Credo CPRBAND User manual

CPRBAND
Model:CREDO‐CB

User Manual

2
Index
Overview -------------------------------------------------------- 3
Summation ----------------------------------------------------- 4
Important Information ----------------------------------------- 6
Warnings and Cautions ---------------------------------------- 7
Items Included -------------------------------------------------- 8
CPR BAND (Model: CREDO-CB) ------------------------------- 9
Appearance ------------------------------------------------------------ 9
Operation -------------------------------------------------------------- 10
Battery Charging ------------------------------------------------------- 11
Battery Indicator ------------------------------------------------------- 12
Wearing CPR BAND (Model: CREDO-CB) ----------------------------- 13
Preparation for use ---------------------------------------------------- 14
CPR Mode -------------------------------------------------------------- 15
Healthcare in CPR BAND (Model: CREDO-CB) ----------------------- 19
Application ----------------------------------------------------- 20
Install and Using ------------------------------------------------------- 20
Device Connection ----------------------------------------------------- 21
Setting ------------------------------------------------------------------ 22
Real Time CPR --------------------------------------------------------- 23
CPR Report ------------------------------------------------------------- 24
Healthcare -------------------------------------------------------------- 27
Cyber security requirement -------------------------------------------- 28
Maintenance ---------------------------------------------------- 29
Troubleshooting tips / service life ------------------------------------ 29
Storage after use ------------------------------------------------------ 30
Storage when not in use ---------------------------------------------- 32
Specifications --------------------------------------------------- 33
Frequently used function -------------------------------------- 35
Essential Performance (EP) ------------------------------------- 36
Symbol Glossary ------------------------------------------------ 37
Regulatory Information ---------------------------------------- 39
Additional Information ----------------------------------------- 43

3
Overview
- Manufacturer: CREDO
- Place of manufacture:
#302, 86, Baeul-ro, Wonju-si, Gangwon-do, Republic of Korea
- EC Representative: KTR Europe GmbH
- Address: Mergenthalerallee 77, Eschborn, Hessen, 65760, Germany
- Product name: Cardiopulmonary Resuscitation Assistance Product
- Device Classification
CE: Class Ⅰ (Rule 13)
FDA: Class II (Product code: LIX)
- FCC ID: 2ANY8-CREDO-CB
- Model name: CREDO-CB
- The term of warranty: A separate mark
- Manufacturing number: A separate mark
- Date of manufacture: A separate mark
- User Manual Date of Issue: 2019-01-01
- Intended use: The CPR BAND (Model: CREDO-CB) is used as a guide in
administering cardiopulmonary resuscitation (CPR) to a suspected SCA victim at
least 8 years old.
This product is 'Medical device'.
User Manual CREDO-MAN-001-CB(rev.0)

4
Summation
The CPR BAND (Model: CREDO-CB) is a small, lightweight device that uses
rechargeable batteries and is worn on the wrist. This device is designed for
first aid personnel trained in CPR and use of the CPR BAND (Model:
CREDO-CB).
The CPR BAND (Model: CREDO-CB) provides real-time information about
chest compression according to the latest CPR guideline when CPR is
performed on patient who is estimated a sudden cardiac arrest (SCA). This
device displays CPR feedback indicator for the chest compression depth. It
guides chest compression rhythm through sound and indicates the total
chest compression time and number of chest compression.
The CPR BAND (Model: CREDO-CB) is a device that provides Bluetooth
function. It can transmit CPR record and confirm information on the smart
device. In the smart device that provides the wireless communication
function by receiving information provided by the CPR BAND (Model:
CREDO-CB), it can display the pressure axis angle, pressure axis average
value, compression depth average value, compression rhythm average
value, and chest compression graph which are not displayed on the CPR
BAND (Model: CREDO-CB).
The device provides other functions on the user's wrist while waiting
without CPR. The time, step count, movement distance and calorie
consumption function are displayed.

5
Summation
Operating Principle
The CPR BAND (Model: CREDO-CB) measures the chest compression depth
during CPR via the built-in accelerometer and displays it on the LED. The
measured data is temporarily stored in the CPR BAND (Model: CREDO-CB)
and transmitted to the application via the Bluetooth interface. In the
application, detailed data information such as compression depth,
compression rhythm, and compression axis angle can be checked.

6
Important Information
Read this User Manual and become familiar with the operation of the
product prior to use. Use the product only as described in this User
Manual.
Warnings and Cautions
'Warning' states a condition, hazard, or unsafe behavior that can result
in serious injury or death.
'Caution' states a condition, hazard, or unsafe behavior that can result
in minor personal injury.
Notes
A note states important information about the product or its
operation.
Warning
Do not use device for SCA patients under the age of 8 years.
Note
CPR cannot assure survival, no matter how well it is performed. In
some patients, the underlying problem causing the cardiac arrest is
not survivable despite any available care.

7
Warnings and Cautions
Warnings
- Do not use the device in conjunction with any mechanical or automated
compression device.
- When using this device, make sure that there are no objects between the
performer's palm and the patient's chest.
- Do not delay CPR. If there are any problems using the device, continue CPR
without it.
- If the device appears to be damaged e.g. develops cracks or sharp edges,
do not use.
- No modification of device is allowed.
- Do not modify device without authorization of the manufacturer.
- If device is modified, appropriate inspection and testing must be conducted
to ensure continued safe use of the device.
Cautions
- If difficulty is encountered in entering CPR mode, do not delay initiation of
CPR.
- The band is made of natural latex, but if you are sensitive to latex, it may
cause an allergic reaction.
- The '!' status indicates a technical error. If this occurs, stop using the CPR
BAND (Model: CREDO-CB) and continue CPR. Contact CREDO technical
support after the event.
- The module is small and can be swallowed by children or pets. It should be
kept out of the reach of children or pets.
Contact a local CREDO representative for further assistance, or visit
www.credo-ltd.com for more information and Frequently Asked Questions
(FAQ).

8
Items Included
Charge Cable may differ in appearance and may be changed.
Contact www.credo-ltd.com for more information including
latest product downloads, spare parts and accessories.

9
CPR BAND (Model: CREDO-CB)
Appearance
1 Combining Part: Combined with the '8' part of the band
2 OLED: Displays information such as time, battery amount, CPR count,
CPR time, and healthcare function
3 Buzzer: Compression rhythm guide at CPR
4 LED: Compression depth feedback at CPR
5 Button: Change mode such as Power On, CPR Mode entry
6 Charging Port: Connect the cable to the battery when charging
7 Band Head: Connected to '11' to wear on user's wrist
8 Band Clip: combined with the '1' part of the module. press this part
when separating it.
9 Band Body: Combined with the bottom of the module
10
Band Body Rubber: Combined with the '6' charging port of the
module. When combining modules and bands, these parts must be
joined first.
11 Band Tail: Connected to '7' to wear on user's wrist

10
CPR BAND (Model: CREDO-CB)
Operation
Power on Press the button briefly to turn on the power
Sleep mode If you do not press the button for 4 seconds, it
becomes sleep mode.
Additional
function
If you press the button briefly, additional functions
including healthcare mode will be sequentially
indicated.
CPR mode
Press button for 3 seconds to start CPR mode. CPR
BAND (Model: CREDO-CB) guides the compression
rhythm through the Buzzer and provides depth
feedback through the LED. To exit CPR mode, press
and hold the button for 2 seconds. OLED displays
the CPR time and the total number of compression
for 10 seconds and then goes into sleep mode.
Rebooting When charging, press button to reboot.
CPR BAND (Model: CREDO-CB) LED
- The LED of the device operates for
feedback of pressure depth in CPR mode.
- Module has 5 LEDs on each
side, total 10 LEDs.
- The colors of LEDs are Orange, Blue, Blue,
Blue, Orange in order.
- If the compression depth is lower than the
correct range, only the Orange LED at the
bottom blinks.
- If the compression depth is within the correct
range, blue LEDs blink.
- If the compression depth exceeds the correct range, all Blue LEDs and
Orange LED at the top blink.

11
CPR BAND (Model: CREDO-CB)
Battery Charging
- Charge the battery by connecting the cable to the charging port of
the module. Use the enclosed cable. Use a power source certified
by IEC 60950 or IEC 60601-1.
- When charging, the OLED indicates the charging status.
- To reboot and reset, press the button during charging. The set
correct depth, rhythm, and stored CPR data will be initialized
Warning
Use a power source certified by IEC 60950 or IEC 60601-1. The rating
should be output 5V-1A (max 2A).
Do not be posited device to the area where it is difficult to operate
the USB Cable
Battery charging connect the cable

12
CPR BAND (Model: CREDO-CB)
Battery Indicator
The CPR BAND (Model: CREDO-CB) constantly monitors battery power.
Check the battery status regularly by turning on the device. The battery
amount is displayed in the top right corner of the OLED as follows
- Duration based on remaining battery power
Battery amount CPR Mode Duration Sleep Mode Duration
100% 5 hours 40 hours
80% 4 hours 32.5 hours
60% 3 hours 25 hours
40% 2 hours 17.5 hours
20% 1 hours 10 hours
- Low battery
If the low battery icon appears, the
product might turn off during operation.
Please use after charging enough
Warning
Do not interrupt CPR to charge the battery. Continue CPR without
feedback from the CPR BAND (Model: CREDO-CB).
Battery amount indicator
-20% 21%-40% 41%-60% 61%-80% 81%-100%
Low battery

13
CPR BAND (Model: CREDO-CB)
Wearing CPR BAND (Model: CREDO-CB)
When combining the module and the band, the charging port of the
module should be connected to the Band Body Rubber. To separate
the module and the band, press the clip.
how to combine module and band
1. Combine Band and
Module charging port
2. Combine Band and
Module combining
part
3. Wear the band on
wrist
how to separate module and band
1. Press the Band Clip 2. Lift up the module
combining part
3. Remove the module
from the band
Cautions
- The band must be worn properly on the user's wrist. Incorrect
wearing can result in inaccurate function.
- Failure to observe the combining method may damage the band.
- Please note that it may irritate the skin when worn for a long time.

14
CPR BAND (Model: CREDO-CB)
Preparation for use
- The product must be powered on.
- Make sure the patient is on a solid surface.
- Remove the patient's upper garment and reveal the chest.
Caution
- Provide chest compressions according to local CPR protocol.
- Keep your wrist at 90º for correct CPR.
Warning
When performing CPR on a patient lying on a mattress, a backboard
must be used to limit the amount of compressed depth which is
absorbed by the mattress. Depending on characteristics of the
mattress, backboard and patient, the depth compensation does not
guarantee that the patient chest is pressed correctly.
CPR posture
Location of products

15
CPR BAND (Model: CREDO-CB)
CPR Mode
- Press button for 3 seconds in Power on state to enter CPR mode.
- CPR BAND (Model: CREDO-CB) guides the compression rhythm
through the Buzzer and provides depth feedback through the LED.
- When CPR is finished, press button for 2 seconds to exit CPR mode.
- Immediately after quitting CPR mode, OLED displays 'Total number
of compression' and 'CPR Time' for 10 seconds and then turns off.
Rhythm guide
Depth feedback
Total number of compression
CPR time

16
CPR BAND (Model: CREDO-CB)
CPR Mode
1) Compression Depth Feedback
The LED lights according to the correct compression depth set in the
[Setting] tab. The maximum value is 10 cm and the minimum value is 1
cm of the correct compression depth you can set. The factory-set values
of correct range is 4.5 cm ~ 6.0 cm.
* DC: Depth of Compression
* M: Maximum depth of setting
* m: Minimum depth of setting
* A1: m󰇛Mm󰇜

* A2: m󰇛Mm󰇜

Compression Depth
① DC < m Lower 1 orange LED lights up
② m ≤ DC < A1 1 blue LED lights up
③ A1 ≤ DC < A2 2 blue LEDs light up
④ A2 ≤ DC < M 3 blue LEDs light up
⑤ M ≤ DC 3 blue LEDs and upper Orange LED light
up

17
CPR BAND (Model: CREDO-CB)
CPR Mode
2) Compression Rhythm Guide
The CPR BAND (Model: CREDO-CB) guides the chest compression
rhythm through the built-in Buzzer. Compression rhythm (BPM) can
be set in the [Setting] tab of the application according to international
standards. Factory-set is 110BPM.
Caution
•Change the setting according to local CPR protocol and provide
chest compressions.
•There is no the time required for the CPR BAND (Model:
CREDO-CB) to warm from the minimum storage temperature
between uses until the device is ready for its intended use when
the ambient temperature is 20 °C
•There is no the time required for the CPR BAND (Model:
CREDO-CB) to cool from the maximum storage temperature
between uses until the device is ready for its intended use when
the ambient temperature is 20 °C.

18
CPR BAND (Model: CREDO-CB)
How to process CPR data
Data process How to process
Data collection
- Data storage items:
① Total CPR time (CPR mode start~CPR mode stop)
② Compression time (2cm or more compression
start ~ last compression)
③ Each compression max depth / count to the next
max depth
④ Compression angle
- Storage capacity:
128KB / Approximately 120 minutes CPR available
Data release
The data is automatically backed up when
connecting with the application, and the data of the
module is deleted.
Data reset
Data reset function does not exist separately, but
data is automatically backed up when the product is
connected to the application, and the data of the
module is deleted (reset).

19
CPR BAND (Model: CREDO-CB)
Healthcare in CPR BAND (Model: CREDO-CB)
The usual CPR BAND (Model: CREDO-CB) provides time and
healthcare functions. If the button is pressed briefly while the product
is on, the following healthcare functions will appear in sequence on
the OLED. If there is no touch for 4 seconds, it goes to sleep mode.
Time: Indicates the current time.
Walk Steps:
Indicates the number of steps of
the day.
Distance Moved:
Indicates the distance
moved of the day.
Calories Burned:
Indicates the calorie
consumption of the day.
Notes
- In order to use more accurate healthcare functions, please input
your information in application. See 'Setting' on page 22 for more
information.
- In all status, press button for 3 seconds to enter CPR mode.
Frequently of administration Daily
Duration of application Within 24 hours