SS-14070W - Blood pressure monitor Sogo - Free user manual and instructions

USER MANUAL SS-14070W Sogo

SOGO M/D 7:27 16:56 HOM SYS mmHg kPa DIA mmHg kPa MDM M 60 W 76 SET FULLmin

TENSIÓMETRO DIGITAL DE MUÑECA WRIST BLOOD PRESSURE MONITOR TENSIOMÈTRE ELECTRONIQUE AU POIGNET TENSIÔMETRO DO PULSO DIGITAL DIGITALES HANDGELENKTENSIMETER TENSIOMETRO DIGITALE DA POLSO

Ref: PG-800 A7 SS-14070W

ISO 13485

Black circular warning symbol with an exclamation mark (no text or numbers)

Prohibition sign with a microphone crossed out by a diagonal line, no text or symbols present.

Icon of a person using a laptop inside a circle (no text or symbols)

Silhouette of an open umbrella with raindrops falling (no text or symbols)

Symbol of a trash bin crossed out by two diagonal lines (no text or numbers present)

Technical diagram showing two views of a medical device with labeled control buttons and directional arrows indicating movement or assembly.

español

Line drawing of a human torso with a heart symbol on the chest (no text or labels)

SET 20-3 00 00 merry

Illustration showing a medical device with a cross mark and a hand cleaning a circular device (no text or symbols)

ESPECIFICACIONES

This instruction manual can also be downloaded from our web page www.sogo.es

INTRODUCTION

The Monitor uses the oscillometric method of blood pressure measurement. Measurement Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on an adult each time, with a wrist cuff wrapped around the left wrist according to the instruction in the “ATTACHING THE WRIST CUFF”.

The product complies with the electromagnetic compatibility requirement of EN60601-1-2 & EN60601-1-11 and safety standards of EN60601-1 and performance of IEC 80601-2-30 as specified in EEC directive 93/42/EEC, Annex II excluding (4).

NOTES ON SAFETY

* The warning signs and sample icons shown here are listed for your safe and correct use of the unit, so as to prevent injuries or damages to the device.
* The icons and meanings are as follow

Examples of signs

No smoking symbol (circle with diagonal line) indicating no restrictions)

The icon indicates prohibitions (what you should not do). Matters involving actual prohibitions are indicated by text or pictures in or near. The left icon refers to “general prohibition”.

Black circular warning symbol with an exclamation mark (no text or numbers)

The icon indicates something that is compulsory (what must always be observed). Matters involving actual compulsory actions are indicated by text or pictures in or near the left icon refers to “general compulsion”.

No smoking sign symbol (circle with diagonal line and pencil icon), no text present

The 📊 icon indicates something can't be disassembled or “Don’ disassemble” Matters involving actual compulsory actions are indicated by text or pictures in or near . The left icon refers to “general prohibition”.

Type BF Applied part IP Classification: IP20 Means protected from touch by fingers and objects greater than 12mm.

MR Unsafe Do not use this equipment in the MRU scar room

Please read these instructions before use

Indicates a medical device that needs to be protected from moisture.

Marking of electrical and electronic equipment in accordance with RoHS Directive 2015/863/EC (WEEE)

The following symbol indicates that the device cannot be used in a MRI scan room

CautionPatient must follow doctor's instruction and should not perform self-judgment and self-treatment by the measuring result, Selfdiagnosis of measured results and treatment are dangerous. The device should not be used to judge illness, first aid and continuously monitor measuring.This device can not be used for Patient transport and surgical care .It can be used in household or fixed places only. Please press "on/off" button to stop work when you feel uncomfortable with the wrist, or if the air is inflating abnormally without stop.
Do not let a child below 12 years old and the people who can't express one's intention.When it is used by the people of 12~18 years old, it should accompanied by the Adult. May cause accident or trouble.
Do not use the unit for purpose other than measuring blood pressure. May cause accident or trouble.
Please do not use mobile phone around the device. Please do not use the device around the magnetic field.
The device is prohibited from being used during movement.
Do not use the equipment in outdoor or shower rooms.
Do not disassemble, repair, or remodel the main unit or the arm cuff of the blood pressure monitor. Will cause the unit to function erroneously

Requests from Manufacturer

Used batteries may leak and damage the main unit. If you are not going to use the device for long time, remove the batteries.

For any patient, do not measure more than 3 times continuously, it should be at least above 5 minutes of interval rest between any two measurements, otherwise will cause extravasated blood.

Do not measure your blood pressure over 6 times each day.

Do not apply the cuff over a wound as this can cause further injury.

When removing the air tube, pull out the plastic connector and hold it tight.

Observe the air pressure value from the LCD display.

When measuring, it could not exceed 280 mmHg, otherwise Please press “on/off” button to stop

Do not use force to bend the arm cuff or the air tube.

Do not knock or drop the main unit.

Always use the specified accessories in the manual, the use of other parts not approved by the manufacturer may cause faults or injuries.

For service information, parts list etc., please contact the dealer.

- The PATIENT is an intended OPERATOR.- Do not do servicing and maintenance while the MAGNETIC ENERGY EQUIPMENT is in use.- The user can maintain the product, the maintenance method is described in the maintenance instructions of manual.- Stop using the equipment immediately, if it is in contact with water.

ABOUT BLOOD PRESSURE

1. What is blood pressure?

Blood pressure is the force exerted by blood against the walls of the arteries. Systolic pressure occurs when the heart contracts. Diastolic pressure occurs when the heart expands.

Blood pressure is measured in millimeters of mercury (mmHg). One's natural blood pressure is represented by the fundamental pressure, which is measured first thing in the morning while one is still at rest and before eating.

2. What is hypertension and how is it controlled?

Hypertension, an abnormally high arterial blood pressure, if left unattended, can cause many health problems including stroke and heart attack. Hypertension can be controlled by altering lifestyle, avoiding stress and with medication under a doctor's supervision.

To prevent hypertension or keep it under control:

• Do not smoke
• Reduce salt and fat intake
• Maintain proper weight
  • Exercise regularly
  • Have regular physical checkups

3. Why measure blood pressure at home?

Blood pressure measured at a clinic or doctor's office may cause apprehension and produce an elevated reading, 25

to 30 mmHg higher than that measured at home, Home measurement reduces the effects of outside influences on blood pressure readings, supplements the doctor's readings and provides a more accurate, complete blood pressure history.

4. WHO blood pressure classification

Standards for assessment of high blood pressure, without regard to age, have been established by the World Health Organization (WHO), and shown in chart below.

5. Blood pressure variations

An individual's blood pressure varies greatly on a daily and seasonal basis. It may vary by 30 to 50mmHg due to various conditions during the day. In phypertensive individuals, variations are even more pronounced.

Normally, the blood pressure rises while at work or play and falls to its lowest levels during sleep. So, do not be overly concerned by the results of onemeasurement.

Take measurements at the same time every day using the procedure described in this manual, and know your normal blood pressure. Many readings give a more comprehensive blood pressure history.

Be sure to note date and time when recording your blood pressure. Consult your doctor to interpret your blood pressure data.

1. If you are taking medication, consult with your doctor to determine the most appropriate time to measure your blood pressure. NEVER change a prescribed medication without first consulting with your doctor.
2. For people with irregular or unstable peripheral circulation problems due to diabetes, liver disease, hardening of the arteries, etc., there may be fluctuation in blood pressure values measured at the upper arm versus at the wrist.
3. Measurements may be impaired if this device is used near televisions, microwave ovens, X-ray, mobile phone equipment or other devices with strong electrical fields. To prevent such interference, use the monitor at a sufficient distance from such devices or turn them off.
4. Before using, should wash your hands.
5. This appliance is designed for adult use. If the device is used on children, old peoples and babies, consult your doctor and continue the measurement.
6. Consult your doctor if the unexpected readings are obtained, also please refer to “Trouble shooting” of the manual.
7. The device is not suitable for the diagnosis of diseases, urgent treatments, follow-up during medical emergencies or operations.

FEATURES OF THE PRODUCT

1. Memory can store 60/60 measurements.
2. Large and clear LCD display
3. WHO blood pressure classification display.
4. Easy to use. Press a button to automatically measure, record the measurement values and measurement time.
5. Automatically turns off (within 1 minute) to save power
6. Irregular Heartbeat Detection

PARTS IDENTIFICATION

LCD Display: Date and Time Systolic Blood pressure Diastolic Blood pressure Pulse/min 6-30 22 30 N/D SYS MPA DIA MPA mmHg MEM Measurement No. 2 Measurement No.1 SET Button Wrist Cuff SET Battery Cover 1.5V Batteries (AAA or LR03) Case

english

SYMBOLS ON DISPLAY

Month/date Hour / Minute 18-88 28:88 WHO blood pressure classification 28.8 Value of systolic Low battery 28.8 Value of diastolic Inflation/ Deflation Kpa mmHg Unit of pressure M 88 188 Vale of pulse per minute Heart beatMemory Irregular heartbeat detection

INSERT OR REPLACE BATTERIES

1. Remove the battery cover.
2. Insert new batteries into the battery compartment as shown, taking care that the polarities (+) and (-) are correct.
3. Close the battery cover. Use only LR03, AAA batteries.

Technical diagram showing two views of a medical device with labeled control buttons and directional arrows indicating movement or assembly.

If you do not insert batteries into the compartment, the unit will not work.

When the icon 📋 blinks in the display, replace ALL the batteries with new ones.

Remove the batteries from the device if it is not going to be used for a long period of time.

IRREGULAR HEARTBEAT DETECTION

Detected during measurement of irregular heartbeat, irregular heartbeat symbol display “‘’”. This device is not suitable for those with a severely irregular heartbeat.

1- 1 12:02 116 72 mmHg 01:00:58

WHO BLOOD PRESSURE CLASSIFICATION DISPLAY

Grade 3 hypertension (severe) Grade 2 hypertension (moderate) Grade 1 hypertension (mild) High-normal Normal Optimal

english

ATTACHING THE WRIST CUFF

1. Fastening the wrist cuff

1) Wrap the wrist cup around your wrist about (1-2) cm above your hand as shown in the figure at the right.
2) Fasten the wrist cuff tightly by using the Velcro Strip. For proper measurements, fasten the wrist cuff tightly and measure on a bare wrist.

1. How to take proper measurements

For best accuracy in blood pressure measurement:

• Sit comfortably at a table. Rest your wrist on the table.
• Relax for about 5 to 10 minutes before measurement.
• Raise your hand so that the wrist cuff is at the same level as your heart
• Remain still and keep quiet during measurement.
• Do not measure right after physical exercise or a bath.
  • Measure your blood pressure at about the same time every day.

(1-2)cm

Line drawing of a human torso with a heart symbol on the chest (no text or labels)

TIME, UNIT AND VOICE SYSTEM SETUP

1. Under Power Off. Press "SET" button, automatically power off in 3 seconds.

SET 18:00 28:00 28.8 28.8 Kpa mmHg MR8 ♥ 188 → 1- 1 0:00

1. Press and hold "SET" button until the year number displays and flashes on LCD to enter setting mode. And press (M2) button to adjust the year. After choosing the year, press the SET button and set the day.

SET 20-33 mmHg

1. Repeat the same operation to adjust the other parameters: days, month, year, measurement units, etc.

Year

Month

Day

Hour Minute Unit

MEASUREMENT METHOD

Attention!

Before starting the following steps, set up the wrist cuff to your left hand wrist as previous section of "ATTACHING THE WRIST CUFF"

1. Press M1 or M2 button, the display shows "0" inflation icon flashes on display when it begins to inflate. During the inflation, please do not move.
2. After the measurement process, the cuff will deflate and the results obtained will appear on the screen.

3. Once the results obtained have been displayed and recorded, press M1 or M2 to turn off the blood pressure monitor.

4. If the letter “E” appears on the screen it is because an error has occurred during the measurement, please refer to the “frequent problems” section.

5. If the cuff has come loose during the inflation process, put it on properly and repeat the measurement process.
6. If any emergency situation arises during the inflation or measurement process, please press M1 or M2 to turn off the meter and deflate the cuff.

graph LR
    A["User icon with M1"] --> B["18:00 3:00:00"]
    B --> C["12:00 12:51:00"]
    C --> D["12:00 12:51:68"]
    D --> E["12:00 12:51:151"]
    E --> F["12:00 12:52:76 68"]

MEMORY STORAGE

1. Under power off. Hold M1 or M2 for 3 seconds, to get into relative memory mode, it reads average of latest 3 measurements.
2. Press ☐ or ☐ to cut off he power. If forget to turn it off, automatically power off in one minute.
3. The stored memory will not lose after replacing battery.
4. Delete memory (all the memory will be deleted) Showing memory, hold "SET" for 5 seconds, display "No" means all the measurements have been deleted.

graph LR
    A["User icon with M2"] --> B["Display screen with 18:88, 28:88, 38.8, 48.8, 58.8, 68.8"]
    B --> C["Navigation with 12:8, 12:52, 116, 72, 01, 68"]
    C --> D["Output screen with no label"]

CARE AND MAINTENANCE

To keep your digital blood pressure monitor in the best condition and protect the unit from damage, follow the directions listed below:

Keep the monitor in the storage case when not in use. Do not fold the wrist cuff too tightly.

The fabric fastener could touch the inner surface of the wrist cuff and damage it.

Clean the monitor and cuff with a soft dry cloth. Do not use any abrasive or volatile cleaners. Do not attempt to clean the arm cuff.

CAUTION:

Do not submerge the device or any of the ocomponents in water. Do not subject the monitor to extreme hot or cold temperatures, humidity or direct sunlight.

Store the device and the components in a clean, safe location.

* Do not subject the monitor to strong shocks, such as dropping the unit on the floor.

* Remove the batteries if the unit will not be used for three months or longer. Always replace all the batteries with new ones at the same time.

ones at the same time.

SPECIFICATIONS

Measuring Method Oscillometric Measurement
Indication Digital LCD	display
Measuring Range Pressure: (30~280) mmHgPulse: (40~199) Beat/min
Accuracy Static Pressure: ± 3mmHg Pulse: ± 5%
Memory 60 memories per person. 2 people
Power supply	2 x 1.5V Batteries (LR03 or AAA) (Not Included)
Operating condition	+5°C~+40°C. 30%RH~80%RH
Storage condition	-20°C~+55°C. 10%RH~93%RH
Dimensions 75 x 68 x	31 mm approx.
Weight 105 gr approx.	(excluding batteries)
Classification	Type BF
Wrist circumference	(13.5~19.5) cm

TROUBLESHOOTING:

Error display Possible cause How to correct
Nothing is displayed When you push the POWER button or battery icon flash	No battery installation In	Insert batteries
	Battery worn out Replace with new batteries
	The polarities of batte-ries laced wrongly	Insert battery in the correct polarities
E1:Can't normally increase pressure	Check your wrist cuff for air leakage	Replace cuff with new one
E3:Inflate pressu-re too high		Remeasure or send back to dealer to recalibrate
E2-E4:Hand shaking during measurement	Hand or body shaking while measurement	Keep static position and measure again
The systolic pressure Value or diastolic Pressure value too high	The cuff was held lower than your heart	Keep correct position and measure again.
	The cuff was not attached properly
	You moved your body or spoke during measurement
The systolic pressure value or diastolic pressure value too low	The cuff was held hig-her than your heart
	You moved your body or spoke during measurement
Guidance and manufacturer's declaration-electromagnetic emissions
This product is intended for use in the electromagnetic environment specified below,the customer or the user must assure that it is used in such an environment.
Emissions test	Compliance	Electromagnetic environment-guidance
RF emissions CISPR 11	Group 1 This model uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment
RF emissions CISPR 11 Class B		This model is suitable for used in domestic establishment and in establishment directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2	Not applicable
Voltage fluctuations /flicker emissions IEC 61000-3-3	Not applicable

Guidance and manufacturer's declaration-electromagnetic immunity
This product is intended for use in the electromagnetic environment specified below, the customer or the user must assure that it is used in such an environment.
Immunity test	IEC 60601 test level	Compliance Level	Electromagnetic environment-guidance
Electrostatic discharge (ESD) IEC 61000-4-2	±6kV contact ±8kV air	±6kV contact ±8kV air	Floors should be wood, concrete or ceramic tile. If doors are covered with synthetic material, the relative humidity should be at least 30%.
Conducted RF IEC 61000-4-6	3 Vrms 150kHz to 80MHz	3V	Portable and mobile RF communications equipment should be used no closer to any part of the model including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitterRecommended separation distance d = 1,2 d = 1,2 80 MHz to 800 MHz d = 2,3 800 MHz to 2,5 MHzWhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, ^a should be less than the compliance level in each frequency range ^b Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC 61000-4-3	3V/m 80MHz to 2,5GHz	3V/m

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the model is used exceeds the applicable RF compliance level above, the model should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the model

b) Over the frequency range 150kHz to 80MHz, field strengths should be less then 3 V/m.

No smoking symbol (circle with diagonal line) indicating no restrictions)

Black circular warning symbol with an exclamation mark (no text or numbers)

No smoking sign symbol (circle with diagonal line) indicating no smoking requirement)

Icon of a person using a document inside a circle (no text or symbols)

Silhouette of an open umbrella with raindrops falling (no text or symbols)

Symbol of a waste bin with no text or labels

CARACTÉRISTIQUES DU PRODUIT

Technical line drawing of a medical device with two views: top shows internal components, bottom shows external casing (no text or symbols)

français

Line drawing of a human torso with a heart symbol on the chest (no text or labels)

SET 20-3 00 00 noisy

Illustration showing a medical device with a cross mark and a hand cleaning a circular device (no text or symbols)

ESPECIFICACIONES

Méthode de mesure	Oscillométrique
Indication Digital LCD	display
Plage de mesure Pressure: (30~280) mmHgPulse: (40~199) Beat/min
Tolérance maximale	Pression statique: 3mmHgPouls :±5%
Emplacements de mémoire	60/60 memories
Alimentation électrique	2 x 1.5V piles (AAA or LR03) (Non Inclus)
Conditions d’utilisation	+5°C~+40°C. 30%RH~80%RH
Conditions de stockage	-20°C~+55°C. 10%RH~93%RH
Dimensions Environ 75 x 68 x 31 mm
Poids Environ 105 gr (piles non inc)
Classification	Type BF
Brassard (13.5~19.5) cm

PROBLEMES FREQUENTS:

No smoking symbol (circle with diagonal line) indicating no restrictions)

Black circular warning symbol with an exclamation mark (no text or numbers)

No smoking sign symbol (circle with diagonal line, plus microphone icon), no text present

Icon of a person using a document inside a circle (no text or symbols)

Silhouette of an umbrella with raindrops falling (no text or symbols)

Symbol of a trash bin with crossed lines and a battery, no text or numbers present

Technical line drawing of a medical device with internal components and directional arrows (no text or symbols)

Line drawing of a human torso with a heart symbol on the chest (no text or labels)

Illustration showing a medical device with a hand cleaning it, alongside a plastic bottle and a kit (no text or symbols)

DADOS TECNICOS

No smoking symbol (circle with diagonal line) indicating no restrictions)

Black circular warning symbol with an exclamation mark (no text or numbers)

Prohibition sign with a microphone and diagonal line, no text or symbols present

Symbol of a waste bin with crossed x- and circular components, no text or numbers present

Technical diagram showing two views of a medical device with labeled control buttons and directional arrows indicating movement or assembly.

deutsch

SET 20-3 00 00 mety

Illustration of three plastic containers with a cross symbol overlay (no text or labels)

Hand cleaning a circular device with a digital display (no text or symbols visible)

SPEZIFIKATIONEN:

No smoking symbol (circle with diagonal line) indicating no restrictions)

Black circular warning symbol with an exclamation mark (no text or numbers)

No smoking sign symbol (circle with diagonal line) indicating no smoking requirement)

Icon of a person using a document inside a circle (no text or symbols)

Simple black-and-white icon of an open umbrella with raindrops falling (no text or symbols)

Symbol of a trash bin with crossed x- and circular components, no text or numbers present

Technical diagram showing two views of a medical device with labeled control buttons and internal components, including directional arrows and measurement markings.

128 italiano

Line drawing of a human torso with a heart symbol on the chest (no text or labels)

SET 20-32 no no no

Illustration showing a bottle and a washing machine with a hand cleaning it (no text or symbols)

134 italiano

SPECIFICHE:

DECLARATION OF CONFORMITY

This device complies with Medical Equipment Directive 93/42/EEC, Electromagnetic Compatibility Directive 2014/30/EU, Directive 2015/863/UE on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

DÉCLARATION DE CONFORMITÉ

This symbol means that in case you wish to dispose of the product once its working life has ended, take it to an authorised waste agent for the selective collection of waste electrical and electronic equipment (WEEE).

Imported by:

Sahysan Appliances S.L, NIF: B98753056, C/ Barcas 2, 2

46002 Valencia, Spain

Product made in P.R.C. – Designed by SOGO based on the European Quality Standards

Customer Service: www.sogosat.com / [e-mail] / 0034 902 222 161

Guarantee Certificate

SERVICIO ATENCION AL CLIENTE: TEL: [phone]

email: [e-mail]

Guarantee Details/Vendor Seal

The following details must be completed in full and without omission for your SOGO product to be officially guaranteed. Please do ensure that all the details are filed in accurately and clearly.

Eadquirido Por Purchased By

Calle Street

Poblacion City

Provincia Province

Warranty Certificate

Thank you for selecting our brand SOGO

This product has been manufactured under the strictest of quality control procedures and using the highest quality materials under the regulations of CE (European Standards) and the UAE safety norms to ensure excellent performance and reliability. This product will provide reliable, long lasting service provided it is properly used and maintained. Nevertheless, if there is any eventuality, that could take place during the period of warranty or outside of this period, we recommend to read the present warranty certificate and go to the nearest Technical Assistance Service Centers of the Official Network of SOGO. SOGO guarantees that this product is free of any manufacturing defects at the time of their acquisition and extends this warranty to cover:

TWO YEARS IN LABOUR AND SPARE PARTS

If during this period, the product suffers some defect due to the materials used or a manufacturing defect, this product will be serviceable at any one of the Technical Assistance Service Centers of the Official Network of SOGO.

THE CONDITIONS

The warranty will be considered valid if and only if the following data is provided:

1. Full signature of the buyer or Name and Seal of the selling establishment.

2. Model Serial Number and Purchase Date of the product

3. In any case, the document must be with the invoice or ticket of purchase showing the date of purchase.

This warranty will not cover periodic inspections of the product nor maintenance operations such as installation, tuning adjustment and antenna problems.

Under the following conditions, this warranty will be considered invalid:

1. When any of the information required above is not provided, or if any information, such as serial numbers, seal of selling establishment or other details have been manipulated or stricken.

2. When damage inflicted upon the product is due to the consequence of abuse or wrong use of the product, including but not limited to:

* Using the product for a purpose for which it is not intended.

* Failure to follow SOGO guidelines and instructions for safe use and maintenance of the product.

* Servicing or repair by any entity other than the officially sanctioned Service Centers of SOGO.

* In the case of air-conditioning machines installed by personnel without the corresponding technical training and approval for it.

* Accidents natural disasters and as a rule, any foreign motive out of the control of SOGO, including but not limited to structural damage due to water and any / all public disturbances.

The terms of the warranty are established without prejudice of the rights of the users contained in the outstanding national legislation (of warranties about consumer goods) and of the rights of the consumers before the retailer that appear in the purchase contract

Manufacturer: ShenZhen Pango Electronic Co., Ltd.

Address: No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, Longgang District, Shenzhen, Guangdong, China.

Additional site: 2-4 Floor, No.5 Shanzhuang Rd., Xikeng Village, Henggang Town, Longgang District, Shenzhen City, Guangdong Province, China

Lotus NL B.V.

Address: Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands

Ref: PG-800 A7 SS-14070W

ISO 13485