BPA-420 - Blood pressure monitor HOMEDICS - Free user manual and instructions

USER MANUAL BPA-420 HOMEDICS

This equipment needs to be installed and put into service in accordance with the information provided in this manual

2 YEAR GUARANTEE

INTRODUCTION

General Description

Thank you for selecting HoMedics arm blood pressure monitor. The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by the blood pressure monitor 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:

• 60mm x 40.5 mm LCD
  • Maximum 60 records
  • Measuring during inflation

Indications for Use

The HoMedics Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 42cm (about 8^3/4 - 16^1/2 ). It is intended for adult indoor use only.

Contraindications

1. The device is not suitable for use on pregnant women or women who think they may be pregnant.
2. The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, defibrillators.

Measurement Principle

This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure” equivalent to the air pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate.

Safety Information

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

	Symbol for “THE OPERATION GUIDE MUST BE READ”		Symbol for “TYPE BF APPLIED PARTS”
	Symbol for “COMPLIES WITH MDD 93/42/EEC REQUIREMENTS”		Symbol for “ENVIRONMENT PROTECTION - Waste electrical products should not be disposed of with household waste. Please follow local guidelines.
	Symbol for “MANUFACTURER”
	Symbol for “SERIAL NUMBER”		Authorized Representative in the European Community
	Symbol for “DIRECT CURRENT” Symbol for “Re
	Symbol for “MANUFACTURE DATE”		The Green Dot is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods.
	Caution: These notes must be observed to prevent any damage to the device

CAUTION

• This device is intended for adult use in homes only.
- The device is not suitable for use on neonatal patients, pregnant women, patients with implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arteriovenous shunt or people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses.

- The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children.

- The device is not intended for patient transport outside a healthcare facility.

- The device is not intended for professional use.

- 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 functions other than obtaining a blood pressure measurement.

- Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. Do not begin or end medical treatment without asking a physician for treatment advice.

- If you are taking medication, consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician.

- Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure.

- When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result.

- Don't kink the connection tube during use, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT.

- When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements; the application of the cuff and its pressurization on any arm

where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy.

• Warning: Do not apply the cuff over a wound; otherwise it can cause further injury.
• Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME equipment.
• On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure > 300mmHg or constant pressure > 15mmHg for more than 3 minutes) applied to the arm may lead to an ecchymosis.
• Please check that operation of the device does not result in prolonged impairment of patient blood circulation.
• When measurement, please avoid compression or restriction of the connection tubing.
• The device cannot be used with HF surgical equipment at the same time.
• The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically investigated according to the requirements of ISO 81060-2:2013.
• To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
• This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
• Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
• This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient's arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
• When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.
• This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application.
• This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.

• The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide.

• Warning: No servicing/maintenance while the ME equipment is in use.
  • The patient is an intended operator.

• The patient can measure data and change batteries under normal circumstances and maintain the device and its accessories according to the user manual.
• To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
• The blood pressure monitor and the cuff are suitable for use within the patient environment. If you are allergic to polyester, nylon or plastic, please don't use this device.
• During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensitization or irritation reaction.
• If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.
• If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the arm and press the START/STOP button to stop inflation.
• Before use, make sure the device functions safely and is in proper working condition. Check the device, do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause injury, improper results, or serious danger.
• 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.
• It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg ).
• Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.

• Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, etc., to assist to service personnel in parts repair.

• The operator shall not touch output of batteries and the patient simultaneously.

• Cleaning: Dust environment may affect the performance of the unit. Please use the soft cloth to clean the whole unit before and after use. Don't use any abrasive or volatile cleaners.
• The device doesn't need to be calibrated within two years of reliable service.
• If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of HoMedics. Don't open or repair the device by yourself in the event of malfunctions. The device must only be serviced, repaired and opened by individuals at authorized sales/service centers.
• Please report to HoMedics if any unexpected operation or events occur.
• Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal.
• Be careful to strangulation due to cables and hoses, particularly due to excessive length.
• At least 30 min required for ME equipment to warm from the minimum storage temperature between uses until it is ready for intended use. At least 30 min required for ME equipment to cool from the maximum storage temperature between uses until it is ready for intended use.
• This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;
• Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d away from the equipment. The distance d is calculated by the MANUFACTURER from the 80 MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
• Please use ACCESSORIES and detachable parts specified/authorised by MANUFACTURER. Otherwise, it may cause damage to the unit or danger to the user/patients.
• There is no luer lock connectors used in the construction of tubing, there is no possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.
• Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.

LCD display signal

HOMEDICS Hypes. Sev. Mod. Mild High-norm. Norm. Opt. 88.0 88.0 88.0 88.0 188 MEMORY TIME/DATE SYS kPa mmHg DIA kPa mmHg Pulse/min M S START STOP

SYMBOL	DESCRIPTION	EXPLANATION
	Systolic blood pressure	High blood pressure
	Diastolic blood pressure	Low blood pressure
	Pulse display	Pulse in beats per minute
	Deflation symbol	The cuff is deflating.
	Memory	Indicate it is in the memory mode and which group of memory it is.
k	kPa	Measurement Unit of the blood pressure
m	mmHg	Measurement Unit of the blood pressure
Lo+☐	Low battery	Batteries are low and need to be replaced
	Irregular heartbeat	Blood pressure monitor is detecting an irregular heartbeat during measurement.
	Blood pressure level indicator	Indicate the blood pressure level
	Current Time	Year/Month/Day, Hour/Minute
	Heartbeat	Blood pressure monitor is detecting a heartbeat during measurement.
	User 1/User G/User 2	Start measurement for User 1/User G/User 2
	Motion indicator	Motion may result in an inaccurate measurement

Monitor Components

CUFF AIR HOSE AIR CONNECTOR PLUG MEMBUTTON SET BUTTON START/STOP BUTTON LCD DISPLAY BATTERY COMPARTMENT COMPONENT list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve

List

1. Automatic Arm Blood pressure monitor

WALMELICS 108 58 66 SYS DIA STREET STOP

1. Cuff (Type BF applied part) 22cm-42cm)

Line drawing of a medical or laboratory device with a coiled tube and attached clip (no text or symbols)

(Please use HoMedics Authorized cuff. The size of the actual cuff please refer to the label on the attached cuff.)

1. 4×AAA batteries

1. User manual

Line drawing of a printer with paper and batteries (no text or symbols)

Replace the batteries under the following circumstances:

• displays on the LCD
• The LCD display is dim
- When powering on the monitor, the LCD doesn't light up.

Installing and replacing the batteries

• Open the battery cover.
• Install the batteries as indicated in the battery compartment. (Always select the authorized / specified battery: 4 x AAA-size batteries).
• Replace the battery cover.

CAUTION

• Do not use new and used batteries together.
• Do not use different types of batteries together.
• Do not dispose the batteries in 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 with daily garbage.
• Remove the old batteries from the device following your local recycling guidelines.

SETTING DATE, TIME AND MEASUREMENT UNIT

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. (The setting range of the year :2018—2058 time format: 12H/24H)

1. When the monitor is off, hold pressing "SET" for 3 seconds to enter the mode for year setting.

Or when the monitor is off, press "SET" button shortly, it will display the time. Then hold pressing "SET" button to enter the mode for year setting.

1. Press the "MEM" to change the [YEAR]. Each press will increase the numeral by one in a cycling manner.

2. When you get the right year, press "SET" to set down and turn to next step.Repeat steps 2 and 3 to set the [MONTH] and [DAY].

20 18 20 19 S M

Two identical rectangular panels with black circular symbols and wavy lines, each containing a small dot (no text or labels)

1. Repeat steps 2 and 3 to confirm the time format [12H] and [24h].

12 h M 24 h S

1. Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].

m: 6:00 S m: 6:00

1. Repeat steps 2 and 3 to set the [UNIT].

0.0 M 0.0 S

1. After the unit is set, the LCD will display "donE" first, then display all the settings you have done and then it will turn off.

do NE

BEFORE YOU START

Select the User

1. When the monitor is off, press and hold the MEM button to enter user setting mode. The user ID will blink.

Simple diagram with a central black symbol and four surrounding dashed lines, no text or labels present.

1. Then press MEM button again, select the user ID user 1, user 2 or user G.

Simple diagram with a central 'A' and four surrounding dots, no text or symbols present.

Simple diagram with a central symbol and four surrounding dots, no text or labels present.

1. After selecting the suitable user ID, press SET button to confirm. Then the LCD will turn off.

A do NE

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.

sleeve facing up and position the tube

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

2. 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 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.

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

2-3cm

1. Sit comfortably with your tested arm resting on a flat 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.

2. Helpful tips for Patients, especially for patients with Hypertension:

• Rest for 5 minutes before first measuring.
- 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 flat 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.

daily

Start the Measurement

1. When the monitor is off, press the "START/STOP" to turn on the monitor, and it will finish the whole measurement. (Take User 1 for example)

LCD display

Sew. Mod. Mild High- norm. Norm. Opt. 8.0.0 8.0.0 8.0.0 1.98 88:88:88 SYS ■ kPa ■ mmHg DIA ■ kPa ■ mmHg ♥ Full/Minh

Adjust the zero

Sév. Mod. Mild High- norm. Norm. Opt. 0 SYS ■ kPa ■ norm.hg DIA ■ kPa ■ norm.hg ● PdA/mh Rs 10:08

Inflating and measuring

Sex. Mod. Mild High- norm. Norm. Opt. 38 SYS ■ kPa ■ mmHg DIA ■ kPa ■ mmHg ♥ Pulvin 10:08

Display and save the results.

Sew. Mod. Mild High- norm. Norm. Opt. 108. 68. 66 & 66 PM 10:08 SYS ■ kPa ■ mmHg DIA ■ kPa ■ mmHg ♥ Painh

1. Press the "START/STOP" to power off, otherwise it will turn off within 1 minute.

DATA MANAGEMENT

Recall the Records

1. When the monitor is off, please press the "MEM" to show the average value of the latest three records. If the records are less than three groups, it will display the latest record first.

Sex Mod. Mild High- norm. Norm. Opt. 118 64 62 RUG SYS ■ kPa ■ mmHg DIA ■ kPa ■ mmHg ♥ Pulmon

1. Press the "MEM" or "SET" to get the record you want.

Sex Mod. Mild High-norm. Norm. Opt 108 108 68 68 66 SYS ■ kPa ■ mmHg DIA ■ kPa ■ mmHg ♥ Pain is UP M

Sex. Mod. Mild High- norm. Norm. Opt. 108. 67. 70 SYS kPa mmHg DIA kPa mmHg Painish DOWN S

The date and time of the record will be shown alternately

The current no. is no.2

The corresponding date is January 1st

The corresponding time is pm 10:08

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 (eg 2 becomes 3, and so on), and the last record (60) is dropped.

Delete the records

If you did not get the correct measurement, you can delete all results by following steps.

1. Hold pressing "MEM" for 3 seconds when the monitor is in the memory recall mode, the flash display will show.

M DEL ALL A

1. Press "SET" to confirm deleting and the monitor will turn off.

s dEL do NE

1. If you don't want to delete the records, press "START/STOP" to escape.

Simple diagram with four horizontal lines and a small icon below (no text or symbols)

1. If there is no record, the above display will show.

INFORMATION FOR USER

Tips for Measurement

Measurements may be inaccurate if taken in the following circumstances.

Cartoon drawing of a person eating with a bowl and spoon (no text or symbols)

Within 1 hour after dinner or drinking

Cartoon illustration of a man sitting at a table with a steaming cup (no text or symbols)

Immediate measurement after tea, coffee, smoking

Simple line drawing of a person holding an object (no text or symbols)

Within 20 minutes after taking a bath

Cartoon illustration of a man in a suit talking on a phone, with no visible text or symbols

When talking or moving your fingers

Simple line drawing of a person holding an apple (no text or symbols)

In a very cold environment

Cartoon illustration of a person with thought bubble containing a male figure (no text or symbols)

When you want to discharge urine

Maintenance

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

Instructions Below.

Put in a dry place and avoid the sunshine

Simple line drawing of a square object with a smiling face and curved lines, partially submerged in water (no text or symbols)

Avoid touching water,

Avoid intense shaking and collisions

Simple line drawing of a square object with decorative swirls around it (no text or symbols)

Avoid dusty and unstable temperature environment

Using wet cloths to remove dirt

Do not attempt to clean the reusable cuff with water and never immerse the cuff in water.

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 blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:

Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Kindly note that only a physician could tell whether your blood pressure value has reached a dangerous point.

Systolic blood discharging artery press

Diastolic blood entering vein relax

Blood pressure (mm Hg) Level	Optimal Normal High-normal Mild Moderate Severe
SYS <120 120-129	130-139	140-159	160-179 ≥180
DIA <80 80-84	85-89	90-99	100-109 ≥110

Irregular Heartbeat Detector

An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure. During each measurement, the monitor records all the pulse intervals and calculate the average; 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 there are four or more pulse intervals, the difference between each interval and the average is more than the average value of ±15% , the irregular heartbeat symbol appears on the display when the measurement results have appeared.

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 everyday. 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.

Illustration of a person measuring blood pressure with a clock in the background (no text or symbols)

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.

Illustration of a person using a pressure monitor on a table (no text or symbols)

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 products is not operating as you think it should, check here before arranging for servicing.

PROBLEM SYMPTOM CHECK THIS REMEDY
No power	Display will not light up.	Batteries are exhausted. Replace with new batteries
		Batteries are inserted incorrectly. Insert the batteries correctly
Low batteries	Display is dim or show +Lo	Batteries are low. Replace with new batteries
Error message	E 01 shows The cuff is too tight or too loose.		Readjust the cuff, not too loose or too tight and then measure again.
	E 02 shows	The monitor detected motion, talking or the pluse is too poor while measuring.	Relax for a moment and then measure again.
	E 03 shows	The measurement process does not detect the pulse signal.	Loosen the clothing on the arm and then measure again
	E 04 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 message measure again. If the problem persists, contact your physician.

SPECIFICATIONS

Power supply 6VDC 4*AAA batteries
Display mode LCD V.A.60mm×40.5mm
Measurement mode Oscillographic testing mode
Measurement range	Rated cuff pressure:0mmHg~299mmHg (0kPa ~ 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±0.4kpa(3mmHg)pulse value:±5%
Normal working condition	A temperature range of :+5°C to +40°CA relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapour partial pressure greater than 50 hPaAn atmospheric pressure range of : 700 hPa to 1060 hPa
Storage & transportation condition	Temperature:-20°C to +60°CA relative humidity range of ≤ 93%, non-condensing, at a water vapour pressure up to 50hPa
Measurement perimeter of the upper arm About 22cm~42cm
Net Weight Approx.169g (Excluding the dry cells)
External dimensions Approx.110mm×110mm×41mm
Attachment 4×AAA batteries,user manual
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against ingress of water	IP21 It means the device could protected 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
Software version A01

WARNING: No modification of this equipment is allowed.

CONTACT INFORMATION

For more information about our products, please visit www.homedics.co.uk

Model: TMB-1491-S

Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd.

Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China

Authorized European Representative:

MDSS - Medical Device Safety Service GmbH

Schiffgraben 41,

30175 Hannover,

Germany

Imported into the UK by:

FKA Brands Ltd, Somerhill Business Park, Tonbridge, Kent, TN11 0GP

Imported into the EU by:

FKA Brands Ltd, 29 Earlsfort Terrace, Dublin 2, IE

Customer Support: [phone] [e-mail]

COMPLIED STANDARDS LIST

Risk management	EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk management to medical devices
Labeling	EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1 : General requirements
User manual EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices
General Requirements for Safety	EN 60601-1:2006+A1:2013+A12:2014/ IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceEN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Electromagnetic compatibility	EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Performance requirements	EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement typeIEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Clinical investigation	EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometersISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
Usability	EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: UsabilityIEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
Software life-cycle processes	EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software life-cycle processes
Bio-compatibility	ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management processISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

EMC GUIDANCE

1. This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
   2.* Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
2. Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!
   4.* Caution: This machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.

Table 1

Guidance and manufacturer's declaration – electromagnetic emission
Emission test Compliance
RF emissionsCISPR 11	Group 1
RF emissionCISPR 11	Class B
Harmonic emissionsIEC 61000-3-2	Class A
Voltage fluctuations/flicker emissionsIEC 61000-3-3	Complies

Table 2

Guidance and manufacturer's declaration - electromagnetic emission
Immunity test IEC 60601 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/burstIEC 61000-4-4	±2 kV for power supply lines±1 kV signal input/output100 kHz repetition frequency	±2 kV for power supply lines±1 kV signal input/output100 kHz repetition frequency
SurgeIEC 61000-4-5	±0.5 kV, ±1 kV differential mode±0.5 kV, ±1 kV,±2 kV common mode	±0.5 kV, ±1 kV differential mode±0.5 kV, ±1 kV,±2 kV common mode
Voltage dips, short interruptions and voltage variations on power supply input linesIEC 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; 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; 300 cycle
Power frequency magnetic fieldIEC 61000-4-8	30 A/m50Hz/60Hz	30 A/m50Hz/60Hz
Conducted RFIEC61000-4-6	3 V0,15 MHz – 80 MHz6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz80 % AM at 1 kHz	3 V0,15 MHz – 80 MHz6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz80 % AM at 1 kHz
Radiated RFIEC61000-4-3	10 V/m80 MHz – 2,7 GHz80 % AM at 1 kHz	10 V/m80 MHz – 2,7 GHz80 % AM at 1 kHz
NOTE UT is the a.c. mains voltage prior to application of the test level.

Table 3

Guidance and manufacturer's declaration - electromagnetic immunity
Radiated RF IEC61000-4-3 (Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment)	Test frequency (Mhz)	Band a) (MHz)	Service a) Modulation b) Modulation		b) (W)	Distance (m) IMMUNITY TEST LEVEL (V/m)
	385 380-390	TETRA 400 Pulse		modulation b) 18Hz	1.8 0.3 27
	450 430-470	GMRS 460,	FRS 460	FM c) ± 5kHz deviation 1kHz sine	2 0.3 28
	710 704-787	LTE Band 13,17	Pulse	modulation b) 217Hz	0.2 0.3 9
	745
	780
	810 800-960	GSM	800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5	Pulse modulation b) 18 Hz	2 0.3 28
	870
	930
	1720 1700-	1990	GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4,25; UMTS	Pulse modulation b) 217 Hz	2 0.3 28
	1845
	1970
	2450 2400-	2570	Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7	Pulse modulation 217 Hz	2 0.3 28
	5240 5100-	5800	WLAN 802.11 a/n	Pulse modulation 217 Hz	0.2 0.3 9
	5500
	5785

2 YEAR GUARANTEE

FKA Brands Ltd guarantees this product from defect in material and workmanship for a period of 2 years from the date of purchase, except as noted below. This FKA Brands Ltd product guarantee does not cover damage caused by misuse or abuse; accident; the attachment of any unauthorised accessory; alteration to the product; or any other conditions whatsoever that are beyond the control of FKA Brands Ltd. This guarantee is effective only if the product is purchased and operated in the UK / EU. A product that requires modification or adaptation to enable it to operate in any country other than the country for which it was designed, manufactured, approved and / or authorised, or repair of products damaged by these modifications is not covered under this guarantee. FKA Brands Ltd shall not be responsible for any type of incidental, consequential or special damages.

To obtain guarantee service on your product, return the product post-paid to your local service centre along with your dated sales receipt (as proof of purchase). Upon receipt, FKA Brands Ltd will repair or replace, as appropriate, your product and return it to you, post-paid. Guarantee is solely through Salter Service Centre. Service of this product by anyone other than the Salter Service Centre voids the guarantee.

This guarantee does not affect your statutory rights.

For your local Salter Service Centre, go to www.salterhousewares.co.uk/servicecentres

INTRODUCTION

HOMEDICS Hype. Sev. Mod. Mld High-norm. Norm. Opt. 88.0 88.0 88.0 88.0 188 MEMORY TIME/DATE SYS kPa mmHg DIA kPa mmHg Pulse/min M S START STOP

Line drawing of a medical pressure monitor with tubing (no text or symbols)

Line drawing of a car with a battery and paper roll, no text or symbols present

Blank white rectangle with a small black dot and two small symbols in the bottom right corner (no text or markings)

Blank white rectangle with a small cluster of small black dots in the bottom-left corner (no text or symbols)

Simple diagram with a central black arrow and four surrounding dots (no text or labels)

Simple diagram with a central black symbol and four surrounding dashed lines (no text or labels)

Simple diagram with a central 'A' and four surrounding dashed lines, no text or symbols present.

Simple line drawing of a person sitting at a desk, possibly working or performing a task (no text or symbols present)

Commencez la mesure

Sey. Mod. Mld High- norm. Norm. Opt. 8.0.0 8.0.0 8.0.0 18.0 88 88:88 SYS MPa mmHg DIA MPa mmHg Pulse

Réglez le zéro

Sov. Mod. Mid High- norm. Norm. Opt. 0 SYS ■ kPa ■ resHg DIA ■ kPa ■ resHg ● Polaris PN 10:08

Gonflez et mesurez

38 SYS ■ kPa ■ mmHg DIA ■ kPa ■ mmHg ♥ Polaris PM 10:08

1. Press the "MEM" or "SET" to get the record you want.

Ses Mod. Mild High- norm. Norm. Opt 108 68 66 SYS UP M DIA HPa HPb HPc Painin

Sex Mod. Mild High- norm. Norm. Opt 108 67 61 70 [2] 0 SYS kPa mmHg DIA DOWN kPa mmHg Painch

START STOP

Simple line drawing of a person eating with a bowl and spoon (no text or symbols)

Cartoon illustration of a person holding a steaming cup (no text or symbols)

Simple line drawing of a person holding an object (no text or symbols)

Cartoon illustration of a man in a suit holding a phone to his ear, with no visible text or symbols.

Simple line drawing of a person holding an object (no text or symbols)

Cartoon illustration of a person with thought bubble containing a male figure (no text or symbols)

Simple line drawing of a square-shaped object with a small screen and a sun icon above it (no text or symbols)

Simple line drawing of a smiling square object partially submerged in water, with no text or symbols present.

Illustration of a square container with decorative swirls around it (no text or symbols)

Illustration of a person using a blood pressure monitor at a desk with a clock in the background (no text or symbols)

Illustration of a person using a pressure monitor on a table (no text or symbols)

DÉPANNAGE

Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China

FKA Brands Ltd, Somerhill Business Park, Tonbridge, Kent, TN11 0GP

FKÅ Brands Ltd, 29 Earlsfort Terrace, Dublin 2, IE

Customer Support: [phone] [e-mail]

LISTE DES NORMES AUXQUELLES L'APPAREIL RÉPOND

HOMEDICS Hyp. Sv. Mod. Mld High- norm. Norm. Opt. 88.0 88.0 88.0 88.0 188 MEMORY TIME/DATE SYS kPa mmHg DIA kPa mmHg Pulse/min M S START STOP

Line drawing of a medical device with a coiled tube and attached tubing (no text or symbols)

Line drawing of a mechanical device with paper and rollers (no text or symbols)

Blank white rectangle with a small black symbol at the bottom left corner (no text or symbols inside)

20 18

2019

Blank white rectangle with a small cluster of small black dots in the bottom-left corner (no text or symbols)

24h

Simple diagram with a central black human figure and four surrounding dashed lines (no text or symbols)

Simple diagram with a central symbol and four surrounding dots (no text or labels)

Simple diagram with a central symbol and four radiating lines, no text or labels present.

Rev. Mod. Mid High- norm. Norm. Opt. 8.0.0 8.0.0 8.0.0 1.0.0 8.0.0 SYS kPa mmHg DIA kPa mmHg Fullok

START STOP

Simple line drawing of a person eating with a bowl and spoon (no text or symbols)

Cartoon illustration of a man holding a steaming cup and coffee cup (no text or symbols)

Cartoon illustration of a man in a suit holding a phone to his ear, with no visible text or symbols.

Simple line drawing of a person with thought bubble showing a person inside (no text or symbols)

Bei Harndrang

Pflege

Illustration of a person measuring blood pressure with a clock in the background (no text or symbols)

Illustration of a person using a pressure monitor on a table (no text or symbols)

PROBLEMLÖSUNG

Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China

FKA Brands Ltd, Somerhill Business Park, Tonbridge, Kent, TN11 0GP

FKA Brands Ltd, 29 Earlsfort Terrace, Dublin 2, IE

Customer Support: [phone] [e-mail]

LISTE DER ERFÜLLTEN STANDARDS

Line drawing of a medical or laboratory device with a coiled tube and attached rod (no text or symbols)

Line drawing of a car with a battery and paper inside, no text or symbols present

Blank white image with a faint, small mark at the bottom left corner (no text or symbols)

Blank white rectangle with a small cluster of small black dots in the bottom-left corner (no text or symbols)

Simple diagram with a central black arrow and four small dots, no text or symbols present

Simple diagram with a central black symbol and four surrounding dots (no text or labels)

Simple diagram with a central symbol and four radiating lines, no text or labels present.

Line drawing of a person seated at a desk, possibly drinking water or performing a medical procedure (no text or symbols present)

START STOP a

Cartoon drawing of a person eating with a bowl and spoon (no text or symbols)

Cartoon illustration of a man sitting at a table with a steaming cup and coffee cup (no text or symbols)

Cartoon illustration of a man in a suit holding a phone to his ear, with no visible text or symbols

Cartoon illustration of a person with thought bubble showing a person inside (no text or symbols)

Illustration of a person measuring blood pressure with a wall-mounted device and clock (no text or symbols)

Illustration of a person using a medical or health device on a desk (no text or symbols visible)

Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China

Representante europeo autorizado:

MDSS - Medical Device Safety Service GmbH

Schiffgraben 41,

30175 Hannover,

Germany

FKA Brands Ltd, Somerhill Business Park, Tonbridge, Kent, TN11 0GP

FKA Brands Ltd, 29 Earlsfort Terrace, Dublin 2, IE

Customer Support: [phone] [e-mail]

LISTA DE ESTÁNDARES QUE CUMPLE

HOMEDICS Hype. Sev. Mod. Mld High-norm. Norm. Opt. 88.0 88.0 88.0 88.0 188 MEMORY TIME/DATE SYS kPa mmHg DIA kPa mmHg Pulse/min M S START STOP

Line drawing of a medical or laboratory device with a coiled tube and attached rectangular box (no text or symbols)

Line drawing of a printer with paper and batteries, no text or symbols present

Installing and replacing the batteries

Blank white image with no visible content or text

Blank white image with a faint, small mark at the bottom left corner (no text or symbols)

Blank white image with a small black 'A' mark in the center (no text or symbols)

Simple diagram with a central 'A' and four surrounding dots (no text or labels)

Simple diagram with a central point labeled 'A' and four surrounding points (no text or symbols beyond the label)

Simple line drawing of a person sitting at a desk, no text or symbols present

Display LCD Sex. Mod. Mild High- norm. Norm. Opt. 8.0.0 8.0.0 8.0.0 1.88 88:88:88 SYS kPa morning DIA kPa morning ♥ Fdd/mn

Rev. Mod. Mid High- norm. Norm. Opt. SYS DIA kPa mmp Hg kPa mmp Hg PdA 10:08

Sex. Mod. Mild High- norm. Norm. Opt. 108.7 67.7 70 SYS kPa mmHg DIA kPa mmHg ♥ Painish DOWN S

START STOP

Cartoon drawing of a person eating with chopsticks and a plate of food (no text or symbols)

Cartoon drawing of a person holding a steaming cup (no text or symbols)

Cartoon illustration of a man in a suit holding a phone to his ear, with no visible text or symbols.

Cartoon illustration of a person with thought bubble containing a human figure (no text or symbols)

Illustration of a person using a blood pressure monitor at a desk with a wall clock (no text or symbols present)

Illustration of a person using a blood pressure monitor on a table (no text or symbols)

RICERCA E RISOLUZIONE DEI PROBLEMI

Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China

FKA Brands Ltd, Somerhill Business Park, Tonbridge, Kent, TN11 OGP

FKA Brands Ltd, 29 Earlsfort Terrace, Dublin 2, IE

Customer Support: [phone] [e-mail]

Line drawing of a medical pressure monitor with tubing (no text or symbols)

Line drawing of a mobile phone with batteries and a paper feed cover (no text or symbols)

Blank white rectangle with a small cluster of small black symbols at the bottom left corner (no text or labels)

Blank white rectangle with a small cluster of small black symbols at the bottom left corner (no text or labels)

1. Herhaal stap 2 en 3 om de tijdsindeling [12H] en [24H] te bevestigen.

12 h

24h

1. Herhaal stap 2 en 3 om [HOUR] en [MINUTE] in te stellen.

m: 6:00 S 6:00

1. Herhaal stap 2 en 3 om [UNIT] in te stellen.

0.0 0.0 M S

Simple diagram with a central symbol and four surrounding dots, no text or labels present.

Simple diagram with a central black symbol and four surrounding dots (no text or labels)

Simple diagram with a central symbol and four surrounding dashed lines, no text or labels present.

START STOP

Simple line drawing of a person eating with a bowl and spoon (no text or symbols)

Cartoon illustration of a man holding a steaming cup and making a peace sign (no text or symbols)

Simple line drawing of a person holding a circular object (no text or symbols)

Cartoon illustration of a man holding a phone to his ear, with no visible text or symbols

Simple line drawing of a person holding an apple (no text or symbols)

Cartoon illustration of a person with thought bubble containing a gender symbol (no text or labels)

Als u moet plassen

Onderhoud

Simple line drawing of a square object with a small screen and a sun icon above it (no text or symbols)

Simple line drawing of a smiling cube with curved lines and small dots, no text or symbols present.

Illustration of a square button with scroll arrows indicating rotation (no text or symbols)

The blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:

WAARSCHUWING

Illustration of a person measuring blood pressure with a clock in the background (no text or symbols)

Illustration of a person sitting at a desk with a medical device (no text or symbols visible)

PROBLEMEN EN OPLOSSINGEN

Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China

FKA Brands Ltd, Somerhill Business Park, Tonbridge, Kent, TN11 0GP

FKA Brands Ltd, 29 Earlsfort Terrace, Dublin 2, IE

Customer Support: [phone] [e-mail]

LIJST VAN NAGELEEFDE NORMEN

Zone A, No 105, Dongli Road, Torch Development District,

Zhongshan, 528437, Guangdong, China

MDSS - Medical Device Safety Service GmbH

Schiffgraben 41, 30175 Hannover, Germany

Imported into the UK by:

FKA Brands Ltd, Somerhill Business Park, Tonbridge, Kent, TN11 OGP

Imported into the EU by:

FKA Brands Ltd, 29 Earlsfort Terrace, Dublin 2, IE

Customer Support: [phone]

[e-mail]

C€0123

IB-BPA3020EU-1120-01

Version: 2.0