Gima PC-300 User manual

Manuale d’uso - User manual
Manuel de l’utilisateur - Guía de Uso
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
35162
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
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) - Italy
Made in China
MONITOR SPOT-CHECK PC-300
PC-300 SPOT-CHECK MONITOR
MONITEUR SPOT-CHECK PC-300
MONITOR SPOT-CHECK PC-300
PROFESSIONAL MEDICAL PRODUCTS
0476

57 ENGLISH
Instructions for User
Dear Customers,
Thank you for purchasing the PC-300 Spot-Check Monitor. Please read the following informa-
tion 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 in-
structions 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 mo-
nitoring 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-

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 specications 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
qualied 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.
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Table of contents
Chapter 1 OVERVIEW......................................................................................................... 61
1.1 Features..............................................................................................................61
1.2 Product Name and Model ..................................................................................62
1.3 Intended Use ......................................................................................................62
1.4 Impact on the Environment and Resources .......................................................63
Chapter 2 OPERATION INSTRUCTIONS ..........................................................................63
2.1 Appearance ........................................................................................................63
2.1.1 The Front Panel .........................................................................................63
2.1.2 The Right and Upper Sides of the Device ................................................65
2.2 Installation ..........................................................................................................67
2.2.1 Power Supply ............................................................................................67
2.2.2 Starting the Monitor................................................................................... 68
2.2.3 Downloading APP software onto Android smart phone............................ 69
2.3 Taking Measurement .......................................................................................... 70
2.3.1 Blood Pressure Measurement ...................................................................70
2.3.2 SpO2Measurement...................................................................................73
2.3.3 Temperature Measurement........................................................................ 76
2.3.4 Blood Glucose Measurement (Optional)....................................................79
2.3.5 ECG Measurement (Optional).................................................................... 83
2.4 Blood Pressure Accuracy Check Method.................................................................... 86
2.5 Symbols .............................................................................................................88
Chapter 3 MONITORING SCREEN DISPLAY....................................................................89
3.1 Measuring Screen............................................................................................... 89
3.2 System Setting Screen....................................................................................... 91
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3.3 History Data Review Screen............................................................................... 93
3.4 Data Uploading................................................................................................... 94
Chapter 4 TECHNICAL SPECIFICATIONS........................................................................ 94
4.1 Blood Pressure Measurement ............................................................................94
4.2 SpO2Measurement............................................................................................95
4.3 Pulse Rate Measurement ................................................................................... 97
4.4 Temperature Measurement................................................................................. 97
4.5 Blood Glucose Measurement (Optional).............................................................97
4.6 ECG Measurement (Optional)............................................................................. 97
4.7 Others.................................................................................................................98
4.7.1 Operating Environment..............................................................................98
4.7.2 Classication .............................................................................................99
Chapter 5 TROUBLESHOOTING .....................................................................................100
Chapter 6 ERROR MESSAGE INTERPRETING ..............................................................101
Chapter 7 PACKING LIST................................................................................................. 102
Chapter 8 MAINTENANCE AND SERVICE...................................................................... 103
8.1 Technical Maintenances ...................................................................................103
8.1.1 Daily Examination .................................................................................... 103
8.1.2 Routine Maintenance...............................................................................103
8.1.3 Battery Maintenance ...............................................................................104
8.2 Cleaning and Disinfection of the Main Unit ...................................................... 105
8.3 Cleaning and Disinfection of Accessories ........................................................106
8.4 Storage .............................................................................................................106
8.5 Transportation................................................................................................... 107
Appendix I Classication 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 tempe-
rature;
•Blood pressure, oxygen saturation, pulse rate and temperature can be measured simultaneou-
sly;
•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 Conguration:
Conguration
Model NIBP SpO2Pulse rate Temperature Blood Display
Glucose LCD
PC-300 √ √ √ √ -- √
NOTE: 1. Spot-Check Monitor can congure 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 para-
meters, 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 Glu-
cose Meter and Easy ECG Monitor are certied 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
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Figure 2.1

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.
4. I/0 : 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 SpO2probe.
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 tempe-
rature probe, smart SpO2probe 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 acces-
sories.
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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
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
I/0
, and the other end to the USB power source with
output capacity of 5Vdc/1.2A.
2.2.2 Starting the Monitor
By pressing and holding down the switch, the software version will be displayed after relea-
sing 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.
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2.2.3 Downloading APP software onto Android smart phone
Terminal devices such as Android smart phones can be used to receive data from the Spot-
Check 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.
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Figure 2.4 QR Code Image

70
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 inatable 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,
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
Figure 2.5 Cuff position
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71
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.
NIBP Measurement Principle
The NIBP measurement is based on oscillation technology. The measurement is started by infla-
ting 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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Level Blood 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

72
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 prema-
ture 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 SpO2Measurement
Operation procedures:
1.Connect the smart SpO2probe 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 SpO2probe 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.
SpO2Measurement Principle
SpO2measurement 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 amplication and lte-
ring. The acquired light intensity signals (plethysmogram) are digitalized and further processed
with proprietary algorithm to determine the SpO2and pulse rate value.
Safety instructions for SpO2measurements
Continuous use of the SpO2probe may result in discomfort or pain, especially for those with
microcirculatory problems. It is recommended that the probe should NOT be applied to the
Figure 2.6 demonstration for SpO2probe
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75
same place for over two hours, change the measurement site periodically and when neces-
sary.
Do NOT place the SpO2probe 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 SpO2sensor, as
using in high temperatures can cause burns.
Do NOT put the SpO2probe and pressure cuff on the same limb, otherwise the blood pres-
sure measurement may affect the SpO2measurement.
The device is calibrated to display functional oxygen saturation.
Do NOT allow the sensor cable to twist or bend.
Check the SpO2sensor and cable before use. Do NOT use a damaged SpO2sensor.
When the temperature of the SpO2sensor 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 SpO2sensor cannot be immersed into water, liquid or cleanser.
The SpO2sensor can be repeatedly used. Please clean and disinfect before reuse.
The SpO2sensor 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 SpO2accuracy. If the patient has
such situation, do not rely on the measured result for diagnostic decision, and it's recommen-
ded for the patient to consult with the doctor.
☞PORT1 or PORT2 can be connected with either temperature probe, smart SpO2probe, 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 SpO2probes, or two
Easy ECG Monitors) to both PORT1 and PORT2.
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