SFT 53 - Thermometer SANITAS - Free user manual and instructions

USER MANUAL SFT 53 SANITAS

1. Signs and symbols

The following symbols appear in these instructions for use and on the device: WARNING Warning notice indicating a risk of injury or damage to health. IMPORTANT Safety note indicating possible damage to the unit/accessory. Note Note on important information Observe the instructions for use Application part, type BF Disposal in accordance with the Waste Electrical and Electronic Equipment EC Directive – WEEE The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical products. Storage/Transport Permissible storage and transport temperature and humidity Operating Permissible operating temperature and humidity Manufacturer IP 22 IP 22, protection against harmful ingress of water and dust

PAP Dispose of packaging in an environmentally friendly manner.

The ear thermometer is intended for measuring the body tem- perature in the ear. Do not use the ear thermometer for meas- urements in other parts of the body. You can also use the ear thermometer to measure room and object temperatures. The ear thermometer has been carefully developed for precise, safe and rapid temperature measurements in the ear. It is a non-invasive ear thermometer with an infra-red detector to de- termine the body temperature in the auditory canal of adults and children. Use the device for the intended purpose only and in the manner specified in these instructions for use. Any form of improper use can be dangerous. The manufacturer is not liable for damage resulting from improper or careless use.18 This device complies with the EU Directive 93/42/EEC con- cerning medical products, the Medizinproduktegesetz (Ger- man Medical Devices Act), the ASTM (American Society for Testing and Materials) E 1965 - 98 and the European Standard EN 12470-5: Clinical thermometers – Part 5: Requirements for infrared ear thermometers (with maximum device) and the Eu- ropean Standard EN60601-1-2 (in accordance with CISPR11, IEC61000-4-2, IEC61000-4-3, IEC61000-4-8), and is sub- ject to particular precautions with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this device.

Safety notes WARNING

To measure temperature, insert the sensor tip of the ear thermometer carefully into the ear.

Use of the ear thermometer on dierent persons can be inap- propriate in the event of certain acute infectious diseases be- cause of the possible spread of germs despite cleaning and disinfection. If you have any doubts, please consult your doctor.

The body temperature measured in the ear may dier from other measurements taken in the mouth, rectum or armpits. Any comparison of these values is therefore futile. Meas- ure temperature regularly to calculate the normal ear tem- perature and then use these measurements as a basis for comparison when taking measurements in the event of a suspected high temperature.

This ear thermometer is intended for measuring the temper- ature in the ear. Do not use this ear thermometer for meas- urements in other parts of the body.

Replace the protective cap after each use to ensure an accu- rate measurement and prevent cross-contamination.

The ear thermometer may only be used with protective caps from Sanitas; other protective caps may result in faulty measurements. If you have run out of protective caps, con- tact the manufacturer or retailer for replacements.

Consult a doctor if you believe your medical condition to be poor. Notes on handling batteries WARNING

If your skin or eyes come into contact with battery fluid, rinse the aected areas with water and seek medical assistance.

Choking hazard! Small children may swallow and choke on batteries. Store the batteries out of the reach of small children.

If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.

Protect batteries from excessive heat.

Risk of explosion! Never throw batteries into a fire.

Do not charge or short-circuit batteries.

If the device is not to be used for a relatively long period, take the batteries out of the battery compartment.19

Use identical or equivalent battery types only.

Always replace all batteries at the same time.

Do not use rechargeable batteries.

Do not disassemble, split or crush the batteries. Risks to the device IMPORTANT

Do not subject the device to mechanical impacts.

Do not expose the device to direct sunlight.

Do not expose the device to liquids. The device is not wa- terproof. Avoid all direct contact with water or other liquids.

Have the device repaired by authorised service centres only, otherwise its warranty is invalidated.

Portable and mobile HF communication systems may inter- fere with this device. More details can be requested from the stated Customer Services address or found at the end of the instructions for use. Notes on electromagnetic compatibility

The device is suitable for use in all environments listed in these instructions for use, including domestic environments.

The use of the device may be limited in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display/device.

Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation. If, however, it is necessary to use the device in the manner stated, this device as well as the other devic- es must be monitored to ensure they are working properly.

The use of accessories other than those specified or provid- ed by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease in the device’s electromagnetic immunity; this can result in faulty operation.

Failure to comply with the above can impair the performance of the device.

1 Protective cap 2 Measuring sensor 3 START button 4 ON/OFF button 5 Battery compartment

The batteries are already inserted in new de- vices. Before first use, remove the protrud- ing plastic insulating strip from the battery compartment. The ear thermometer will then switch on automatically.

6.1 Setting the time/date

Before beginning to take measurements, we recommend that you set the current time and date. This will allow you to organise the saved measurements more easily later.

1. Press and hold the ON/OFF but-

ton on the switched-o de- vice for three seconds. “24 H” appears on the display.

3. The hour setting appears on the

The minute setting appears on the display. Use the START but- ton to select the current minute and confirm using the ON/OFF button .

5. The year setting appears on the

The day flashes on the display. Use the START button to select the current day and confirm us

The device then switches itself o automatically. The date and time are now saved.

Press and hold the START but- ton on the switched-o device for three seconds. “°C” ap- pears on the display.

Note Check before each use that the lens is intact. If it is damaged, contact your retailer or the service address. Bear in mind that the ear thermometer needs to have been in the room in which the measurement is taken for at least 30 minutes before use.

7.1 Measuring body temperature

Some people produce dierent readings in their left and right ear. In order to record temperature changes, always measure a person's temperature in the same ear.

The ear thermometer may be used by children only under adult supervision. Measurement is usually possible over the age of 6 months. In infants under 6 months, the ear canal is still very narrow so the temperature of the eardrum often cannot be recorded and the result displayed is often too low.

The measurement must not be taken in an ear aected by inflammatory diseases (e.g. discharging pus or secretion), after possible ear injuries (e.g. eardrum damage) or in the22 healing period after operative procedures. In all of these cases, please consult your doctor.

Use of the ear thermometer on dierent persons can be in- appropriate in the event of certain acute infectious diseases because of the possible spread of germs despite cleaning and disinfection. If you have any doubts, please consult your doctor.

This ear thermometer may only be used with the protective cap in place.

The following circumstances may influence the temperature in the ear: if you have been lying on the ear for an extended period, the ears are covered, the ears are exposed to exces- sive heat/cold, or after swimming or bathing. In the event of one of these circumstances, wait 20 minutes before per- forming the measurement.

As ear wax can aect the measurement, you should clean the ear before measuring if necessary.

1. Place a clean protective cap on to the

sensor tip of the ear thermometer.

2. Press the ON/OFF button to switch

on the ear thermometer. Three acoustic signals sound and the display switch- es on.

3. As the ear canal is slightly curved, you

have to pull the ear slightly up and backwards before inserting the sensor tip. This is important so that the tip of the protective cap can be pointed di- rectly at the eardrum.

Insert the sensor tip with the protec- tive cap carefully into the ear canal and press the START button to begin the measurement.

After approx. one second, a long acoustic signal sounds and the meas- urement is shown in the display. Press the ON/OFF button to switch o the ear thermometer.23 Note If no button is pressed for one minute after the measurement, the ear thermometer automatically switches itself o again. Fever indicator If the measured temperature is < 38 °C (100.4 °F), a laughing smiley appears on the display and a short acoustic sig- nal sounds. If the measured temperature falls between 37.5 and 37.9 °C, two short acoustic signals will also sound (the indication for “raised temperature”). If the measured temperature is ≥ 38 °C (100.4 °F), a sad smiley appears on the display and a short, a long and three short acoustic signals sound one after the other.

Remove the protective cap from the sensor tip of the ear thermometer (if it is on).

2. Press the ON/OFF button

to switch on the ear thermometer. Three acoustic signals sound and the display switch- es on.

3. Ensure that you are in object tempera-

ture mode ( ). To switch between body temperature and object temperature mode, brief- ly press and hold the ON/OFF button and the START button at the same time.

Hold the sensor tip of the ear thermom- eter 1 to 2 cm from the desired measur- ing point and press the START button.

nal sounds and the measurement is shown in the display. Briefly press the ON/OFF button to switch o the ear thermometer.24

7.3 Displaying room temperature

When you switch on the ear thermometer, the room tempera- ture, the date and time appear alternately on the display every 3 seconds.

7.4 Displaying stored measurements

The ear thermometer automatically stores the last 10 temper- ature measurements of body and object temperature respec- tively (incl. date and time). To recall the stored measurements, proceed as follows:

Press the ON/OFF button to switch on the ear thermometer.

2. Press and hold the ON/OFF but-

ton for 3 seconds. An M and the last stored measurement ap- pear on the display.

3. To switch between the individu-

al stored measurements, press the ON/OFF button . With each subsequent pressing of the ON/OFF button , the memory space number is displayed first followed by the measurement.

If you would like to proceed with a measurement, press the START button. Press and hold the ON/OFF button for 3sec- onds to switch o the ear thermometer.25

8. Replacing the battery

Before replacing the battery, ensure that the device is switched

Replace the batteries as soon as the battery symbol ( ) appears on the display.

Slide open the battery compartment and remove the used batteries from the battery compartment.

Insert two new 1.5 V AAA batteries. Make sure that the batteries are in

serted the right way round. Close the battery compartment.

9. Cleaning and storage

Protective caps are only intended for single use. The sensor tip is the most sensitive part of the ear thermometer. Work carefully when cleaning the sensor tip to avoid causing any damage. Use a clean cloth or cotton bud that can be moistened with disinfectant, alcohol or warm water. To clean the entire device, use a soft cloth slightly moistened with a mild soapy solution. Do not use any harsh cleaning products. If prolonged storage is intended, you should remove the bat- teries. The device must not be stored or used at an excessively high or low temperature or humidity (see technical data), in sunlight, in association with an electrical current or in dusty locations. Otherwise inaccuracies can occur.

The empty, completely flat batteries should be disposed of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries. Note: The codes below are printed on batteries containing harmful substances: Pb = Battery contains lead, Cd = Battery contains cadmium, Hg = Battery contains mercury.26 For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the unit at a suitable local collection or recycling point. Dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities responsible for waste disposal.

11. What if there are error messages?

Error message Cause Solution ER1 The ear thermometer is not yet ready for measurement. Take measurements only once body ( ) or object temperature mode (

appears on the display. ER2 The measured ambi- ent temperature is not in the range from 10 °C – 40 °C (50 – 104 °F). Place the ear thermometer in a room with an ambient temperature between 10 °C and 40 °C (50 °F and 104 °F) for at least 30minutes. ER3 The ear thermometer is not placed in the ear correctly. Please observe the notes in the chapter “Measuring”. Perform the measurement again. ER4 The ear thermometer registered a large change in the ambient temperature. Place the ear thermometer in a room with an ambient temperature between 10 °C and 40 °C (50 °F and 104 °F) for at least 30minutes. Error message Cause Solution ER5 The ear thermom- eter is not working properly. Replace the batteries and try again. If the fault occurs again, contact Customer Services. ER6 You are in the “Measur- ing object temperature” mode and the protec

tive cap is still on. The protective cap must be removed to measure object temperatures. In-ear measurement: the measured tem

perature is over 43 °C (109.4 °F). Object measurement: the measured temper

ature is over 100 °C (212 °F). Ensure that the device and the protective cap are fully functioning. Perform the measurement again.

In-ear measurement: the measured temper

ature is below 34°C (93.2°F). Object measurement: the measured temperature is below -20 °C (-4 °F). Ensure that the device and the protective cap are fully functioning. Perform the measurement again. The batteries are empty. Remove the two empty batteries and insert two new 1.5 V AAA batteries in

to the ear thermometer.27 If you cannot find a solution to your problem here, contact our Customer Services.

In ear: 34.0 – 43.0 °C (93.2 – 109.4 °F)

Room temperature: 0 – 50 °C (32 – 122 °F) Laboratory measurement accuracy

In ear: ± 0 .2 °C (0.4 °F) in meas- urement range of 35.5 – 42.0 °C (95.9 – 107.6 °F); ± 0.3 °C (0.5 °F) in measurement range of ≤35.5 °C (95.5 °F) and ≥42.0 °C (107.6 °F)

Room temperature: ± 2 °C (± 4 °F) Clinical reproducibility 0.11 °C (0.2 °F) Duration of measurement Approx. one second Operating temperature range 10 – 40 °C (50 – 104 °F), humidity 15 – 85% (non-condensing) Storage temperature range -25 – 55 °C (-13 – 131 °F), humidity 15 – 95% (non-condensing) Memory 10 memory spaces Display resolution 0.1 °C or 0.1 °F Battery DC 3 V (2 x 1.5 V AAA batteries) Dimensions 155 x 38 x 47 mm Weight Approx. 63 g (without batteries) Protective caps 10 Automatic switch-o 60 seconds Battery operating life 3,000 measurements in succession or one year with one to two measurements per day, including standby mode. Safety classification Connected medical device of typeBF IP protection class IP 22, protection against harmful ingress of water and dust The serial number is located on the device or in the battery compartment.

13. Warranty / service

Hans Dinslage GmbH, Riedlinger Straße 28, 89524 Uttenweiler, Germany (hereinafter referred to as “HaDi”) provides a warranty for this product, subject to the requirements below and to the extent described as follows. The warranty conditions below shall not affect the sell- er’s statutory warranty obligations which ensue from the sales agreement with the buyer. The warranty shall apply without prejudice to any man- datory statutory provisions on liability. HaDi guarantees the perfect functionality and completeness of this product.28 The worldwide warranty period is 2 years, commencing from the purchase of the new, unused product from the seller. The warranty only applies to products purchased by the buyer as a consumer and used exclusively for personal purposes in the context of domestic use. German law shall apply. During the warranty period, should this product prove to be incomplete or defective in functionality in accordance with the following provisions, HaDi shall carry out a repair or a re- placement delivery free of charge, in accordance with these warranty conditions. If the buyer wishes to make a warranty claim, they should approach their local retailer in the first instance: see the attached “International Service” list of service addresses. The buyer will then receive further information about the pro- cessing of the warranty claim, e.g. where they can send the product and what documentation is required. A warranty claim shall only be considered if the buyer can pro- vide HaDi, or an authorised HaDi partner, with - a copy of the invoice/purchase receipt, and - the original product. The following are explicitly excluded from this warranty: - deterioration due to normal use or consumption of the prod- uct; - accessories supplied with this product which are worn out or used up through proper use (e.g. batteries, rechargeable batteries, cus, seals, electrodes, light sources, attachments and nebuliser accessories); - products that are used, cleaned, stored or maintained im- properly and/or contrary to the provisions of the instructions for use, as well as products that have been opened, repaired or modified by the buyer or by a service centre not authorised by HaDi; - damage that arises during transport between manufacturer and customer, or between service centre and customer; - products purchased as seconds or as used goods; - consequential damage arising from a fault in this product (however, in this case, claims may exist arising from product liability or other compulsory statutory liability provisions). Repairs or an exchange in full do not extend the warranty pe

9. Nettoyage/stockage

Вухе: 34,0–43,0°C (93,2–109,4°F)

Ucho: 28,0–43,0°C (82,4–109,4°F)