TRANSTEK TMB-995-BS Blood Pressure Monitor User Manual

version:1.0
User Manual
Blood Pressure Monitor TMB-995-BS
Arm Type

• Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-995-BS.
• To use the monitor correctly and safely, please read the manual thoroughly.
• Please keep well this manual in order to reference in the future.

INTRODUCTION

General Description
Thank you for selecting TRANSTEK arm-type blood pressure Monitor (TMB-995-BS). The monitor features blood pressure measurement, pulse rate measurement, and result storage. The design provides you with two years of reliable service.
Readings taken by the TMB-995-BS are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information and provides step-by-step instructions for using the product. Read the manual thoroughly before using the product.

Features:

• 80*60mm Digital LCD display
• Maximum 60 records per user
• Measuring during inflation technology

Indications for Use
The Transtek Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with an arm circumference ranging from 22 cm to 32 cm ( about 8¾˝-12½˝ ) or 22cm to 42cm(about 8¾˝-16½˝). It is intended for adult indoor use only.

Contraindications

1. The device should not be used by any person who may be suspected of or is pregnant.
2. The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, and defibrillators.

Measurement Principle
This product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a “zero point” equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and diastolic pressure as well as pulse rate.

Safety Information
The signs below might be in the user manual, labeling, or other components.
They are the requirement of the standard and using.

| Refer to the instruction manual/booklet To signify that the instruction manual/booklet must be read.
---|---
****| The symbol for “Type BF applied part”

| Caution Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
| The symbol indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling.
****| The symbol for “Recycle”

**SN**

| The symbol for “Serial Number”
| The symbol for “Direct Current”
| The symbol for “Manufacturer”
| The symbol for “Date and Country of manufacture”
| For indoor use only
| The symbol for “Class II Equipment”

CAUTION

• This device is intended for indoor, home use.
• This device is not intended for public use.
• This device is portable, but it is not intended for use during patient transport.
• This device is not suitable for continuous monitoring during medical emergencies or operations.
• This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm, or for any purpose other than obtaining a blood pressure measurement.
• This device is for adults. Do not use this device on neonates or infants. Do not use it on children unless otherwise instructed by a medical professional.
• Do not use on women in pregnant, including pre-eclamptic, patients.
• The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, and defibrillators.
• The effectiveness of this device has not been established for use: -on users with common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, -on users with peripheral arterial disease, -on users undergoing intravascular therapy, or with arteriovenous (AV) shunt. Consult a medical professional before use.
• Do not use this device for diagnosis or treatment of any health problem or disease. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or health care professional.
• If you are taking medication, consult your physician to determine the proper time to measure your blood pressure.
• This device may be used only for the intended use described in this manual, the manufacturer shall have no liability for any incidental, consequential, or special damages caused by misuse or abuse.
• Report any unexpected operation or events to the manufacturer.
• Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.
• Warning: Do not kink, fold, stretch, compress, or otherwise deform the tube during measuring, as the cuff pressure might continuously increase, which could prevent blood flow and result injury.
• Warning: Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries.
• Warning: Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site frequently for irritation.
• Warning: Do not place the cuff on the arm of a person whose arteries or veins are undergoing medical treatment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V) shunt, which could disrupt blood circulation and cause injuries.
• Do not place the cuff on the arm on the same side of a mastectomy (especially when lymph nodes have been removed). it is recommended to take measurements on the unaffected side.
• Do not wrap the cuff on the same arm to which another monitoring device is applied. One or both devices could temporarily stop functioning if you try to use them at the same time. * Please check that the operation of the device do not result in prolonged impairment of patient blood circulation.
• Warning: On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, loosen and remove the cuff immediately. Prolonged high pressure applied to the arm (cuff pressure >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) might lead to bruising and discolored skin.
• Warning: Do not use this device with high-frequency (HF) surgical equipment at the same time.

CAUTION

• Warning: This device is not AP/APG equipment. Do not use the device where flammable anesthetics is present or in environments mixed with an air of oxygen or nitrous oxide.
• The device contains sensitive electronic components. To avoid measurement errors, avoid taking blood pressure measurements near a strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
• Wireless communication equipment, such as wireless home network devices, mobile phones, cordless telephones, and their base stations, and walkie-talkies may cause interference that may affect the accuracy of measurements. A minimum distance of 1 foot (30 cm) should be kept from such devices during a measurement.
• You can use this device to take your own measurement, no third-party operator is required.
• Please use the device under the environment which is provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.
• The device may require up to 30 minutes to warm up / cool down from the minimum/maximum storage temperature before it is ready for use.
• Warning: Excessive cuff tube lengths could cause strangulation if you don’t manage them properly.
• Warning: Do not touch the output of the batteries/adapter and the user simultaneously.
• Adapter is specified as a part of ME EQUIPMENT.
• Warning: The power cord is considered the disconnect device for isolating this equipment from supply mains. Do not position the equipment so that it is difficult to reach or disconnect.
• The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient environment.
• Warning: Do not use this device if you are allergic to polyester, nylon, or plastic.
• Warning: Only use accessories approved by the manufacturer. Using unapproved accessories might cause damage to the unit and injure users.
• Warning: If you experience discomfort during measurements, such as pain in the arm or other complaints, press the Power button immediately to release the air from the cuff.
• No calibration is required within two years of reliable service.
• Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out by authorized service centers.
• At the request of authorized service personnel, circuit diagrams, component part lists, descriptions and calibration procedures will be made available by the manufacturer or
  distributor.
• It is recommended that the performance should be checked after repair, maintenance, and every two years of use, by retesting the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50 mmHg and 200 mmHg).
• Warning: Do not use the device while under maintenance, or being serviced.
• Store your device, cuff, and adapter in a clean and dry place, protect it against extreme moisture, heat, lint, dust, and direct sunlight. Never place any heavy objects on it.
• Make sure the rubber tube of the cuff is not squeezed, stretched, or kinked during storage.
• Warning: Keep the device, cuff, and batteries away from children as they may pose a risk of choking or strangulation if used improperly.
• Clean both device and cuff with a soft, dry cloth. If necessary use a dampened cloth and natural detergent. Do not use alcohol, benzene, or other harsh chemicals.
• Do not wash the cuff in a washing machine or dishwasher!
• The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times.
• Dispose of accessories, detachable parts, and the device according to the local guidelines.

LCD Display Signal

**SYS**

| Systolic blood pressure| High pressure result

**DIA**

| Diastolic blood pressure| Low pressure result

| Pulse| Pulse/minute
| Deflating| CUFF air is exhausting of deflating
| Current Time| Time(year:month:day:hour:minute)
| Memory| If “MEM” shows, the displayed measurement values is from the memory.

**mmHg**

| mmHg| Measurement Unit of the blood pressure

**KPa**

| kPa| Measurement Unit of the blood pressure
| Battery Indicator| Indicate the current battery
| Irregular heartbeat| Irregular heartbeat
| Grade| The grade of the blood pressure
| Heartbeat| Heartbeat detection during the measurement
| User 1| Start measurement and transmit the results to User 1
| User 2| Start measurement and transmit the results for User 2
| Shocking reminder| Shocking will result in inaccurate

Monitor Components

Component list of pressure measuring system:

1. Cuff
2. Air pipe
3. PCBA
4. Pump
5. Valve

List

1. Blood Pressure Monitor (TMB-995-BS)

2. Cuff (22~32cm or 22~42cm) (Type BF applied part)

3. User manual
   

4. 4*AA batteries

5. AC adaptor (BLJ06L060100P-U)

BEFORE YOU START

The Choice of Power Supply

1. Battery-powered mode: 6VDC 4*AA batteries
2. AC adaptor powered mode: 6V 1A
   (Please use the AC adaptor which is authorized by the manufacturer!) The right picture is the hole-in for the power adaptor.

CAUTION
In order to get the best effect and protect your monitor, please use the right batteries and a special power adapter that complies with the CE safety standards.

Installing and Replacing the Batteries

1. Slide off the battery cover.
2. Install the batteries by matching the correct polarity, as shown.
3. Replace the cover.

Replace the batteries whenever the below happens

• The shows
• The display dims
• The display does not light up

CAUTION

• Do not use new and used batteries together.
• Do not use different types of batteries together.
• Do not dispose of the batteries in a fire. Batteries may explode or leak.
• Remove batteries if the device is not likely to be used for some time.
• Worn batteries are harmful to the environment. Do not dispose of with daily garbage.
• The typical service life of the new and unused batteries is 180 measurements for the operation time is 60s.
• Remove the old batteries from the device following your local recycling guidelines.

Setting Date and Time
It is important to set the clock before using your blood pressure monitor so that a time stamp can be assigned to each record that is stored in the memory. (year :2018—2058 time:12 H)

1. When the unit is off, hold pressing the “ SET ” button for 3 seconds to enter the mode for the year setting.

2. Press the “ MEM ” button to change the [YEAR].

3. When you get the right year, press the “ SET ” button to set it down and turn to the next step.

4. Repeat steps 2 and 3 to set the [MONTH] and [DAY].
   

5. Repeat step 2 and 3 to set the [HOUR] and [MINUTE].
   

6. After the [UNIT] is set, the LCD will display “donE”, and then turn off.

Select the User

1. When the monitor is off, press the “ SET ” button to enter user setting mode.

2. Then press the “ SET ” button again, and select the user ID between user 1 and user 2 .

3. After selecting the suitable user ID, press the “START/STOP” button to save the setting you have done then the device will turn off.

MEASUREMENT

Tie the Cuff

1. Remove all jewelry, such as watches and bracelets from your left arm.
   Note: If your doctor has diagnosed you with poor circulation in your left arm, use your right arm.

2. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight.

3. Hold your arm with your palm facing up and tie the cuff on your upper arm, then position the tube off-center toward the inner side of arm in line with the little finger. Or position the artery mark Φ over the main artery (on the inside of your arm).
   Note: Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery.

4. The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm.

5. Sit comfortably with your tested arm resting on a fiat surface. Place your elbow on a table so that the cuff is at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths.

6. Helpful tips for Patients, especially for Patients with Hypertension:
   • Rest for 5 minutes before first measurement.
   • Wait at least 3 minutes between measurements. This allows your blood circulation to recover.
   • Take the measurement in a silent room.
   • The patient must relax as much as possible and do not move and talk during the measurement procedure.
   • The cuff should maintain at the same level as the right atrium of the heart.
   • Please sit comfortably. Do not cross your legs and keep your feet fiat on the ground.
   • Keep your back against the backrest of the chair.
   • For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician.

Start the Measurement

1. When the monitor is off, press the START/STOP button to turn on the monitor, and it will finish the whole measurement, save and transmit the measurement data to the desired user. (Take User 1 for example.)
   Inflating and measuring.
   Display and save the results. The data transmission will proceed.
   

2. This device will proceed to data transmission after measurement. The Bluetooth symbol blinks on the LCD indicating data is transmitting.

3. If the data is successfully transmitted, the Bluetooth symbol doesn’t blink anymore, and the will disappear. If the data transmission fails, the will proceed.
   

4. Press the “START/STOP” button to power off, otherwise, it will turn off within 1 minute.
   Tips:
   A. You can press the “START/STOP” button at any time to stop measuring during the process of measurement.
   B. Maximum 60 records are both for USER 1 and USER 2.
   C. If the measurement result is out of the measurement range (SYS: 60mmHg to 230mmHg; or DIA: 40mmHg to 130mmHg;or Pulse: 40-199 pulse/minute), the LCD will display “out”.

CAUTION

• Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-995-BS may interfere with vicinity electrical equipment.
• Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit whenever possible.
• Keep the monitor at least 20 centimeters away from the human body (especially the head) when the data transmission is proceeding after measurement.
• To enable the data transmission function, this product should be paired to a Bluetooth end at 2.4 GHz.

How to mitigate possible interference?

1. The range between the device and the BT end should be reasonably close, from 1 meter to 10 meters. Please ensure no obstacles between the device and the BT end so as to obtain quality connection and to lower the RF output range.
2. To avoid interference, other electronic devices (particularly those with wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor.

DATA MANAGEMENT

Recall the Records

1. When the monitor is off, please press the “ MEM ” button to show the average value of the latest three records.If the records are less than 3 groups, it will display the latest record instead. Displays different colors at different levels when the monitor is under the memory inquiry mode. (Take user 1 for example.)
   

2. Press the “ MEM ” or “ SET ” button again to rotate the records. The order of the record, date and time will be displayed alternatively.
   

CAUTION
The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list.

Delete the Records
If you did not get the correct measurement, you can delete all results of the selected user by following the steps below.

1. Hold pressing the “ MEM ” button for 3 seconds when the monitor is under the memory inquiry mode. The LCD will display the blinking “Use ID + dEL ALL”.
   

2. Press the “ MEM ” button to confirm deleting all the memories, the LCD will display “Use ID + dEL dOnE” and the monitor will turn off.
   Bluetooth Module No.: LS51802
   RF Frequency Range: 2.402 – 2.480 GHz
   Output Power Range: -2.36 dBm
   Transmitting Distance: 1-10 meters
   Supply Voltage: 1.8V – 3.6V

3. Hold pressing the “ SET ” button for 3 seconds when the monitor is under the memory inquiry mode (excluding the LCD displays AVG). The LCD will display the blinking “ Use ID + dEL ONE”.
   

4. Press the “ MEM ” button to confirm deleting the last record, the LCD will display “Use ID + dEL dOnE” and the monitor will turn off.
   

5. If you don’t want to delete the records, press the “START/STOP” button, it will turn off and quit the deletion. Or when it is in the deleting memory mode, it will turn off and quit the deletion if there is no operation in one minute.

6. If there is no record, the LCD will be shown as below:

INFORMATION FOR USER

Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.

Maintenance
In order to get the best performance, please follow the instructions below.

ABOUT BLOOD PRESSURE

What are systolic pressure and diastolic pressure?

When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.

What is the standard blood pressure classification?

The chart on the right is the standard blood pressure classification published by American Heart Association (AHA).
This chart reflects blood pressure categories defined by American Heart Association.

CAUTION
Please consult a physician if your measuring result falls outside the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point.

Irregular Heartbeat Detector
An irregular heartbeat is detected when a heartbeat rhythm varies while the device is measuring systolic pressure and diastolic pressure. During each measurement, the blood pressure monitor will keep a record of all the pulse intervals and calculate the average value of them. If there are two or more pulse intervals, the difference between each interval and the average is more than the average value of ±25%, or if there are four or more pulse intervals, the difference between each interval and the average is more than the average value of ±15%, then the irregular heartbeat symbol will appear on the display with the measurement result.

CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually, this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination but serves to detect pulse irregularities at an early stage.

Why does my blood pressure fluctuate throughout the day?

1. Individual blood pressure varies multiple times every day. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions.
2. If the person takes medicine, the pressure will vary more.
3. Wait at least 3 minutes for another measurement.

Why do I get a different blood pressure at home compared to the hospital?
The blood pressure is different even throughout the day due to weather, emotion, exercise, etc, Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings.

Is the result the same if measuring on the right arm?
It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time. What you need to pay attention to when you measure your blood pressure at home: If the cuff is tied properly. If the cuff is too tight or too loose. If the cuff is tied on the upper arm. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring. Advice: Relax yourself for 4-5 minutes until you calm down.

TROUBLESHOOTING

This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the product is not operating as you think it should check here before arranging for servicing.

new batteries
Error message| E 1 shows| Communication error| Check if the APP is on, operate and send the data again.
E 3 shows| The cuff is not secure.| Readjust the cuff and relax for a moment and then measure again.
E10 or E11 shows| The monitor detected motion, talking or the pluse is too poor while measuring.| Movement can affect the measurement. Relax for a moment and then measure again.
E20 shows| The measurement process does not detect the pulse signal.| Loosen the clothing on the arm and then measure again
E21 shows| The treatment of the measurement failed.| Relax for a moment and then measure again.
EExx,shows on the display.| A calibration error occurred.| Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance.Refer to the warranty for contact information and return instructions.
**Warning message| ** out shows| **** Out of measurement range| Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician.

SPECIFICATIONS

Power supply| Battery powered mode: 6VDC 4xAA batteries AC adaptor powered mode: 6V 1A (Please only use the recommended AC adaptor model).
---|---
Display mode| Digital LCD V.A.60mm80mm
Measurement mode| Oscillographic testing mode
Measurement range| Rated cuff pressure: mmHg∼299mmHg(OkPa ∼39.9kPa)
Measurement pressure: SYS: 60mmHg∼230mmHg (8.0kPa-30.7kPa) DIA: 40mmHg∼130mmHg (5.3kPa∼17.3kPa) Pulse value: (40∼199)beat/minute
Accuracy| Pressure: 5 C ∼40 C within±3mmHg(0.4kPa) Pulse value:±5%
Normal working condition| A temperature range of :+5°C to +40°C
A relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapor partial pressure greater than 50 hPa
An atmospheric pressure range of : 700 hPa to 1060 hPa
Storage & Transportation condition| Temperature:-20°C to +60°C
A relative humidity range of 5 93%, non-condensing, at a water vapor pressure up to 5OhPa
Measurement perimeter of the upper arm| About 22cm-32cm or 22cm-42cm
Weight| Approx.300g(Excluding the batteries)
External dimensions| Approx.102mm143mm*73mm
Attachment| 4xAA batteries, user manual,AC adapter
Mode of operation| Continuous operation
Degree of protection| Type BF applied part
Protection against
ingress of water| IP21 It means the device could protect against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops.
Device Classification| Battery Powered Mode: Internally Powered ME Equipment AC Adaptor Powered Mode: Class II ME Equipment
Software Version| A01

WARNING: No modification of this equipment is allowed.

AUTHORIZED COMPONENT

Authorized Component

1. please use the TRANSTEK authorized adapter.

Adaptor
Type: BLJ06L060100P-U
Input: 100-240V 50-60Hz,0.2Amax
Output: 6V 1000mA

Contact Information
For more information about our products, please visit www.transtekcorp.com.you  can get customer service, usual problems, and customer download, transfer will serve you anytime.

Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd.
Company: Guangdong Transtek Medical Electronics Co., Ltd.
Address: Zone A, No.105,Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong,China

FCC STATEMENT

FCC ID:OU9TMB995BS2
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

EMC Guidance

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Warning: Don’t be near the active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment TMB-995-BS including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Technical description：

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity.

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions CISPR 11| Group 1
RF emissions CISPR 11| Class [ B ]
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations / flicker emissions IEC 61000-3-3| Comply

Table 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2 Test level| Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2| ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air| ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air
Electrical fast transient/burst IEC 61000-4-4| ±2 kV for power supply lines ±1 kV signal input/output 100 kHz repetition frequency| ±2 kV for power supply lines Not Applicable 100 kHz repetition frequency
Surge IEC61000-4-5| ±0.5 kV, ±1 kV differential mode ±0.5 kV, ±1 kV, ±2 kV common mode| ±0.5 kV, ±1 kV differential mode Not Applicable
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| 0% UT; 0,5 cycle. At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°. 0% UT; 1 cycle and 70% UT; 25/30 cycles; Single phase: at 0°. 0% UT; 250 / 300 cycle| 0% UT; 0,5 cycle. At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°. 0% UT; 1 cycle and 70% UT; 25/30 cycles; Single phase: at 0°. 0% UT; 250 / 300 cycle
Power frequency magnetic field IEC 61000-4-8| 30 A/m 50 Hz / 60 Hz| 30 A/m 50 Hz / 60 Hz
Conducted RF IEC61000-4-6| 3 V 0,15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz| 3 V 0,15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz
Radiated RF IEC61000-4-3| 10 V/m 80 MHz – 2,7 GHz 80% AM at 1 kHz| 10 V/m 80 MHz – 2,7 GHz 80% AM at 1 kHz
NOTE UT is the a.c. mains voltage prior to application of the test level.

Table 3

Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development District,
528437 Zhongshan, Guangdong, China

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