Active Control - Blood pressure monitor Geratherm - Free user manual and instructions

Product Type	Electronic Wrist Blood Pressure Monitor
Brand	Geratherm
Model	Active Control (GT-1215)
Measurement Method	Oscillometric
Measurement Range (Pressure)	0 to 299 mmHg
Measurement Range (Pulse)	40 to 199 beats/min
Blood Pressure Accuracy	± 3 mmHg
Heart Rate Accuracy	± 5%
Dimensions	84 mm x 70 mm x 40 mm
Weight (with cuff)	104 g
Power Supply	Built-in lithium-polymer battery 3.7 V 420 mAh
Charging	Via USB cable (power adapter 5 V = 1000 mA not included)
Battery Life	Approx. 15 days (3 measurements/day)
Memory	60 measurements with date and time
Special Functions	Arrhythmia detection, position control, WHO color classification, automatic shut-off, average of last 3 measurements
Wrist Circumference	13.5 to 21.5 cm
Maintenance	Clean with a soft, dry cloth. Do not use abrasive products. Do not wash the cuff in a machine.
Warranty	2 years (excluding battery and cuff)
Repairability	Do not repair yourself. Contact an authorized service center.
Standards	CE 0197, EN ISO 13485, EN 60601-1-2

Frequently Asked Questions - Active Control Geratherm

How to properly apply the cuff?

Place the cuff around the bare wrist, with the display facing the palm. The edge of the cuff should be about 1 cm from the palm. Make sure it is not too tight.

What to do if the screen displays "Lo"?

This indicates the battery is low. Recharge the device using the provided USB cable. You can finish the current measurement before disconnection.

How to set the date and time?

With the device off, press and hold the MEM button for 3 seconds. Use the START button to adjust the year, month, day, hour, and minutes. Confirm each step with MEM.

How many measurements can the device store?

The device can store up to 60 measurements with date and time. The most recent measurement is saved in position 1.

What does the arrhythmia symbol mean?

The arrhythmia symbol appears if the device detects an irregular heartbeat. Consult your doctor if this symbol appears frequently.

How to clear measurements stored in memory?

In memory mode, press and hold the MEM button for 3 seconds until "dEL ALL" appears. Press MEM again to confirm. The screen displays "dEL dOnE" once deletion is complete.

What is the accuracy of the device?

The accuracy is ± 3 mmHg for blood pressure and ± 5% for heart rate.

Can I use the device with a pacemaker?

The device is contraindicated for patients with electrical implants such as pacemakers. Consult your doctor before use.

How to charge the battery?

Use the provided USB cable and plug it into a power adapter (5 V = 1000 mA, not included) or a computer USB port. The screen shows the charge level.

What to do in case of error E1?

Error E1 means the cuff is not applied correctly or is over-inflated. Rest, reposition the cuff, and restart the measurement.

USER MANUAL Active Control Geratherm

88.0 mmHg AVG 88:88 ♥180 18/88 M 180

Diagram showing a digital pressure meter connected to a laptop via cable, with both devices labeled in English.

Simple line drawing of a person sitting on a bench inside a dashed border (no text or symbols)

Funktion

Geratherm Medical AG

Fahrenheitstraße 1

99331 Geratal

Deutschland

www.geratherm.com

CE0197

Digital wrist blood pressure monitor

Geratherm®

active control

1.4 mmHg AVG 6.9 M 7.1 SYS DIA THERM PULSE MEM START Gerathem®

INSTRUCTION FOR USE
GT-1215

CE 0197

Contents

Indications for use 37

Contraindications 37

Precautions 38

Cleaning 39

Maintenance and Disposal 39

Storage 40

Warranty 40

Information You Should Know Before Operating the Unit 40

Measurement Principle 43

About the Unit

Information about the Device 44

Explanation of Display 45

Preparation for Use

Power Supply and Charging Power 46

Activate your Blood Pressure Monitor 49

Setting Date and Time 49

Attaching the Cuff 51

Measuring Posture 51

How to Operate the Unit

Measuring Blood Pressure 52

Retrieving Readings 54

Deleting Readings 55

Care and Maintenance 56

Error Messages 58

Specifications 59

Quality Standard 60

Symbol Index 60

Information on electromagnetic compatibility (EMC) 61

Annex 62

Thank you for choosing the Geratherm® active control blood pressure monitor.

This unit uses an oscillometric measurement method in order to measure systolic and diastolic blood pressure, as well as the heart rate. The measurement is conducted on the wrist and all values appear on an LCD display screen.

Before using your device for the first time, please read this instruction manual carefully.

Indications for use

This device is intended for non-invasive measuring and monitoring of arterial blood pressure. This device should only be used by adults over 18 years of age with a wrist circumference between 13.5 and 21.5 cm.

This unit was developed for home use exclusively.

Contraindications

This device is not intended for infants, pregnant women, patients with implanted electronic devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral artery disease and patients who are undergoing intravascular therapy or who have an arteriovenous shunt, or persons who have had a mastectomy. A doctor must be consulted prior to using the device on any of the persons listed above, and the suitability of the measuring method must be assessed.

This device is not suitable for continuous monitoring during medical emergencies and surgery. This device cannot be used simultaneously with HR surgical devices. The device is not intended for the transportation of patients outside medical establishments.

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

Do not wrap the cuff around an arm in which an arteriovenous shunt has been implanted or to which other medical devices are attached, as this could lead to temporary functional failure of the medical devices being used.

If you are allergic to polyester, nylon or plastic, please do not use this device.

The manufacturer cannot be held liable for any damage caused by improper use or failure to comply with the safety instructions in the instruction manual.

Precautions

• The device is intended for private use only.
• These instructions and the device are no substitute for visiting your doctor. Neither the information contained here nor this device may be used to diagnose or treat health problems or to prescribe medicines. If you have a medical problem or suspect that you may have such a problem, please seek immediate advice from your doctor.
• Do not mistake self-monitoring for self-diagnosis. This device enables you to monitor your blood pressure. Do not undertake any therapeutic measures on the basis of measurements you have taken yourself.
• Before using the device, ensure that it functions safely and is in perfect condition. Check the device. Do not use the device if it is damaged in any way. Continuing to use a damaged device can lead to injuries, false readings and serious danger.
• Keep the unit out of the reach of toddlers, children and pets. The inhalation or swallowing of small parts is dangerous and could be fatal.
• Please use only accessories that have been approved by the manufacturer. Otherwise, damage may be caused to the unit, the user may suffer injury or inaccurate measurements may occur.
• Please operate the unit under the environmental conditions described in the instructions. Otherwise, the performance and service life the blood pressure monitor will be adversely affected.
• This blood pressure monitor is not an AP/APG device and is not suitable for use in the presence of inflammable anaesthetic gases with air containing oxygen or nitrous oxide.
• If the cuff pressure reaches 300 mmHg (40 kPa), the air in the cuff is automatically released. If the cuff does not empty when the pressure reaches 300 mmHg (40 kPa), remove the cuff from your wrist and press the „START“ button to stop the inflation process.
• Too frequent and successive measurements may lead to disturbances of the blood circulation and cause injury.
• If you experience any discomfort during measurement, such as pain in the arm or other complaints, press the 'START' button to deflate the cuff. Release the cuff and remove it from your arm.
• Please ensure that the operation of the device does not permanently impair the patient's blood flow.
• Do not use the cuff on damaged skin.
• The material of the cuff has been tested and meet the requirements for the biological evaluation of medical devices in accordance with the standards DIN EN ISO 10993-5 and DIN EN ISO 10993-10. The constituent materials do not have the potential to produce any irritation or allergic reactions.
• If you need to test the measuring accuracy of the Geratherm ^ active control, please contact the manufacturer or your retailer.

Cleaning

• Please use a soft cloth for cleaning and do not use any abrasive or volatile cleaning agents. Use a solvent-free cleaner.
• Do not wash the cuff in the washing machine or dishwasher!
• The service life of the cuff can vary according to the frequency of washing, the condition of the skin and the manner of storage. The typical service life is approximately 10.000 measurements.
• Do not clean the blood pressure monitor while it is charging. Before cleaning, always remove it from the charger first.

Maintenance and Disposal

• Warning: Do not carry out any maintenance or upkeep while the device is in operation.
• Dispose of the unit, accessories and components in accordance with local regulations.
• In the event of malfunction, do not attempt to repair the device yourself. Only permit repairs to be carried out by authorised technicians.
• Upon request, the manufacturer will provide circuit diagrams, parts lists, descriptions, calibration instructions, etc., to support service personnel in the repair of parts.
• The device does not need to be calibrated for two years after reliable maintenance.
• Do not dispose your blood pressure monitor in fire. The rechargeable battery can explode and lead to injury or death.
• Batteries (battery pack or inserted batteries) must not be exposed to excessive heat such as sunshine, fire or similar.

Storage

• When it is not in use, please store the blood pressure monitor in a dry room and protect it from extreme humidity, heat, fluff, dust and direct sunlight. Do not place any heavy objects on top of the storage bag.
• This device contains sensitive parts and must be handled with care. Pay attention to the storage and operating instructions.
• It takes at least 30 minutes for the device to warm up from the minimum storage temperature to be ready for its intended use. The device must be allowed to cool down from the maximum storage temperature for at least 30 minutes before it is ready to be used again.
• Store the blood pressure monitor in a cool, dry and well-ventilated place. Keep it away from fire and heat sources, otherwise the battery could explode!

Warranty

The warranty for this blood pressure monitor is valid for any error on the part of the manufacturer under normal use for 2 years from the date of purchase.

If your unit does not function properly due to defective parts or assembly, we will repair it free of charge. With the exception of the battery and cuff, all parts of the unit are subject to this warranty.

Damage caused by improper use or handling of this blood pressure monitor is not covered by the warranty.

Information You Should Know Before Operating the Unit

What is blood pressure?

A force is created by the heart as the ventricle forcibly ejects blood into the blood vessels and through the vascular system. Another force is created by the arteries as they resist the blood flow. Blood pressure is the result of these two forces.

What are systolic and diastolic blood pressures?

Systolic blood pressure is the highest pressure at the heart's maximum contraction. Diastolic blood pressure is the lowest pressure when the heart is resting.

Information You Should Know Before Operating the Unit

Is my blood pressure normal?

See the following blood pressure classification chart released by the WHO (World Health Organization) for evaluation of your blood pressure level.

Classification of blood pressure monitor Systolic mmHg	Diastolic mmHg	Colour indicator
Optimal < 120 < 80 green
Normal 120 - 129 80 - 84 green
High - Normal 130 - 139 85 - 89 green
Grade 1 Hypertension 140 - 159 90 - 99 yellow
Grade 2 Hypertension 160 - 179 100 - 109 orange
Grade 3 Hypertension ≥ 180 ≥ 110 red

Information You Should Know Before Operating the Unit

What does low blood pressure mean?

In general, a lower blood pressure reading is better unless it causes unpleasant symptoms such as fainting and/or lightheadedness.

Fluctuation and variation in blood pressure

The following chart shows possible blood pressure fluctuations during a 24-hour period.

The following factors will influence blood pressure measurement results and cause variations:

• Bathing • Conversation
• Drinking alcohol • Exercise
• Moving - Stress
• Meals • Temperature change
• Thoughts • Smoking etc.

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 cuff. As it does so, the unit detects pressure oscillations generated by the pulsation of the blood flow.

The device compares the longest and the shortest time intervals of detected pulse waves with the mean time interval and then calculates the standard deviation.

Along with the blood pressure reading, the device also shows a symbol (arrhythmia icon) if the heart beat is irregular.

About the Unit

Information about the Device

LCD Display WHO - grade Time "MEM" button MEM START Geratherm® 788 298 AVG 88:88 10888 SYS Systolic DIA PULSE USB power interface Systolic Diastolic Pulse rate "START" button Cuff

Content:

1. Blood pressure monitor wrist type (GT-1215)
2. User manual
3. USB cable
4. Storage bag

Cuff

The cuff is suitable for wrist circumferences between 13.5 and 21.5 cm.

Explanation of the Display

88.0 mmHg AVG 88:88 ♥ 188 18/88 M 190

Symbol	Description Explanation
SYS	Systolic blood pressure	High pressure result
DIA	Diastolic blood pressure	Low pressure result
PULSE	Pulse Pulse/Minute; Beats/ Minute
	Movement detector	Movement will lead to inaccurate readings
	Arrhythmia Irregular heartbeat Detection
	Position control	Taking up the correct position is necessary for obtaining accurate readings.
AVG	The average value	The average value of the latest 3 blood pressure measurement results
- Lo	Low battery	Battery is low and needs to be charged
	WHO Grade	Classification of the reading according to the WHO
88:8818/88	Current date and time	Month/day, hour/minute
	Memory	The displayed measurement values is from the memory.
	Heartbeat	Heartbeat detection during the measurement

Preparation for Use

Power Supply and Charge Power

1. The battery of the Geratherm ^® active control is a built-in lithium-polymer battery with an electrical charge of 420 mAh.
2. Please use a power adapter with a USB connection (not included) or another source of power with a USB connection and the enclosed USB cable for charging the rechargeable battery, as shown in the following illustrations:

Method 1

AC - adaptor

Method 2

Diagram showing a digital pressure monitor connected to a laptop via cable, with measurement labels and connection points.

Note: Optional Adapter

(Please use an authorised adapter)

Input: AC 100 - 240 V \~ 50/60 Hz 0.2 A Max

Output: 5 V 1000 mA

Power needs to be charged under the following circumstances:

-on the LCD display

Preparation for Use

If you switch on the blood pressure monitor and the LCD display flashes “☐”, this means that the battery charge is low. Please recharge it in good time. You can still carry out the measurement.

If the LCD displays “- Lo” means the battery is too low, the blood pressure monitor will turn off automatically, you must charge the power at once.

During the process of charging, the LCD display will display the blinking power level, just like the following pictures:

Preparation for Use

CAUTION:

• The battery of Geratherm ^® active control is a built-in rechargeable lithium-polymer battery, please do not attempt to disassemble the blood pressure monitor or force open the built-in battery by the unauthorized maintenance personnel.
• In normal use, the battery can be recharged about 300 times. If the battery fails to recharge or the unit cannot be used normally, please contact your dealer. If you measure your blood pressure three times a day, the unit can be used for up to 15 days without recharging.
• Do not attempt to replace the battery of your blood pressure monitor. The battery is built-in and is not replaceable
• Avoid recharging your blood pressure monitor in extremely high or low ambient temperatures.
• Do not clean the blood pressure monitor during recharging. Always remove the charging unit before cleaning.
• While it is charging, do not touch the charger connection and the patient simultaneously.

Preparation for Use

Activate your blood pressure monitor

Your blood pressure monitor is activated when the date and time are set.

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. (time format: 24 h)

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

2. Press "START" button to change the year. Each press will increase the numeral by one in a cycling manner.

3. When you get the right year, press "MEM" button to set down and turn to next step.

20 19 2020 2020 2020

Preparation for Use

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

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

2. Repeat steps 2 and 3 to switch position control on or off. After confirming this as described in step 3, all the settings will be successively shown on the display. Then the unit will turn off.

20:20 10:1 20:20, 10:20 0:00 13:40 = on = off

Preparation for Use

Attaching the cuff

1. Wrap the cuff around the bare wrist. The display should face the side of the palm of the hand.

2. Fasten the cuff. Make sure it is not too tight. The cuff's upper edge should be approximately 1 cm (0.39 inch) from the palm line.

1cm

Measuring posture

1. Rest for five minutes before measuring. Wait at least three minutes between measurements. This will enable your circulation to recover.

2. Sit upright and position your lower arm in such a way that the unit is at heart level. Relax and retain a natural posture during measurement.

Illustration of a person sitting at a desk with a heart symbol and a hand near the arm (no text or symbols present)

1. Measure and record blood pressure at the same time every day to establish your blood pressure pattern.

How to Operate the Unit

Measuring Blood Pressure

1. When the monitor is off, press the "START" button to turn on the monitor, and it will finish the whole measurement.

LCD display 0 - value is show

Value is shown 0.88 mmHg 3.88 AVG 0.88:00 ♥100 18/88 M 100

0 mmHg 14:09 10 13

Inflating and measuring

63 mmHg 14:09 10 13

Results are dis- played and stored in the memory

108 mmHg 69 14:09 85 10 13

1. As soon as the measurement is completed, the blood pressure and pulse readings appear on the display. Press the "START" button to switch off the unit. Otherwise, the unit will switch off automatically after one minute.

How to Operate the Unit

Note:

If you have turned on the Position Control function, once the measurement starts, the blood pressure monitor will detect the gesture first. The wrist must be between the angle of 30^ and 45^ . If the position is out of this angle, the measurement will not start and the display will show Symbol ERR until you have the correct position.

Err EN

Note:

If you have the correct position, the display will show 📄 for about 3 seconds, and then continue with the measurement.

Simple line drawing of a person sitting at a desk inside a dashed border (no text or symbols)

How to Operate the Unit

Retrieving Readings

1. When the monitor is off, please press "MEM" button to show the average value of the latest three records. (Note: If the records are less than 3 groups, the LCD will display the recent record instead.)

Note:

The device can record 60 measurements.

95 mmHg AVG 60 M 84 108 mmHg 69 01 10 13 M 85

1. By pressing again on the "MEM" button, all stored readings can be retrieved. The number of the stored reading is shown in the bottom left-hand corner. This appears alternately with the time when the reading was taken. The date is shown underneath.

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 is dropped from the list.

01 stored value No. 1 10 13 Month and day 0:38 Time 10 13 Month and day 108 mmHg 69 01 10 13③ M 85

How to Operate the Unit

Deleting Readings

1. Hold pressing "MEM" button for 3 seconds when the monitor is in memory mode, the display will show "dEL ALL" ("delete all").

2. Press "MEM" button to confirm deleting and the monitor will display "dEL dOnE" ("deletion done") and then turn off.

3. If there is no record press "MEM" button, the LCD will display "0".

dEL ALL dEL DONE 0 mmHg 0 0 EN

Note:

To exit out of delete mode without deleting any records, press "START" button before pressing "MEM" button to confirm any delete commands.

Care and Maintenance

Do not drop the unit.
Do not modify or disassemble the unit or the cuff.
Do not twist the cuff.
Use a cloth moistened with water or neutral detergent to clean the body of the unit and then wipe it dry.

Care and Maintenance

Avoid thinner, benzine, and other harsh cleaners.
Keep the unit in a suitable place.Avoid high temperature, direct sunlight, high moisture, and dust.
Do not press the “START” button until the cuff has been properly fastened on the wrist.

Error messages

Problem Display symbol Cause Solution
No power	Nothing appears on the display	Battery charge too low Charge battery
Low battery power	Lo Indicator	Battery charge low Charge battery
No power	Nothing appears on the display	Adapter / charging cable is not connected correctly	Check adapter and charging cable and plug in correctly
No display	No display when buttons pressed	Unit is not activated	Press and hold down „MEM“ button to activate the unit
Error messages	E 1	The cuff is not properly fastened or pressure in the cuff is too high	Rest for a short period of time, re-fasten the cuff and measure the blood pressure again
	E 2	The unit hast detected movement or pulse rate is too low	Movement can influence the measurement.Relax for a moment and then measure again
	E 3	No pulse signal is detected	Loosen clothing around the arm and measure again
	E 4	The measuring process was not successful	Rest for a short time and retake the measurement
	EExx	A calibration error has occurred	Repeat the measurement.If the problem persists, contact your dealer or our customer service department for further support
		Measured values are outside the measurement range	Relax for a moment. Re-fasten the cuff and measure again. If the problem re-occurs, consult your physician

Specifications

Model no. GT-1215
Power supply 3.7 V 420	mAh Built-in rechargeable lithium-polymer battery
Display mode Digital LCD Display V.A. 44.8 mm x 35.6 mm
Measurement mode Oscillographic testing mode
Measurement range	Rated cuff pressure: 0mm Hg ~ 299 mmHg (0 kPa ~ 40 kPa)Measurement pressure:SYS: 60 mmHg ~ 230 mmHg (8.0 kPa ~ 30.7 kPa)DIA: 40 mmHg ~ 130 mmHg (5.3 kPa ~ 17.3 kPa)Pulse value: (40 - 199) beat/minute
Accuracy	Pressure: ±3 mmHg (0.4 kPa)Pulse value: ±5 %
Operating condition	A temperature range between: +5 °C and +40 °CA relative air humidity range of: ≤85 % non-condensing but not requiring water vapour partial pressure of more than 50 hPaAn atmospheric pressure range of: 700 hPa to 1060 hPa
Storage & transportation condition	Temperature: -20 °C to 60 °CA relative air humidity range of ≤ 93 %, non-condensing, with water vapour pressure up to 50 hPa
Cuff size 13.5 cm ~ 21.5 cm
Weight 104 g (including the cuff)
External dimensions approx. 84 mm x 70 mm x 40 mm
Attachment USB cable, storage bag, user manual
Degree of protection	IP22, The device is protected against penetration by solid objects ≥ 12.5 mm in diameter and against the ingress of water in the form of vertically falling drops.
Device classification Battery mode: ME device with built-in lithium-polymer rechargeable battery
Software Version A01

Subject to changes in the interests of technical progress.

Quality Standard

Geratherm® is certified in accordance with Council Directive 93/42/EEC and EN ISO 13485 and is entitled to affix the CE-mark (Notified Body: TÜV Rheinland LGA Products GmbH).

Symbol Index

	Follow the instructions for use
	Keep dry Manufacturer
	Store at relative humidity levels ≤ 93 %
	Store between -20 °C and +60 °C
	The device must not be disposed of with household waste
	Direct current Reference number

	Type BF Equipment
	Batch code (YYMMXXX, Year/Month / Identification number)
	Caution! Read the instruction manual.
	Manufacturing date

Information on electromagnetic compatibility (EMC)

Electronic devices such as PCs and mobile phones can lead to medical devices in operation being exposed to electromagnetic interference from other devices. This can lead to malfunction of the medical device and create a potentially unsafe situation.

Medical devices should also not interfere with any other equipment.

The EN 60601-1-2 standard regulates the requirements for EMC (electromagnetic compatibility) and defines the levels of immunity to electromagnetic interference and the maximum electromagnetic emission levels for medical devices.

This blood pressure monitor, which is manufactured by Geratherm Medical AG, complies with the EN 60601-1-2 standard in relation to both immunity and emissions.

Nevertheless, special precautions should be observed:

Please only use the device indoors and not in the vicinity of mobile phones or microwave ovens. This device should not be used adjacent to or stacked with other devices; and if it has to be used adjacent to or stacked with other devices, it should be observed to verify normal operation in the configuration in which it is being used.

In the case of devices exceeding the maximum power of 2 W, the minimum distance from your blood pressure monitor should be 3.3 metres.

Warning:

The use of accessories, transducers and cables other than those specified or provided by the manufacturer of this device may result in increased electromagnetic emissions or reduced electromagnetic immunity of the device and may cause it to malfunction.

Annex

Guidance and manufacturer's declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environments listed below, and should only beused in such environments:
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1		RF energy is used only to maintain device's operation. Therefore, its RF emissions are so low that it's not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B		The device is suitable for use in all establishments, including domestic establishments, and those directly connected to the public low-voltage power supply net-workthat supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations / flicker emissions IEC 61000-3-3	complies

Guidance and manufacturer's declaration – electromagnetic emissions
The device or system is intended for use in the electromagnetic environments listed below. The customer and/or user of the device or system must ensure that it is used in an electromagnetic environment as described below:
Immunity test	IEC 60601 – test level	Compliance level	Electromagnetic environment - guidance
Electrostatic discharge (ESD) IEC 61000-4-2	± 6 kV contact ± 8 kV air	± 6 kV contact ± 8 kV air	Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8	3 A/m 3 A/m		Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Annex

Recommended separation distances between portable and mobile RF communication
The device is intended for use in an electromagnetic environment where radiated RF disturbances are under control.User can help prevent electromagnetic interference by keeping the device at a minimum distance from portable andmobile RF communications equipment (transmitters). Below table details the maximum output power of transmitter:
Rated maximum output powerof transmitters in Watt	Separation distance / m
	150 kHz to 80 MHzd = 1.2 √P	80 MHz to 800 MHzd = 1.2 √P	800 MHz to 2.5 GHzd = 2.3 √P
0.01	0.12	0.12	0.23
0.1	0.38	0.38	0.73
1	1.2	1.2	2.3
10	3.8	3.8	7.3
100	12	12	23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximumoutput power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorptionand reflection from structures, objects and people.

Annex

Guidance and manufacturer's declaration - electromagnetic immunity
The device or system is intended for use in the electromagnetic environments listed below. The customer and/or user of the device or system must ensure that it is used in an electromagnetic environment as described below:
Immunity test	IEC 60601 - test level	Compliance level	Electromagnetic environment - guidance
			Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
			Recommended separation distance:
Conducted RF IEC 61000-4-6	3 Vrms 150 kHz to 80 MHz	3 Vrms d= 1.2 √P
Radiated RF IEC 61000-4-3	3 V/m 80 MHz to 2.5 GHz	3 V/m	d = 1.2 √P80 MHz to 800 MHz
			d = 2.3 √P800 MHz to 2.5 GHz
			where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).Field strengths from fixed RF transmitters, as determined by an electro-magnetic site survey, ^a should be less than the compliance level in each frequency range. ^b Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorpti-on and reflection from structures, objects and people.

Annex

Guidance and manufacturer's declaration – electromagnetic immunity
a)	Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
1)	This equipment needs to be installed and put into service in accordance with the information provided in the user manual;
2)	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 = 3,3 m away from the equipment. (Note: As indicated in Table 6 of IEC 60601-1-2 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m)

The current version of the standards is valid.

Geratherm Medical AG

Fahrenheitstraße 1

99331 Geratal

Germany

www.geratherm.com

CE0197

88.0 mmHg AVG 88:88 ♥180 18/88 M 180

Diagram showing a digital thermometer connected to a laptop via cable, illustrating the connection or data flow between devices.

Illustration of a person interacting with a smartphone at a desk, with a heart symbol and dotted line indicating interaction (no text or symbols present)

Simple line drawing of a person sitting on a bench inside a dashed rectangular frame (no text or symbols)

Fonctions

Geratherm Medical AG

Fahrenheitstraße 1

99331 Geratal

Allemagne

www.geratherm.com

CE0197

88.0 mmHg AVG 88:88 ♥180 18/88 M 180

Diagram showing a digital pressure meter connected to a laptop via cable, with measurement labels and connection point.

≡ on ≡ off

Illustration of a person sitting at a desk with hands near a heart symbol (no text or symbols present)

Funzione

Simple line drawing of a person sitting on a bench inside a dashed border (no text or symbols)

Funzione

Geratherm Medical AG

Fahrenheitstraße 1

99331 Geratal

Germania

www.geratherm.com

CE0197

88.0 mmHg AVG 88:88 ♥180 18/88 M 180

Diagram showing a digital pressure meter connected to a laptop via cable, with both devices labeled in English.

Illustration of a person interacting with a wristwatch (no text or symbols present)

Simple line drawing of a person sitting on a bench inside a dashed border (no text or symbols)

Funcionamiento

Geratherm Medical AG

Fahrenheitstraße 1

99331 Geratal

Alemania

www.geratherm.com

CE0197

Simple line drawing of a rolled-up book or document (no text or symbols)

88.8 mmHg AVG 88:88 ♥180 18/88 M 180

Diagram showing a digital pressure meter connected to a laptop via cable, with both devices labeled in English.

Illustration of a person sitting at a desk with a heart symbol and a hand near the arm (no text or symbols present)

Função

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Função

Consulta dos valores memorizados

Geratherm Medical AG

1.4 mmHg AVG 6.9 M 7.1 MEM START Gerathem® SYS DIA THERM PULSE

GEBRUIKSAANWIJZING

GT-1215

CE 0197

Inhoud

88.8 mmHg AVG 88:88 ♥188 18/88 M 188

Diagram showing a digital pressure monitor connected to a laptop via cable, illustrating measurement or data transfer.

Illustration of a person sitting at a desk with a heart symbol and a hand near the arm (no text or symbols present)

Simple line drawing of a person sitting on a bench inside a dashed border (no text or symbols)

Functie

Geratherm Medical AG

Fahrenheitstraße 1

99331 Geratal

Duitsland

www.geratherm.com

C€0197

88.0 mmHg AVG 88:88 ♥100 18/88 M 100

Diagram showing a digital temperature meter connected to a laptop via cable, with measurement labels and connection arrows.

تنبيه: محول بديل

20:20 10 1 20:20, 10:20 0:00 13:40 = on = off

Illustration of a person sitting at a desk with a heart symbol above, no text or symbols present

Geratherm Medical AG

Fahrenheitstr. 1

Geratal 99331

Deutschland

ألمانيا autocادية

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Geratherm

Professional Diagnostic

GERMANY

Geratherm Medical AG

Fahrenheitstraße 1

D-99331 Geratal

Germany

Phone: [phone]

Fax: [phone]

www.geratherm.com

PUBDAC0003V05

2021-02