Guilin Royalyze Medical Instrument Co.,Ltd.

Add: 18 Li River Road, Qixing District, Guilin 541004

Guangxi P.R. China

[Link]
[Link]

Tel:86-773-5810745

Royalyze Medical
 COMPANY PROFILE

Royalyze Medical was established on Feb.2, 2007 in Guilin, which integrates R&D CERTIFICATE
and manufacture of IVD products. It was awarded as an excellent enterprise in
Guangxi medical device industry in 2016. The double parameters gout classification
system was supported by science and technology innovation fund. It is the pioneer
enterprise in China which master the core technology of enzyme electrode.

Royalyze Medical has 100 thousand level clean workshop 525.6 m 2, 10 thousand
level clean area 30.5 m 2. Since 2015, it has passed ISO13485 quality system
authentication and CE certificate of 12 kinds products, which enjoy great sales in
Germany, Italy, Spain and other European Union countries.

The patent product includes: Double parameters gout classification system, Multi-
monitoring system. Especially the Intelligent multi-monitoring system which combi-9
test in one meter, It requires about 15 micro liter blood sample and 15 seconds for
lipid profile test, it is the pioneer in the international market. With accurate and fast
testing feature, it is suitable for integration of disease prevention, health surveillance,
old-age management and medical service under the condition of informationization,
and greatly facilitates the use of clinicians at home and abroad.

In order to promote the rapid electrochemical detection technology, Royalyze Medical

has set up Royalyze Health Science and Technology Company in Shenzhen, which
undertakes the intelligent design of new technology and new products. It integrates ISO13485
the responsibility of network marketing, marketing and technical cooperation while
Royalyze Medical focus on R&D and production. CE ISO15197

Medical Device
Manufacturing License

FSC Business License

1 2
 ● Strip Ejection ● Large Display ● Strip Ejection ● Large Display
● No coding ● Results in 5s ● No coding ● Results in 5s
● Temperature adjustment and automatic equalization ● Temperature adjustment and automatic equalization

3 4
 4 in 1
LBM-01 Bluetooth (Optional)
Blood Glucose Test Strips Hemoglobin Test Strips
(BG01) (HB01)

● Total Cholesterol ● Blood Glucose

● Uric Acid ● Hemoglobin
Total Cholesterol Test Strips Uric Acid Test Strips
(TC01) (UA01)

● Automatic ON & OFF ● Auto-eject strip button

● Auto-recognition strip ● Small blood sample
● 7 days, 14 days, 28 days average result ● Quick result
● TC: 15s, BG: 5s, UA: 5s, HB: 5s

ACCURACY
Total Cholesterol Uric Acid Blood Glucose Hemoglobin
linear regression
linear regression y= 0.9485x + 0.1859 linear regression y= 0.9757x + 0.5201
2
20 y= 0.9647x + 12.411
R =0.9501
480 2
R =0.9505 linear regression y= 1.0215x-0. 3435 30 R² =0.9606
2
R =0.9749
16.66
400 630 25
HITACHI 7600 (mg/dL)

EKF C-Line Clinic (mg/dL)

HITACHI 7600 (mg/dL)

540
HITACHI 7600 ( mg/dL )

13.33 data point

320 data point data point 20
450
upper limit
upper limit 360 upper limit
240 10 lower limit
lower limit 270 lower limit 15
linear （data point) linear （data point)
160 6.66 180 linear （data point)
10
90
80 3.33 0 5
0 90 180 270 360 450 540
0 0 0
0 80 160 240 320 400 isaw (mg/dL)
0 3.33 6.66 10 13.33 16.66 0 5 10 15 20 25 30
isaw (mg/dL) isaw (mg/dL) isaw (g/dL)

5 6
 Lipid Profile INTELLIGENT ANALYSIS AND APPLICATION
LBM-02 Multi-Monitoring Meter ● 4G Data storage function ● Touch screen
● Remote upgrade function ● WIFI
● Bluetooth ● NFC
● GPRS ● Camera ● Fit all kinds of networks
● Automatic code recognition by NFC intelligent identification

SYSTEM SETTING

● USB charge ● Network data communication

● Color LCD display ● Power save program
● Touch code ● Strip ejection button
● Built-in battery with continuous display function
● Triglycerides
2 6
● Total Cholesterol
● LDL 4
● DHL 7
● Blood Glucose
3
● Urine Glucose
● Blood Uric Acid
● Urine Uric Acid 1
● Hemoglobin 5

1. Power Button: Press this button to turn on or turn off the meter.
2. Test Strip Port: The test strip is inserted here.
3. Display Screen: Touch Screen for information processing, shows test
results, messages, time, date, and stored results.
4. Ejection Button: Eject used test strip out.
5. USB: Charge, program input.
6. Camera: Take photos or scan.
7. NFC: Touch to read test strips name, code information.

7 8
 Lipid Profile
LBM-02 Multi-Monitoring Meter Test Parameter Measure Range Reference Range Test
Time
Sample
Volume
Hematocrit

44-1062mg/dL or 50-150mg/dL or
LAB-ACCURATE TEST RESULTS TEST PARAMETERS: Triglycerides
0.50-12.00 mmol/L 0.57-1.70mmol/L
Perform the test(Automatic Test) 20-400mg/dL or 134-208mg/dL or
Total Cholesterol
0.50-10.00 mmol/L 3.35-5.2mmol/L
15 Sec 3µL
20-100mg/dL or 28-80mg/dL or
HDL 30-55%
0.50-2.50 mmol/L 0.7-2.0mmol/L

62-260mg/dL or 0-124mg/dL or
LDL 1.56-6.50 mmol/L 0-3.1mmol/L

20~600 mg/dL or 70-105 mg/dL or 1.5µL

Blood Glucose 5 Sec
1.1~33.3 mmol/L 3.90-5.80mmol/L

1~1800 mg/dL or 0-99mg/dL or

Urine Glucose 10 Sec 1.5µL /
0.01~99.98 mmol/L 0-5.5mmol/L
Male: 2.5-6.9 mg/dL or
Turn on the meter 1.5-20mg/dL or 149-416μmol/L
Blood Uric Acid Female: 1.5-5.95mg/dL or 5 Sec 1.5µL 30-55%
90-1190 μmol/L
90-357μmol/L
Close the NFC lable on the test strip bottle cap to the NFC sensor behind Normal Adult :71-351mg/dL/24h or
the meter, the meter will beep and automatically enter the test interface. 8~202 mg/dL or 1.20-5.90mmol/L/24h,
Urine Uric Acid 5 Sec 1.5µL /
0.5~12 mmol/L morning urine 131-326mg/dL or
Insert the test strip 2.20-5.48 mmol/L

Male: 13-18g/dL or 8-11mmol/L

Hemoglobin 5.0~27.0 g/dL Female: 11.5-16.5g/dL or 5 Sec 1.5µL /
7.1-10.2mmol/L

SYSTEM ACCURACY

Total Cholesterol Triglycerides HDL

y = 0.9407x + 0.0768
y = 0.9458x + 0.2418 y = 1.0384x - 0.0295
R²= 0.9705
R²= 0.975

isaw Data Dr 4S Pro(mmol/L)

8 R²= 0.8916

isaw Data Dr 4S Pro(mmol/L)

9 3.5

isaw Data Dr 4S Pro(mmol/L)

8 7
3
7 6
6 2.5
5
5 2
4
4
1.5
3
3
2 2 1

1 1 0.5
0 0
0
0 2 4 6 8 10
0 1 2 3 4 5 6 7 8 0 0.5 1 1.5 2 2.5 3
Chemistry Analyzer (mmol/L)
Chemistry Analyzer (mmol/L) Chemistry Analyzer (mmol/L)
Apply the sample
The meter will count down Blood Glucose Uric Acid Hemoglobin
linear regression
20 y=0.9647x + 12.411 linear regression y=0.9757x + 0.5201
linear regression y=1.0215x-0.3435 2
R² =0.9606
R =0.9505 30

Show the test result.

2
R =0.9749
16.66
630
25
EKF C-Line Clinic (mg/dL)

540

HITACHI 7600 (mg/dL)

13.33

HITACHI 7600 ( mg/dL )

data point data point
450 20
upper limit

Print the test result if you needed. 360

270
180
upper limit

lower limit
10 lower limit

linear （data point)

15
linear （data point) 6.66 10
90
0 3.33 5
0 90 180 270 360 450 540
0 0
isaw (mg/dL)
0 3.33 6.66 10 13.33 16.66 0 5 10 15 20 25 30
isaw (mg/dL) isaw (g/dL)

9 10
 Significance of the parameters Urine Reagent Test Strips
The medical context of urine parameters Glucotest
Urine test strips are indispensable tools in medical diagnostics to gain a rapid survey of the
state of health of a patient
Leukocytes: Symptonmatic of inflammatory renal and urinary tract diseases Specifications: 50pcs/bottles,100pcs/bottles

Nitrite: Bacterial infection of kidneys or urinary tract Shelf Life: 24 months

Urobilinogen: Acute and chronic liver parenchyma damage, hemolytic
Testing Items: Glucotest
jaundice, pathological state of the intestinal tract
Protein: Symptomatic of renal and urinary tract diseases Storage Conditions: Store at temperatures between
2℃-30℃ and out of direct sunlight.
pH: Useful in relation to other parameters

Blood: Serious infections of the kidneys and urinary tract, urolithiasis,

suspected renal or bladder neoplasms
Specific Gravity: Concentration ability of kidneys, supplement for
other parameters Product feature
Ketone: Metabolic abnormalities, indication of ketoacidosis
Analytical sensitivity better High quality color chart
Bilirubin: Liver parenchyma damage, obstructive jaundice Anti-VC interference than or comparable to market ensures accurate visual
(also for indicating biliary obstructions) leaders reading
Glucose: Early detection and supervision of diabetes
mellitus
ASCORBIC ACID: Concentration of ascorbic acid
in urine which varies with the intake

Urine Reagent Test Strips

Uric-Ket
EASY TO USE: Please follow these instructions
1 2 3 Specifications: 50pcs/bottles,100pcs/bottles

Shelf Life: 24 months

Testing Items: Ketone

Storage Conditions: Store at temperatures between

2℃-30℃ and out of direct sunlight.

1. Immerse the reagent 2. Run the edge of the strip 3. Hold the strip up horizontally
area of the strip in the urine
specimen and take it up
against the rim of the container
to remove excess urine. Lay the
and compare the reagent areas
on the strip to the corresponding
Product feature
quickly and immediately. strips on a paper towel with the color chart on the bottle label at
Start timing. reagent areas upward. the exact times specified and in Analytical sensitivity better High quality color chart
good light. Hold the strips close Anti-VC interference than or comparable to market ensures accurate visual
to the color blocks and match leaders reading
carefully. Make note of the
result.
11 12
 Urine Reagent Test Strips Urine Reagent Test Strips
Uric 2VGK Uric 3V

Specifications: 50pcs/bottles,100pcs/bottles Specifications: 50pcs/bottles,100pcs/bottles

Shelf Life: 24 months Shelf Life: 24 months

Testing Items: Glucotest, Ketone Testing Items: Glucotest, Protein, pH

Storage Conditions: Store at temperatures between Storage Conditions: Store at temperatures between
2℃-30℃ and out of direct sunlight. 2℃-30℃ and out of direct sunlight.

Product feature Product feature

Analytical sensitivity better High quality color chart Analytical sensitivity better High quality color chart
Anti-VC interference than or comparable to market ensures accurate visual Anti-VC interference than or comparable to market ensures accurate visual
leaders reading leaders reading

Urine Reagent Test Strips Urine Reagent Test Strips

Uric 2VGP Uric 4V SG

Specifications: 50pcs/bottles,100pcs/bottles Specifications: 50pcs/bottles,100pcs/bottles

Shelf Life: 24 months Shelf Life: 24 months

Testing Items: Glucotest, Protein Testing Items: Specific Gravity,Glucotest, Protein, pH

Storage Conditions: Store at temperatures between Storage Conditions: Store at temperatures between
2℃-30℃ and out of direct sunlight. 2℃-30℃ and out of direct sunlight.

Product feature Product feature

Analytical sensitivity better High quality color chart Analytical sensitivity better High quality color chart
Anti-VC interference than or comparable to market ensures accurate visual Anti-VC interference than or comparable to market ensures accurate visual
leaders reading leaders reading

13 14
 Urine Reagent Test Strips Urine Reagent Test Strips
Uric 8V Uric 10CF

Specifications: 50pcs/bottles,100pcs/bottles Specifications: 50pcs/bottles,100pcs/bottles

Shelf Life: 24 months Shelf Life: 24 months

Testing Items: Leukocytes, Nitrite, Protein, pH, Blood, Testing Items: Leukocytes, Nitrite, Urobilinogen, Protein,
Specific Gravity, Ketone, Glucose pH, Blood, Specific Gravity, Ketone, Bilirubin, Glucose

Storage Conditions: Store at temperatures between Storage Conditions: Store at temperatures between
2℃-30℃ and out of direct sunlight. 2℃-30℃ and out of direct sunlight.

Product feature Product feature

Analytical sensitivity better High quality color chart Analytical sensitivity better High quality color chart
Anti-VC interference than or comparable to market ensures accurate visual Anti-VC interference than or comparable to market ensures accurate visual
leaders reading leaders reading

Urine Reagent Test Strips Urine Reagent Test Strips

Uric 9V Uric 11V

Specifications: 50pcs/bottles,100pcs/bottles Specifications: 50pcs/bottles,100pcs/bottles

Shelf Life: 24 months Shelf Life: 24 months

Testing Items: Nitrite, Urobilinogen, Protein, pH, Blood, Testing Items: Leukocytes, Nitrite, Urobilinogen, Protein,
Ketone, Bilirubin, Glucose, Ascorbic Acid pH, Blood, Specific Gravity, Ketone, Bilirubin, Glucose,
Ascorbic Acid
Storage Conditions: Store at temperatures between
2℃-30℃ and out of direct sunlight. Storage Conditions: Store at temperatures between
2℃-30℃ and out of direct sunlight.

Product feature Product feature

Analytical sensitivity better High quality color chart Analytical sensitivity better High quality color chart
Anti-VC interference than or comparable to market ensures accurate visual Anti-VC interference than or comparable to market ensures accurate visual
leaders reading leaders reading

15 16
 Lancets

Type Diameter
I 21G/0.80mm
I 23G/0.60mm
I 25G/0.50mm
I 26G/0.45mm
I 27G/0.40mm
I 28G/0.37mm
I 30G/0.32mm

Product feature
Ultra-fine tri-bevel Universal design fits Not made with natural
needle tip most lnacing device Devices latex free
rubber latex

Blood Pressure Monitor

BP-JC312
Display LCD digital display
Measuring principle Oscillometric method
Measuring localization Upper arm
Pressure 30~280mmHg(4~37.3kPa)
Measurement range
Pulse 40~200 pulses/min
Pressure ±3mmHg(±0.4kPa)
Accuracy
Pulse +5% ofreading
Memory function 1*200 sets memory of measurement values
Power source 4pcs (LR6)AA alkaline battery DC.6V orAC adapter
Automatic power off In 3 minutes
Battery life Could be used for 300 times for normal condition
Accessories Cuff, instruction manual
Temperature 5-40℃
Operating Humidity 15%~85%RH
environment
Air pressure 86kPa~106kPa
Temperature -20℃~55℃, Humidity : 10%-85%,
Storage
Humidity :10%-85%avoid crash,
environment
sun burn or rain during transportation.

17