Vet420a manual 2005

VET420A

Multi-parameter Veterinary Monitor M1.0a

OPERATOR’S MANUAL

Goldway, Inc.

Melville, NY USA

VET420A GOLDWAY, INC.

TABLE OF CONTENTS

SECTION 1: INTRODUCTION 1.1 About This Manual 1 1.2 Warranty 1 1.3 Unpacking 1 1.4 Product Support 1 1.5 General Information 1 SECTION 2: BASIC DESCRIPTION 2.1 Front Panel 2 2.2 Side Panel 4 2.3 Rear Panel 4 2.4 Control keys and Buttons 5 2.5 Operation 6 2.6 Display Illustrations 6 2.7 System Setup 9 2.8 Accessories 10 2.9 Power 11 2.10 Printing 11 2.11 Trend Display 14 SECTION 3: ALARM CONTROL 3.1 Introduction 15 3.2 Alarm Setup 15 SECTION 4: ECG MONITORING 4.1 Animal Preparation 18 4.2 General Electrode Placement 18 4.3 Setup 18 4.4 Troubleshooting 20 SECTION 5: NIBP MONITORING 5.1 General Information 22 5.2 Cuff Selection & Placement 23 5.3 NIBP Setup 23 5.4 Troubleshooting 25 5.5 Maintenance 26 SECTION 6: SpO2 MONITORING 6.1 Introduction 27 6.2 Sensor Placement 27 6.3 Probes 28 6.4 Troubleshooting 28


SECTION 7: RESPIRATION & TEMPERATURE MONITORING 7.1 Respiration Monitoring 29 7.2 Temperature Monitoring 30 APPENDIX I: TECHNICAL SPECIFICATIONS 32 APPENDIX II: MAINTENANCE 35

APPENDIX III: SAFETY 37


SECTION 1: INTRODUCTION

1.1 About This Manual

Welcome and thank you for choosing the VET420A portable multi-parameter veterinary monitor. This operator’s manual contains detailed information about the performance specifications, operation and maintenance of the VET420A. Before using the veterinary monitor, please read this manual carefully and thoroughly in order to use the monitor correctly and make sure the monitor performs according to the specifications and in conformity with the safety standards.

1.2 Warranty

The warranty does not apply if the product: 1 has been damaged from improper operation (misuse). 2 has been damaged because of improper connection to other equipment. 3 has been damaged by accident. 4 has been modified without written authorization of the Company. 5 has had the serial number removed or defaced.

1.3 Unpacking

After unpacking the system, keep the packing materials for future return for service when necessary.

Carefully check the main unit and the accessories against the packing list and check to see if there are any damages. Please fill in the product warranty card carefully and mail it to our service center.

1.4 Product Support

To make a service call or to obtain product support, please contact your representative or distributor. Have the following information available before calling:

• Part number of the defective part • Or model and serial number of the equipment

1.5 General Information

This manual is an integral part of the product and describes its intended use. It should always be kept close to the equipment. Observance of the manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. GOLDWAY quality management system complies with the international standards ISO 9001 and EN 46001.

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SECTION 2: BASIC DESCRIPTION

2.1 Front panel

Figure 2-1

The front panel of the VET420A multi-parameter veterinary monitor is as shown in the figure as follows.

(1) Handle (2) Display screen (3) Power Button (4) Power Indicator LED

This handle is convenient for the operator to carry the monitor. 7 inch TFT LCD screen for displaying waveform, menu, alarm status and vital sign measurement results. Press the button for 1.5 seconds to turn on the patient monitor. Press again to turn off the monitor. Press the Power Button twice rapidly and continuously in the period of 3 seconds when turning on the monitor, then the monitor will enter DEMO mode. If you want to exit the DEMO mode, just turn off the monitor and press the button for 1.5 seconds to turn on and enter monitor mode. When the patient monitor is on by using AC power, both of the green LED and the orange LED are lit. When the

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(5)

(6)

(7)

(8) (9) Mouse Knob (10) Printer Cover

(11) (12) (13) Printing status LED (14) Receptacle

patient monitor is connected to AC power supply but not turned on, only the orange LED is on, indicating that the internal battery is being charged. When the monitor is on by using battery, only the green LED is lit. WAVEFORM FREEZE/RESTORE: When a waveform sweep is displayed, press the key to freeze the waveform. When a waveform is being frozen, press this key to unfreeze the waveform and restore waveform sweep. NIBP MEASURE START/STOP: Press this key to start a blood pressure measurement. If the veterinary monitor is in the process of blood pressure measurement, press this key to stop blood pressure measurement. SILENCE: Press this key to enable or disable Alarm sound. ECG MENU: Press this key to enter ECG and NIBP setup menu. When menu is displayed, rotate the knob to select the functions. When the desired function is highlighted in pink, press the knob to confirm your selection. Rotate the knob again to select the desired item and press the knob to confirm. Paper-loading cover, open it then load print paper.

Paper advance key. Press the key after installing the paper, the paper will step out from (10).

Print key. Press the key, the printer start printing, press the key again, the printer stop printing. Green: The printer is ready for printing; Red: The paper is lack, please put paper into the printer; or the red LED also indicate other trouble, please check it carefully and ask for engineer’s help. Flash: The printer is printing. Power supply receptacle.

There is a power supply adaptor in the printer. Insert the AC line cord into the three-pronged IEC receptacle (14 in Fig.2-1) on the adaptor. The other end of the AC line cord

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is then inserted into an appropriate wall outlet.

2.2 Side Panel

There are three sockets/receptacles on the left side panel, respectively: SpO2: This socket accepts SpO2 probe. NIBP: This receptacle accepts the hose connector plug from the blood pressure cuff. ECG : This socket accepts ECG cable accompanying the veterinary monitor.

2.3 Rear Panel

The rear panel of VET420A is as shown in Figure 2-2.

Figure 2-2

1. Temp socket 1 2. Temp socket 2

3. Central station communication port (RS422)

4. Printing communication port (include power supply 15V,2A)

5. Heat Exhaust 6. Product label 7. Printing communication port

RS422 communication port can only be connected with GOLDWAY central

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station.

Power Supply Adaptor – there is a power supply adaptor between the veterinary monitor and the power cord. The power supply adaptor consists of a tabletop box with a permanently attached cable and a separate AC line cord. The attached cable is inserted into its mating connector (4 in Fig.2-2) located on the rear of the monitor. Insert the AC line cord into the three-pronged IEC receptacle on the adaptor. The other end of the AC line cord is then inserted into an appropriate wall outlet.

2.4 Control Keys and Buttons

This veterinary monitor has three kinds of keys and buttons: 2.4.1 Function Key

ECG MENU

SILENCE

NIBP MEASURE START/STOP

WAVEFORM FREEZE/RESTORE

PAPER ADVANCE PRINT

2.4.2 Mouse knob Located at the lower right of the front panel, corresponding to a

combination of the left/right shift key (rotate the knob) and confirm key (press the knob).

2.4.3 Menu key When you rotate the knob, the following menu keys will be displayed in the menu area.

ECG Setup

Trend Display

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System Setup

Screen Brightness & Volume Adjustment

Print setup

Holograph recall, press this key and system will recall the waveform and data for fifty-eight seconds before the current time. The screen color turn into blue and the signal will twinkle on the last line.

Exit.

2.5 Operation

2.5.1 Rotate the knob, select the menu key and press the knob to enter the corresponding Setup menu. 2.5.2 Operation of Setup: Rotate the knob, when the color of a certain key changes from green to pink, press the knob and confirm, then rotate the knob to select the desired option and confirm the selection by pressing the knob. 2.5.3 The volume can be adjusted by the menu key. The volume for the monitor tone is adjusted first, and then the alarm’s tone:

Rotate Knob→ →Press Knob→ →Rotate Knob → Press Knob → → Rotate Knob→ Press Knob 2.5.4 The screen brightness can be adjusted after the above volume adjustment, in the following order,

Press Knob→ → Rotate Knob→ Press Knob The main operator control is the Trim Knob control. The Trim Knob rotates in either direction to highlight parameter labels and menu options. After highlighting the desired selection, press the knob to view a new popup menu or selection. Remember, when using the Trim Knob control, rotate to highlight, then press to select.

2.6 Display illustrations

This patient monitor displays the monitoring results as shown in Fig.2-3:

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Figure 2-3 Screen Display 1

The screen can display clear vital sign readings, large alarm status, four-channel waveform and data display (ECG waveform, SpO2 waveform and Heart rate/Pulse rate, SpO2, NIBP Readings, TEMP1, TEMP2, RESP). At the bottom line of the ECG waveform channel, a time mark appears every second, forming a time scale, which is convenient for observation, calculation and diagnosis. Press the knob, the screen is turned to be as shown in Fig.2-4:

Figure 2-4 Screen Display 2 Screen Display 2 can display 600-set NIBP data with 10-set per page. The operator can observe the data by rotating the knob. 2.6.1 Waveform Data Area In this area, the monitor changes from WAVEFORM AREA to DATA AREA when the knob is pressed. As shown in Figure 2-3, Waveform channel 1 displays ECG waveform; Waveform channel 2 displays SpO2 waveform.

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DATA AREA displays NIBP reading set as shown in Figure 2-4. NIBP reading set includes Date, Time, NIBP Pulse, SYS, DIA , SpO2, SpO2 Pulse, RESP, HR, TEMP1, TEMP2.

This system is capable of storing up to 200 sets of blood pressure measurement results, but only 10 sets of readings can be displayed on each page. The status bar at the left side of the reading indicates the current position of the reading. Rotate the mouse knob to browse the pages one by one.

NOTE: If ECG or SpO2 waveform channel displays “No signal received”, please turn off the monitor and turn it on again. If the message still remains, please contact the dealer. 2.6.2 Parameter Area

In the Parameter area, the following parameters are displayed in real time: Heart Rate/Pulse Rate, SpO2, NIBP (SYS/DIA/MAP), Respiration rate, Temp, ∆T.

When “ECG” of Priority HR/PR is selected in the ECG setup menu bar, it means heart rate tone will be heard prior to pulse rate tone. The heart shaped symbol, which is at the bottom of the screen, will be displayed in green.

When “SpO2” of Priority HR/PR is selected in the ECG setup menu bar, it means pulse rate tone will be heard prior to heart rate tone. The heart shaped symbol, which is at the bottom of the screen, will be displayed in red. NIBP parameter is displayed in mmHg or kPa which can be selected by operator, while “Manual/Auto/Stat” are indicated behind “NIBP”. 2.6.3 Status Box In the status box, alarm status and battery power status are displayed.

2) Alarm Status: is used to indicate whether the alarm sound is enabled or disabled. 2 Battery Power Status: The battery power status is indicated by the black Segments in . The more segments there are, the more battery power there is. When there are no segments, the symbol turns red and flashes with alarm sounds to indicate that the battery power is about to be used up. If the battery is not recharged within the next 3-10 minutes, the patient monitor will be automatically powered off.

2.6.4 Waveform Speed

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It is displayed on the first row and indicates the sweep speed of vital sign in mm/s. User may select 12.5, 25 or 50mm/s. 2.6.5 Patient ID and Monitoring Time Patient ID and the current monitoring time are displayed in the corner.

2.7 System Setup

The system setup is the monitor system setup, which allows you to setup a new patient’s bed ID or edit the ID, setup the current date and time, select the alarm mode, turn on/off the alarm sound, and restore the default data.

Rotate Knob Press Knob

Figure 2-5

2.7.1 Time Setup The monitor displays the current time and date. Every time when the monitor is turned on, the system will display the time and date on the first row. To set up the time:

Rotate Knob Press Knob Rotate Knob Date/Time Press Knob Rotate Knob Press Knob Rotate the knob to change the day, month, year, second, minute and hour. The new information will not be updated in the system until the knob is pressed. 2.7.2 Input and edit patient’s ID When starting to monitor a new patient, medical personnel should input the patient’s ID first:

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Rotate Knob Press Knob Rotate Knob New Patient Press Knob Rotate Knob Press Knob If there is some mistake with the patient ID, you can enter edit menu to correct it:

Rotate Knob Press Knob Rotate Knob Edit Patient Press Knob Rotate Knob Press Knob 2.7.3 Alarm sound and Alarm mode To turn off the alarm sound:

Rotate Knob Press Knob Rotate Knob Alarm sound Press Knob Rotate Knob Press Knob To setup the alarm mode (Auto/Standard):

Rotate Knob Press Knob Rotate Knob Alarm mode Press Knob Rotate Knob Press Knob 2.7.4 Restore default data To restore the default data, which has been setup before the monitor left the factory:

Rotate Knob Press Knob Rotate Knob Restore Default Press Knob

2.8 Accessories

Recommendations: It is recommended to use the accessories listed in the following table, or accessories with CE mark or in conformity with IEC60601-1 standards. Otherwise the performances of the patient monitor may be degraded and patient safety may be endangered. Accessory Description

Cuff 1 set of cuffs (6 different sizes of cuffs per set)

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Temperature Probe Rectal / Esophageal Temperature Probe

SpO2 Sensor Lingual Sensor

ECG Cables and leadwires

with Vet clips

5-Lead ECG set (includes ECG cable, 5-lead

leadwires, and 5 veterinary clips.)

2.9 Power

2.9.1 Battery Power The monitor has a built-in battery to provide power to the monitor whenever AC power is interrupted. You must charge the battery before using it. There is no external charger. The battery is charged when the monitor is connected to AC power. A fully depleted battery will take 8 hours when the monitor is in use, to fully recharge. To assure a fully charged battery which is ready for use, we recommend that the monitor be plugged into AC power whenever it is not in use. The LED is lighted in yellow when the monitor is connected to AC power but not in use. The monitor can work for 1.5 hours on a new, fully charged battery. NIBP monitoring and the usage of the recorder will drain battery power faster than other parameters. NOTE: The battery signal, which is at the bottom of the screen, will flash and the alarm will sound when the battery power is about to be used up. If the battery is not recharged within 5 minutes, the patient monitor will be automatically powered off. You should connect the monitor to an AC power source as soon as you can. CAUTION: The battery discharges even when the device is not operating. • Please ensure that the battery is always fully charged when you are keeping the device in storage for an extended period of time. • Check the battery status at least once every month and recharge the battery. 2.9.2 Power shut off When the supply mains to the monitor is interrupted for more than 30 seconds, the built-in battery will run automatically. If the battery’s power is used up, the monitor will save the current working status and responding information, relax the pressure in the cuff to undertake the patient’s safety.

2.10 Printing

2.10.1 Recorder The monitor’s recorder is a external thermal array recorder. Patient waveforms and most

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information can be printed continuously or discontinuously. Link the printing communication port of the monitor and the recorder with a cable, then turn on the monitor and press the Print key on the right of the recorder, the recorder will start printing real time waveform and data, the printing speed are 25.0 or 12.5 mm/S selectable. If you want to stop printing, just press the Print key again. 2.10.2 Loading print paper

Figure 2-6

Figure 2-6 shows what the printer looks like under the printer cover. Put a fold of print paper into (1), then roll a piece of paper up to the roll axis (2) parallel. The print paper will be fed into the printer automatically by the roll axis, as shown in Figure 2-7, after that close the paper-loading cover, and press PAPER ADVANCE key, the paper will move out of the printer’s outlet, as shown in Figure 2-8.

Figure 2-7 Figure 2-8

When you need to withdraw the paper from the printer, first open the printer cover, then uplift the tab shown on (3), which will loosen the roll axis (2), allowing you to withdraw the paper easily. 2.10.3 Print and Paper Advance Keys As shown in Fig. 2-7, the left key on the printer is the PAPER ADVANCE key, the key at the right side is the PRINT key.

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After paper is loaded, press PAPER ADVANCE. The printer paper will move out of the printer’s outlet, as shown in Fig. 2-8. CAUTION: Please do not press the PAPER ADVANCE key during printing to avoid printing interruption. If you press the PRINT key, real-time waveform and data will be printed. Press it again and the printing will be stopped. 2.10.4 Printing content Printing content includes: patient ID, printing date and time, printing speed, parameters’ value, blood pressure's unit and value.

2.10.5 Print Setup menu Print mode, alarm trigger ON/OFF, timing print length, printing time, preset time and printing speed can be selected in the printing setup menu.

Rotate the knob→ → press the knob

Figure 2-9 Print Mode: Length/ Data/Track selectable. LENGTH: Fix printing time length under Manual, Alarm trigged or Timing print manner. DATA: Print NIBP list under manual or timing printing manner, it can print 10 groups newest data. TRACK: Press Print key to start/stop printing under Manual manner, it will print ECG and SpO2 waveform. Alarm Trigger: Alarm-triggered printing, ON/OFF selectable. A graph strip is automatically printed when a crisis or warning alarm occurs. It runs for preset time or until you manually stop it. The printing time can be selected in the print

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setup menu. Timing Print: ---/15minutes/30minutes/1hour/4hours/8hours/12hours. Manual print: Press Print key to start/stop printing. PRINT TIME: 8 Seconds/16 Seconds/32 Seconds selectable. FORMER TIME: 2 Seconds/5 Seconds selectable. PRINT SPEED: 12.5/ 25.0 mm/S selectable.

2.11 Trend Display

The device provides up to 48-hour monitoring history data, which can be displayed through trend display function. Follow the steps below to enter trend display:

Rotate the knob→ → Press the knob

Figure 2-10 The monitor can display 48-hour trend of SpO2\PR\RESP\HR\TEMP1\TEMP2. As shown in the above figure, vertical is parameter’s value, horizontal is monitoring time. The current time is on the right of the trend figure. Scale: To move the scale and observe different time. Up/Down: To move up and down and display different parameter’s trend. Page: To display previous or next page’s trend.

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SECTION 3: ALARM SETUP

3.1 Introduction

Alarm is used to alert the user when abnormal data occur in a monitoring process. It includes audible and visual alarm. Audible alarm: When monitoring parameter is outside the preset limits, the monitor will automatically activate audible alarm. Visual alarm: When a monitoring parameter is outside the preset limits, an underline of the parameter will occur and automatically twinkle with the alarm signal in the parameter area. The alarm lever is divided into three classifications: 1. Crisis: ASYSTOLE, SYS-DIA is too low; alarm tone is 5 beep; 2. Warning: Patient condition exceeds parameter limits, Abnormal Status alarm; alarm

tone is 3 beep; 3. Message: Battery is low power; alarm tone is 1 beep. NOTE: When “Asystole” is displayed on the screen, please check for the ECG Gain to see if it is too low to detect for its heart rate. If so, user can switch the ECG lead. Alarm messages are as follows: LEAD OFF PROBE OFF LOOSE CUFF AIR LEAK WRONG POSITION RANGE EXCEEDED OVERPRESSURE FAIL SEARCH OUT OTHER ERROR

3.2 Alarm Setup

To effectively control the system alarm function, the monitor has alarm ON/OFF, alarm mode selection which can be selected through key or menu setup. 3.2.1 Alarm ON/OFF

Press the silence key on the front panel of the monitor to turn on the alarm sound and set alarm silence within a certain period of time. The system alarm sound ON/OFF status is displayed in the Status Box of the screen, respectively:

Alarm sound is enabled.

Alarm sound will be silenced for 1 minute. Time is counted down. If the selected

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alarm mode is “Standard mode”, any new alarm will sound and the silence command is cancelled.

Alarm sound will be silenced for 2 minutes. Time is counted down. If the selected alarm mode is “Standard mode”, any new alarm will sound and the silence command is cancelled.

NOTE: Press the SILENCE key on the front panel, and at the same time, • pay attention to the time display under the alarm sign in the Status Box until it is

switched to the desired time duration of silence. • The alarm sound setup is valid to all monitoring parameters. • In the stage of silence, if the selected alarm mode is “Standard mode”, any new alarm

will sound and the silence command is cancelled. The alarm tone is the new alarm tone in the first 10 seconds, then transfers recording to the lever of alarm.

• Low power alarm isn’t controlled by the silence key, whenever the battery’s power is low, the monitor will alarm instantly.

• The monitor can turn off/on the alarm sound of all parameters in the system setup menu.

• The monitor can also turn off/on the alarm sound separately in each parameter’s setup menu.

3.2.2 Alarm Limits Alarm limits are the basis for the monitor to judge if a parameter is normal or not. There are upper and lower alarm limits. To be higher than upper limits or lower than lower limits are both abnormal and can activate the alarm. Doctors can set the upper and lower limits according to the patient’s status in each parameter setup menu. When the upper and lower limits of alarm are setup, the system will retain the setting until the next change. • Even when the monitor is powered off, the alarm limits will still remain in the

memory. 3.2.3 Alarm Volume The menu key can adjust the volume. The volume of the monitor tone is adjusted first before the volume of the alarm tone:

Rotate Knob→ →Press Knob→ →Rotate Knob → Press Knob → → Rotate Knob→ Press Knob 3.2.4 Default Alarm Limits

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After having respectively set the parameter alarm limits, user may hope to return to the original alarm settings of factory, that is the default setting. Now the steps are as follows:

Rotate Knob Press Knob Rotate Knob Restore Default Press Knob The default settings of the monitor are as follows: Parameter Default upper limit Default lower limit HR/PR ST SpO2NIBP SYS NIBP DIA SYS-DIA TEMP RESP rate

120bpm 0.30 100% 160mmHg/21.3kPa 100mmHg/13.3kPa --- 42.0� 40brpm

40bpm -0.30 90% 100mmHg/13.3kPa 60mmHg/8.0kPa 20 mmHg 30.0� 6brpm

3.2.5 Alarm mode The monitor has two alarm modes, one is standard mode, and the other is auto mode. The setup steps are as follows:

Rotate Knob Press Knob Rotate Knob Alarm mode Press knob Rotate Knob Standard/Auto Press Knob (1) Standard alarm mode When the abnormal status occurs, if the alarm is on, all alarms are enabled and keep alarming until someone responds. The priority and intermission time of the alarm coincides with the corresponding standards that are set. (2) Auto alarm mode Under the following circumstances of LEAD OFF, PROBE OFF, if the alarm is on, the system will automatically alarm for 30 seconds and corresponding messages will be displayed. When blood pressure value is abnormal, and the alarm is on, the monitor will alarm for 30 seconds and the abnormal parameter will continue flashing. If abnormal HR/PR or SpO2 occurs (exceeding the upper or lower limits), and the alarm is on, the monitor will activate real-time audible and visual alarms.

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SECTION 4: ECG MONITORING

4.1 Animal Preparation

ECG Cables and Electrodes: The VET420A ECG is equipped with a five lead ECG cable. To connect this cable, insert the cable connector into the lower round socket marked “ECG” on the side panel of the monitor. Rotate the plastic cuff to lock it in place.

The ECG cable connector is insulated and it is defibrillator-proof Use only the cables recommended by the manufacturers. These cables ensure patient safety and protect the device during defibrillation and electro-surgery.

WARNING: Do not come into contact with patients during defibrillation, and make sure that the patient cable is not touching any metal parts. All of the lead wires should be fully inserted in the cable during defibrillation. Otherwise serious injury or death could result.

4.2 General Electrode Placement

Accurate electrode placement is very important for obtaining a clear quality ECG trace. The following steps should be taken to ensure the highest quality trace:

1. The skin should be cleaned with alcohol and parted so the lead can be attached to as much of the skin as possible.

2. The foreleg leads are attached to the appropriate foreleg just above the elbow. The hind leg leads are attached to the appropriate rear leg immediately proximal to the stifle.

3. You can use conductive gel, saline and/or alcohol to wet all contact sites to establish a good electrode to skin contact.

Electrode Label Location Color

RA Right Foreleg White RL Right Hind Leg Green LA Left Foreleg Black LL Left Hind Leg Red V 4th Intercostal Space Brown

The brown veterinary clip electrode does not have to be used for normal screening purposes. It is an option if you wish to use it for precordial lead (V).

4.3 ECG Setup

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Rotate Knob Press Knob

Or press ECG MENU directly. The ECG lead and scale selected will both be displayed on the top of the ECG waveform channel.

ECG Lead: Lead selections include I / II/ III/ aVR/ aVL/ aVF/ V/ GND. Default is II.

Wave Speed:

ECG waveform speed selections include 12.5/ 25.0/ 50.0mm/s. Default is 25.0mm/s.

ECG Gain:

Selections include X1/4, X1/2, X1, X2, X4, Auto. Default is X1. Manual adjustment is available if wave is too small to see.

ECG Mode: Monitor/Operation/Diagnosis are available for selection

straining waveform mode. If Diagnosis mode is selected, the monitor displays unstrained ECG waveform. If Monitor mode is selected, the monitor displays ECG waveform whose false error of fake alarm have been strained. Operation mode is suppose to be select during an operation for the mode can decrease false error and interference from electro-surgery equipment. The ECG mode selected displays on the ECG1 channel.

HR Source: ECG1/ECG2 are available for selections.

Waveform Mode: Selections include Standard/Amplify. Default is Standard.

HR Upper Limit: ~300

HR Lower Limit: ~15

ST Upper Limit: ~0.80

ST Lower Limit: ~ -0.80

Alarm Sound: On/Off

1mV CAL: When triggered during ECG monitoring, a 1mV calibration

square wave will overlap on the ECG waveform.

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Priority HR/PR: ECG/SpO2

To manually select ECG LEAD, follow this procedure:

ECG MENU Rotate Knob ECG LEAD Press Knob Rotate Knob I / II /III / aVR/ aVL/ aVF/ V/ GND Press Knob

The monitor obtains the respiration signal through the same electrodes used for ECG. The ECG lead selection does not affect the respiration signal. Be sure to use the correct placement methods for the ECG electrodes. Setup the alarm limits of respiration rate, please refer to the section on Alarm Control.

Operation of ECG Setup: Rotate the knob, when arrow is pointing to a certain key, press the knob, then rotate the knob to select the desired option and confirm the selection by pressing the knob. For example,

ECG MENU Rotate Knob Prior Disp. Press Knob Rotate Knob ECG /SpO2/IBP1/IBP2 Press Knob

4.4 Troubleshooting

Inaccurate heart rate and false asystole:

1. Check ECG signal from patient a. Check/adjust lead placement b. Check/perform skin preparation c. Check/replace electrodes d. Check/adjust amplitude of ECG waveform

No ECG waveform: When the lead wires are connected and there is no ECG waveform, the screen will display “LEAD OFF” or “NO SIGNAL”.

1. Check ECG electrode contact with patient’s skin and check all lead wire connections.

2. No resistance should exist between extension wires applied to the patient’s body

and the leads of the ECG connector. If it is indefinitely large, it shows that the lead wire is broken and should be replaced.

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3. If ECG waveform channel shows “No Signal”, then it shows there are some

problems in the communication between ECG module and the main system. If this message still remains after the monitor is turned off and on again, please contact your supplier.

ECG baseline shift: When the ECG baseline is not stable and occasionally shifts out of the display area.

1. Check to see if the working environment is very humid and if the monitor has moisture inside. If so, turn on the monitor and let it run for 24 hours to remove the moisture.

2. Check if the electrodes’ quality is still good. If not, replace with new electrodes.

3. Check to see if the skin surface where the electrode is applied to is clean. If not,

clean the area and reapply the electrodes.

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SECTION 5: NIBP MONITORING

5.1 General Information

The monitor’s automatic electronic sphygmomanometer measures and displays a patient’s arterial blood pressure, mean arterial pressure, and pulse rate using the oscillation technique. Oscillations are caused by blood pressure pulses against the cuff. When the pressure in the cuff decreases, a sensor located in the monitor detects pressure fluctuations in the cuff. These pressure fluctuations are due to arterial volume changes that result from the blood flow as cuff pressure falls. The first number of a typical blood pressure reading (systolic) represents the maximum pressure generated when the left ventricle of the heart contracts. When the ventricles relax, pressure in the arteries decrease as blood flows out of the arterial system into the capillary system. The lowest point that the pressure reaches before the next ventricular contraction represents the second number of the blood pressure measurement (diastolic). The mean arterial pressure (MAP), which is calculated by the equation 1/3 (systolic+2×diastolic), corresponds to the maximum pulse amplitude at the lowest pressure level. WARNING: 1. The patient measure selected in the NIBP setup menu and the cuff size used must be

correct to obtain reliable NIBP data and to prevent overpressure. 2. The monitor is not recommended for patients experiencing seizures or tremors, or

patients with hypotension, hypertension, arrhythmias, or extremely high or low heart rate. The software algorithm cannot accurately compute NIBP on patients with these conditions.

3. Do not place the cuff on a limb being used for A-V Fistulas, intravenous infusion, or

any area where circulation is compromised or has the potential to be compromised.

4. Use care when placing cuff on extremity used to monitor other parameters. 5. Use only the accessories suggested by the manufacturer. Otherwise the safety will be

degraded. 6. The monitor is coincidence with EMC requirements, but if the electromagnetic

interference is too intense, the NIBP measuring may be influenced. 7. Continuous use may cause the skin under the cuff to exhibit nerve damnified or blood

lost. Periodically check patient limb circulation distal to the cuff. Check frequently when using Auto NIBP in 1 and 2 minute intervals and continues mode. Intervals below 10 minutes are not recommended for extended periods of time.

8. The operator should take off the cuff from the patient when the power is shut off.

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9. After monitoring, the cuff should be cleaned and sterilized for next use. 10. The equipment is suitable for use in the presence of electrosurgery. 11. When using High Frequency surgical equipment, you should put the patient tube and

cuff far from the surgical operation in order to reduce the hazards of burns in the event of a defect in the HF surgical equipment neutral electrode connection.

The NIBP cable connector is insulated and it is defibrillator-proof. Use only the cuffs recommended by manufacturers. These cuffs ensure patient safety and protect the device during defibrillation and electrosurgery.

WARNING: Do not come into contact with patients during defibrillation, and be sure that the patient cable is not touching with the metal parts. Otherwise serious injury or death could result.

5.2 Cuff Selection & Placement

Always have the Adult setting on. The following is a guide for accurate NIBP measurements.

1. Cuff sizing: The width of the cuff should represent 30-40% of the circumference of the limb or tail.

2. When possible, attach the cuff to the base of the tail. 3. Alternate location is above the Achilles tendon 4. If you are doing BP from an awake animal, calm them as much as possible and

then take 10 readings and do an average. 5. To ensure that you have the BP and all the other parameters showing up on the

Screen Display, set the Measure Time on the BP menu for 3 minutes.

5.3 NIBP Setup

NIBP(Non-Invasive Blood Pressure) setup includes: change NIBP units, select patient, change NIBP measurement mode (Auto/Manual/Stat), setup the interval of automatic NIBP measurement.

Rotate Knob Press Knob Rotate Knob NIBP Press Knob the screen display is as follows,

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5.3.1 NIBP measure mode NIBP measurement mode: • Manual • AUTO • STAT (Continuous) The current NIBP mode is displayed at the upper right of the NIBP parameter.

Under Manual mode, press NIBP MEASURE START/STOP key on the front panel, blood pressure measurement will start immediately. When blood pressure measurement starts, the monitor first inflates the cuff to a certain pressure, then slowly releases the cuff pressure and measures the patient’s blood pressure value. Under Auto blood pressure measurement mode, the monitor will start inflating at the start of every auto cycle and measures the patient’s blood pressure value automatically. Under Auto mode, if the patient’s blood pressure is too high, the monitor will adjust the maximum inflation pressure according to the actual blood pressure level. Under Stat blood pressure measurement mode, the patient’s blood pressure is measured continuously within five minutes. This mode is used to closely observe patient’s blood pressure changes under a very special situation. When blood pressure is measured manually or through pressing keys, the initial pressure value of cuff is 175mmHg for adults and 95mmHg for neonates. For Auto and Stat modes, the initial inflation pressure is the same as above, and then, based on the previous measurement results, adjust the initial inflation value of auto measurement. To change the blood pressure measurement mode under the NIBP menu, Rotate Knob Measure Mode Press Knob Rotate Knob

Auto/Manual/STAT Press Knob

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5.3.2 Measurement Time The current blood pressure measurement time is displayed after the measurement mode. Total continuous measurement time is displayed after “STAT”: 0:05(5 minutes). Automatic measurement time interval is displayed after “Auto”. Selections can be made from 1-10´, 15´, 30´, 60´, 90´, 120´ (´ is for minute, the time is the interval between the start of last blood pressure measurement and the start of next measurement), which can be adjusted by rotating the knob left or right. To adjust the interval under the NIBP menu, Rotate Knob Measure Time Press Knob Rotate Knob

0:01/0:02…/2:00 Press Knob 5.3.3 Changing NIBP Unit The monitor has two blood pressure measurement unit, i.e. mmHg and kPa. Default is mmHg. User may set the blood pressure unit according to the needs. The change of the blood pressure scale will be displayed with all the blood pressure parameters, e.g. parameter area and trend graph. To change the blood pressure scale under the NIBP menu, Rotate Knob Pressure Unit Press Knob Rotate Knob

mmHg/kPa Press Knob

5.3.4 NIBP Alarm NIBP SYS and DIA alarm upper or lower limits can be setup in the NIBP menu.

The monitor will send out danger alarm when the difference between SYS and DIA is lower than one certain value. SYS-DIA alarm limit setup range is 1-40mmHg, default is 20 mmHg, the setup value can be saved even after the power supply is shut off. NIBP abnormal messages:

5.4 Troubleshooting

5.4.1 Status Messages A status message will be displayed in the NIBP values windows if a measurement is

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unable to be completed. The following is a list of status messages with monitor response and action to take.

Status Message Monitor Response Solution

LOOSE CUFF System status alarm. Check cuff’s size and placement. Select proper cuff and place it correctly.

AIR LEAK System status alarm. Check for leak in cuff or tubing. If there is an air-leak, then replace it.

WRONG POSITION System status alarm. Check patient and cuff placement. If wrong, correct it.

OVER PRESSURE System status alarm. Remove cuff and contact service. RANGE EXCEEDED System status alarm. Contact service. OTHER ERROR System status alarm. Possible excessive patient movement or

arrhythmia condition. Check patient or contact service.

5.4.2 Prevent Erroneous NIBP measurement To prevent erroneous NIBP measurement: 1. Check for proper cuff size, too small a cuff can give an erroneously high value, too

large a cuff can give an erroneously low value. 2. Check for residual air left in the cuff from a previous measurement. 3. Make sure cuff is not too tight or too loose. 4. Make sure cuff and heart are at the same level, otherwise hydrostatic pressure will

offset the NIBP value. 5. Minimize patient movement during measurement. 6. Check for leak in cuff or tubing. 7. Calibration should be taken at least once a year.

5.5 Maintenance

Cuff should be cleaned with a warm and mild detergent solution after each using. Calibration should be taken by qualified professional once a year. The method for calibrating is introduced in the technical manual. Qualified professional may refer to the technical manual.

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SECTION 6: SpO2 MONITORING

6.1 Introduction

SpO2 monitoring is a noninvasive technique used to measure the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the probe passes through the tissue and is converted into an electrical signal by the photo detector in the probe. The monitor processes the electrical signal and displays on the screen a waveform and digital values for SpO2 and pulse rate.

6.2 Sensor Placement

For best results, use the following placement guides:

1. Place the clip on the tongue with dampened tissue paper. 2. On smaller tongues you may have to fold the tongue and clamp the double

thickness 3. It works great on cat’s ears. 4. On larger dogs, it can be used on the prepuce or vulva 5. The achilles tendon of cat or small dog will also work well.

To get good penetration for the sensor, you may have to shave any area that is fur bearing. 6.2.1 SpO2 Setup Menu: To enter the SpO2 setup menu,

Rotate knob→ →Press knob→ Rotate knob→SPO2→Press knob

You can setup the SpO2 and Pulse Rate alarm upper/lower limit, waveform mode and speed, turn on/off the alarm sound of SpO2, and setup the priority of HR/PR.

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6.3 Probes

To ensure conformance with all safety and performance specifications, use only the recommended accessories when performing Oxygen Saturation monitoring. These are available from GOLDWAY.

The signal input is insulated and it is defibrillator-proof. The insulated input ensures patient safety and protects the device during defibrillation and electrosurgery.

CAUTION: Use only accessories supplied by the manufacturer. Use of any other accessories may result in out-of specification performances. WARNING: Do not come into contact with patients during defibrillation, and be sure that the patient cable is not touching the metal parts. Otherwise serious injury or death could result.

6.4 Troubleshooting

6.4.1 No SpO2 reading If in the process of monitoring, there is no SpO2 waveform and data. Check the finger probe to see if there is a red light, if the arm is being pressed, and if the room temperature is too low. If there is no red light in the finger probe, check the extension cable and connecting part. When room temperature is very low, do not expose patient’s arm outside, which will affect the measurement results. Do not measure blood pressure and SpO2 on the same arm. Pressing the arm will affect SpO2 measurement. If SpO2 waveform channel shows “NO SIGNAL”, it indicates that there is a problem in the communication between SpO2 module and the main system. If the message still remains after turning the monitor off and on again, please change the SpO2 board. 6.4.2 Intermittent SpO2 Signal During SpO2 measurement, the reading is off and on. Inspection method: 1. During prolonged monitoring and surgery, check if the patient arm movement results

in interruption of SpO2 measurement. 2. Check the SpO2 extension cable. Solution: Keep the patient steady. It is normal if SpO2 value is lost due to hand movement. If SpO2 extension cable is faulty, replace it.

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SECTION 7: RESPIRATION & TEMPERATURE MONITORING

7.1 Respiration monitoring

This monitor provides thoracic impedance respiration monitoring. When ECG clips are placed on the arms, the impedance respiration monitoring is not very reliable. ECG Menu→ Rotate the knob → RESP-TEMP → Press the knob

RESP Lead: RA-LA/RA-LL/LA-RL/LL-RL are available for selection. RESP Gain: ×½ /×1 /×2 are available for selection. Through selecting respiration gain, the respiration waveform can be zoomed in or out for convenient observation. RESP Upper limit: Setup range is from lower limit to 150. RESP Lower limit: Setup range is from 0 to upper limit. Apnea Alarm: Apnea Alarm Time setup, ---/5/10/15/20……/120 seconds are selectable. Waveform mode: Standard/Amplify/Fill in. Convenient to observe from far distances. Waveform Speed: 6.25/12.5/25.0mm/S are available for selection. RESP Alarm Sound: ON/OFF are available for selection. To fill up RESP waveform: Rotate knob → Waveform Mode → Press knob → Rotate knob → Press knob To setup RESP alarm limits:

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Rotate knob → RESP Upper Limit → Press knob → Rotate knob → Press knob Apnea alarm will be triggered when the system detects an abnormality according to Apnea Alarm Time setup. Apnea Alarm belongs to Emergency Alarm. Medical personnel should watch out for the Apnea alarm. WARNING: Medical personnel should watch out patients who move around too much because excessive movement may cause the monitor’s alarm system to function improperly.

7.2 Temperature Monitoring

The temperature can be measured in two ways. The core body temperature can be measured with the probe down the esophagus. The second method is to insert the probe in the rectum. If you use this method, make sure any feces is cleaned from the site. Temperature monitoring results are displayed in digital form only, without waveform. The temperature readings are displayed on the right side of the screen. ECG Menu → Rotate the knob → RESP-TEMP → Press the knob

Then you can enter the temperature setup menu as shown in the above figure. To set the alarm limits and temperature units, please operate the knob through rotating and pressing it. For example, to set the temperature unit: Rotate the knob → TEMP Unit → Press the knob → Rotate the knob → oC / oF → Press the knob

To set the TEMP1 alarm limits: Rotate the knob→ TEMP1 Upper limit → Press the knob → Rotate the knob (Increase or decrease the value) → Press the knob

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WARNING: 1. Before performing temperature measurement, do not get the temperature probe close to a heat source. If it has been close to a heat source, then let it cool down for 5 minutes before performing measurement. 2. When the temperature probe is not connected or the temperature probe falls off, the monitor will stop the measurement and display “----” in the parameter area but without any alarm sound. To ensure accurate patient monitoring, it is recommended to check the connection of the temperature probe regularly. 3. We provide skin probes and rectal probes, which are not exchangeable. Note: 1. To ensure the contact between the probe and the skin, please let the patient hold the probe tightly with his arm and close to armpit artery. 2. It takes 10 seconds for the temperature measurement to reach a steady value. 3. If you use a disposable temperature probe, please do not reuse it and discard it properly. 4. Reusable probes can only be sterilized with alcohol. Do not steam it. If abnormal HR/PR or SpO2 occurs (exceeding the upper or lower limits), and alarm is on, the monitor will activate real-time audible and visual alarm.

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APPENDIX I: TECHNICAL SPECIFICATION

I Safety Approval & Quality System

Designed to meet IEC 60601-1:1990 + A1:1993 + A2:1995 Class II Equipment, internally powered equipment, double insulated Type BF, CF applied parts ISO 9001 & EN 46001 & ISO 13485 Certified

II Power Requirements

Power Supply: 110-230 VAC, 50/60 Hz, via power adapter Input Power: ≤ 80VA Battery: Charge time: Operating time:

DC 12V/2.2AH sealed lead-acid 10 hours 1.5 hours (full recharge)

Battery Charging Method: Automatic charging after monitor is connected to AC power supply (with charge protection function)

Discharge Protection: When powered by battery, the monitor will be automatically turned off when battery power is almost used up.

III Performance Specifications

1 ECG Patient Safety Standard: IEC 60601-1: 1990 CMRR: ≥60dB (Common Mode Rejection Ratio) Heart Rate Range: 15 ~ 300bpm ± 2bpm Heart Rate Averaging: 8 second average Interface: AAMI 6-pin Lead Selection: I, II, III, V, aVR, aVL, aVF (5 lead mode) Lead Fault Alarm: Audible, Visual Input: 5-lead ECG patient cable QRS Indicator: Audible and Visual Alert Sweep Speed: 12.5/25/50 mm/sec Gain Selection: x4, x2, x1, x1/2, x1/4, Auto Trends: 48 hours Patient Isolation: Frequency range:

Breakdown voltage: 4000VAC 50Hz 60 seconds Leakage current: <10µA 0.5 ~ 35Hz (+0.4dB,-3.0dB)

Patient Drive Current: <10µA Enclosure Leakage Current: <0.1mA Maximum T wave Rejection Capability: 1.2mV

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Heart Rate Alarm Response Time: < 12 seconds Aspect Ratio: 0.24 ~ 0.6 sec/mV Defibrillator Protected & ESIS Protected: Tested with 5kV Recovery Time Following Defibrillation: <5 seconds 2 Pulse Oximetry ( SpO2 ) Measure Range: 0 ~ 100% SpO2 Averaging: 8 second average SpO2 Accuracy: ±2% (70 ~ 100%), ±3% (50 ~ 69%) Pulse Rate Range : 30 ~ 254bpm Pulse Rate Averaging: 8 beat average Pulse Rate Accuracy: ±2 % ( 30 ~ 100bpm) Sensor Types: Small and Large Lingual Sensors Pulse Rate Display: Digital Pulse Rate Alarm Limit: 0 ~ 240bpm Pulse Rate Tone: Volume adjustable Refurbish Time: About 2 seconds Wavelength: Infrared: 940nm Red: 660nm Energy: Infrared ≤ 22.5 mW Red ≤ 30 mW Trends: 48 hours 3 Non-Invasive Blood Pressure ( NIBP ) Method: Automatic oscillometric Parameters: Systolic, diastolic, mean arterial pressure, pulse Scale: mmHg or kPa Operating Modes: Manual, Automatic, Continuous Repeat Cycles: 1 ~ 10, 15, 30, 60, 90, 120 minutes Measure Range: Systolic: 30 ~ 254mmHg (4.0 ~ 33.9kPa) 30 ~ 135mmHg (4.0 ~ 18.0kPa) Diastolic: 10 ~ 220mmHg (1.3 ~ 29.3kPa) 10 ~ 110mmHg (1.3 ~ 14.7kPa) Cuff Pressure Range: 0 ~ 280mmHg (0 ~ 37.3kPa) 0 ~ 150mmHg (0 ~ 20.0kPa) Initial Cuff Inflation: 170±10mmHg (22.7±1.3kPa) 100±10mmHg (16.0±1.3kPa) Deflation Pressure: 30mmHg(4.0kPa) higher than the last systolic

pressure. Cuff Inflation Rate: No greater than 40-50mmHg/sec Measurement Time: Typical 25 seconds Maximum 40 seconds Typical Stat 20 seconds

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Pressure Display Accuracy: ±3mmHg BP Pulse Rate Accuracy: ±2% @ 40 ~ 240bpm. Cuff: 5 different sizes. Trend Diagram: 600 groups 4 Respiration (RESP) Measurement Method: Thoracic impedance Respiration Rate Measurement and Alarm Range: 0 ~ 150 brpm±2brpm Waveform Speed: 6.25, 12.5, 25mm/S Trends: 48 hours 5 Temperature (TEMP) Measurement and Alarm Range: 0 ~ 50 oC Measure Channel: 2 Probe: Skin surface or rectal/Esophageal Unit: Celsius /Fahrenheit Accuracy: ±0.1 oC Resolution: 0.1 oC Trends: 48 hours

IV TFT Color Display

Size: 7″ Matrix: 480 (H)x 234 (V) pixels Viewing Angle: 160°

V Printer

Type: External thermal printer Resolution: Vertical: 400dpi, Horizontal: 800dpi Printing Speed: 12.5/25.0 mm/S Paper Type: Standard Z-fold paper 110mmX100mmX100pages

VI Environmental Specifications

Temperature: Operating +10 ~ +40°C Transport and Storage -20 ~ +60°C Relative Humidity: Operating ≤85% (non-condensing) Transport and Storage 10 ~ 90% (non-condensing) Atmospheric Pressure: Operating 860 ~ 1060 hPa Transport and Storage 500 ~ 1060 hPa

Specifications subject to change without prior notice.

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APPENDIX II: MAINTENANCE

I Patient Monitor When the patient monitor needs to be cleaned, use soft cloth dampened in mild soap water to wipe the patient monitor. Make sure to not let liquid flow into the machine. • Before cleaning, make sure to disconnect the AC power to avoid shock or fire. • Do not clean any part of the patient monitor with acetone.

• Never autoclave the patient monitor. Do not stack on the patient monitor. Do not immerse it into any liquid. Do not steam it for sterilization.

WARNING: If liquid is accidentally splashed on the patient monitor, please wipe it dry and do not let liquid flow into the machine. If liquid has flown into the machine, please turn off the machine immediately and contact qualified service personnel. • The screen can be cleaned with soft cloth dampened in alcohol. Never use abrasive

material, tools, brushes or any material which may scratch the screen. • When finding any damage or malfunction of the patient monitor, please stop using it

and contact qualified service personnel. II Cuff and Sensors (SpO2 sensor, TEMP probe) Cuff and sensors are accessories in contact with the patient. So each time after use, the cuffs and sensors shall be cleaned.

Check the reusable sensors and cuffs regularly. If any damage is found, please replace them immediately and discard the defective accessories properly.

Sensors and cuffs should be sterilized regularly with ethane oxide. Each time after sterilization, check if the sensor is damaged. If yes, it should be replaced immediately.

III Patient Cable (ECG Cable, SpO2 Extension Cable) • Do not autoclave the patient cables.

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• Each time before using the cable, please carefully check the cable to see if there is any damage. If any damage is found on the cable, please replace it immediately and discard it properly.

▲ Do not immerse the cables into liquid or let liquid flow into the electric connecting

part. When cleaning the patient monitor, wipe the cable surface with soft cloth dampened in soap water or alcohol. Make sure no liquid flows into the connectors.

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APPENDIX III: SAFETY

I Intended Use

VET420A is a multi-parameter veterinary monitor, providing continuous monitoring, display of electrocardiograph, non-invasive blood pressure, blood oxygen saturation, temperature and respiration of patients by means of display on a non-permanent graphical display. This device is for use only by trained medical personnel in the hospitals and clinics. It is not designed for home use. The device is restricted to be used on one patient at a time.

II Terminology

The terms danger, warning, and caution are used throughout this manual to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with their definitions and significance. Hazard is defined as a source of potential injury to a person. WARNING indicates a potential hazard or unsafe practice, which, if not avoided, could result in death or serious injury. CAUTION indicates a potential hazard or unsafe practice which, if not avoided, could result in minor personal injury or product /property damage. NOTE provides application tips or other useful information to assure that you get the most from your equipment.

III Monitor Safety

The safety statements presented in this chapter refer to the equipment in general and, in most cases, apply to all aspects of the monitor. There are additional safety statements in the parameter chapters, which are specific to that monitored parameter. The order in which safety statements are presented in no way implies order of importance. There are no dangers that refer to the equipment in general. Specific “Danger” statements may be given in the respective sections of this manual.

IV Safety Requirements

The following warnings and cautions must be read and understood before operation of

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the patient monitor. Warnings • VET420A veterinary monitor is not intended to be used as an apnea monitor. • VET420A veterinary monitor is not intended to be used during MRI or CT scan. • OPERATOR – Medical technical equipment such as this monitor must only be used

by persons who have received adequate training in the use of such equipment and who are capable of applying it properly.

• EXPLOSION HAZARD – Do not use the VET420A veterinary monitor in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur.

• POWER SUPPLY – The device must be connected to a properly installed power outlet with protective earth contacts only. If the installation does not provide earth conductor, disconnect the monitor from the power line and operate it on battery power, if possible.

• Do not connect to an electrical outlet controlled by a wall switch. • When using High Frequency surgical equipment, you should put the patient cables far

from the surgical operation in order to reduce the hazards of burns in the event of a defect in the HF surgical equipment neutral electrode connection.

• Route all cables away from patient’s throat to avoid possible strangulation. • For safety reasons, all connectors for patient cables and sensor leads are designed to

prevent inadvertent disconnection, should someone pull on them. Do not route cables in a way that they may present a stumbling hazard. For device installed above the patient, adequate precautions must be taken to prevent them from dropping on the patient.

• DEFIBRILLATION – Do not come into contact with patients during defibrillation, and be sure that the patient cable does not come in contact with the metal parts. Otherwise serious injury or death could result.

• Conductive Connections – Extreme care must be exercised when applying medical electrical equipment. Many parts of the man/machine circuit are conductive, such as the patient, connectors, and electrodes. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the insulated patient input of the device. Such contact would bridge the patient’s insulation and cancel the protection provided by the insulated input. In particular, there must be no contact of the neutral electrode and the ground.

• The leakage current will rise up due to simultaneous use of other PATIENT-connected MEDICAL ELECTRICAL EQUIPMENT, for example, a cardiac pacemaker or other electrical stimulators. Before connecting each other, the leakage current test should be done by qualify personnel and the leakage current should be within the limit of EN 601-1 standard.

• Disconnection From Mains – When disconnecting the system from the power line, remove the plug from the wall outlet first. Then you may disconnect the power cord from the device.

• SHOCK HAZARD – Do not attempt to connect or disconnect a power cord with wet hands. Make certain that your hands are clean and dry before touching a power cord.

• Electro-surgery return circuit must be connected properly to prevent burns at

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monitoring sites and even death. • Do not touch signal input or output outlets and the patient simultaneously. • Do not use unprotected lead wires having exposed conductors at the cable end. The

use of unprotected lead wires and cables may pose an unreasonable risk of adverse health consequences or death.

• Before putting the system into operation, visually inspect all connecting cables for signs of damage. Damaged cables and connectors must be replaced immediately.

• This patient monitor has no defibrillator synchronization output. Please do not connect the monitor to a defibrillator.

• ALARMS – Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.

• The functions of the alarm system for monitoring the patient must be verified at regular intervals.

• Before using the system, the operator must verify that it is in correct working order and operating condition.

• INTERFACING OTHER EQUIPMENT – Devices may only be interconnected with each other or to parts of systems when it has been determined by a qualified biomedical engineer that there is no danger to the patient, the operator, or the environment as a result. In those instances where there is any element of doubt concerning the safety of the connected devices, the user must contact the manufacturers concerned. Proper operation should be verified with the applicable manufacturer’s instructions for use, and system standards IEC 60601-1-1/EN 60601-1-1 must be complied with.

• Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards ( e.g. IEC 950 for data processing equipment and IEC 601-1 for medical equipment ). Furthermore, all configurations shall comply with the valid version of the system standard-EN 601-1-1. Anyone who connects additional equipment to the signal input part or signal output part is configuring a medical system, and is therefore responsible that the system complies with the requirement of EN 601-1-1. If in doubt, consult the technical service department or your local representative.

• In all cases, safe and proper operation should be verified with the applicable manufacturer's instructions for use and system standards EN 60601-1-1/EN60601-1-1 must be complied with.

• Every 12 months a calibration of all measuring functions should be performed by authorized personnel.

• The monitor is not for home use. • ACCIDENTAL SPILLS – To avoid electric shock or device malfunction, liquids must

not be allowed to enter the device. If liquids have entered the device, take it out of service and have it checked by a service technician before it is used again.

• LEAKAGE CURRENT TEST – When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients.

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Cautions • EMC – Electromagnetic field may interfere with the proper performance of the

patient monitor. Make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. Also keep cellular telephones or other telecommunication equipment away from the monitor.

• ECG patient cable shall be connected to the ECG lead wire supplied with this monitor. Please do not connect other signal source and pay attention to the color and label on the ECG lead wires.

• Use only parts and accessories supplied with the veterinary monitor. Use of any other accessories may result in out-of-specification performance and possible safety hazards.

• The monitor must be repaired or disassembled by a qualified biomedical engineering person.

• DEFIBRILLATOR PRECAUTIONS – Patient signal inputs labeled with the CF and BF symbols with paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only the recommended cables and lead wires.

• The monitor is intended for use by persons trained in professional health care. The operator must be thoroughly familiar with information in this manual before using the monitor.

• It is the operator’s responsibility to set alarm limit appropriately for each individual patient.

• If the accuracy of any measurement is in question, verify the patient’s vital signs by an alternative method and then check the monitor for proper function. Set up the monitor in a location for sufficient ventilation. The ventilation openings of the device must not be obstructed. The ambient conditions specified in the manual must be always ensured.

• Keep the operating environment free of dust, corrosive, or flammable materials, and extremes of temperature and humidity.

• Do not operate the patient monitor if it is damp or wet because of condensation or spills. Avoid using the equipment immediately after moving it from a cold environment to a warm, humid location.

• Never use sharp or pointed objects to operate the front-panel keys. • MAINTENANCE – Regular preventive maintenance should be carried out by a

qualified biomedical engineer annually (Technical Inspections). You are responsible for any requirements specific to your country.

• BATTERY POWER – The device is equipped with a battery pack. The battery discharges even when the device is not in use. Store the device with a fully charged battery and check the battery status of devices in storage once a month.

• DISPOSABLES – Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur.

• DISPOSAL – At the end of its service life, the monitor, as well as its accessories, must be disposed of in compliance with local governing ordinances and recycling instructions.

• The built-in battery must be disposed of separately according to the national laws after the useful life of the device.

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• INSTRUCTIONS FOR USE – For continued safe use of this equipment, it is necessary that the listed instructions are followed. However, instructions listed in this manual in no way supersede established medical practices concerning patient care.

• LOSS OF DATA – Should the monitor at any time temporarily lose patient data, the potential exists that active monitoring is not being done. Close patient observation or alternate monitoring devices should be used until monitor function is restored.

• Do not autoclave, ethylene oxide sterilize, or immerse the monitor in liquid. Unplug the monitor before cleaning or disinfecting the monitor.

• NEGLIGENCE – The manufacturer does not assume responsibility for damage to the equipment caused by improperly vented cabinets, improper or faulty power, or insufficient wall strength to support equipment mounted on such walls.

Notes • Put the monitor in a location where you can easily see the screen and access the

operating controls. • This monitor is protected against the effects of cardiac defibrillator discharges to

ensure proper recovery, as required by test standards. • Hazards arising from software errors have been minimized. Hazard analysis was

performed to meet EN1441:1997. • Each input and output connection of the monitor is electrically isolated. • Performance and safety test data are available upon request. • The equipment is suitable for connection to public mains as define in CISPR 11. Reference Literature • Medical Device Directive 93/42/EEC • EN 60601-1:1990 + A1:1993+A2:1995: Medical electrical equipment general

requirements for safety • EN 60601-1-1:1994 + A1:1995: General requirements for safety. Requirements for

the safety of medical electrical systems.

V Safety Symbols

NOTE: Some symbols may not appear on all equipment.

Type BF Applied Part: Insulated (floating) applied part is not suitable for cardiac application. “Paddles” outside the box indicate the applied part is defibrillator proof.

Medical Standard Definition: F-type applied part (floating/insulated) complying with the specified requirements of EN 60601-1 Medical Standards to provide a higher degree of protection against electric shock than that provided by Type B applied parts.

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Type CF Applied Part: Insulated (floating) applied part is suitable for direct cardiac application. “Paddles” outside the box indicate the applied part is defibrillator proof.

Medical Standard Definition: F-type applied part (floating/insulated) complying with the specified requirements of EN 60601-1 Medical Standards to provide a higher degree of protection against electric shock than that provided by Type BF applied parts.

Type of protection against electric shock: Class II equipment.

Attention: Consult accompanying documents.

VI Classifications

VET420A veterinary monitor is classified, according to EN 60601-1 as: • Type of protection against electric shock: II, internally powered equipment. • Degree of protection against electric shock: BF – NIBP, SpO2, TEMP; CF – ECG, RESP. • Degree of protection against harmful ingress of water: Ordinary Equipment. (enclosed equipment without protection against ingress of water) • Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide: Not suitable. • Working mode: Continuous running mode. II: Class II equipment; BF: Type BF applied part; CF: Type CF applied part; Not suitable: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

VII Periodic Safety Checks

The following safety checks should be performed at least once every 12 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests. • Inspect the equipment and accessories for mechanical and functional damage. • Inspect the safety relevant labels for legibility. • Inspect the fuse to verify compliance with rated current and breaking characteristics. • Verify that the device functions properly as described in the instructions for use. • Test the protection earth resistance according to IEC 601-1/1990: Limit 0.1 ohm. • Test the earth leakage current according to IEC 601-1/1990: Limit: NC 500 uA, SFC

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1000uA. • Test the patient leakage current according to IEC 601-1/1990: Limit: 100 uA (BF),

10 uA (CF). • Test the patient leakage current under single fault condition with mains voltage on the

applied part according to IEC 601-1/1990: Limit: 5 mA (BF), 50uA (CF). The leakage current should never exceed the limit. The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the above tests, the device has to be repaired.

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Documents

Vet420a manual 2005