RICE LAKE H651-10 Class I MDR Baby Scale Instruction Manual

RICE LAKE H651-10 Class I MDR Baby Scale

Specifications:

• Product Name: Class I MDR Baby Scale Model 2 and 4
• Type: Baby Scale
• Class: Class I Medical Device Regulation (MDR)
• Model Options: Model 2 and Model 4

Product Usage Instructions

Setup:
Follow the steps below to set up your Baby Scale:

• Power Supply: Connect the power supply to the scale following the provided instructions.
• Scale Setup: Adjust the scale settings according to your preference using the controls on the device.

Operation:
To operate the Baby Scale:

1. Place the baby gently on the scale platform.
2. Ensure the baby is still and wait for the weight measurement to stabilize on the display.
3. Record the weight displayed for tracking purposes.

Maintenance:
To ensure proper functioning of the Baby Scale:

• Regularly clean the scale platform with a damp cloth and mild detergent.
• Avoid exposing the scale to extreme temperatures or moisture.

FAQ:

• Q: Where can I find warranty information for the Baby Scale?
  A: Warranty information can be found at www.ricelake.com/warranties.

• Q: How can I access manuals for the Baby Scale?
  A: Manuals are available from Rice Lake Weighing Systems at www.ricelake.com/manuals.

Healthweigh® H651-10

Class I MDR Baby Scale Model 2 and 4

Operation Manual

© Rice Lake Weighing Systems. All rights reserved.
Rice Lake Weighing Systems® is a registered trademark of Rice Lake Weighing Systems.
All other brand or product names within this publication are trademarks or registered trademarks of their respective companies.
All information contained within this publication is, to the best of our knowledge, complete and accurate at the time of publication. Rice Lake Weighing Systems reserves the right to make changes to the technology, features, specifications and design of the equipment without notice.
The most current version of this publication, software, firmware and all other product updates can be found on our website:
www.ricelake.com

Revision History

This section tracks and describes manual revisions for awareness of major updates.

Table i. Revision Letter History
Technical training seminars are available through Rice Lake Weighing Systems. Course descriptions and dates can be viewed at www.ricelake.com/training or obtained by calling 715-234-9171 and asking for the training department.

Introduction

The Healthweigh® Baby Scale is an electrically-powered device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes during critical care procedures. It typically consists of a weight tray, a flexure plate or bending beam, an electronic transducer and an analog or digital display. It may also include markings to measure infant length. The device is also known as a paediatric or baby scale.
The scale provides accurate, reliable and repeatable weighing information with special motion  sensing weighing technology, which compensates for involuntary movement caused by an active baby. The baby’s weight is displayed in kilograms/grams.

Manuals are available from Rice Lake Weighing Systems at www.ricelake.com/manuals Warranty information is available at www.ricelake.com/warranties

Safety Definitions:

DANGER: Indicates an imminently hazardous situation that, if not avoided, will result in death or serious injury. Includes hazards that are exposed when guards are removed.
WARNING: Indicates a potentially hazardous situation that, if not avoided, could result in serious injury or death. Includes hazards that are exposed when guards are removed.
CAUTION: Indicates a potentially hazardous situation that, if not avoided, could result in minor or moderate injury.
IMPORTANT: Indicates information about procedures that, if not observed, could result in damage to equipment or corruption to and loss of data.

General Safety

Do not operate or work on this equipment unless this manual has been read and all instructions are understood. Failure to follow the instructions or heed the warnings could result in injury or death. Contact any Rice Lake Weighing Systems dealer for replacement manuals.

WARNING: Failure to heed could result in serious injury or death.

• Do not use in the presence of flammable materials.
  Operating at other voltages and frequencies than specified could damage the equipment. Use only medical approved mains adapters compliant with EN60601-1 standard.

• Do not modify this equipment without authorization of the manufacturer.

• Do not put this equipment next to or stacked on top of other equipment. This may result in malfunction. If such placement is unavoidable, ensure equipment is monitored regularly for correct operation.

• Do not use accessories, transducers or cables other than those specified or provided by manufacturer. This could result in increased electromagnetic emissions or decreased electromagnetic immunity leading resulting in malfunction (see Section 6.0 on page 15).

• Portable RF communications accessories (including peripherals such as antenna cables and external antennas) should be used no closer than 30 mm to the equipment or cables specified by the manufacturer. This may result in equipment performance degradation (see Section 6.0 on page 15).

• Ensure the equipment is located in a shielded location. Failure to do so may result in performance degradation, interference with other equipment or interference with radio services.

• This equipment has been tested for radiated RF immunity at selected frequencies. Using this equipment near equipment emitting other frequencies could result in improper operation (see Section 6.0 on page 15).

CAUTION: To prevent injury, never leave the person being weighed unattended while on the scale.

• To prevent injury, do not transport the scale while a patient is on the scale.

• Make sure no load is on the scale before transporting the scale.

• Do not drop the scale or subject it to violent shocks.

• The scales are for determining weight of persons in rooms intended for carrying out medical care. The scales are NOT intended to diagnose, prevent and monitor diseases. The scales are equipped with  serial interface that can connect to the equipment compliant with EN60601-1 standard.
  IMPORTANT: For accurate weighing, the scale must be placed on a flat, stable surface.

• For accurate weighing, verify proper operation according to the procedure described in this manual before each use.

• If the “LO Bat” indicator activates, for accurate weighing, recharge the battery or connect the scale to an AC power source as soon as possible.

• To avoid cross-contamination, clean the scale plate after each weighing. Avoid direct skin contact during weighing. Materials in the products have been tested and approved for the safe use by operator and patient.

• All batteries included with Healthweigh products intended for sale in the EU market are classified as ‘Portable Batteries for General Use’ and comply with European Battery Regulation (EU) 2023/1542.

Disposal

Product Disposal

The product must be brought to appropriate separate waste collection centers at the end of its life cycle.
Proper separate collection to recycle the product helps prevent possible negative effects on the environment and to health, and promotes the recycling of the materials. Users who dispose of the product illegally shall face administrative sanctions as provided by law.

Battery Disposal
Dispose of batteries at appropriate waste collection centers at the end of their life cycle in accordance with local laws and regulations. Batteries and rechargeable batteries may contain harmful substances that should not be disposed of in household waste. Batteries may contain harmful substances including but not limited to: cadmium (Cd), lithium (Li), mercury (Hg) or lead (Pb). Users who dispose of batteries illegally shall face administrative sanctions as provided by law.
WARNING: Risk of fire and explosion. Do not burn, crush, disassemble or short- circuit lithium batteries.

Setup

The H651 scales been calibrated at the plant. The scale is shipped in two assembled pieces: the weighing tray and the base assembly. Remove each part from its packing and remove the packing material carefully to prevent scratching the unit’s parts.

1. Place the base assembly on a steady surface.
2. Remove the two transport protection units from each corner.
3. Attach weighing tray to the base assembly.

Power Supply

The scale built-in rechargeable batter; USB boost or on 240V/100V AC adapter. The scale will automatically switch to battery operation when an AC power source is absent or USB boost is absent. AC/DC adapter is used as a disconnection device from the mains.

CAUTION: Use only medically approved power sources compliant with EN60601-1 standard.

Scale Setup

Follow the procedure below to set up the scale device:

1. To operate using the AC adapter, insert the AC adapter cable into the back of the scale and the AC adapter plug into a power source.
2. Press the ON/OFF button to turn the scale on.
3. The display will show START and then 00.0.
4. When the self-test function is complete, the digital display should read 00.0 and the charge indicator should be illuminated on the back.
5.  Place a weight not exceeding 15 kg on the scale. The digital display should blink “ ” until the weight calculation is complete. Press the KG/LB button to select the weight mode, in either kilograms or pounds.
6. Press the REWEIGH button; the digital display should again show the weigh of the item on the scale.
7. Press the HOLD button; the HOLD flag will appear on the display scales.
8.  Remove the weight from the scale. The digital display should continue to show the weight of the item that was on the scale.
9. Press the HOLD button, the HOLD indicator will disappear and the digital display should return to zero.
10.  Disconnect the scale from the AC power source. The scale should automatically switch over to the battery power and if a rechargeable battery is in use, the charge indicator should turn off.

NOTE : If the set up procedure failed, refer to teh TROUBLESHOOTING section for instructions. If the problem is not resolved, refer to qualified service personnel.
The Rechargeable batteries automatically go into recharge mode when the AC adaptor connected to the power source When the cable is inserted into the power source the LED lights up red. When the battery is completely recharged, the LED changes from red to green. After the procedure, if you are using a rechargeabel battery, connect the scale to an AC power source for at least eight hours to recharge the battery.

Operation

Keypad

A long key press activates the print function.

| Hold/Release| Long press keeps the most current weight value shown on the display along with the HOLD indicator. Pressing on this key while HOLD indicator is on will release the weight and turn off the HOLD indicator. This key is not active on BMI mode.
| Tare| For weight under the limit, will enter manual tare. If above the limit will enter tare function.

NET and GROSS indicators are on according to the tare operation. The maximum tare value is 4.000 kg/9.000 lb.

| Zero| Zeroes the weight on the scale if the scale is stable. This function will work only if the actual weight is up to 2% of the Max Weight.
| Clear|
KG/LB| Toggles between pounds and kilograms (providing it is enabled on configuration mode).
__| Enter| Accepts the value of the parameter last entered and moves to the next stage.

A long press during scales start-up process will enter id display (pre- parameter mode).

Table 3-1. Keypad Functions

Preset Tare

1. When the weight is below the limit, press the TARE key.
2. The default tare value is displayed while the zero is flashing
3. UP/DOWN key used to adjust the value.
4. Press enter to start the tare function. NET annunciator turned on instead of the GROSS annunciator.

Toggle Tare

1. When the wieght is above the limit, press the TARE key.
2. The tare activated with the value that displayed at the time of the tare activation.
3. NET annunciator turned on instead of the GROSS annunciator.

In both cases, to exit the Tare function, press TARE key.

Display

Battery Indicator

Table 3-2. Battery Status Indicators

• If external power supply is connected the battery flag is turned off.
• When on battery, the backlight power is reduced to 60 percent.

NOTE: A Philips head screwdriver is required for battery removal.
IMPORTANT : Dispose of batteries at appropriate waste collection centers at the end of their life cycle in accordance with local laws and regulations. Batteries and rechargeable batteries may contain harmful substances that should not be disposed of in household waste. Batteries may contain harmful substances including but not limited to: cadmium (Cd), lithium (Li), mercury (Hg) or lead (Pb). Users who dispose of batteries illegally shall face administrative sanctions as provided by law.

Weighing

1. Press the ON/OFF button to turn the scale on.
2. Wait until 00.0 appears on the digital display.
3. Place a pad/paper towel on the weighing tray. Make sure that the edges of the pad are on the tray and are not touching the surface on which the scale positioned.
4. Press the ZERO button to cancel the weight of a pad or other accessory that is on the weighing tray.
5. Place the infant on the scale. The display will blink ===== until the weight of the infant is determined.
6. Press the REWEIGH button; the digital display should again show the weight of the item on the scale.
7. Press the HOLD button; the HOLD flag will appear on the display scale.
8. Remove the infant from the scale. The digital display should continue to read the infant’s weight until HOLD button pressed again.

WARNING : Three beeps sound upon weighing. Make sure the HOLD button is released if no beeps were sounded.
NOTE: IF the scale has not been used for two minutes, it switches off in order to save battery life and power. To restart the scale, press the ON/OFF button.

Communication

For connecting the scales with the computer, please refer to Rice Lake Weighing Systems’ technical support or distributor.

Maintenance

This section provides instructions for maintenance, cleaning, troubleshooting and operator replaceable parts for the Healthweigh® Baby Scale Model H650/H651. Maintenance operations other than those described in this section should be performed by qualified service personnel.

IMPORTANT : Before first use and after periods of non-use, check the scale and batteries for proper operation and function.

• If the scale does not operate correctly, refer to qualified service personnel.
• Check overall appearance of the scale for damage, wear and tear.
• Check the batteries for damage, wear and tear. Do not use if damaged.
• Inspect AC adapter for cord cracking or fraying or for broken or bent prongs.
• For models with dry batteries, before period of non-use remove the batteries.

WARNING : Maintenance operations not mentioned in this section, should be perform by qualified service personnel.

Cleaning

Proper care and cleaning is essential to ensure a long life of accurate and effective operation.

WARNING : Disconnect the scale from the AC power source before cleaning.
CAUTION: Do not immerse the scale into cleaning or other liquid solution. Do not use Isopropyl Alcohol or other solutions to clean the display surface.
Clean all external surfaces with a clean damp cloth or tissue. To clean the tray:

1. Remove the tray|
2. Wash with mild solution of soap and water.
3. Make sure the tray is dry before replacing it on the scale.

Replacing Batteries

Use the following instructions to replace batteries:

1. Turn off the scale.
2. Turn over the scale
3. Using a cross-head screw  driver remove the battery cover, keep the screw for reassembly.
4. Replace the batteries with a new set of 6 AA 1.5V batteries.
5. Close the battery cover using the same screws.
6. Turn over the scale and replace the scale.

IMPORTANT: Dispose of batteries at appropriate waste collection centers at the end of their life cycle in accordance with local laws and regulations. Batteries and rechargeable batteries may contain harmful substances that should not be disposed of in household waste. Batteries may contain harmful substances including but not limited to: cadmium (Cd), lithium (Li), mercury (Hg) or lead (Pb). Users who dispose of batteries illegally shall face administrative sanctions as provided by law.

WARNING: Before you replace the batteries, disconnect the scale from the AC power source.
Replacing the rechargeable battery should be performed by qualified service personnel, refer to Service Manual AB0031 chapter 3 – repair procedures 1.
Model H650 has primary Lithium batteries – in case of batteries leakage – disconnect power supply and call Service.
Inappropriate Batteries placement – will cause to damage to batteries and might ignite the batteries.

Calibration Procedure

Calibration to be performed by authorized personnel only

IMPORTANT : Scales with OIML Class III compliance have a seal to prevent any unauthorized person from performing calibration.

Troubleshooting

Refer to the following instructions to check and correct any failures before contacting service personnel.

Table 4-1. Troubleshooting Checklist

scale to power source
Replace batteries
Faulty electrical outlet| Use a different outlet
Bad power supply| Replace adapter
Questionable weight/ Scale does not zero| External object interfering with the scale| Check and remove all interference from the scale
Weighing tray is not placed properly| Place the tray in its proper place
Display did not show 0.0 kg before weighing| Remove patient, zero the scale and begin weighing process again
Scale not placed on a stable surface| Place the scale on a stable surface and begin weighing process again
Scale is out of calibration| Check weigh with known weight value
The display shows STOP| Load on the scale exceeds the capacity| Remove the excess weight and use the scale according to its limits
the display shows __| Load is in under-load condition| Make sure the weighing tray is placed on the base
The display shows LO Bat| Rechargeable battery is low| Recharge the battery according to  instructions

Table 4-2. Error List

board – Call technician

 Specifications

H651-10 Capacity and Graduation

• Max 20 kg, Min 0.1 kg, Graduation (“e”) 0.005 kg

Power Requirements

• Adapter 240V/10, 50/60Hz-9 VDC, 500 mA
• Use only medically approved mains adapters compliant with EN60601-1 standards.

Environmental

• Operating Temperatures: 0°C to 40°C / 0°F to 104°F
• Storage Temperatures: 0°C to 50°C / 32°F to 122°F
• Humidity: 85% Use in atmospheric pressure

Product Dimensions

• Length: 61 cm
• Height: 16 cm
• Width: 45 cm
• Weight: 9.2 kg

WARNING: In order to comply with EN60601-1, use UL/CE approved AC/DC adapter UE15WPC-1201255PA.

• The scale is not intended for use in the presence of flammable mixtures.
• In order to comply with EN60601-1 use rechargeable battery supplied by Rice Lake Weighing Systems.
• In order to comply with EN60601-1 USB Power supply will be from a medical grade approved source only. Client will take full responsibility upon use of USB power connection.

Appendix

Guidance and Manufacture’s Declaration – Electromagnetic Immunity

The medical scale is suitable for use in the specified electromagnetic environment and it has meets the following immunity test levels. Higher immunity levels may cause the medical scale’s essential performance lost or degraded.

Phenomenon| Basic EMC Standard or Test Method| Home healthcare facility environment
---|---|---
Electrostatic discharge| IEC 61000-4-2:2008| +/- 8 kV contact

+/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV air

Radiated RF EM fields| IEC 61000-4-3:2006+A1+A2| 10 V/m

80MHz-2.7GHz

80%AM at 1kHz

Proximity fields from RF wireless communications equipment| IEC 61000-4-3:2006+A1+A2| See the RF wireless communication equipment table in “Recommended minimum separation distances”.
Rated power frequency magnetic fields| IEC 61000-4-8:2009| 30A/m; 50 Hz or 60Hz
Electric fast transients bursts| IEC 61000-4-4:2012| Input a.c. power PORT, Input d.c. power PORT, ±2kV, 100kHz repetition frequency PATIENT coupling PORT, Signal input/output parts PORT: ± 1 kV, 100 kHz repetition fre- quency
Surges| IEC 61000-4-5:2014| Input a.c. power PORT, Input d.c. power PORT, Line to line: ±0.5kV, ±1kV

Line to earth: ±0.5kV, ±1kV, ±2kV

Signal input/output parts PORT?

±2kV

Conducted disturbances| IEC 61000-4-6:2013| Input a.c. power PORT, Input d.c. power PORT,
induced by RF fields| | PATIENT coupling PORT, Signal input/output parts
| | PORT
| | 3 V in 0.15 MHz – 80 MHz
| | 6 V in ISM and/or amateur radio bands between 0.15 MHz and 80 MHz
| | 80 % AM at 1kHz
Voltage dips| IEC 61000-4-11:2004| 0% U T: 0.5 cycle

at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0% U T: 1 cycle and 70% U T: 25/30 cycles sine phase at 0°

Voltage interruptions| IEC 61000-4-11:2004| 0% U T: 250/300 cycle
Proximity magnetic fields| IEC 61000-4-39:2017| No.
immunity test| | Test frequency
| | Modulation
| | Immunity test level (A/m)
| | 30 kHz
| | CW
| |  8
| | 134.2 kHz
| | Pulse modulation, 2.1 kHz
| | 65
| | 13.56 MHz
| | Pulse modulation, 50 kHz
| | 7.5
U T: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz

Guidance and Manufacture’s Declaration – Electromagnetic Emissions
The medical scale is suitable for use in the specified electromagnetic environment and it has meets the following standard’s emission requirements.

Phenomenon| Profession Healthcare Facility Environment| Home Healthcare Environment
---|---|---
Conducted and radiated RF emissions| CISPR 11, Group 1, Class B| CISPR 11, Group 1, Class B
Harmonic distortion| IEC 61000-3-2:2005+A1+A2, Class A| IEC 61000-3-2:2005+A1+A2, Class A
Voltage fluctuations and flicker| IEC 61000-3-3:2013| IEC 61000-3-3:2013

Recommended Minimum Separation Distances

Nowadays, many RF wireless equipments have being used in various healthcare locations where medical equipment and/or systems are used. When they are used in close proximity to medical equipment and/or systems, the medical equipment and/or systems’ basic safety and essential performance may be affected. This medical scale has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1-2:2014. The customer and/or user should help keep a minimum distance between RF wireless communications equipment and this medical scale as recommended below.

Test Frequency (MHz)| Band (MHz)|

Service

|

Modulation

| Maximum Power (W)| Distance (m)| Immunity Test Level (V/m)
---|---|---|---|---|---|---
385| 380-390| TETRA 400| Pulse modulation 18Hz| 1.8| 0.3| 27
450| 430-470| GMRS 460

FRS 460

| FM

± 5 kHz deviation 1 kHz sine

| 2| 0.3| 28
710| 704-787| LTE Band 13, 17| Pulse modulation 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 18Hz| 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 217Hz| 2| 0.3| 28
1845
1970
2450| 2400-2570| Bluetooth, WLAN,

802.11 b/g/n, RFID 2450, LTE Band 7

| Pulse modulation 217Hz| 2| 0.3| 28
5240| 5100-5800| WLAN 802.11

a/n

| Pulse modulation 217Hz| 0.2| 0.3| 9
5500
5785

Visit our website www.RiceLake.com

© Rice Lake Weighing Systems Content subject to change without notice.

• 230 W. Coleman St.
• Rice Lake, WI 54868
• USA USA: 800-472-6703
• International: +1-715-234-9171

www.ricelake.com

References

• Rice Lake Weighing Systems
• Videos and Webinars | Rice Lake Weighing Systems
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