Manuale d’uso - User manual
Manuel de l’utilisateur - Guía de Uso
ATTENZIONE: Gli operatori devono leggere e capire
completamente questo manuale prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.
AVIS: Les opérateurs doivent lire et bien comprendre
ce manuel avant d’utiliser le produit.
ATENCIÓN: Los operadores tienen que leer y entender
completamente este manual antes de utilizar el producto.
M35162-M-Rev.4-07.19
35162
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) - Italy
Made in China
0476
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Instructions for User
Dear Customers,
Thank you for purchasing the PC-300 Spot-Check Monitor. Please read the following information before using the device.
These instructions describe the operating procedures which are to be strictly followed, read
these instructions carefully before using the Spot-Check Monitor. Failure to follow these instructions can cause monitoring abnormalities, damage to the monitor and personal injury. The
manufacturer is NOT responsible for the safety, reliability and performance issues or any monitoring abnormalities, personal injury and equipment damage due to user's negligence of the
operation instructions. The manufacturer's warranty service does not cover such faults.
Warnings:
Do NOT use the device under ammable gas condition or in any environment that may lead
to explosion.
The device and accessories that should not be serviced or maintained while the device is in
use.
The doctor or patient is the intended operator.
Do not modify this equipment without authorization from the manufacturer.
The SpO2, NIBP, Temperature, and ECG (optional) measurements are frequently used fun-
ctions.
The device is IP22 and is protected against solid foreign objects of 12.5mm or greater, and
protected against vertically falling water drops when the enclosure is tilted up to 15.
Please check the monitor before use to verify that the accessories can function safely and
correctly.
f the monitor is connected with other devices, the total leakage current may exceed the limi-
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58
tation and as a result this can cause potential danger to the user.
Although biocompatibility tests have been performed on all the applied parts, under excep-
tional circumstances, allergic patients may have anaphylaxis. Do NOT use the monitor on
patient with anaphylaxis.
All connecting cables and rubber tubes of the applied parts should be kept away from the
patient’s neck to prevent suffocation.
As a standard, please only use the components provided by the manufacturer or those that
are of the same model and specications as the accessories.
If the monitor falls off a surface accidentally, please do NOT operate it before its safety and
technical performance have been tested, and positive results obtained.
Do NOT open the device cover without authorization. The cover should only be opened by a
qualied service personnel.
When disposing of the monitor and its accessories, the national regulation should be fol-
lowed.
There are some electromagnetic or inductance circuit designed in the device, use during MRI
environment could burns or adversely affect the MRI image or the device’s accuracy. So the
device is MR unsafe.
The device and accessories are provided non-sterile.
The device has no alarm and is intended only for spot-checking.
Appendix I Classication of Blood Pressure Level ......................................................... 107
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Chapter
1 OVERVIEW
1.1 Features
• Small in size, light in weight, easy to carry and operate;
• Clear and large numeric display, segmented LCD panel, real-time clock display;
• Accurate blood pressure measurements can be activated or canceled by one shortcut button;
• Unique oximetry technique ensures quick and accurate SpO2 & pulse rate measurements by
smart sensors;
• Smart infrared temperature probe ensures quick and accurate measurements of body temperature;
• Blood pressure, oxygen saturation, pulse rate and temperature can be measured simultaneously;
• Blood Glucose meter option can be connected to the device.
• Up to 100 user ID can be marked;
• Data storage with recall, up to 999 groups of records can be stored and recognised by patient
ID.
• Power management with power saving mode, auto power off and low battery indicator;
• Data upload to PC by USB cable and real-time data transmission to smart phones by wireless
connections.
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1.2 Product Name and Model
Name: PC-300 Spot-Check Monitor
Model and Conguration:
Conguration
Model NIBP SpO2 Pulse rate Temperature Blood Display
Glucose LCD
PC-300 √√√√ -- √
NOTE: 1. Spot-Check Monitor can congure with ECG and blood glucose function, details see
the User Manual for Easy ECG Monitor and Glucose Meter respectively.
2. "√" means function is available, and "--" means function is not available.
1.3 Intended Use
The Spot-Check Monitor is a device designed for spot-checking the user's physiological parameters, such as non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), pulse
rate (PR), and body temperature (TEMP). Additionally, the device can take measurements from
the Blood Glucose Meter function, and ECG data from the Easy ECG Monitor (both Blood Glucose Meter and Easy ECG Monitor are certied separately). This device is applicable for use in
clinical institutions and has no conditions or factors of contraindication.
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1.4 Impact on the Environment and Resources
Low
Chapter 2
OPERATION INSTRUCTIONS
2.1 Appearance
2.1.1 The Front Panel
Description:
1/2. / up/down key: on the setup display screen,
a short press will change the parameter value step by step,
press and hold to change the parameter values quickly;
on the review display screen, short press to review the
history data records, press and hold to recall the history
data records quickly.
3. Memory key: on the measurement display
screen, press and hold the key (for 3 seconds) to enter
into the review display screen; once the review display
screen, a short press will recall the history data
records. On the setup display screen, all parameters
Figure 2.1
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64
can be set in anticlockwise order by pressing and holding , key, similarly, a short press of
key will set the parameters in clockwise order.
4. Menu key: on the measurement display screen, press and hold the menu key to enter the
setup screen; on the setup or review display screen, press and hold the key to go back to
the measurement display screen.
5. Start/cancel button: on the measurement display screen, a short press of this button will
activate or cancel the blood pressure measurement.
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2.1.2 The Right and Upper Sides of the Device
Figure 2.2 Figure 2.3A Vista lato superiore
The power switch and external DC power input socket are on the right side of the monitor as
shown in gure 2.2.
The signal input/output ports are on the upper side of the monitor as shown in gure 2.3.
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66
Description:
1. : External DC power input socket.
2. : Power switch: = press and hold to turn on/off monitor.
3. Battery cover.
I/0
4.
: Charge / USB data interface.
5. : Connector to link with the blood glucose meter.
6. NIBP: Cuff connector.
7/8. Port 1/Port 2: Connector to link with the temperature probe or smart SpO2 probe.
NOTE: Figure 2.3A is the upper-side-view for the previous version device, and Figure 2.3B is the
upper-side-view for the current version device. The difference between the two versions is seen
on the upper-side panel. The previous version device has only 2 ports, marked "PORT1" and
"PORT2", which are the generic connectors capable of connecting any combination of temperature probe, smart SpO2 probe or ECG accessory (for example Easy ECG Monitor). However,
the current version device has 3 porte, contrassegnate ports, marked "SpO2", "TEMP" and
"ECG" respectively, which can be used only to connect the corresponding sensors or accessories.
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Description:
1.: External DC power
input socket.
2.: Power switch: = press and hold
to turn on/off monitor.
3. Battery cover.
4. : Charge / USB data interface.
5. GLU : Connector to link to the blood
glucose meter.
6. NIBP: Cuff connector.
7.
SpO2: Smart
SpO2 probe connector.
8. TEMP: Temperature probe connector.
9. ECG: Connector to link with ECG accessories..
2.2 Installation
2.2.1 Power Supply
1. Internal power supply to the built-in battery
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Figure 2.3B Upper-side view
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When the battery indicator displays full grids, the built-in battery is fully charged. When
it blinks, the battery voltage is low, and the user should charge the battery by connecting the
device to the AC power adapter or a USB power source via USB cable. When the grids of the
battery indicator are rolling circularly, the battery is being charged.
2. External power supply from the AC power adapter
Use the AC power adapter provided by the manufacturer. Make sure that the mains power
supply is 110~240VAC with 50/60Hz.
3. External power supply from the USB cable
Use the USB data cable with micro-USB connector, connect one end of the data cable to
the connector on the device marked
output capacity of 5Vdc/1.2A.
I/0
, and the other end to the USB power source with
68
2.2.2 Starting the Monitor
By pressing and holding down the switch, the software version will be displayed after releasing the switch, the device will enter the measurement display screen automatically. The user
can then begin to operate the monitor.
Note: Do not touch the 4 touch-keys during switching on the monitor, or the touch-keys may
be out of work temporarily. If the touch-keys are not sensitive enough, do not operate them
for over 8 seconds, then the touch-keys will resume to its normal sensitivity automatically.
The monitor is powered by built-in Lithium battery, when the battery voltage is low, the
measurement and wireless connection may be unstable.
For electric safety, do not use the monitor during its battery is in charging.
Please make measurement for a single person at a time
If monitor fails to start by pressing the switch, please use the external power supply.
Terminal devices such as Android smart phones can be used to receive data from the SpotCheck Monitor in real-time, store the received data, and also review the stored data. To use this
function, download the corresponding APP software onto the smart phone device.
For terminal devices with the Android system, please follow the procedure to download:
1. Install an APP software for scanning QR Codes with a smart phone.
2. Run the APP software to scan the QR Code image in Figure 2.4, please focus the QR Code
frame while scanning.
3. When successfully scanned, a web link for downloading the APP software will be displayed.
4. Open the web link to download the APP software. Install the software when successfully
downloaded.
For terminal devices with the iOS system (such as iPhone, iPad), please follow this procedure
to download:
1. On the App Store of the device, enter "Shenzhen Creative"
into the search function. Note: if you use an iPad to search,
please select "iPhone only" when searching.
2. Once the search results are listed, select the result with
@Health icon , then download the corresponding APP
software.
Instruction for Measurement
☞ Make sure the APP software successfully connects with
the Spot-Check Monitor.
☞ Refer to the manual of the APP software for more detailed
information for operation.
Figure 2.4 QR Code Image
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2.3 Taking Measurement
2.3.1 Blood Pressure Measurement
1. An appropriate cuff should be selected according to the age and arm circumference of the
patient. The cuff width should be 2/3 of the length of the upper arm. The inatable part should
be long enough to permit wrapping approximately
80% of the limb.
2. Applying the cuff: unfold the cuff and wrap it around the
upper arm evenly to the appropriate tightness.
The correct cuff position is shown in gure 2.5.
3. Connect the hose from the cuff to the connector on
the upper-side of the device where marked “NIBP”.
4. Long press menu key to enter the setup screen,
select the proper patient category, for example,
Figure 2.5 Cuff position
if you select "Child", then the indicator on the screen
will focus towards "Child", shown as which means that the current
patient type is set to Child. Note: refer to Section 3.2 for detailed setting operation.
5. Press the start/cancel button to begin the blood pressure measurement. The result will be
displayed on the screen, and the corresponding blood pressure level will be indicated, shown
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as , which means that the adult’s blood pressure result is normal. Please re-
fer to the form below for detailed blood pressure levels. Note: blood pressure level indication
is only for "Adult" patient type.
LevelBlood pressure range (Unit: mmHg)
N (Normal)SIS <130mmHg, and DIA <85mmHg
H-N (High normal)130 mm Hg ≤ SIS <140mmHg, and 85mmHg ≤ DIA <90mmHg
HT (Hypertension)SIS ≥140mmHg, or DIA ≥90mmHg
NIBP Measurement Principle
The NIBP measurement is based on oscillation technology. The measurement is started by inflating the cuff by a pump automatically after the cuff pressure is high enough to block the arterial
blood flow within the upper arm, then the cuff pressure is deflated slowly, and all the change of
cuff pressure in the deflation process is recorded to calculate blood pressure based on certain
algorithm. The device will judge whether the quality of signal is good enough. If the signal is not
good enough (such as sudden movement or touch of cuff while measurement), the device will
stop deflating or re-inflating, or aborting this measurement and calculation.
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Safety Instructions for blood pressure measurement
Blood pressure measurement is prohibited to those who have severe hemorrhagic tenden-
cies or with sickle cell disease, as partial bleeding maybe caused.
Too frequent measurements or connection tube kinking may result in purpura, neuralgia and
lack of blood.
Wrap the cuff and operation of the start/cancel button are the frequently used functions.
Do NOT apply the CUFF over a wound, as this can cause further injury.
Operation of the device does not result in prolonged impairment of PATIENT blood circulation.
Do NOT wrap the cuff on limbs with transfusion tubes, intubation or skin lesions on the area,
as damage may be caused to the limbs.
The equipment can be used on pregnant or pre-eclamptic patients.
The proper operating steps are needed to obtain accurate resting Blood Pressure reading
routinely:
-- Patient position in normal state, including comfortably seated, legs uncrossed, feet flat on
the floor, back and arm supported, middle of the cuff at the level of the right atrium of the
heart.
-- The patient should be as relaxed as possible and should not talk during the measurement
procedure.
-- 5 minutes should elapse before the first reading is taken.
The user needs to check the operation of this equipment does not result in prolonged impair-
ment of patient blood circulation.
Readings can be affected by the measurement site, the position of the patient(standing, sit-
ting, lying down), exercise, or the patient’s physiological condition.
The performance of the equipment can be affected by extreme temperature, humidity and
altitude.
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Avoid compressing or restricting the connection tubing.
The patient should be comfortably seated with their legs uncrossed and feet flat on the floor.
The patient's back and arm should be supported, and the middle of the cuff should be level
with the right atrium of the heart.
The environment or operational factors which can affect the performance of the device and/
or its blood pressure reading (e.g. common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion diabetes, age, pregnancy,
pre-eclampsia, renal diseases, patient motion, trembling, shivering).
Measurements should be taken at appropriate intervals. Frequent measurements with short
intervals may lead to pressed arm, reduced blood flow, low blood pressure, and result in an
inaccurate reading.
It is recommended that the measurements are taken in intervals of more than two minutes.
Before use, empty the cuff until there is no residual air inside.
Do NOT allow the cuff to twist or bend.
Do NOT twist the cuff hose or put heavy things on it.
Please hold the connector of the hose while connecting and disconnecting it to the device.
If arrhythmia or auricular fibrillation occurs, take measurement again.
The patient should sit or lay down with calm condition and make the cuff and the patient's
heart on the same level to get accurate measurement. Other positions may lead to inaccurate
measurement.
2.3.2 SpO2 Measurement
Operation procedures:
1. Connect the smart SpO2 probe to the connector on the upper-side of the device marked
"SpO2" ("PORT1" or "PORT2" for previous versions of the device). When disconnecting the
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connector, be sure to hold the head of the connector rmly and pull.
2. The red blinking light inside the clip of the SpO2 probe indicates a successful connection.
3. Insert one nger (index nger is preferred, the nail should be not too long) into the clip of the
probe according to the nger mark shown as below.
4. The device will begin to take the measurement.
Figure 2.6 demonstration for
SpO
2 probe
SpO2 Measurement Principle
SpO2 measurement is based on dual wavelength opto-plrthysmometry technology, a unique
hardware and software design.
By use of red and infra-red light emitting through the patient’s nger, the photo-detector at the
other side senses the transmitted light and converts to current for later amplication and ltering. The acquired light intensity signals (plethysmogram) are digitalized and further processed
with proprietary algorithm to determine the SpO2 and pulse rate value.
Safety instructions for SpO2 measurements
Continuous use of the SpO2 probe may result in discomfort or pain, especially for those with
microcirculatory problems. It is recommended that the probe should NOT be applied to the
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same place for over two hours, change the measurement site periodically and when necessary.
Do NOT place the SpO2 probe on a nger with edema or fragile tissue.
When the ambient temperature is over 35°C, please change the measuring site every two
hours; when the ambient temperature is over 37°C, please do NOT use the SpO2 sensor, as
using in high temperatures can cause burns.
Do NOT put the SpO2 probe and pressure cuff on the same limb, otherwise the blood pres-
sure measurement may affect the SpO2 measurement.
The device is calibrated to display functional oxygen saturation.
Do NOT allow the sensor cable to twist or bend.
Check the SpO2 sensor and cable before use. Do NOT use a damaged SpO2 sensor.
When the temperature of the SpO2 sensor is abnormal, do not use it further.
Remove nail polisher or other cosmetic products from the ngernail.
The ngernail should be of normal length.
The SpO2 sensor cannot be immersed into water, liquid or cleanser.
The SpO2 sensor can be repeatedly used. Please clean and disinfect before reuse.
The SpO2 sensor can be repeatedly used. Please clean and disinfect before reuse.
Anemia or low hemoglobin concentrations, intravascular dyes, carboxyhemoglobin, methe-
moglobin, and dysfunctional hemoglobin may effect the SpO2 accuracy. If the patient has
such situation, do not rely on the measured result for diagnostic decision, and it's recommended for the patient to consult with the doctor.
☞PORT1 or PORT2 can be connected with either temperature probe, smart SpO2 probe, or
Easy ECG Monitor, but not any other devices or probes. Do NOT connect two probes or
devices with the same type (e.g. two temperature probes, or two smart SpO2 probes, or two
Easy ECG Monitors) to both PORT1 and PORT2.
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2.3.3 Temperature Measurement
The infrared temperature probe is a delicate transducer. To operate please follow these steps
and procedures. Failure to accurately operate may cause damage to the probes
1. The infrared temperature probe
Please place the infrared temperature probe in a stable ambient temperature for 30 minutes
before taking a measuring.
Measuring tip
of temperature probe
Temperature probe
cover
Battery
cover
Figure 2.7A sonda per la temperatura a infrarossi Figure 2.7B
Operation procedure:
1. Connect the infrared temperature probe to the connector on the upper side of device marked
"TEMP" ("PORT1" or "PORT2" for previous versions of the device). When the LCD screen
Measuring
key
Display screen
Power on/off key
The display screen
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displays , this indicates that the probe is successfully connected.
2. When the screen shows as gure 2.7B and the temperature unit "°C" is blinking, the user can
begin to take the measurement.
3. Insert the tip of the temperature probe into the earhole and press the measuring key to start
the measurement. A short beep means the measurement has nished and the result will be
displayed on the screen.
Note:
If the temperature probe detects a hardware failure, the display screen on the infrared tempe-
rature probe will show "Err" and will not enter into measuring mode.
The infrared temperature probe will switch to stand by automatically if there is no operation
for 1 minute. If a further measurement is needed, please press the measuring key and repeat
step 2 and step 3.
Normal body temperature varies depending on the position/area the measurement is taken from.
The following table shows the varying temperature = ranges of the different body positions.
Temperature varying range at different body positions:
Besides, each person has his/her own normal temperature value, and the normal temperature
value also changes at different time within a day. Therefore, it's recommended to report your
doctor not only the temperature value, but also the measuring position, if possible you may
provide your own normal temperature range to your doctor for reference.
Press and hold the power on/off key can shift the temperature unit.
Safety Instruction for Temperature Measurement
This device meets requirements established in ASTM Standard (E1965-98).
Do NOT use the infrared temperature probe when the subject temperature and ambient tem-
perature are outside the operating ranges specied by the manufacturer.
Performance of the device may be adversely affected when one or more of the following
occur:
A. Operation outside of the manufacturer specied subject temperature range.
B. Operation outside of the manufacturer specied operating temperature and humidity ran-
ges.
C. Storage outside of the manufacturer specied ambient temperature and humidity ranges.
D. Mechanical shock.
Manufacturer dened soiled or damaged infrared optical components.
Do NOT take a measurement when the patient is moving.
Patients with tympanitis and otitis problems should NOT use this device for measuring.
When the infrared temperature probe is connected to the device, the probe will consecutively
be at power-on status, therefore pressing the power on/off key on the temperature probe will
not take effect.
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2.3.4 Blood Glucose Measurement (Optional)
Using the optional link cable for the On Call Plus Blood Glucose Meter, connect the Glucose
Meter to the connector on the right side of the Spot-Check Monitor marked "GLU”
Appearance and key functions of the On Call Plus Blood Glucose:
1. Test strip: the strip with chemical reagent attachment used
for the meter to measure glucose concentration in blood.
2. Test strip slot: a test strip is inserted into the slot to perform
a test.
3. LCD display: display the test result and help you go through
the testing process.
4. M key: recall previous test results from the meter memory
and performs other menu selection functions.
5. S key: select meter setting, perform other menu selection
functions. Please refer to the User Manual of "On Call Plus
Blood Glucose Monitoring System” for detailed function
descriptions.
6. Data interface: used to connect to the Spot-Check
Monitor for data transmitting.
Figure 2.8 Appearance of the
On Call Plus Glucose Meter
.
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Operations for the Lancing Device and Blood Lancet
1. Unscrew the lancing device cover from the body of the lancing device. Insert a sterile lancet
into the lancet holder and push it until the lancet comes to a complete stop in the lancet holder.
2. Hold the lancet rmly in the lancet holder and twist the safety tab of the lancet until it loosens,
then pull the safety tab off the lancet. Save the safety tab for lancet disposal.
3. Carefully screw the cover back onto the lancing device. Avoid contact with the exposed needle. Make sure the cover is fully sealed on the lancing device.
4. Adjust the puncture depth by rotating the lancing device cover. There are ve puncture depth
settings.
5. Pull the cocking barrel back to set the lancing device. You may hear a click. The device is now
ready for obtaining a drop of blood.
Refer to gure 2.9A.
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Figure 2.9A Operation for Lancing Device and Blood Lancet
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Quick operation procedure for On Call Plus Glucose Meter:
1. Insert a new test strip into the strip slot, contact bars end rst and facing up, to turn on the
meter and display all the display segments. If the audio option is on, the meter will beep, signaling the meter is turned on.
2. The blinking test strip and blood drop icon will indicate that the test strip is inserted correctly
and a drop of blood can be added.
3. Touch the blood sample to the sample tip at the end of the test strip. If the audio option is
turned on, the meter will also beep to indicate the sample is sufcient and the measurement
is started.
4. The meter will count down from 9 to 1 and then display the measurement results.
The meter will also beep to indicate that measurement is complete.
Refer to Figure 2.9B.
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Figure 2.9B Testing instruction
82
Refer to the provided User Manual of the “On Call Plus Blood Glucose Monitoring
System” for further detailed instructions.
Safety Instruction for Blood Glucose Measurement
The provided test strips should be used with the On Call Plus Glucose Meter.
Do NOT clean or disinfect nger with iodine.
The calibration code must be the same with what on the packaging.
The On Call Plus Glucose Meter will automatically switch to stand-by mode if a test strip is
not inserted for 1 minute.
The testing strip will suck blood at one end automatically, do not make it sucking at both
ends.
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Do NOT press or scrape the bleeding nger.
The testing strip should be used as soon as possible after unpacking, and the unused strips
should be kept in the bottle with airproof condition.
Take measurement only once within 1 min.
☞ If the monitor is connected with both temperature probe and the blood glucose meter, the
screen will show .
The blood-collect pinhead is a disposable item. It’s recommended to insert it back to the
plastic cover and throw it into the specic dustbin.
2.3.5 ECG Measurement (Optional)
1. Connect the Easy ECG Monitor to the connector on the upper side of device marked "ECG"
("PORT1" or "PORT2" for previous version of the device).
2. Choose one of the methods (refer to gure 2.10B/C/D/E) to take the ECG measurement.
3. When the Easy ECG Monitor and Spot-Check Monitor are successful connected, press the
"Start" button on the Easy ECG Monitor to activate the ECG measurement.
4. When "ECG" appears on the display screen of the Spot-Check Monitor, it means the Easy
ECG Monitor has begun to take the ECG measurement.
5. 30 seconds later, the result will display on the screen of the terminal device, and the measu-
To obtain a clear and high quality ECG signal, the lead wire measurement can be used. Connect
the lead wire rmly to the lead wire socket of the device. Place the electrodes and connect the
lead wires as shown in Figure 2.10E to obtain the Lead II ECG signal. If you want to measure
Lead I and Lead III ECG signal, connect the lead wires to the electrodes (Note: lead wire is optional) as detailed in table below.
Safety Instructions for ECG Measurement
1. Check the device to make sure that there is no visible damage that may affect the user’s sa-
fety and the measurement performance. If there is obvious damage, stop using the unit.
2. Do NOT make a diagnosis of oneself according to the measurement and measurement resul-
ts, always consult a doctor if abnormal information is presented frequently.
3. Do NOT use the device in a bathroom or humid environments.
Figure 2.10E Lead wire measurement
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Table 1 ECG Leads Conguration and Electrodes Location Table
Lead Lead I Lead II Lead III
Electrode
Name & Color
Electrode
Location
The intersection between the centerline R (Red)/ R (Red)/ L (Yellow)/
of the right clavicle and Rib 2. RA (White) RA (White) LA (Black)
The intersection between the centerline F (Green)/ L (Yellow)/ R (Red)/
of the left clavicle and Rib 2. LL (Red) LA (Black) RA (White)
Between the left edge of the breast L (Yellow)/ F (Green)/ F (Green)/
bone and Rib 5. LA (Black) LL (Red) LL (Red)
2.4
Blood Pressure Accuracy Check Method
Operation procedure:
1. Unscrew the M3x6 screw from the battery compartment on the back of the Spot-Check Mo-
nitor, as shown in gure 2.11.
2. Take a NIBP connector plug from the battery cover, as shown in gure 2.12. (Note: there are
two plugs but you will only need one.)
3. Air Path Connection: Take a piece of air tube (0.5~1m long, Φ8.0mm/Φ4.0mm diameter). Atta-
ch the NIBP connector with a connector plug on to one end of the air tube. Connect the other
end to the 3-way connector. Connect the other 2 ends of the 3-way connector to a Mercury
Sphygmomanometer as shown in Figure 2.13.
86
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4. Connect the NIBP connector end to the NIBP port on the Spot-Check Monitor as shown in
gure 2.14.
5. Turn on the Spot-Check Monitor. Press the menu button to go to the settings. Press and hold
the large NIBP measurement button to enter the Pressure Check Mode.
6. Start pumping, and check if the pressure reading on the Spot-Check Monitor matches the
mercury pressure reading.
M3x6 Screw
Figure 2.11Figure 2.12Figure 2.13
NIBP Port
Figure 2.14Figure 2.15
Air tubeNIBP Connector NIBP Connector Plug
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2.5 Symbols
Symbol DescriptionSymbol DescriptionSymbolDescription
Wireless Keep in a cool, dry place
AlarmKeep away from sunlight
Memory iconDate of manufacture
Power on/off switchWEEE disposalProduct code
I/0
External DC power
input
Charger or USB Data
interface /
Connector to link with
blood glucose meter
Follow instructions for
use
88
Type BF applied
parts
Serial numberBattery voltage indicator
ManufacturerUSB icon
Class II appliedNo SpO2 Alarms
Pulse rate
(unit: bpm, beat per min)
Lot number
Medical Device
complies with
Directive 93/42/EEC
Caution:
read instructions
(warnings) carefully
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Chapter 3
MONITORING SCREEN DISPLAY
3.1 Measuring Screen
Screen Description:
1. USB connection icon
2. wireless transmission icon;
: means that the wireless transmission
function is on; when the icon is blinking,
the wireless connection set up is unsuccessful;
when this icon is steady, the wireless
connection set up is successful;; ;
the wireless transmission function is off.
3. : Beep sound indicator; : pulse
beep is on; : pulse beep is off.
4. Battery voltage indicator. When the
battery is full, the battery voltage indicator
displays a full grid.
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Figure 3.1 Measuring screen
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When the indicator is blinking, it means the battery voltage is low and the user should charge
the battery. Please connect the device to the external power supply to ensure the correct use
of the monitor, and the battery will be charged. During charging, the grids in the battery indicator with roll circularly.
5.~7. : means the ination pressure during cuff ination. When displaying the measurement
result, the indicator appears on the corresponding blood pressure level, such as N (Nor-
mal), H-N (High normal), and HT (hypertension).
8~10: Indicates the NIBP measurement mode, the indicator appears on the corresponding
patient type,, for Adult, for Child, and for Infant.
11. M: memory
12. ID: the patient ID, which can be set from 0 to 99.
13. NO.: the number of stored data, ups to 999 records can be stored for each ID.
14. H:M: the time stamp (hour: minute). The time can be set in the system setup screen.
15. M-D: the time stamp (month-day). The date can be set in the system setup screen.
16. SYST: systolic pressure
17. DIAS: diastolic pressure
18. kPa/mmHg: unit of blood pressure, 1kPa=7.5mmHg.
19. SpO2: the value of SpO2 with unit of %.
20. : pulse bar-graph.
21. PR: pulse rate with unit of bpm.
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22. the heart beat symbol which ashes with heart beat.
23. TEMP/GLU: the current displayed temperature with an option of °C for Celsius, or °F for
Fahrenheit.
When the optional GLU (Blood glucose) is chosen, the blood glucose value will be displayed
with the default unit of mmol/L.
3.2 System Setting Screen
On the measurement display screen, press and hold the
menu key to setup the display screen, as shown in gure
3.2. The user can choose the settings for the wireless
function, pulse beep, blood pressure unit, temperature unit,
date and time.
Operation Instruction:
1. Press and hold the key, and release after hearing
one beep, to enter into the setup screen. When the
patient ID blinks, the setup function is available.
2. A short /long press of the key to cycle select the
setting item, the item will be blinking if selected.
For example, if NIBP patient type is selected, then NIBP
indicator will be blinking. (All parameters can be set
Figure 3.2 Setup display screen
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in the order of anti-clockwise by pressing and holding the , key, the order will be: ID
Minute Hour Day Month Year TEMP NIBP unit Alarm sound Wireless
transmission function NIBP mode).
3. A short press of the / key sets the detailed item. For example, if you want to choose
Child type, then press up/down key to move the indicator on the label of "Child".
4. A short press of the key conrms the setting
5. Press and hold the key brings the screen display back to the measurement display scre-
en. The monitor will also switch back to the measurement display screen as well if there has
been no operation for 30 seconds.
Note: 1. On the setup display screen, all parameters can be set in anticlockwise order by
pressing and holding the key.
2. For setting the date, the century is xed to be 20, i.e. “13y”
indicates the year 2013.
Please see the following example for the date and time: 11:14",
March 23, 2013.
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3.3 History Data Review Screen
On the measurement display screen, press and hold key to recall the stored data records,
as shown in gure 3.3.
Operation instructions:
1. Press and hold the , key, release the key after
hearing one beep. The memory mark"
will appear (i.e. entering to review display screen).
The patient's ID number will blink at the same time.
2. A short press of the / key will browse the
patient's ID number.
3. A short press of the key will conrm the setting,
and the recorded number (No.) will blink.
4. A short press of the / key will set the recorded
number to be recalled. The data displayed on the screen
is for the specic record of the patient that you selected.
Note: when selecting the patient ID, the screen only
displays patients with history data records.
Figure 3.3 History data review screen
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3.4 Data Uploading
1. When the wireless transmission function is on, the monitor can communicate with a host
device such as a PC, smart phone or other wireless enabled devices for real-time data transmission.
2. When connected to a USB cable, the history data can be uploaded to a PC for viewing and
6. Blood pressure measuring accuracy:
Maximal mean difference: ≤ ±5mmHg (0.67kPa)
Maximal standard deviation: ≤8mmHg (1.067kPa)
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4.2 SpO2 Measurement
1 Technique: optical with dual-wavelength
LED wavelength: Red light: 663nm,
Infrared light: 890nm
Maximal optical output power: less than 2mW maximum average
2. SpO2 display range: 0%~100%
3. SpO2 measuring accuracy: Arms is not greater than 3% for SpO2 range from 70% to 100%,
undened during range 0%~70%
Note: Arms is dened as root-mean-square value of deviation according to ISO 80601-2-61 /
ISO 9919
4. Measuring mode: spot-checking
5. SpO2 display update: every second
6. SpO2 averaging: Averages the recent eight seconds value falling within the acceptable limits
7. The table with measured SpO2 accuracy specication in the discrete SpO2 ranges:
SpO2 rangeArms
70%~80%1,62
80%~90%1,09
90%~100%1,58
70%~100%1,42
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8. The graphical plot of all sampled data points:
9.
Note: The data is obtained from UP-7000 (K123711), which has the same technology as the
PC-300, through a controlled, induced hypoxia study, which was conducted with healthy adult
volunteers. The device uses the same
SpO2 measurement technology provided in the subject
device.
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4.3 Pulse Rate Measurement
1. PR measuring range: 30bpm~240bpm
2. Pulse rate measuring accuracy: ±2bpm or ±2%, which is greater
4.4 Temperature Measurement
1. Measuring range: 32.0°C~43.0°C
2. Measuring accuracy: ±0.2°C is for TEMP range from 36.0°C to 39.0°C, and ±0.3°C is for the
rest; ±0.4°F is for TEMP range from 96.8°F to 102.2°F, and ±0.5°F is for the rest.
2. Heart Rate measuring accuracy: ±2bpm or ±2% whichever is greater
3. Display scale: 5.0mm/mV±10%
4. Common-mode rejection ratio (CMRR): ≥60dB
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98
4.7 Others
4.7.1 Operating Environment
1 Operating temperature: 5°C~40°C;
Relative humidity: 30%~80%;
Atmospheric pressure: 70.0kPa~106.0kPa;
Power supply: a.c. 110V-240V AC, 50/60Hz;
Internal power supply: d.c.3.7V (rechargeable Lithium battery);
Input: 15VA
2. The device should be situated in a place protected against direct sunlight, to prevent overhe-
ating inside of the equipment.
3. Do not use this equipment in combination with any equipment other than those approved in
the user manual.
4. The device should be stored and used in a specied temperature, humility and atmospheric
pressure range, or damage maybe caused to the device and as a consequence, record inaccurate results.
5. If the device gets wet by accident, the operator should NOT turn on the power until it has been
thoroughly air dried.
6. Do not use this equipment in an environment with toxic or inammable gas.
7. Only monitor a single person at a time.
8. Do not expose the device to a magnetic resonance (MR) environment.
• The device may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core.
• Thermal injury and burns may occur due to the metal components of the device that can
heat during MR scanning.
• The device may generate artifacts in the MR image.
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• The device may not function properly due to the strong magnetic and radiofrequency elds
generated by the MR scanner.
Warning: Do not use any other adapters than those provided.
4.7.2 Classication
1. Protection against electric shock: Class II equipment and internally powered equipment
2. The degree of protection against electric shock: Type BF applied part
3. Dene apply part: cuff, SpO2 probe, temperature probe, ECG lead wires (optional).
4. The degree of protection against harmful ingress of liquid: The equipment is IP22 with protection against ingress of liquid
5. Electro-magnetic Compatibility: Group I, Class A
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Chapter 5
TROUBLESHOOTING
TroublePossible reasonSolution
Ca not turn on the deviceThe built-in battery is drainedRecharge by connecting the power
Battery is not installedInstall the Lithium battery
Some parts provided by other manufactures are inserted to the connector
No blood pressure resultThe cuff is wrapped around the arm
incorrectly
The windpipe is not correctly inserted to
the NIBP jack
No SpO2 resultThe SpO2 probe is not plugged into the
"SpO2" connector (or Port1 or Port2)
No TEMP resultThe temperature probe is not correctly
plugged into "TEMP" connector (or Port1
or Port2)
Taking measurements before "READY"
appears on the temperature probe screen
supply adapter
Remove the related parts and try again
Wrap the cuff around the arm correctly
Insert the windpipe to the NIBP jack
Plug the SpO2 probe into the "SpO2"
connector (or Port1 or Port2)
Plug the temperature probe into
"TEMP" connector (or Port1 or Port2)
Do not take a measurement until
"READY" appears on the temperature
probe screen
100
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Chapter 6
ERROR MESSAGE INTERPRETING
Error code Description
ERR 01 Fails to inate pressure to 30mmHg within 7 seconds
(The cuff is not well-wrapped)
ERR 02 Cuff pressure is over 295mmHg (Overpressure protection)
ERR 03 No valid pulse is detected
ERR 04 Excessive motion artifact
ERR 05 Invalid measured result
ERR 06 Air leakage is detected
ERR 07 Self-test fail
ERR 08 Pneumatic system error
ERR 09 Signal saturation
ERR 10 Air leakage check fail
ERR 11 Hardware fault
ERR 12 Measurement timeout (the max. measurement time for adult is
120 seconds when the pressure is over 200mmHg,
90 seconds when the pressure is less than 200mmHg,
and 90 seconds for neonate.)
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Chapter 7
PACKING LIST
Item Description Quantity Check
1 Spot-Check Monitor One piece OK
2 Handbag One piece OK
3 User Manual One piece OK
4 Cuff One piece OK
5 USB cable One piece OK
6 Charger (with USB socket) One piece
7 Temperature probe One piece
8 Smart SpO2 probe One piece
9 Glucose Meter
(with lancing device and link cable ) One set
10 Blood glucose test strips (with blood lances) One pack Optional
11 Spot-Check Monitor Data Manager Software One set
12 Easy ECG Monitor One piece
13 ECG lead wire (snap) One piece
14 Disposable adhesive ECG electrodes Six pieces
102
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Chapter 8
MAINTENANCE AND SERVICE
The Spot-Check Monitor should be properly maintained to ensure its maximum performance
and long service life. In addition to the warranty period, the company also offers long-term service for each customer.
It is important that the user reads and follows the operation instructions, important information
and maintenance measures.
8.1 Technical Maintenances
8.1.1 Daily Examination
Before using the monitor, the following checks should be carried out:
• Check the monitor for any mechanical damage;
• Inspect the exposed parts and the inserted parts of all the leads, and the accessories;
• Examine all the functions of the monitor that are likely to be used for patient monitoring, and
ensure that it is in good working condition.
If there is any indication of damage, or if damage is accurately proven, do not use the device.
Contact your supplier for advice and to reach a satisfaction solution.
8.1.2 Routine Maintenance
If the hospital fails to carry out a satisfactory maintenance program on the monitor, it may
cause harm to the patient.
If there is any indication of cable and transducer deterioration or damage, please do not use.
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The SpO2 function has been adjusted before vending. If the user needs to adjust the SpO2,
adjust by using the simulator mode FLUKE INDEX2.
The adjustable units in the monitor such as the potentiometer cannot be adjusted without
permission so to avoid unnecessary failures that may affect the normal application.
It is recommended to use the battery once a month to ensure a strong power supply capacity
and long service life, and recharge once the power has completely run out..
8.1.3 Battery Maintenance
Please pay attention to the polarity of the battery, do NOT insert into the battery compart-
ment with reversed polarities.
In order to avoid damaging the battery, do NOT use other power supply device to charge the
battery.
After use, dispose of the battery according to local regulations, do NOT throw into re.
Do NOT hit or strike the battery with force.
Do NOT use this battery in other devices.
Do NOT use this battery below -20°C or above 60°C.
In order to maintain the battery supply and prolong the battery lifetime, please charge the
battery routinely. Regularly, charge the battery every 3 months even if the device has not
been used.
Only use a battery with the specication recommended by the manufacturer.
Whether the monitor is on or off, the built-in battery will charge as long as the monitor is
connected to an AC adapter and the AC power is on. When the battery is full, it will stop
charging to avoid causing any damage. If the monitor is connected to an AC adapter and the
AC power is on, it will use the AC power, but when the AC power is off, the battery power will
be used. Priority of using the AC power and the power switch between the AC and battery is
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automatic and seamless.
If the battery is damaged, please replace it with a battery with "CCC" or "CE" mark. The
model and specications of the battery should be the same as the original battery. The user
must ensure that the battery meets all applicable safety codes. The user can also contact the
distributor for service.
8.2 Cleaning and Disinfection of the Main Unit
Switch off the monitor and disconnect the power cord before cleaning.
Keep the monitor free from dust.
It is recommended to regularly clean the outer shell and screen of the monitor. Only use a
non-corrosive cleanser such as clear water.
Wipe the surface of the monitor and transducers with an alcohol impregnated wipe, and dry
with a clean cloth or just air-dry.
Dilute the cleaner.
Do NOT use scrubbing materials.
The monitor can be disinfected. Please clear the monitor rst.
To avoid damage do not let liquid cleaner ow into the connector jack of the monitor.
Clean the exterior of the connector only.
Do NOT let any liquid ow into the shell or any other parts of the monitor.
Do NOT leave any residue liquid or disinfectant on the surface of the monitor.
Do NOT perform high pressure sterilization on the monitor.
Do NOT immerse any parts of the monitor or its accessories in the liquid.
If the monitor accidentally becomes wet, it should be thoroughly dried before use. The rear
cover can be removed by a qualied service technician to verify the absence of water.
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Do NOT pour disinfectant on the monitor's surface while disinfecting.
106
8.3 Cleaning and Disinfection of Accessories
It is recommended to clean and disinfect the accessories (excluding the SpO2 probe) with a
piece of gauze soaked in 75% Alcohol or 70% Isopropanol.
Do not use damaged accessories.
Accessories cannot be entirely immerged into water, liquid or cleanser.
Do NOT use radiation, steam or epoxyethane to disinfect accessories.
Wipe off any remaining residue of alcohol or isopropanol after disinfection.
To prevent cross infection, the user wipes the temperature sensitive probe with 75% alcohol
before and after use, then wipes the residue clean with clean dry cloth.
Disinfect the temperature sensitive probe with alcohol.
Wipe the thermometer clean with a mild cloth if it becomes dirty.
Wipe the thermometer clean and return to packaging after use.
8.4 Storage
If the equipment will not be used for a long time period of time, wipe it clean and return it to the
packaging.
Store in a dry well ventilated place free from dust and corrosive gases.
Storage environment: Ambient temperature: -20°C~60°C
Relative humidity: 10%~95%, non-condensing
Atmospheric pressure: 53.0kPa~106.0kPa
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8.5 Transportation
The monitor should be transported by land (vehicle or railway) or air in accordance with the
contractual terms. Do NOT hit or drop with force.
Reference:
The 1999 WHO-ISH
Guidelines for the
Management of
Hypertension
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Disposal: The product must not be disposed of along with other domestic waste.
The users must dispose of this equipment by bringing it to a specic recycling point
for electric and electronic equipment. For further information on recycling points
contact the local authorities, the local recycling center or the shop where the product was purchased. If the equipment is not disposed of correctly, nes or penalties
may be applied in accordance with the national legislation and regulations.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product. This product meets high qualitative standards
both as regards the material and the production. The warranty is valid for 12 months from the
date of supply of GIMA. During the period of validity of the warranty, GIMA will repair and/or
replace free of charge all the defected parts due to production reasons.
Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty. The repair or replacement
performed during the warranty period shall not extend the warranty. The warranty is void in the
following cases: repairs performed by unauthorized personnel or with non-original spare parts,
defects caused by negligence or incorrect use. GIMA cannot be held responsible for malfunctioning on electronic devices or software due to outside agents such as: voltage changes,
electro-magnetic elds, radio interferences, etc. The warranty is void if the above regulations
are not observed and if the serial code (if available) has been removed, cancelled or changed.
The defected products must be returned only to the dealer the product was purchased from.
Products sent to GIMA will be rejected.
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