Philips DL8765-15 User Manual

DL8765

EN-UK

Specifications are subject to change without notice.

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1 - 2 cm

"- ¾"

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Philips Consumer Lifestyle BV Tussendiepen 4, 9206AD Drachten, Netherlands Fax +31 (0)512594316

4222.100.4515.4 (11/2016)

>75% recycled paper >75% papier recyclé

English

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Introduction

Congratulations on your purchase and welcome to Philips! To fully benefit from the support that Philips offers, register your product at www.philips.com/welcome.

General

The Philips wrist blood pressure monitor with Bluetooth® enables you to perform blood pressure measurements, heart rate (pulse) measurements, transmit data via Bluetooth® to your mobile device and display your personal measurement results in the Philips HealthSuite health app. The device can also be used as a standalone device. This user manual contains important safety information and provides step-by-step instructions for using the blood pressure monitor. Read this information carefully before you use the blood pressure monitor and save it for future reference. Features:

- 46.8mm×29.3mm display with white backlight

- Measure-during-inflation technology

- Supports 2 users

Intended use

The Philips wrist blood pressure monitor is a digital monitor intended for use in measuring blood pressure and heart rate in adult patient population, with wrist circumference ranging from 13.5 cm to

21.5 cm (about 5-8.5 inches). The device is intended to be used in a home environment.

Explanation of symbols

The warning signs and symbols are essential to ensure that you use this product safely and correctly and to protect you and others from injury. Below you find the meaning of the warning signs and symbols on the label and in the user manual.

Symbol for 'follow instructions for use'.

This symbol means that the part of the device that comes into physical contact with the user (also known as the applied part) is of type BF (Body Floating) according to IEC 60601-1. The applied part is the cuff.

Symbol for 'the device complies with European Medical Device Directive 93/42/EEC requirements'. 0344 refers to the notified body.

Symbol for WEEE, waste electrical and electronical equipment. Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice and see chapter 'Battery recycling'.

This symbol means that this product contains batteries which shall not be disposed of with normal household waste (2006/66/EC).

Indicates the manufacturer, as defined in EU Directives 93/42/EEC.

Indicates manufacturing date.

Symbol for 'direct current'.

Symbol for the 'Bluetooth Combination mark'. The device uses Bluetooth for communication.

Indicates the manufacturer's batch code.

Indicates the manufacturer's serial number so that a specific medical device can be identified.

Fuse T1A/250V Φ3.6*10CCC.

Symbol for 'Class II Equipment'. The adapter is double insulated (Class II) and complies with IEC 60601-1.

Symbol for indoor use only.

–20ºC

60ºC

Symbol for 'Including RF transmitter'. This means that this device emits non-ionizing radiation. All devices with RF transmitters or that use RF electromagnetic energy must have a label with this symbol.

Indicates caution.The user should consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

Symbol for micro-USB connector.

Symbol for USB connector.

This symbol on the device means: protected against access to hazardous parts with a finger and against vertically falling water drops when tilted up to 15 degrees.

Indicates the storage and transportation temperature limits to which the medical device can be safely exposed: -20°C to 60°C.

Symbol for the 2 year Philips guarantee.

The Green Dot ('Der Grüne Punkt' in German) is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods.

General description (Fig. 1)

1 Bluetooth® symbol 2 Battery symbol 3 Lock switch 4 Socket for micro USB plug 5 Blood pressure classification 6 Heart rate/irregular heart rate detector 7 Movement detector 8 User IDs 9 Cuff 10 On button 11 User ID button 12 Heart rate 13 Diastolic blood pressure 14 Inflation/deflation indicator 15 Systolic blood pressure 16 USB plug 17 Micro USB plug

Important safety information

Read this important information carefully before you use the device and save it for future reference.

Warning

- Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts can be dangerous or even fatal.

- The device is not suitable for measuring the blood pressure of children.

- The device is not suitable for persons who have electrical implants.

- Do not use this blood pressure monitor on any arm where intravascular access or therapy (such as an intravenous drip or a blood transfusion), or an arterio-venous shunt (A-V shunt) is present. The temporary interference to blood flow by the blood pressure measurement could result in injury.

- If you had a mastectomy (breast amputation) do not use this blood pressure monitor on the arm on the side of the mastectomy. The inflating cuff can lead to pain, trauma and further injury in the arm on the side of the mastectomy.

- Consult your doctor if your suffer from illnesses prior to using the device.

- No modifications of this equipment are allowed. This may result in increased emissions or decreased immunity of the device.

- Do not use the blood pressure monitor during charging as it can cause injury.

- Do not touch the output of the adapter as it can cause injury.

- Do not dispose of batteries in fire. Battery may explode or leak.

- If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the 'on' button to release the air immediately from the cuff. Loosen the cuff and remove it from your wrist.

- 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 >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) applied to the arm, may lead to bruises (ecchymosis).

- Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.

- Beware of strangulation particularly for children and infants due to cables.

- Do not connect the tube to other medical equipment, as this could lead to dangerous injuries.

- This device is not intended for patients outside a home environment.

- Never use any accessories or parts from other manufacturers or that Philips does not specifically recommend. Using such accessories or parts could cause a hazardous situation for the user or damage to the device.

- Only use the accessories and detachable parts authorized by the manufacturer. The use of unauthorized parts or accessories may cause damage to the device or injury to the user.

Caution

- Always check the device before you use it. Do not use the device if it is damaged, as this may cause injury.

- The effectiveness of this blood pressure monitor has not been established in pregnant (including pre-eclamptic) women.

- Common arrhythmias (such as atrial or ventricular premature beats or atrial fibrillation) and peripheral artery disease / arteriosclerosis can affect the performance (accuracy) of this blood pressure monitor. Please consult your doctor how to best use this blood pressure monitor if you suffer from any of these conditions.

- Only use this device for its intended purpose as described in this user manual.

- Do not confuse self-monitoring with selfdiagnosis. This device allows you to monitor your blood pressure. Do not begin or end medical treatment based on the measurement results. Always consult your doctor for treatment advice.

- Do not take any therapeutic measures on the basis of a self-measurement. Never change prescribed medication without consulting your doctor. Consult your doctor if you have any questions about your blood pressure.

- If you are taking medication, consult your physician to determine the most appropriate time to measure your blood pressure.

- This device is not intended for use on extremities other than the wrist or for functions other than obtaining a blood pressure measurement.

- If the cuff pressure exceeds 40kPa (300mmHg), the unit will deflate automatically. If the cuff does not deflate when pressures exceeds 40kPa (300mmHg), detach the cuff from the wrist and press the 'on' button to stop inflation.

- Do not attach the cuff on the same arm on which other monitoring medical electrical equipment is attached simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring medical electrical equipment.

- Never attach the cuff on injured skin, an injured arm or an arm under medical treatment as this can cause further injury.

- Do not use the device in case of existing polyester or nylon material allergies.

- This device is not washable. Never immerse the device in water and do not rinse it under the tap.

- This device is not suitable for continuous monitoring during medical emergencies or operations.

- This device cannot be used with HF (High Frequency) surgical equipment at the same time.

- Never use compressed air, scouring pads, abrasive cleaning agents or aggressive liquids such as petrol or acetone to clean the device.

- If the battery can no longer be recharged or when the device does not function properly anymore (see 'Specifications'), please contact the Philips Consumer Care center in your country.

- Keep the device away from fire and heat sources, as the battery can overheat, causing fire or bursting. The battery could explode, causing injury or death.

- After charging, remove the micro USB plug from the device and remove the USB plug from USB portal.

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

- To avoid measurement errors, do not use the device near strong electrical or magnetic fields, for example magnets, radio transmitters, microwave ovens.

- To avoid measurement errors, do not use the device near a strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.

- Use this device under the right environmental conditions as indicated in this user manual. If not, this could affect the performance, lifetime of the device and measurement results.

- Use a soft cloth to clean the whole unit. Do not use any abrasive or volatile cleaners.

- Only use the micro USB cable supplied to charge the device.

- The device does not need to be calibrated for two years of normal use. After two years the measurements may become less accurate.

- If you have any problems with this device, such as setting up, malfunction, maintaining or using, please contact Philips Consumer Care.

- Do not open, disassemble or repair the device yourself. Modification of the device voids your warranty.

- Report to Philips Consumer Care if any unexpected operation or events occur.

- Dispose of accessories, detachable parts, and the ME equipment according to the local guidelines.

- Do not attempt to replace your blood pressure monitors battery. It is built-in and not changeable.

- Avoid charging your blood pressure monitor in extremely high or low temperatures (see 'Specifications').

- Do not clean the blood pressure monitor when it is being charged. Always unplug the charger first before cleaning the blood pressure monitor.

Compliance with standards

- The device meets the relevant standards for this type of Class IIa electrical medical equipment for home use.

- This Philips device complies with all applicable standards and regulations regarding exposure to electromagnetic fields and complies with EN 60601-1-2.

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