Manual for Vital Signs Monitor

Thank you very much for purchasing our product. Please read the following information very carefully before using this device. 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 abnormity, 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.  WARNING-PACEMAKER PATIENTS. This monitor may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon this monitor ALARMS. Keep pacemaker patients under close surveillance.  Monitoring a single person at a time.  The monitor is defibrillator proof. Verify that the accessories can function safely and normally and the monitor is grounded properly before conducting defibrillation.  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.  If you have any doubt to the grounding layout and its performance, you must use the built-in battery to power the monitor.  All combinations of equipment must be in compliance with standard of IEC 60601-11 for medical electric system requirements.  Check SpO 2 probe application site periodically (every 30 minutes) to determine circulation, positioning and skin sensitivity.  The SpO 2 measurement of this monitor may not work for all testees. If stable readings can not be obtained at any time, discontinue use.  Do not immerse the monitor or its accessories in liquid to clean.  Do not use accessories other than those provided/recommended by the manufacturer.  Each time the monitor is used, check the alarm limits to ensure that they are appropriate for the patient being monitored.  The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.  When taking the measure of an infant or neonate’s (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.  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.  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.  Continuous use of SpO2 sensor may result in discomfort or pain, especially for those with 2

User Manual for Vital Signs Monitor

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.  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.  To prevent the risk of the short circuit and to ensure the ECG signal quality, the equipment must be properly grounded.  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.  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.  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.  DO NOT stare at the infrared light of SpO2 sensor when switch it on, for the infrared may do harm to the eye.  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.  It is recommended to take the blood pressure measurement manually. The automatic or continuous mode should be used at the presence of a doctor/nurse.  Please peruse the relative content about the clinical restrictions and contraindication.  When disposing of the monitor and its accessories, the local law should be followed.

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User Manual for Vital Signs Monitor

Table of Contents Chapter 1 Overview ...1 1.1 Features ...1 1.2 Product Name and Model...1 1.3 Intended Use ...1 1.4 Safety ...1 1.5 Symbols on the Monitor...1 Chapter 2 Operating Principle ...3 2.1 Overall Structure ...3 2.2 Conformation ...3 Chapter 3 Installation and Connection ...4 3.1 Appearance...4 3.1.1 Front Panel ...4 3.1.2 Side Panel...6 3.1.3 Rear Panel ...6 3.2 Installation...7 3.2.1 Opening the Package and Check...7 3.2.2 Connecting the Power Supply...7 3.2.3 Starting the Monitor ...7 3.3 Sensor Placement and Connection ...8 3.3.1 ECG Cable Connection ...8 3.3.2 Blood Pressure Cuff Connection...10 3.3.3 SpO2 Sensor Connection ...13 3.3.4 TEMP Transducer Connection ...14 3.3.5 Loading printing paper...15 3.3.6 Battery Installation ...16 Chapter 4 Operations ...18 4.1 Initial Monitoring Screen ...18 4.2 Default Screen...18 4.2.1 Default Display Screen Description...18 4.3 SpO2 Monitoring Screen ...19 4.4 SpO2 Trend Graph Display ...19 4.5 NIBP List Screen...20 4.6 SpO2/PR List Screen ...21 4.7 Alarm Event List Screen ...21 4.8 Setup Menu Screen ...22 4.8.1 SpO2 Setup ...22 4.8.2 NIBP Setup...23 4.8.3 Nurse Call ...26 4.8.4 System Setup...27 4.8.5 Patient Info...27 4.8.6 Date/Time...28 4.8.7 Recover Default Settings...28 4.9 Alarm Settings...28 4.10 Power Saving Mode ...29 4

User Manual for Vital Signs Monitor

4.11 Key-lock Mode ...30 Chapter 5 Alarm ...30 5.1 Alarm Priority ...30 5.2 Alarm modes ...31 5.3 Alarm Silence...32 5.4 Alarm Setting ...32 5.5 Verify Adjustable Alarm Function ...32 Chapter 6 Technical Specifications...32 6.1 ECG Monitoring ...32 6.2 TEMP Monitoring...33 6.3 NIBP Monitoring ...34 6.4 SpO2 Monitoring...34 6.5 Pulse Rate monitoring...34 6.6 Data Recording ...34 6.7 Other Technical Specifications ...35 6.8 Operating Environment...35 6.9 Classification ...35 6.10 Guidance and manufacturer’s declaration-Electromagnetic compatibility ...36 Chapter 7 Packaging and Accessories...42 7.1 Packaging...42 7.2 Accessories ...42 Chapter 8 Monitoring Parameter...43 8.1 ECG Monitoring ...43 8.1.1 How to Obtain High Quality ECG and Accurate Heart Rate Value...43 8.1.2 Factors affecting ECG signal ...43 8.2 NIBP Monitoring ...44 8.2.1 Measuring Principle ...44 8.2.2 Factors affecting NIBP measuring ...45 8.2.3 Clinical Limitations ...45 8.3 SpO2 Monitoring...46 8.3.1 Measuring Principle ...46 8.3.2 SpO2 Measurement Restrictions (interference reason) ...46 8.3.3 Low SpO2 measuring value caused by pathology reason ...46 8.3.4 Clinical Limitations ...47 8.3.5 Points to be noted in SpO2 and Pulse Measuring...47 8.4 Temperature Monitoring ...48 Chapter 9 Troubleshooting...49 9.1 No Display on the Screen ...49 9.2 Excessive ECG Signal Interference or Too Thick Baseline...49 9.3 No Blood Pressure and Pulse Oxygen Measures ...49 9.4 Blank Printing Paper...49 9.5 System Alarm...49 Chapter 10 Maintenance ...50 10.1 Service and Examination ...50 10.1.1 Daily Examination ...50 10.1.2 Routine Maintenance ...50 5

User Manual for Vital Signs Monitor

10.1.3 Battery Maintenance ...50 10.1.4 Service...51 10.2 Cleaning and Disinfection...51 10.3 Cleaning and Disinfection of Accessories...52 10.4 Storage ...52 10.5 Transportation ...52 Chapter 11 Appendix ...53 11.1 Prompt information explanations ...53 11.2 Default Alarming Values and Setup Range ...54 11.3 Abbreviation of arrhythmia ...55 11.4 Accessories List...56 11.5 Instructions for SpO2 Probe...57

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Chapter 1 Overview 1.1 Features 

Blood Pressure, SpO2 and Pulse Rate are displayed by big, bright digital LEDs;

 Accurate NIBP measurement with hardware and software over-pressure protection;  Unique SpO2 measuring technique ensures sensitive and accurate SpO2, Pulse Rate and Perfusion Index measurement;  12000 groups of NIBP measurements (nonvolatile) can be stored and reviewed by list;  Up to 96-hour SpO2 trend can be stored and recalled;  Multi-level of audible & visible alarm function;  Nurse call output is available  With tourniquet function;  Data exportation is available;  Built-in printer is optional to print out waveforms, and text information.

1.2 Product Name and Model Name: Vital Signs Monitor Model: PC-900

1.3 Intended Use This 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 non-invasive blood pressure, body temperature, functional oxygen saturation 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.

1.4 Safety a) This device conforms to IEC60601-1, electric safety classification: Class I, with Type BF and CF applied parts. b) This device can resist against the discharge of defibrillator and the interference of electro-surgical unit. c) This device can monitor the patients with pace-maker. d) DO NOT use this device while the patient is under MRI scanning.

1.5 Symbols on the Monitor Adult Patient

Power switch

Pediatric Patient

NIBP setup

User Manual for Vital Signs Monitor

Power saving mode setup

Neonatal Patient NIBP Start/Cancel

～

AC Power indicator

Alarm Silence

DC Power indicator

Print

Type BF applied part

Up

Type CF applied defibrillator protection

OK

Warning, refer to User Manual.

Down

Equal potential terminal

Display

MAP, Time

Alarm lamp

Pulse bar-graph SYS

Systolic Pressure

PR

Pulse Rate (bpm)

Mean arterial pressure. Measuring time.

DIA SpO2

Diastolic Pressure Oxygen Saturation (%)

2

part

with

User Manual for Vital Signs Monitor

Chapter 2 Operating Principle 2.1 Overall Structure The overall structure of the monitor is shown in Fig. 2.1.

Figure 2.1

2.2 Conformation PC-900 Vital Signs Monitor is module designed product; it consists of NIBP module (optional), SpO2 module (optional), main control unit, printer module (optional), display panel, and power supply block etc. and the related accessories for NIBP, SpO2 and Temperature measurement. ☞ According to different needs, you can customize the module configuration by choosing necessary modules. Therefore, your monitor may not have all the monitoring functions and accessories. 1. The SpO2 module detects and calculates pulse rate and oxygen saturation (SpO2), and provides plethysmogram and perfusion index as well. 2.

The NIBP module performs the measurement of blood pressure by non-invasive way of oscillometric technology, including the diastolic, systolic and mean arterial pressure. The cuffs are designed for adult, pediatric and neonate respectively.

3. The main control unit is in charge of LED and LCD display, keyboard input, data storage, printing and networking function.

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User Manual for Vital Signs Monitor

Chapter 3 Installation and Connection 3.1 Appearance 3.1.1 Front Panel

Figure 3.1 Front panel illustration

Description: 1

Alarm indicator Indicator

Alarm Level

Red flashing

High priority alarm

Exceeding the limits, low battery voltage

Orange flashing

Medium priority alarm

Leads or probe off

Green light

Normal

2

SYS: display systolic pressure value.

3

DIA: display diastolic pressure value.

4

PR: display the measured pulse rate; unit: bpm.

5

SpO2: Display SpO2 value; Unit: “%”.

6

LCD panel

7

"

Alarm Event

": Power button: Press power button for 3 seconds to start the monitor or shut off the monitor.

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User Manual for Vital Signs Monitor

8

～: AC Power indicator. : DC Power indicator.

9

10 MAP: When NIBP measurement mode is set to “manual” and “STAT”: Display mean arterial pressure or measuring time of the latest group of NIBP measurement; they will be displayed alternately. The format of NIBP measuring time is “hh:mm”. If the tourniquet is in use, the cuff pressure will be displayed here; When NIBP measurement mode is set to “AUTO”: Display real-time pressure value during measurement. Countdown time will be displayed in the MAP when the measurement finishes. Countdown time has two formats (＞1 hour HH: mm; ＜1 hour mm: ss). Note: two formats to display NIBP value: “×××mmHg” and “××.×kPa”. Refer to section “4.6.2 NIBP Setup” to set the unit of NIBP value; the conversion relation between “mmHg” and “kPa”: 1mmHg=0.133kPa. 11 "

"NIBP Setup key: on plethysmograph displaying screen, trend graph screen and NIBP list screen,

pressing this key to enter into " NIBP Mode Setup" screen. 12 "

"Power Saving Mode Setup key: on plethysmograph displaying screen, trend graph screen and SpO2

list screen, pressing this key to enter into "Power Saving Mode" setting screen. 13 Pulse sync indicator patient category indicator: “ ” for adult; “ ” for pediatric; “ Patient category is selected under sub-menu “Patient Info” within the setup menu. 14 "

” for neonate;

" Alarm silence key: Enable/disable alarm silence function. When the alarm silence indicator on the

left of keys is on, it means the system is in alarm silence status. Short press this key and it lasts this status for 2 minutes. When finishing counting down, the system will resume normal alarm status automatically; Long press this key, the alarm sound of the current event will be disabled, but if alarm event occurs at this time, the alarm sound will be effective again. 15 "

" Print: the internal printer is optional, press this key to print the current measuring data.

16 Alarm silence indicator: When it is on, it indicates that the monitor stays in alarm silence status. 17 "

" NIBP: start/cancel NIBP measurement.

18 “ ”: Bar-graph of pulse intensity. 19 "

" Up: shift cursor forward/upward

20 "

" OK: to confirm selection or modification

21 "

"Down: shift cursor backward/downward

22 "

" Display: short time pressing to shift LCD display modes; longtime pressing to enter into Setup Menu

display screen. 23 TEMP: TEMP probe connector 24 NIBP: NIBP hose connector 25 SpO2: SpO2 sensor connector Description to AC, DC Power indicator：

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User Manual for Vital Signs Monitor

AC Power indicator DC Power indicator

Status

Descriptions

ON

ON

this device is using AC power supply

OFF

ON

the battery is being used

ON

OFF

the battery is being recharged while the device is off

3.1.2 Side Panel The built-in thermal printer is in the left panel. It is easy for user to print plethysmograph and data.

3.1.3 Rear Panel

Figure 3.2 Rear Panel

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User Manual for Vital Signs Monitor

3.2 Installation 3.2.1 Opening the Package 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 accompanying document to sort the accessories according to the packing list.  Inspect the monitor for any mechanical damages  Check all the accessories for any scratch or deformity, especially on connector, wire and probe parts ☞ You 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. If in doubt, please contact the local dealer or our company in case of any problems. We are to offer you the best solution for your satisfaction.

3.2.2 Connecting the Power Supply 1. When powered by AC mains power supply: 

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



Use the power cable prepared by the manufacturer. Insert one end of it to the power port of the monitor and the other end to the grounded three-phase power jack.



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. 2. When powered by built-in battery Caution: it’s better to recharge the battery after it is used up, the charging time should be 13~15 hours long. The provided battery of the monitor must be recharged after transportation or storage. So if the monitor is switch on without being connected to the AC power socket, it may not work properly due to insufficient power supply.

3.2.3 Starting the Monitor The system performs self-test and enters initial display after switching on the monitor, and the orange alarm indicator blinks to inform that the user can begin operating it.  Check all the applicable functions to make sure that the monitor works normally.  If the battery is applied please recharge it after using the monitor to ensure sufficient power storage. It will take minimal 8 hours to charge battery from depletion to 90% charge.  Do not use the device to monitor the patient if there are indications of damage or reminders of error. Please contact the local dealer or our company.  It’s recommended to delay 1 minute to start it again.

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User Manual for Vital Signs Monitor

3.3 Sensor Placement and Connection 3.3.1 ECG Cable Connection ECG measurement is to collect the ECG signal via the ECG electrodes. Electrode connects the patient and the lead. The lead connects the monitor. The locations of the electrodes are very important for obtaining accurate ECG signals. 1. Connect the cable to the right-panel connector marked with the ECG icon. 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 

Clean and dry-abrade skin to ensure low sensor impedance. Mild soap and Water is recommended as a skin cleanser. Note: Alcohol is not recommended as a skin cleanser; it leaves a film layer that may cause high sensor impedance. If alcohol is used, ensure 30-second dry time.



Dry-abrading the skin gently with a dry wash cloth, gauze, or skin preparation product is helpful to remove the non-conductive skin layer. The symbol indicates that the cable accessories are designed to have special protection against electric shocks, and is defibrillator proof.

The locations of the electrode are in the following Figure:

Figure 3.3 Electrode Location Note: If skin rash or other unusual symptoms develop, remove electrodes from patient. 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 wave with 3 leads. The 5 leads should be used to have ECG wave.

6 The ECG leads and their corresponding locations are as follows:

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User Manual for Vital Signs Monitor

Lead connection 1

Lead connection 2

（IEC standard）

（AHA standard）

Electrode placement

Color

Electrode label

Color

Electrode label

Red

R

White

RA

Place on the right arm，or the intersection between the centerline of the right clavicle and Rib 2

Yellow

L

Black

LA

Place on the left arm，or the intersection between the centerline of the left clavicle and Rib 2

Green

F

Red

LL

Place on the left leg，or left parter of the upper abdomen

Green

RL

Place on the right leg，or right parter of the upper

Black

N or RF

abdomen

White

C

Brown

V

An individual and movable electrode pasted on the chest

White or Red

C1

Brown

V1

On the 4th intercostal space at right border of sternum

C2

Brown or Yellow

V2

On the 4th intercostal space at left border of sternum

C3

Brown or green

V3

The middle line between V2 and V4

C4

Brown or blue

V4

The intersection between the centerline of the clavicle and the 5th intercostal

V5

The intersection between the left anterior axillary line and the horizontal level of V4

V6

The intersection between the left mid-axillary line and the horizontal level of V4

White or Yellow

White or Green

White or brown(Blue) White or Black

White or Purple

C5

C6

Brown or Red

Brown or purple

Table 3-1 Safety Instructions for ECG Monitoring  Use the same type electrode on a patient. If skin rash or other unusual symptom occurs, remove electrodes from patient. Do not attach electrodes on the patient with an inflammation of the skin or scores on skin.  PC-900 Vital Signs Monitor can only be equipped with ECG leads provided by our company; using ECG leads supplied by other companies may cause improper performance or poor protection while using defibrillator.  Electric parts of electrodes, leads and cable are forbidden to contact any other conductive parts (including 9

User Manual for Vital Signs Monitor

ground). 

PC-900 Vital Signs 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 you put the electrodes and cable in proper places according to this manual’s instructions and the instructions for using electrode, the chance of this transient occurring will be decreased.  Besides the improper connection with electrosurgical unit may cause burns, the monitor may be damaged 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 with the patient properly.  ECG leads may be damaged while using defibrillator. If the leads are used again, please do the functional check first.

 When removing the ECG cable, hold the head of the connector and pull it out.  When the monitor is inoperable due to an overload or saturation of any part of the amplifier, it will prompt “Lead off” to remind operator.

 No predictable hazard will be caused by the summation of leakage currents when several item of monitor are interconnected.

3.3.2 Blood Pressure Cuff Connection 1. Connect the cable to the right-panel connector marked with the NIBP icon. 2. Unveil and wrap the cuff around patient’s upper arm. Requirements of the cuff: 1) Appropriate cuff should be selected according to the age of the subject. Its width should be 2/3 of the length of the upper arm. The cuff inflation part should be long enough to permit wrapping 50-80% of the limb concerned. See the table below for the dimensions: Note: The size of the cuff selected should suit the subjects while measuring. Cuff Model

Arm Circumference

Cuff Width

Small-sized Pediatric Cuff

6cm～11cm

4.5cm

10cm～19cm

8cm

Large-sized Pediatric Cuff

18cm～26cm

10.6cm

Adult Cuff

25cm～35cm

14cm

Middle-sized Pediatric Cuff

Table 3-2  When putting on the cuff, unveil and wrap it around the upper arm evenly to appropriate tightness. 2) Remember to empty the residual air in the cuff before the measurement is commenced. 3) Locate the cuff in such a way that the “φ” mark is at a location where the clearest pulsation of brachial artery is observed. 4) The cuff should be tightened to a degree where insertion of one finger is allowed. 5) The lower end of the cuff should be 2cm above the elbow joint. 10

User Manual for Vital Signs Monitor

Figure 3.4 Cuff Placement 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 standard pressure meter as the reference equipment like a mercury pressure meter

Figure 3.5 Connection of Pressure calibration fixture Mode 1: The inflation can be activated by Monitor 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 11

User Manual for Vital Signs Monitor

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: No automatic inflation by Monitor during the pressure accuracy verification. Increase the pressure manually by the 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.  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 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 Monitoring When taking the measurement of a pediatric or an infant or neonate’s (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. It is recommended to take the blood pressure measurement manually. Automatic measurement should be used at the presence of a doctor/nurse. NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or with sickle cell disease, or partial bleeding will appear. Pay attention to the color and sensitivity of the limb when measuring NIBP; make sure the blood circulation is not blocked. If blocked, the limb will discolor, please stop measuring or remove the cuff to other positions. Doctor should examine this timely. Confirm your patient category (adult, pediatric or neonate) before measurement. Do NOT bind NIBP cuff on limbs with transfusion tube or intubations or skin lesion area, otherwise, damages may be caused to the limbs. If the time of the automatic pattern noninvasive blood pressure measurement is too long, the body connected with the cuff will possibly occur the purpura, lack the blood and the neuralgia. In order to protect patient, it is requested to inspect the luster, the warmth and the sensitivity of the body far-end frequently. Once observes any abnormity, please immediately stop the blood pressure measurement. The patient should lie on the back so that the cuff and the heart are in a horizontal position and the most accurate measure is taken. Other postures may lead to inaccurate measurement. 12

User Manual for Vital Signs Monitor

Do not speak or move before or during the measurement. Ensure that the cuff will not be hit or touched by other objects. The measures should be taken at appropriate intervals. Continuous measurement at too short intervals may lead to pressed arm, reduced blood flow and lower blood pressure, and resulting inaccurate measure of blood pressure. It is recommended to take measurement at intervals of more than two minutes. When an adult is monitored, the machine may fail in giving the blood pressure measure if the infant 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 symbol indicates that the cable and accessories are designed to have special protection against electric shocks, and is defibrillator proof.

3.3.3 SpO2 Sensor Connection SpO2 sensor is a very delicate part. Please follow the steps and procedures in operating it. Failure to operate it correctly can cause damage to the SpO2 sensor. Operation procedure: 1. Connect the SpO2 sensor to the connector labeled “SpO2”. When unplugging the probe, be sure to hold the head of the connector and pull it out. 2. If the finger clip SpO2 sensor is used, insert one finger into the sensor (index finger, middle finger or ring finger with short nail length) as shown in the figure below.

Figure 3.6 Finger clip SpO2 sensor placement When selecting a sensor, 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. Refer to Chapter 11.5 for the detailed instructions of each SpO2 probe. SpO2 Probe

Patient Category

SpO2 Finger clip Sensor (reusable)

Pediatric

SpO2 Finger rubber Sensor(reusable)

Adult

SpO2 Finger clip Sensor(reusable)

Adult

3. If the neonate SpO2 sensor is used, please follow Figure 3.7 to connect.

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